chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: swelling at injection shot 3" in diameter and hot to the touch; swelling at injection shot 3" in diameter and hot to the touch; chills; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 14:30 (Lot number: FE3594) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 23Dec2021, outcome "not recovered" and all described as "swelling at injection shot 3" in diameter and hot to the touch"; CHILLS (non-serious) with onset 23Dec2021, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 23Dec2021, outcome "not recovered", described as "fever". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site warmth, chills, pyrexia.  Additional information:Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: N/A. Since the vaccination, has the patient been tested for COVID-19?: No. known allergies: NKA. other medical history: N/A  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Tinnitus
Clinical narrative: Felt fullness in his left ear and tinnitus in his left ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 04Feb2021 (Lot number: EL9262) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Meniere's disease" (unspecified if ongoing); "allergies" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot No: EL8982), administration date: 14Jan2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "Felt fullness in his left ear and tinnitus in his left ear". Relevant laboratory tests and procedures are available in the appropriate section. Patient's wife looked up what temperature to go to the ER if someone's temperature drops and she told him if his temperature was 95 degrees then he should go to ER, but he was at 96, so he was still one degree off and did not go to ER.   Additional info: Patient got monthly allergy shots and has been getting these for about 7 years.  No follow-up attempts are possible. No further information is expected.  Follow-up (04Jan2022): Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: large, swollen, hot, painful lump at the site of the injection; large, swollen, hot, painful lump at the site of the injection; large, swollen, hot, painful lump at the site of the injection; large, swollen, hot, painful lump at the site of the injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) via Agency. The reporter is the patient. A 49-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 16:00 (Lot number: EW0176) at the age of 49 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, Product: COVID 19, Brand: Pfizer, Lot number: ER8737, Administration time: 02:00 PM, Vaccine location: Left arm), administration date: 06Apr2021, when the patient was 49 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE MASS (non-serious) all with onset 2021, outcome "unknown" and all described as "large, swollen, hot, painful lump at the site of the injection".  Additional Information: Previous dose details: Dose number: 2, Product: COVID 19, Brand: Pfizer, Brand unknown: False, Administration time: 04:00 PM. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. There was no Known Allergies. Adverse event: After the second dose i had a large, swollen, hot, painful lump at the site of the injection. After 3 dose (booster) i have been experiencing large painful boils and lumps in my armpits and under breasts  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: 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 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: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "excessive itching on the injection site". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Hangover
Clinical narrative: It was a slight hangover about a day or 2 after the first 2 Covid shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: GP6855) at the age of 41 years as dose 1, single and administered in arm left, administration date Apr2021 (Lot number: ER8735) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Vertigo" (unspecified if ongoing), notes: he does suffer from vertigo and had had it in the past. The patient took concomitant medications. The following information was reported: HANGOVER (non-serious) with onset 2021, outcome "unknown", described as "It was a slight hangover about a day or 2 after the first 2 Covid shots".  Additional information: He states he was a little hung over for a day or 2. He was able to work and drive and function. It was normal and there were no other issues.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: fever; felt achey; chilled; exhausted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28May2021 13:15 (Lot number: EWER8134) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known Allergy: penicillin" (unspecified if ongoing), notes: Known Allergy: penicillin. Concomitant medication(s) included: IRBESARTAN. Past drug history included: Irbesartan 75mg for blood presure, notes: blood pressure being treated with, Irbesartan 75mg. Vaccination history included: Bnt162b2 (DOSE NUMBER: 1st, lot number=EW0170, location=Right arm), administration date: 07May2021, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "felt achey"; CHILLS (non-serious), outcome "unknown", described as "chilled"; FATIGUE (non-serious), outcome "unknown", described as "exhausted". Therapeutic measures were not taken as a result of pyrexia, pain, chills, fatigue.  Follow-up attempts are completed. No further information is expected.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Product administered at inappropriate site, Rash, SARS-CoV-2 test
