chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Influenza like illness, Lymph node pain, Nasopharyngitis
Clinical narrative: Felt crummy; Sore, my lymph node; Slight headache; Like I was coming down with the cold or flu or something; Like I was coming down with the cold or flu or something; 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) (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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt crummy"; LYMPH NODE PAIN (non-serious), outcome "unknown", described as "Sore, my lymph node"; HEADACHE (non-serious), outcome "unknown", described as "Slight headache"; NASOPHARYNGITIS (non-serious), INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown" and all described as "Like I was coming down with the cold or flu or something".  Additional information: This was the second case out of 2 cases in which reporter was reporting for herself. Consumer stated that she had some really sharp abdominal pain, she had her shot (Shot name not clarified, hence suspect captured as Unspecified Shot and is this a Pfizer product tab left unchecked), and felt crummy but it was like sore, her lymph node, like a slight headache, like she was coming down with the cold or flu or something but she said she had got really sharp pain in her stomach.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Illness, Lymphadenopathy
Clinical narrative: my second shot I got fairly sick; with the second shot my lymph nodes have swollen in my armpit to the point I feel like they are too warm under my armpits.; with the second shot my lymph nodes have swollen in my armpit to the point I feel like they are too warm under my armpits.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: ILLNESS (non-serious), outcome "unknown", described as "my second shot I got fairly sick"; LYMPHADENOPATHY (non-serious), FEELING HOT (non-serious), outcome "unknown" and all described as "with the second shot my lymph nodes have swollen in my armpit to the point I feel like they are too warm under my armpits.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: chills; fever; nausea; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache".  Additional information:  The patient stated that she was over 65-year-old and has received both doses of the Pfizer COVID-19 vaccine as well as the booster dose last Thursday and she has not felt any of the symptoms like she did after receiving the first two doses. She stated after the Second dose in April, she "really got hit with it" She stated, she had chills, fever, nausea, headache and she was wondering why she has not had much of a reaction this time other than a sore arm and she has been waiting for it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gait disturbance
Clinical narrative: chills; extreme exhaustion; it took a substantial amount of effort to walk from the bedroom to the kitchen; 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 59 year-old female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "extreme exhaustion"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "it took a substantial amount of effort to walk from the bedroom to the kitchen".  Additional information: Patient stated that she had experienced chills after both her initial doses of the Pfizer COVID-19 Vaccine, as well as the booster shot. She also stated that she had experienced "extreme exhaustion" for about a week after each shot, stating that it took a substantial amount of effort to walk from the bedroom to the kitchen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiolipin antibody, Cardiolipin antibody positive, Pain in extremity
Clinical narrative: her cardiolipin antibodies tested on 05Mar2021 and she had a 40 result; her Cardiolipin level was about 40, AbigM.; sore arm; 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 (159558). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date 08Feb2021 (Batch/Lot number: unknown) at the age of 79 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "positive cardiolipin antibodies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1,Single, Manufacturer unknown), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm"; CARDIOLIPIN ANTIBODY (non-serious) with onset 08Feb2021, outcome "unknown", described as "her Cardiolipin level was about 40, AbigM."; CARDIOLIPIN ANTIBODY POSITIVE (non-serious) with onset 05Mar2021, outcome "unknown", described as "her cardiolipin antibodies tested on 05Mar2021 and she had a 40 result". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She got her booster dose of Pfizer Biontech COVID-19 vaccine on 22Sep2021. After the booster dose, she got tested again on 27Oct2021 and got a level of 102.1 which she refers to as "quite high". Her physician told her not to worry. Asks if there are any reports of a rise in cardiolipin antibodies caused by the vaccine. She called to report that her cardiolipin antibodies went up after the COVID booster higher than normal. She was taking blood test after the second dose, and booster dose. After the booster dose, her cardiolipin went up high. She also mentioned a sore arm. She didn't really say when she got the sore arm. She said it was a minimal condition. The caller confirmed some of the details provided by the transferring agent. This didn't occur after the second COVID dose. Her cardiolipin IgM levels 102.1. Which was quite high. It was a little higher which was concerning to her. She knows cardiolipins can be a problem with blood clotting. Caller declined health care provider information. She must leave at a quarter to two. She doesn't have time to do this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Exercise electrocardiogram, Fatigue, Full blood count, Investigation
