chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Sep2021 (Lot number: EN3592) as dose 3 (booster), single and intramuscular, administered in arm left, administration date 25Feb2021 (Lot number: EN6200) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Polio", start date: 1950, stop date: 1951, notes: Pertinent details: Chemo & Radiation; "Rectal cancer", start date: 1998 (unspecified if ongoing), notes: Pertinent details: Chemo & Radiation; "Surgery", start date: 2008 (unspecified if ongoing); "Beneign neurofibroma neck", start date: 2008, stop date: 2008; "Right Bundle Branch Block", start date: 2017, stop date: Dec2017. Concomitant medication(s) included: TIMOLOL MALEATE; DILTIAZEM; METOPROLOLSUCCINAAT; DRONEDARONE; ATORVASTATIN; LEVOTHYROXINE; ASPIRINE; ALPRAZOLAM; OMEPRAZOLE; FLUTICASONE PROPIONATE; CIALIS; MAGNESIUM OXIDE; MULTIVITAMIN & MINERAL; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; VITAMIN B COMPLEX; MELATONIN; DIPHENHYDRAMINE HCL. Vaccination history included: Bnt162b2 (Pfizer/BioNTech covid-19 vaccine details:, Dose: 1st, Date: 04Feb2021, Site and route of injection:, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: Lot EN5318), administration date: 04Feb2021, when the patient was 72 years old, for Covid-19 immunization, reaction(s): "Sore arm to the touch". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Feb2021, outcome "recovered" (11Sep2021), described as "sore arm at injection site".  Additional information: The patient did not taken any other vaccine prior or within four weeks. She took concomitant as Vitamins/Supplements Medication: Fish Flaxseed, Borage oil-omega 3,6,9 Dosage: Omega 3 800mg, Omega 6 380mg, Omega 9 300mg with frequency Two daily am. On 26Feb2021 7AM and 10Sep2021 he had experienced sore arm at injection site for 1 day which was recovered.  He did not taken the event initiation of new medication/other treatment/procedure.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Marital problem, Social problem
Clinical narrative: suffered significant undisclosed side effects that have affected his social life and his marital status; suffered significant undisclosed side effects that have affected his social life and his marital status; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOCIAL PROBLEM (non-serious), MARITAL PROBLEM (non-serious), outcome "unknown" and all described as "suffered significant undisclosed side effects that have affected his social life and his marital status".  Additional information included: The report was not related to a study or programme. On 25Jan2022, the Pfizer employee received the voicemail at 13:32 PM and he listened to it at 15:30 PM. Pfizer employee stated that he received a voicemail from someone calling to say, he assumes for Pfizer, that they are having side effects from Comirnaty. There was very little detail in the voicemail and he guessed that the little bit that he does know he had to report. The patient was suffered from adverse events from Comirnaty and that's all that the Pfizer employee knows. The person who left the voicemail stated that he has "suffered significant undisclosed side effects that have affected his social life and his marital status that was the only level of detail.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11May2021 (Lot number: EW0171) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diverticulitis", start date: Jan2021 (ongoing), notes: Verbatim: Diverticulitis; "Retinitis pigmentosa" (ongoing), notes: Verbatim: Retinitis pigmentosa. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 08Apr2021, when the patient was 55 years old, for COVID-19 Immunization, reaction(s): "arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness". Relevant laboratory tests and procedures are available in the appropriate section.   Additional Information: She was first told about her diverticulitis in Jan2021, and she had an issue in her sigmoid area, she had a micro perforation and a small abbess that they had to drain. At that time, Jan2021, she had a fever, a high white blood cell count and pain that was much, much greater. Honestly, if she wouldn't have had the neck and shoulder pain she may have ignored the discomfort in her pelvic area at this time because it felt so minor. But that is what they called it, but she did not have the elevated white blood cells and it didn't seem to be like the infection she had in Jan2021, it was just inflammation that was visible on a CT scan that they did on her pelvis. She says that the only symptoms that she had seemed to be that she was tired for so many hours after the 1st COVID vaccines and then she had a little arm soreness afterwards but nothing else. She confirms these were side effects were felt after her 1st and 2nd dose of the Pfizer COVID vaccine. She got those doses in her right arm and for some reason the pharmacist suggested that she have the booster dose in her left arm, which is a different arm.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Pain
Clinical narrative: body hurts; dizzy; stomach ache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 20 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Jan2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "body hurts"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach ache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 52-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FA6780), at the age of 52, on Jul 22, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient felt fatigue, and vaccination site pain/tenderness at the injection site, onset Jul 2021, with outcome of unknown. No follow-up attempts possible. No further information expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure measurement, Blood test, Chest X-ray, Computerised tomogram head