Clinical narrative: Dry skin rash on both sides of the neck and around the eyes; Dry skin rash on both sides of the neck and around the eyes; vaccine location Right leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in leg right, administration date 23Dec2021 15:30 (Lot number: Fk5127) at the age of 6 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: Fz0007, Location of injection: Leg Right, Vaccine Administration Time: 03:15 PM), administration date: 30Nov2021, when the patient was 6 years old, for COVID-19 Immunization, reaction(s): "vaccine location=Right leg". The following information was reported: DRY SKIN (non-serious), RASH (non-serious) all with onset 24Dec2021, outcome "recovering" and all described as "Dry skin rash on both sides of the neck and around the eyes"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 23Dec2021 15:30, outcome "unknown", described as "vaccine location Right leg". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dry skin, rash.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia, SARS-CoV-2 test
Clinical narrative: The day after the shot and For three months had up to 10 episodes a day of extreme nerve pain in chest area for up to 2 minutes then went away and return again and again daily.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Mar2021 09:00 (Lot number: En6204) at the age of 17 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SIMBICORT TURBUHALER; ZAFIRLUKAST. The following information was reported: NEURALGIA (non-serious) with onset 14Mar2021, outcome "recovered" (2021), described as "The day after the shot and For three months had up to 10 episodes a day of extreme nerve pain in chest area for up to 2 minutes then went away and return again and again daily.". The event "the day after the shot and for three months had up to 10 episodes a day of extreme nerve pain in chest area for up to 2 minutes then went away and return again and again daily." was 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 neuralgia.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: The patient had high fevers after each dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adolescent male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (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: PYREXIA (non-serious), outcome "recovered", described as "The patient had high fevers after each dose of the vaccine".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Paraesthesia, Vaccination site pain
Clinical narrative: her arm tingles and feel heavy; her arm tingles and feel heavy; Left arm pain at injection site/it really hurt like something was in her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Apr2021 12:00 (Lot number: EW0176) at the age of 22 years 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: LIMB DISCOMFORT (non-serious), PARAESTHESIA (non-serious) all with onset 26Apr2021, outcome "not recovered" and all described as "her arm tingles and feel heavy"; VACCINATION SITE PAIN (non-serious) with onset 26Apr2021, outcome "not recovered", described as "Left arm pain at injection site/it really hurt like something was in her arm".  Additional Information: She stated she was a Dietary Aide before. No Prior Vaccinations within 4 weeks prior to the first administration date of the suspect vaccine(s). She went in and got shot and a day after, it really hurt like something was in her arm.  Ever since then, her arm tingles and feel heavy.  Left arm pain at injection site was reported as worsened. She has previous health problems and she got it to prevent herself from getting sick. Left arm pain at injection site - she woke up first thing in the morning with really bad pain in that arm.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Paraesthesia
Clinical narrative: Intermittent electric shock sensations and pricks all over; Pricks all over/a pricking sensation; 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 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Dec2021 18:40 (Lot number: FD7218) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "WPW: Wolf Parkinsons White Syndrome", start date: 2012 (ongoing), notes: Verbatim: WPW: Wolf Parkinsons White Syndrome. The patient's concomitant medications were not reported. The following information was reported: ELECTRIC SHOCK SENSATION (non-serious) with onset 27Dec2021, outcome "not recovered", described as "intermittent electric shock sensations and pricks all over"; PARAESTHESIA (non-serious) with onset 27Dec2021, outcome "unknown", described as "pricks all over/a pricking sensation".  Additional Information: Patient got her first Pfizer covid vaccine on 27Dec and about 3 to 4 hours later, started experiencing intermittent electric shock sensations and pricks all over. The first occurred in her stomach, then in other parts like her arms, legs, right shoulder and it is a singular electric shock sensation. Patient is frustrated that there is no information on the side effect she is having. Pfizer is pushing the vaccine and there are mandates all over so she is forced to get it. She sees people reporting it on the internet. She took the vaccine because the government is mandating the vaccine for all private workers. Patient described the sensation similar to a belt that is used in physical therapy to decompress muscles and provides electric shocks. Patient describes as random and intermittent. Patient asked if this effect been reported. She needs concrete assistance because this is a problem. She said here is no level of accountability because the vaccine is mandated. She feels like a guinea pig, taking this vaccine. Patient did not receive additional vaccines on the same day of suspect. The events did not require emergency room or physician office visit. Patient did not receive any vaccinations within four weeks and there were no adverse events following prior vaccinations. Patient did not underwent any relevant test.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Insomnia, Pain in extremity, Vertigo, Vomiting