Clinical narrative: sore arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 24Jan2021 13:00 (Lot number: EL3247) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Onset date : years ago, Stop date: Ongoing; "Fibromyalgia" (ongoing), notes: Onset date : years ago, Stop date: Ongoing; "Hypothyroid" (ongoing), notes: Onset date : years ago, Stop date: Ongoing; "Obesity" (ongoing), notes: Onset date : years ago, Stop date: Ongoing; "Multiple sclerosis" (unspecified if ongoing), notes: Family medical history relevant to ae to sister; "Kidney failure" (unspecified if ongoing), notes: Family medical history relevant to ae to sister; "Stroke" (unspecified if ongoing), notes: Family medical history relevant to ae to mother; "Asthma" (unspecified if ongoing), notes: Family medical history relevant to ae to mother; "Congestive Heart failure" (unspecified if ongoing), notes: Family medical history relevant to ae to father; "Kidney disease" (unspecified if ongoing), notes: Family medical history relevant to ae to father; "Alcoholism" (unspecified if ongoing), notes: Family medical history relevant to ae to father; "Type 2 Diabetes" (unspecified if ongoing), notes: Family medical history relevant to ae to father. Concomitant medication(s) included: DULOXETINE taken for fibromyalgia (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); NALTREXONE taken for fibromyalgia (ongoing); BREO ELLIPTA taken for asthma (ongoing); DEXAMETHAZONE, start date: 29Aug2021; ALBUTEROL [SALBUTAMOL SULFATE] taken for dyspnoea, start date: 29Aug2021; MONOCLONAL, ANTIBODIES taken for covid-19, start date: 01Sep2021. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Jan2021, outcome "unknown", described as "sore arm"; FATIGUE (non-serious) with onset 24Jan2021, outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical course: Dose: 2nd :Date: 14Feb2021:Time: 13:00:Site and Route of injection:Anatomical Site of injection: L Arm:Route of administration: Intramuscular Batch/Lot Number: EL9263:On 14Feb2021: Covid Vaccine: Fever, Chills, fatigue, Headache, Nausea (Few hours):27Aug2021: Covid Test: Pos: Fever, Chest Congestion etc. basically every covid symptom except covid es and rash:It took about 3 weeks to recover and over a month to fully recover with lingering Fatigue  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: sore arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 24Jan2021 13:00 (Lot number: EL3247) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Onset date : years ago, Stop date: Ongoing; "Fibromyalgia" (ongoing), notes: Onset date : years ago, Stop date: Ongoing; "Hypothyroid" (ongoing), notes: Onset date : years ago, Stop date: Ongoing; "Obesity" (ongoing), notes: Onset date : years ago, Stop date: Ongoing; "Multiple sclerosis" (unspecified if ongoing), notes: Family medical history relevant to ae to sister; "Kidney failure" (unspecified if ongoing), notes: Family medical history relevant to ae to sister; "Stroke" (unspecified if ongoing), notes: Family medical history relevant to ae to mother; "Asthma" (unspecified if ongoing), notes: Family medical history relevant to ae to mother; "Congestive Heart failure" (unspecified if ongoing), notes: Family medical history relevant to ae to father; "Kidney disease" (unspecified if ongoing), notes: Family medical history relevant to ae to father; "Alcoholism" (unspecified if ongoing), notes: Family medical history relevant to ae to father; "Type 2 Diabetes" (unspecified if ongoing), notes: Family medical history relevant to ae to father. Concomitant medication(s) included: DULOXETINE taken for fibromyalgia (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); NALTREXONE taken for fibromyalgia (ongoing); BREO ELLIPTA taken for asthma (ongoing); DEXAMETHAZONE, start date: 29Aug2021; ALBUTEROL [SALBUTAMOL SULFATE] taken for dyspnoea, start date: 29Aug2021; MONOCLONAL, ANTIBODIES taken for covid-19, start date: 01Sep2021. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Jan2021, outcome "unknown", described as "sore arm"; FATIGUE (non-serious) with onset 24Jan2021, outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical course: Dose: 2nd :Date: 14Feb2021:Time: 13:00:Site and Route of injection:Anatomical Site of injection: L Arm:Route of administration: Intramuscular Batch/Lot Number: EL9263:On 14Feb2021: Covid Vaccine: Fever, Chills, fatigue, Headache, Nausea (Few hours):27Aug2021: Covid Test: Pos: Fever, Chest Congestion etc. basically every covid symptom except covid es and rash:It took about 3 weeks to recover and over a month to fully recover with lingering Fatigue  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort, Movement disorder, Pain in extremity, Peripheral swelling