Clinical narrative: he would say in the morning, he's not positive but not late afternoon; had sore arm.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 02Feb2021 (Lot number: EN6203) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: states he takes Metformin. States his sugar level goes up and down and he goes every 3-6 months. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. The following information was reported: MOOD ALTERED (non-serious) with onset 02Feb2021, outcome "unknown", described as "he would say in the morning, he's not positive but not late afternoon"; PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "had sore arm.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: states he takes Metformin. States his sugar level goes up and down and he goes every 3-6 months and his last was 7.1 before was 6.6. Caller states he has been on Metformin for a couple years No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Mood altered, Pain in extremity
Clinical narrative: he would say in the morning, he's not positive but not late afternoon; had sore arm.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 02Feb2021 (Lot number: EN6203) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: states he takes Metformin. States his sugar level goes up and down and he goes every 3-6 months. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. The following information was reported: MOOD ALTERED (non-serious) with onset 02Feb2021, outcome "unknown", described as "he would say in the morning, he's not positive but not late afternoon"; PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "had sore arm.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: states he takes Metformin. States his sugar level goes up and down and he goes every 3-6 months and his last was 7.1 before was 6.6. Caller states he has been on Metformin for a couple years No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood pressure measurement, Blood test, Chest X-ray, Computerised tomogram
Clinical narrative: Dose #1 Pfizer Covid 19 vaccine on 2Feb2021 Dose #2 Pfizer Covid 19 vaccine on 21Mar2021; Sick; Bed achy; Sweaty; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 21Mar2021 (Lot number: ER8727) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: he takes Metformin. States his sugar level goes up and down and he goes every 3-6 months. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing). Vaccination history included: Bnt162b2 (dose 1 single, lot number: EN6203, Anatomical Location: arm), administration date: 02Feb2021, when the patient was 61 years old, for COVID-19 immunization, reaction(s): "he's not positive but not late afternoon", "sore arm". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Mar2021, outcome "unknown", described as "Dose #1 Pfizer Covid 19 vaccine on 2Feb2021 Dose #2 Pfizer Covid 19 vaccine on 21Mar2021"; ILLNESS (non-serious) with onset 21Mar2021, outcome "recovered" (22Mar2021), described as "Sick"; PAIN (non-serious) with onset 21Mar2021, outcome "recovered" (22Mar2021), described as "Bed achy"; HYPERHIDROSIS (non-serious) with onset 21Mar2021, outcome "recovered" (22Mar2021), described as "Sweaty". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: The patient received Pfizer Covid 19 vaccine dose 2, on 21Mar2021 in his arm, does not recall which one, in the morning or early afternoon but not late afternoon. Stated  that was a hour and a half wait, that was a bitch, there was a computer glitch that happened. lot ER8727 Caller does not have NDC or expiry to provide.  Caller stated that, 2nd dose he was sick for about 24 hours in bed achy and sweaty. States his wife said suck it up it's only the vaccine and you will be better, there is nothing wrong with you you'll be ok. States he was better the next day, he was fine running around. No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Hyperhidrosis, Illness, Inappropriate schedule of product administration, Pain
Clinical narrative: Dose #1 Pfizer Covid 19 vaccine on 2Feb2021 Dose #2 Pfizer Covid 19 vaccine on 21Mar2021; Sick; Bed achy; Sweaty; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 21Mar2021 (Lot number: ER8727) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: he takes Metformin. States his sugar level goes up and down and he goes every 3-6 months. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing). Vaccination history included: Bnt162b2 (dose 1 single, lot number: EN6203, Anatomical Location: arm), administration date: 02Feb2021, when the patient was 61 years old, for COVID-19 immunization, reaction(s): "he's not positive but not late afternoon", "sore arm". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Mar2021, outcome "unknown", described as "Dose #1 Pfizer Covid 19 vaccine on 2Feb2021 Dose #2 Pfizer Covid 19 vaccine on 21Mar2021"; ILLNESS (non-serious) with onset 21Mar2021, outcome "recovered" (22Mar2021), described as "Sick"; PAIN (non-serious) with onset 21Mar2021, outcome "recovered" (22Mar2021), described as "Bed achy"; HYPERHIDROSIS (non-serious) with onset 21Mar2021, outcome "recovered" (22Mar2021), described as "Sweaty". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: The patient received Pfizer Covid 19 vaccine dose 2, on 21Mar2021 in his arm, does not recall which one, in the morning or early afternoon but not late afternoon. Stated  that was a hour and a half wait, that was a bitch, there was a computer glitch that happened. lot ER8727 Caller does not have NDC or expiry to provide.  