Clinical narrative: numbness on the arm where she got the vaccine; numbness in the place of the vaccine, started to go down her arm to her fingers; vertigo/two days after the vaccine she had vomiting that triggered an episode; vomiting; pain in the left arm; couldn't sleep all night; 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 female patient in her 60's received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 11:00 (Lot number: FH8028, Expiration Date: 31May2022) at the age of 7 decade as dose 1, single for covid-19 immunisation. Relevant medical history included: "Vertigo" (unspecified if ongoing), notes: Verbatim: Vertigo. There were no concomitant medications. Vaccination history included: Pneumonia vaccine, administration date: 2018, for Immunization, reaction(s): "redness". The following information was reported: HYPOAESTHESIA (non-serious) with onset 18Dec2021, outcome "recovering", described as "numbness on the arm where she got the vaccine"; VERTIGO (non-serious) with onset 17Dec2021 23:00, outcome "recovering", described as "vertigo/two days after the vaccine she had vomiting that triggered an episode"; VOMITING (non-serious) with onset 17Dec2021 23:00, outcome "recovering", described as "vomiting"; PAIN IN EXTREMITY (non-serious) with onset 16Dec2021 23:00, outcome "recovering", described as "pain in the left arm"; HYPOAESTHESIA (non-serious) with onset 18Dec2021, outcome "recovering", described as "numbness in the place of the vaccine, started to go down her arm to her fingers"; INSOMNIA (non-serious) with onset Dec2021, outcome "recovering", described as "couldn't sleep all night". The event "vertigo/two days after the vaccine she had vomiting that triggered an episode" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of hypoaesthesia, vertigo, vomiting, pain in extremity, hypoaesthesia, insomnia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not admitted to emergency room.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 27Aug2021 (Lot number: FD8448) at the age of 38 years 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: TINNITUS (non-serious) with onset Aug2021, outcome "recovering", described as "ringing in ears". Additional information: It was reported that, a couple of days probably 2-4 days after she developed ringing in her ears during the day. It was changing pitches. It would happen at night too. It gradually became less often. It was no longer during the day, but she still had it every night. When she would lie down the pitches would change. Now, when she wakes up in the middle of the night she can hear it. This has been four months now and the ringing was still occurring. It does happen less often, but the intensity hasn't changed. So it has improved some because it was less often, but it doesn't appear that was going to go away. She did not get the second vaccine because she was afraid of hearing loss because of this. She was trying to avoid the doctor. She has read it can cause hearing loss. She has also read there isn't much doctors can do for it. It was potentially long lasting. That was why she wants it reported so others will know. No history of all previous immunization. No additional vaccines administered on same date of the Pfizer Suspect. AE(s) not resulted to emergency room and physician office visit. No prior Vaccinations (within 4 weeks) to Covid vaccine. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; horrible headache; 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 patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administration date 12Feb2021 (Lot number: EL9267) as dose 1, single and administration date 06Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Acne" (unspecified if ongoing), notes: Verbatim: Acne; "Acid reflux (esophageal)" (unspecified if ongoing), notes: Verbatim: Acid reflux (esophageal); "Birth Control" (unspecified if ongoing). Concomitant medication(s) included: TRI-SPRINTEC taken for contraception; CALCIUM; PEPCID [FAMOTIDINE]; SPIRONOLACTONE taken for acne. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "horrible headache". Therapeutic measures were taken as a result of headache with 3 Aleve and a Tyleno.  Additional information: With the first dose the caller had a sore arm, but she got that with all of them, and then she had a horrible headache. Earlier that day the caller went on a run before that but she doesn't know if that had anything to do with it. The caller tried to knock it back with 3 Aleve and a Tylenol but it was a hard night.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; she felt a headache coming on; 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 patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Lot number: EN6198) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Acne" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing); "birth control" (unspecified if ongoing). Concomitant medication(s) included: TRI-SPRINTEC taken for contraception; CALCIUM; PEPCID [FAMOTIDINE] taken for gastrooesophageal reflux disease; SPIRONOLACTONE taken for acne. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, lot EL9267), administration date: 12Feb2021, for COVID-19 immunization, reaction(s): "sore arm", "horrible headache". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "sore arm"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "she felt a headache coming on". Therapeutic measures were taken as a result of pain in extremity, headache.  Additional information: After the second dose, she felt a headache coming on she took a Tylenol and it didn't turn into a headache. She knows that the headache was common side effect with the vaccine. She tried to knock the headache back with 3 Aleve and a Tylenol. Concomitant Products included Multivitamin: (Start: Unspecified Stop: Unspecified).  