Clinical narrative: I had the second vaccine in April and still have a bump on my arm and so hard to move it, very painful.; I had the second vaccine in April and still have a bump on my arm and so hard to move it, very painful.; I had the second vaccine in April and still have a bump on my arm and so hard to move it, very painful.; swollen for 3 weeks after second; 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 59 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Apr2021 (Lot number: ER18735) as dose 2, single and administration date 04Nov2021 (Lot number: FH8030) as dose 3 (booster), 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, Lot number: EN6204, Anatomical site : Intramuscular, Route of administration: Left arm), administration date: 14Mar2021, for COVID-19 Immunization. The following information was reported: LIMB DISCOMFORT (non-serious), MOVEMENT DISORDER (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2021, outcome "not recovered" and all described as "I had the second vaccine in April and still have a bump on my arm and so hard to move it, very painful."; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "swollen for 3 weeks after second".  Additional information: Very healthy women 59 years at time of vaccine. It was so swollen for 3 weeks after second. Then she hasn't had full mobility in left arm since. When she has check-up in July her doctor said people get covid arm, but this was ridiculously painful. Can't hook her bra or so certain stretches/ exercises. She was on zero medications.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: tender lymph node underarm; swollen lymph node underarm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPH NODE PAIN (non-serious), outcome "unknown", described as "tender lymph node underarm"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph node underarm".  Additional Information: Description of Event: 34yr, female, experienced swollen/tender lymph node underarm. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly
Clinical narrative: diagnosed with an enlarged heart; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (Dose:1), administration date: 13Mar2021, for COVID-19 Immunization. The following information was reported: CARDIOMEGALY (non-serious) with onset 14Oct2021, outcome "unknown", described as "diagnosed with an enlarged heart". Additional information: The patient mentioned that she took her first dose of the vaccine last 13Mar2021 and her second dose on 3Apr2021, her booster dose last 17Dec2021. She also mentioned that she was diagnosed with an enlarged heart on 14Oct2021, for which she blamed Pfizer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left arm sore within 12 hours of each dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Mar2021 (Lot number: ENS318) as dose 1, single and intramuscular, administered in arm left, administration date 23Mar2021 (Lot number: ENS318) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered", described as "Left arm sore within 12 hours of each dose". Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: The patient also received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Dec2021 02:00 PM, (Lot number: FF2S89) as dose 3, single for covid-19 immunisation. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. Adverse events: Left arm sore within 12 hours of each dose. Experienced Headache and exhaustion, felt nauseated, shortness of breath. The patient was not affected by covid prior vaccination and was not tested with covid post vaccination. No Known allergies. The other medical history was Asthma.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Menstrual disorder
Clinical narrative: My period stopped for 78 days; hot flashes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: ER8734) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 19Apr2021, outcome "recovered" (2021), described as "My period stopped for 78 days"; HOT FLUSH (non-serious) with onset 19Apr2021, outcome "recovered" (2021), described as "hot flashes". Therapeutic measures were not taken as a result of menstrual disorder, hot flush.  Additional information: No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: menstruating; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Apr2021 14:15 (Lot number: ER8734) at the age of 40 years as dose 1, single and administered in arm right, administration date 23Apr2021 14:15 (Lot number: EW0164) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Idiopathic Thrombocytopenia Purpura" (unspecified if ongoing), notes: Idiopathic; "acid reflux" (unspecified if ongoing); "osteopenia" (unspecified if ongoing). Concomitant medication(s) included: TRI-SPRINTEC; MOMETASONE FUROATE; FLORAJEN. Past drug history included: Neomycin, reaction(s): "Allergy:Neomycin", notes: known allergies: Neomyacin; Tetracain, reaction(s): "Allergy:tetracain", notes: known allergies: tetracain. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "menstruating". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included vitamin. She experienced heavy menstruation for 3 weeks after the booster shot. Since she was already menstruating for several days prior to getting the shot, the menstruation ended up lasting for 4 weeks straight. Below she answered unknown to the question regarding if she have recovered because she don't know if next month's period will be affected, but bleeding has stopped as of earlier this week. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device Date: 22Dec2021.  No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Motion sickness, Vomiting