Caller stated that, 2nd dose he was sick for about 24 hours in bed achy and sweaty. States his wife said suck it up it's only the vaccine and you will be better, there is nothing wrong with you you'll be ok. States he was better the next day, he was fine running around. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (parent). A 15-year-old male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had an unexpected therapeutic response (toenail fungus started to improve after the vaccine), with outcome of unknown. Additional information: 15-year old son had the Pfizer COVID-19 vaccines. His toenail fungus started to improve. Expiry date of COVID-19 vaccine: Not provided. Other products: Not provided. Investigation assessment: Not provided. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: My daughter's lymph/ under arm got really swollen for about 4 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jan2022 12:00 (Lot number: FL0007) at the age of 7 years as dose 2 (tris), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1 single, Batch/Lot No: Fk5127, Location of injection: Left Arm, Vaccine Administration Time: 04:00 PM), administration date: 29Dec2021, when the patient was 7 years old, for Covid-19 Immunization.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 20Jan2022, outcome "recovered" (Jan2022), described as "My daughter's lymph/ under arm got really swollen for about 4 days". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Loss of personal independence in daily activities, Tinnitus
Clinical narrative: Dose 1:administration date Mar/2021, Dose 2: administration date May/2021; I developed Tinnitus; It is very loud at times and effects my daily life; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date May2021 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. , Does Administration date: Mar2021, Dose Administration time: 12:00 PM, Vaccine location: Left arm), administration date: Mar2021, when the patient was 63 years old, for COVID-19 Immunization.The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset May2021, outcome "unknown", described as "Dose 1:administration date Mar/2021, Dose 2: administration date May/2021"; TINNITUS (non-serious) with onset May2021, outcome "not recovered", described as "I developed Tinnitus"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset May2021, outcome "not recovered", described as "It is very loud at times and effects my daily life". The events "i developed tinnitus" and "it is very loud at times and effects my daily life" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus, loss of personal independence in daily activities.  Additional information: patient did not infected with covid-19 prior and not tested post vaccination. Known allergies: No. it was reported that Within a few days of receiving the second vaccine I developed Tinnitus. It is very loud at times and effects my daily life. No other vaccine in four weeks. No other medications in two weeks: No  It was reported that the Pfizer product had no casual effect to adverse event(s).  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: Joint pain; Decrease in appetite; Weight loss; Feeling mentally foggy; Low on energy; Nauseous; Lightheadedness; Diarrhea; Stiffness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4407934.  A 74 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Idiopathic pulmonary fibrosis" (ongoing), notes: Patient's concurrent condition included: Idiopathic pulmonary fibrosis. Concomitant medication(s) included: ESBRIET taken for idiopathic pulmonary fibrosis. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Decrease in appetite"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Weight loss"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling mentally foggy"; ASTHENIA (non-serious), outcome "unknown", described as "Low on energy"; NAUSEA (non-serious), outcome "unknown", described as "Nauseous"; DIZZINESS (non-serious), outcome "unknown", described as "Lightheadedness"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Stiffness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient's past medical history was not reported. And reported that, we have no further information regarding the reported event(s) described above. Any additional material information received will be forwarded to you in accordance with withheld policies and procedures.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Musculoskeletal stiffness, Nausea, Weight, Weight decreased
Clinical narrative: Joint pain; Decrease in appetite; Weight loss; Feeling mentally foggy; Low on energy; Nauseous; Lightheadedness; Diarrhea; Stiffness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4407934.  A 74 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Idiopathic pulmonary fibrosis" (ongoing), notes: Patient's concurrent condition included: Idiopathic pulmonary fibrosis. Concomitant medication(s) included: ESBRIET taken for idiopathic pulmonary fibrosis. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Decrease in appetite"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Weight loss"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling mentally foggy"; ASTHENIA (non-serious), outcome "unknown", described as "Low on energy"; NAUSEA (non-serious), outcome "unknown", described as "Nauseous"; DIZZINESS (non-serious), outcome "unknown", described as "Lightheadedness"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Stiffness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient's past medical history was not reported. And reported that, we have no further information regarding the reported event(s) described above. Any additional material information received will be forwarded to you in accordance with withheld policies and procedures.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Herpes zoster, SARS-CoV-2 test
Clinical narrative: blisters appear on my buttocks/diagnosed as having shingles; blisters appear on my buttocks/diagnosed as having shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20May2021 (Batch/Lot number: unknown) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Psoriasis" (unspecified if ongoing); "hx of shingles" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE HCL. Past drug history included: Biaxin; Penicillin; Codeine intollerance. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 20Apr2021, when the patient was 37 years old, for COVID-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 21May2021, outcome "recovered", described as "blisters appear on my buttocks/diagnosed as having shingles". The event "blisters appear on my buttocks/diagnosed as having shingles" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of herpes zoster.   Additional information: Patient reported that within 24 hours of completing her second vaccine patient had blisters appear on her buttocks. After contacting a doctor and having a doctor examine them,  was diagnosed as having shingles. Patient received treatment with Valtrez. Patient did not have covid prior to vaccination. Patient tested for covid after vaccination. Patient had also received booster dose on 12Jan2022 (14:00) as dose 3 (booster), single.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: my arm was heavy and painful to lift/my husband had it too; my arm was heavy and painful to lift/my husband had it too; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, single and intramuscular (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), LIMB DISCOMFORT (non-serious), outcome "unknown" and all described as "my arm was heavy and painful to lift/my husband had it too". Additional information: Caller received the Pfizer Covid 19 Vaccine booster dose and has a swollen arm pit, and it was painful. On Wednesday, 09Feb2022, caller got the booster dose and the next day her armpit was swollen and painful. She got it on the left-hand side, the injection site was tender but under her armpit was painful. After she got the first and second dose and she did not have this, but her arm was heavy and painful to lift, which she knows others experience that too, her husband had it too after the first and second dose. Response: Spoke from attached Pain at injection site, muscle pain and joint pain were reported. As well as swollen lymph nodes which may be found under arm pit. Persons 18 Years and Older: Local reactions lasted between 1 and 2 days and systemic reactions lasted around 1 day. Swollen lymph nodes (lymphadenopathy) were also reported and generally resolved within 10 days.   Follow-up attempts completed. No further information is expected.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Biopsy, Therapeutic response unexpected
Clinical narrative: it has calmed down considerably/the lichen planus has not flared up since/ it started clearing up and has improved ever since; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 69 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Mar2021 14:30 (Lot number: ER2613) at the age of 69 years as dose 1, single, intramuscular, administered in arm left, administration date 13Apr2021 13:30 (Lot number: EW0158) as dose 2, single and intramuscular, administered in arm right, administration date 23Nov2021 14:00 (Lot number: FH8028) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Lichen Planus" (unspecified if ongoing); "Weakened immune system" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "recovering", described as "it has calmed down considerably/the lichen planus has not flared up since/ it started clearing up and has improved ever since". Relevant laboratory tests and procedures are available in the appropriate section. Additional information  The patient had no adverse reaction but wanted you to know for research that it has slowed  immune system down from turning on itself. The patient hope that in future this can help others with autoimmune disease, feel free to contact  for a better explanation.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vertigo
Clinical narrative: sick; vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 75 year-old female patient received bnt162b2 (COMIRNATY), administration date 31Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (ongoing), notes: she has a lot of other health problems., Onset Date: Approx 2015, Stop Date: Ongoing , Pertinent Details: L2 L3 hemicolectomy 8-19; "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: LEFLUNOMIDE taken for rheumatoid arthritis (ongoing); PRAVASTATIN (ongoing); AMITRIPTYLINE (ongoing). The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; VERTIGO (non-serious), outcome "unknown", described as "vertigo".   Additional information: She suffered from vertigo and got sick even when she puts on her eyeglasses. She did not indicate whether these health issues began before or after getting Comirnaty. Use of medications that suppress the immune system (e.g., high-dose of corticosteroids, cyclosporine, methotrexate, azathioprine, and biologic therapies like rituximab and etanercept). she wanted to get a fourth dose of the vaccine, but she heard there may be another formulation coming out in Mar2022 that specifically targets the Omicron variant. Caller asked if this was true and if the vaccine had a specific lot number that she can ask about at the pharmacy or doctor's office when she goes to get the shot. Vaccine was not administered at military Facility. There was no prior vaccinations within four weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: temperature excursion; received Comirnaty (orange cap) vaccines after the "excursion."; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown", described as "temperature excursion"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "received Comirnaty (orange cap) vaccines after the "excursion."  