Clinical narrative: Could have been car sickness, though; Vomited; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 15:45 (Lot number: FK5127) at the age of 11 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MOTION SICKNESS (non-serious) with onset 21Dec2021 16:45, outcome "recovered", described as "Could have been car sickness, though"; VOMITING (non-serious) with onset 21Dec2021 16:45, outcome "recovered", described as "Vomited". Therapeutic measures were not taken as a result of motion sickness, vomiting.  Additional information: No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination: No Known allergies. Vomited 1hour post vaccination. Could have been car sickness, though.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Chills; fatigue; Muscle aches; Sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 05Mar2021 09:00 (Lot number: EN6199) at the age of 48 years as dose 2, single and intramuscular, administered in arm left, administration date 11Feb2021 09:00 (Lot number: EN6201) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Environmental allergies" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA taken for hypersensitivity (ongoing). The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "fatigue"; MYALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Muscle aches"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sore throat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported that she was healthy. Patient received Dose 3 (Batch/Lot number: EW0176), on 30Nov2021 at 4PM, Anatomical site of injection: Left Arm, Route of Administration: Intramuscular. Vaccination facility type: Health clinic/Veterans administration facility. With vaccine 1,2,3 (booster) she had similar symptoms of chills, fatigue, muscle aches and sore throat that lasted 24 hours. With the booster shot she also had wheezing, swollen lips, swollen tongue, soreness and bumpiness of the inside of the cheeks. This lasted about 8 hours. She took Allegra. Prior vaccinations and specific Relevant Test for Thromboembolic Events with Thrombocytopenia was reported as none. She do not have any filler in her lips but 5 years ago she had filler put in around the lips in the smile lines.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: immune response; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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: Bnt162b2 (dose 1), for COVID-19 immunization. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "immune response".  Additional information: Caller had both doses of the vaccine. She was planning to get the booster dose in January next year, 8 months after her second dose of the vaccine. She mentioned as well after getting the second dose she had an immune response. She was not up to date on a new variant Omicron. She wanted to know the efficacy of the booster dose to the new variant Omicron and what would be the difference of getting the booster for 8 months after the second dose instead of 6 months.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: big sore neck; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: NECK PAIN (non-serious), outcome "unknown", described as "big sore neck".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 31 year-old male patient received bnt162b2 (BNT162B2), administration date 21Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Dec2021, outcome "unknown", described as "Patient experiencing lymphadenopathy after Covid booster". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: Now I have a rare overactive immune system; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Now I have a rare overactive immune system".  Additional information: Nothing is wrong with me, but I just would like to donate my blood for one of your Covid-19 studies. I heard that you may need it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: Dizzy; Weak; Tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4509846.  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date 17Dec2021 (Batch/Lot number: unknown) at the age of 68 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Primary-Progressive Multiple Sclerosis" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS; BACLOFEN; CYMBALTA. Vaccination history included: Covid-19 vaccine (Unknown manufacturer.), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Dizzy"; ASTHENIA (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Weak"; FATIGUE (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Tired". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: The patient has been in a fatigue since the vaccination.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date 20Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 20Dec2021, outcome "recovering", described as "The patient has been in a fatigue since the vaccination.". It was unknown if therapeutic measures were taken as a result of fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Hair texture abnormal, SARS-CoV-2 test
Clinical narrative: Since the vaccines I lost 2/3 of my hair; Within a week my hair texture changed dramatically. It went from soft, not oily or dry and curly to dry and straw like.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jul2021 (Lot number: EW0181) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Complex Regional Pain" (unspecified if ongoing); "Tarsal Tunnel" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Benadryl, reaction(s): "Allergy: Benadryl", notes: known allergies: Benadryl and Voltarin; Voltarin, reaction(s): "Allergy:Voltarin", notes: known allergies: Benadryl and Voltarin. The following information was reported: ALOPECIA (non-serious) with onset 16Jul2021, outcome "not recovered", described as "Since the vaccines I lost 2/3 of my hair"; HAIR TEXTURE ABNORMAL (non-serious) with onset 16Jul2021, outcome "not recovered", described as "Within a week my hair texture changed dramatically. It went from soft, not oily or dry and curly to dry and straw like.". The events "since the vaccines i lost 2/3 of my hair" and "within a week my hair texture changed dramatically. it went from soft, not oily or dry and curly to dry and straw like." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of alopecia, hair texture abnormal.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient received subsequent dose 2 on 30Jul2021( LOT number :EW0198) left arm for covid-19 immunization   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: Dose number 1: 03Mar2021/ Dose number 2: 15Apr2021; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Apr2021 10:00 (Lot number: EW0162) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE,Lot Number: ER8730, Administration Time: 10:00, Anatomical Location: Left arm), administration date: 25Mar2021, when the patient was 61 years old, for COVID-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Dose number 1: 03Mar2021/ Dose number 2: 15Apr2021"; FATIGUE (non-serious), outcome "recovered", described as "Fatigue". Additional information:The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. After dose 2 Some fatigue a couple hours after the vaccine .This passed in a few hours No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101826755 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 18Dec2021 (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: FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "Fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Migraine
Clinical narrative: Weird "zaps" In head; Headaches every day; Migraines; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 17:30 (Lot number: FJ8757) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Autoimmune overlap Disease: Hashimotos" (unspecified if ongoing); "Autoimmune overlap disease: Apls" (unspecified if ongoing); "Autoimmune overlap disease: Sjogrens" (unspecified if ongoing); "Known allergies: shell fish" (unspecified if ongoing); "known allergy: Bee stings" (unspecified if ongoing); "Known allergy: Iodine" (unspecified if ongoing), notes: Known allergy: Iodine. Concomitant medication(s) included: SYNTHROID. Past drug history included: Plaquenil, reaction(s): "Known allergy: Plaquenil", notes: Known allergy: Plaquenil. Vaccination history included: Bnt162b2 (previous dose product=COVID 19, brand: Pfizer, lot number: FH8030, administration time: 05:30PM , dose number 1, vaccine location: Left arm), administration date: 15Nov2021, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Weird "zaps" In head"; HEADACHE (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Headaches every day"; MIGRAINE (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Migraines". Therapeutic measures were not taken as a result of feeling abnormal, headache, migraine.  Additional Information: Patient did not receive other vaccine in four weeks. Did not had covid prior vaccination and not tested for covid post vaccination. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: being sick ain't fun; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "being sick ain't fun".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discharge, Computerised tomogram, Lymphadenopathy, Magnetic resonance imaging, Mammogram