Additional information: Physician Assistant calling to report a temperature excursion for Comirnaty (orange cap and gray cap) and stated all product was being stored under refrigeration and experienced a first time temperature excursion lasting 2 hours, 54 minutes and reaching a maximum temperature of 49.1 F. Seven children received Comirnaty (orange cap) vaccines after the "excursion."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: This is a spontaneous report received from a contactable pharmacist. A female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st and the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown) for immunization. The patient had pruritus (developed severe skin itchiness since taking the Pfizer booster August 2021), onset Aug 2021, with outcome of unknown. Additional information: Their HCP tried to prescribe medication that would help them with skin irritation. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). Other case identifier: NVSC2022US033954_NS. A 62-year-old male patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 62, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the COVID-19 vaccine (primary series immunization completed, manufacturer unknown), for immunisation. The patient developed illness (sickness for a couple of weeks), with outcome of recovered. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Hair texture abnormal, Trichorrhexis
Clinical narrative: Since I have gotten it, I have had massive hair loss; Hair has become very dry and brittle; Hair has become very dry and brittle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 37 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 05May2021 (Lot number: ER8735) at the age of 37 years as dose 2, single and intramuscular, administered in arm, administration date 14Apr2021 (Lot number: EP7534) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "not recovered", described as "Since I have gotten it, I have had massive hair loss"; HAIR TEXTURE ABNORMAL (non-serious), TRICHORRHEXIS (non-serious) all with onset 2021, outcome "not recovered" and all described as "Hair has become very dry and brittle". Therapeutic measures were not taken as a result of alopecia. Therapeutic measures were taken as a result of hair texture abnormal, trichorrhexis.  Additional Information: Vaccination facility type was reported as Doctor's Office/Urgent care. Prior vaccination (before 4 weeks) was reported as no. Anatomical site of injection for both doses of vaccine was reported as upper arm. Consumer stated, "I just wanted to report a adverse effect from the vaccine. Since I have gotten it, I have had massive hair loss. I have experience extreme hair loss 4-5 months and continuing after have both my covid shots. What can I do to fix this. My hair has become very dry and brittle no matter what I put in it. It's not helping." Investigation assessment was reported as no. Relevant tests were reported as None. Specific relevant test for thromboembolic events with thrombocytopenia was reported as None.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pain
Clinical narrative: My arm of injection is very sore; my arm pit is visibly swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Feb2022 15:30 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing), notes: sulfa drugs. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), administration date: 11Aug2021, when the patient was 45 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), administration date: 19Jul2021, when the patient was 45 years old, for COVID-19 immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Feb2022 19:00, outcome "not recovered", described as "My arm of injection is very sore"; SWELLING (non-serious) with onset 15Feb2022 19:00, outcome "not recovered", described as "my arm pit is visibly swollen". It was unknown if therapeutic measures were taken as a result of vaccination site pain, swelling.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. No Hospitalization Prolongation. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Broke out in a rash on my neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 10Feb2022 (Lot number: FL3198) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 12Feb2022, outcome "unknown", described as "Broke out in a rash on my neck".  Additional information:Consumer stated, "On her neck. She want to know if the vaccine was not kept cold enough (Further clarification unknown) could that cause a reaction? Phone Out 1:43PM, 1st attempt by phone to consumer to obtain mailing information. Phone answered by consumer who provided mailing address and stated she has been experiencing 'other things'.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program. A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient's platelet count decreased (platelet count is 17/1000), with outcome of unknown. Relevant laboratory tests and procedures available in the appropriate section. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Eyelid sensory disorder, Hypoaesthesia, Hypoaesthesia oral, Pain in extremity