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 13Mar2021 (Lot number: EN6207) at the age of 72 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 (First Dose, Lot No: EL3302, Anatomical location: Left arm), administration date: 13Feb2021, when the patient was 72 years old, for COVID-19 Immunization. The following information was reported: BREAST DISCHARGE (non-serious) with onset 2021, outcome "unknown", described as "leaky breasts on both sides"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "swollen lymph nodes in her arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Enquired that, call transferred from (withheld) with Pfizer. Stated that, the caller was a 73-year-old female who has had both doses of her Pfizer COVID 19 vaccinations. Stated that, one shot in 13Feb2021 & the 2nd in 13Mar2021. Stated that, she received the doses at two different (withheld) and she received no other vaccines within 4 weeks of the Covid vaccines. The caller stated that, one month after her 2nd dose, after she was already experiencing swollen lymph nodes in her arm, she began experiencing leaky breasts on both sides. Stated that, after she got the second one she got a swollen glands under her opposite arm and towards her breast, stated if she put her arm out she could feel the swollen gland. Stated that, it was a month after the second dose that she had leaky breasts. Stated that, this occurred 3 times and was a significant amount. Stated that, it happened 3 times, that the first time she was doing dishes and her shirt got all wet. Stated that, the next time it happened, it was the other side, stated then, the next time it happened it was both sides and she was soaked, her whole bra and everything. Stated that, she told her doctor and she sent her for every test in the book, a mammogram, a CT, a MRI, states they looked all around the breast and they found nothing. All the reports were negative. Stated that, the caller was now worried about it due to the push to get the booster dose, whereas she was not before. Stated that, she has followed up with her HCP regarding the concern and they did tests but nobody could give her a reason why other than the possible connection with the vaccine. HCP details were not provided. Expirations and dosages were unknown. Stated that, leaking didn't start for like a month, swollen gland she noticed about a week or so after second dose. Stated that, exact dates were unknown. Stated that, the caller wanted to know whether this was a reported side effect. Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: being sick aint fun / its not fun indeed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 26Dec2021, outcome "unknown", described as "being sick aint fun / its not fun indeed". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: individual on stream live in PM  yesterday said being sick ain't fun and another on stream said "its not fun indeed". Unsure vaccine status of either, or what exactly they were talking about.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Malaise
Clinical narrative: flu; She feels sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious) with onset Dec2021, outcome "unknown", described as "flu"; MALAISE (non-serious) with onset Dec2021, outcome "unknown", described as "She feels sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Platelet count, Platelet count decreased, SARS-CoV-2 test
Clinical narrative: low platelet count; swollen lymph nodes in neck; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administration date 10Jun2021 13:30 (Lot number: EW0186) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0186, Vaccine Administration Time: 01:30 PM), administration date: 20May2021, when the patient was 54 years old, for Covid-19 Immunization. The following information was reported: PLATELET COUNT DECREASED (non-serious) with onset 15Oct2021, outcome "unknown", described as "low platelet count"; LYMPHADENOPATHY (non-serious) with onset 15Oct2021, outcome "unknown", described as "swollen lymph nodes in neck". The events "low platelet count" and "swollen lymph nodes in neck" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of platelet count decreased, lymphadenopathy. Additional Information: The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient not received list of any other medications within 2 weeks of vaccination. patient not diagnosed with COVID-19 prior to vaccination .  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Fatigue, Headache
Clinical narrative: fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 24Feb2021 08:00 (Lot number: EN6202) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HYPERLIMIDEMIA", start date: 2018 (ongoing). Concomitant medication(s) included: FLUAD QUAD, administration date 11Oct2021; PRAVASTATIN taken for hyperlipidaemia, start date: Jun2019 (ongoing). The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue"; HEADACHE (non-serious), outcome "unknown", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Ultrasound Doppler
Clinical narrative: fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 24Feb2021 08:00 (Lot number: EN6202) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HYPERLIMIDEMIA", start date: 2018 (ongoing). Concomitant medication(s) included: FLUAD QUAD, administration date 11Oct2021; PRAVASTATIN taken for hyperlipidaemia, start date: Jun2019 (ongoing). The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue"; HEADACHE (non-serious), outcome "unknown", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.