Clinical narrative: experienced numbness on the right side of the face which started from the eyelid up to the forehead and moving up the scalp; pinch her hair and scalp but she doesn't feel anything, not even any pain; arm is hurting; feeling really weak; numbness initially started in her eyelid up until her forehead, but now the numbness is going up until her scalp; feel numbness in her lip as well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Feb2022 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "experienced numbness on the right side of the face which started from the eyelid up to the forehead and moving up the scalp"; SENSORY LOSS (non-serious), outcome "unknown", described as "pinch her hair and scalp but she doesn't feel anything, not even any pain"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm is hurting"; ASTHENIA (non-serious), outcome "unknown", described as "feeling really weak"; EYELID SENSORY DISORDER (non-serious), outcome "unknown", described as "numbness initially started in her eyelid up until her forehead, but now the numbness is going up until her scalp"; HYPOAESTHESIA ORAL (non-serious), outcome "unknown", described as "feel numbness in her lip as well".  Additional information: It was reported that, she received the second dose of the Pfizer BioNTech COVID-19 vaccine last night and experienced numbness on the right side of the face which started from the eyelid up to the forehead and moving up the scalp. she tried to pinch her hair and scalp but she does not feel anything, not even any pain. her husband stated that, arm is hurting, that is normal, and that caller does not feel like she was vomiting. Upon follow-up (16Feb2022) Updated Information Include: Reporter Information (true reporter), Historical vaccine, biological product, vaccine facility information. She took the COVID-19 shot. She explains she got the second shot last night. She woke up feeling really weak, sore arm and she understands that is normal. She has numbness in her face, clarified as the right side of face. The numbness initially started in her eyelid up until her forehead, but now the numbness is going up until her scalp. She can pinch her hair on her scalp and she doesn't feel any pain. She is starting to feel numbness in her lip as well.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Sensory loss
Clinical narrative: experienced numbness on the right side of the face which started from the eyelid up to the forehead and moving up the scalp; pinch her hair and scalp but she doesn't feel anything, not even any pain; arm is hurting; feeling really weak; numbness initially started in her eyelid up until her forehead, but now the numbness is going up until her scalp; feel numbness in her lip as well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Feb2022 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "experienced numbness on the right side of the face which started from the eyelid up to the forehead and moving up the scalp"; SENSORY LOSS (non-serious), outcome "unknown", described as "pinch her hair and scalp but she doesn't feel anything, not even any pain"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm is hurting"; ASTHENIA (non-serious), outcome "unknown", described as "feeling really weak"; EYELID SENSORY DISORDER (non-serious), outcome "unknown", described as "numbness initially started in her eyelid up until her forehead, but now the numbness is going up until her scalp"; HYPOAESTHESIA ORAL (non-serious), outcome "unknown", described as "feel numbness in her lip as well".  Additional information: It was reported that, she received the second dose of the Pfizer BioNTech COVID-19 vaccine last night and experienced numbness on the right side of the face which started from the eyelid up to the forehead and moving up the scalp. she tried to pinch her hair and scalp but she does not feel anything, not even any pain. her husband stated that, arm is hurting, that is normal, and that caller does not feel like she was vomiting. Upon follow-up (16Feb2022) Updated Information Include: Reporter Information (true reporter), Historical vaccine, biological product, vaccine facility information. She took the COVID-19 shot. She explains she got the second shot last night. She woke up feeling really weak, sore arm and she understands that is normal. She has numbness in her face, clarified as the right side of face. The numbness initially started in her eyelid up until her forehead, but now the numbness is going up until her scalp. She can pinch her hair on her scalp and she doesn't feel any pain. She is starting to feel numbness in her lip as well.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Those of us who have had the vaccines know about a sore arm and fatigue, but his is worse.; Those of us who have had the vaccines know about a sore arm and fatigue, but his is worse.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "blood cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "Those of us who have had the vaccines know about a sore arm and fatigue, but his is worse.". Additional information: Reporter's friend has blood cancer and had 4th dose (booster for immunocompromised) of the PBCV on Monday, 14Feb2022, following "an infusion of some kind on Friday, 11Feb2022. Since receiving the booster dose, he was extremely fatigued, had a very sore arm at the injection site and and "he was so weak his wife had to pick him up and put him into bed" Is this part of the normal side effects. Have you had other reports of immunocompromised patients having these symptoms. Should they be seeking out other treatment or is this normal. Those of us who have had the vaccines know about a sore arm and fatigue, but his was worse.   The lot number for bnt162b2 was not provided and will be requested during follow up.