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Bone swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: It was not this painful last time; It was not this painful last time; Swollen clavicle and lymph nodes; Swollen clavicle and lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 (Lot number: EL9264) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LOVASTATIN taken for blood cholesterol (ongoing); AMLODIPINE taken for blood pressure measurement (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Lot: EL3248, Exp: Unknown, Administered left upper arm), administration date: 03Feb2021, when the patient was 55 years old, for Covid-19 Immunization. The following information was reported: BONE SWELLING (non-serious), LYMPHADENOPATHY (non-serious) all with onset Feb2021, outcome "recovered" and all described as "Swollen clavicle and lymph nodes"; BONE PAIN (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "It was not this painful last time".  Additional information: The patient had swollen clavicle and lymph nodes after booster dose. The same thing happened after getting the second Pfizer Covid Vaccine, but it's not as severe as this. At end of call, patient commented she was hoping this hurt goes away. It was not this painful last time (after second dose). She still had the knots and swelling like she does now, but not as bad. She mentioned she did not make the report last time until a week or half into it and then it went away.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: sore jaw; 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.  An elderly male 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: PAIN IN JAW (non-serious), outcome "unknown", described as "sore jaw". Therapeutic measures were taken as a result of pain in jaw.  Additional information: Patient mentioned he was taking Amoxicillin 500 mg and wants to get a booster shot of the vaccine but is afraid the medication might interact with booster shot. Patient was taking Amoxicillin for a sore jaw after his dentist recommended he take it. He said it was time for his booster so he was wondering if this could conflict with taking Amoxicillin. He said he the sore jaw was probably because he had a root canal years ago that needs to be revisited, and he was not going to be able see him for that for a couple weeks. He said the dentist is having him take Amoxicillin because of infection, so he was wondering if he can get the booster dose now or if he needs to wait.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Heart rate, Lymph node pain, Lymphoedema
Clinical narrative: racing heart was less; shortness of breath; itchy like under arm pit and breast that comes and goes/itchy arm, it was red, covid arm; itchy like under arm pit and breast that comes and goes/itchy arm, it was red, covid arm; lymphedema; lymph node pain that was into the breast; tachycardia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 07May2021 15:00 (Lot number: EW0167) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Dry eye" (unspecified if ongoing); "GERD", start date: 18Sep2018 (ongoing), notes: Patient's Medical History: , Illness/AE: Gerd , Onset Date: 18Sep2018, Stop Date: Ongoing; "Lyme", start date: 18Sep2018, stop date: 18Oct2018, notes: Patient's Medical History: , Illness/AE: Lyme, Onset Date: 18Sep2018, Stop Date: 18Oct2018. Concomitant medication(s) included: B COMPLEX (B50); FISH OIL taken for dry eye; GATORADE ENERGY DRINK; LUMIGAN; VIT D3. Vaccination history included: Bnt162b2 (Dose 1, Lot: EW0150 , Administered in left upper deltoid, rapid heart beat), administration date: 04Apr2021, when the patient was 64 years old, for COVID-19 Immunization, reaction(s): "rapid heart beat", "tachycardia", "shortness of breath". The following information was reported: DYSPNOEA (non-serious) with onset 07May2021, outcome "recovering", described as "shortness of breath"; TACHYCARDIA (non-serious) with onset 2021, outcome "recovering", described as "tachycardia"; PALPITATIONS (non-serious) with onset 07May2021, outcome "unknown", described as "racing heart was less"; ERYTHEMA (non-serious) with onset May2021, outcome "unknown", PRURITUS (non-serious) with onset May2021, outcome "not recovered" and all described as "itchy like under arm pit and breast that comes and goes/itchy arm, it was red, covid arm"; LYMPHOEDEMA (non-serious) with onset May2021, outcome "unknown", described as "lymphedema"; LYMPH NODE PAIN (non-serious) with onset May2021, outcome "recovered" (2021), described as "lymph node pain that was into the breast". The events "shortness of breath" and "tachycardia" 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 tachycardia.  Additional Information: Patient got Flu shot on Oct2021  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Palpitations, Pruritus, Tachycardia
Clinical narrative: racing heart was less; shortness of breath; itchy like under arm pit and breast that comes and goes/itchy arm, it was red, covid arm; itchy like under arm pit and breast that comes and goes/itchy arm, it was red, covid arm; lymphedema; lymph node pain that was into the breast; tachycardia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 07May2021 15:00 (Lot number: EW0167) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Dry eye" (unspecified if ongoing); "GERD", start date: 18Sep2018 (ongoing), notes: Patient's Medical History: , Illness/AE: Gerd , Onset Date: 18Sep2018, Stop Date: Ongoing; "Lyme", start date: 18Sep2018, stop date: 18Oct2018, notes: Patient's Medical History: , Illness/AE: Lyme, Onset Date: 18Sep2018, Stop Date: 18Oct2018. Concomitant medication(s) included: B COMPLEX (B50); FISH OIL taken for dry eye; GATORADE ENERGY DRINK; LUMIGAN; VIT D3. Vaccination history included: Bnt162b2 (Dose 1, Lot: EW0150 , Administered in left upper deltoid, rapid heart beat), administration date: 04Apr2021, when the patient was 64 years old, for COVID-19 Immunization, reaction(s): "rapid heart beat", "tachycardia", "shortness of breath". The following information was reported: DYSPNOEA (non-serious) with onset 07May2021, outcome "recovering", described as "shortness of breath"; TACHYCARDIA (non-serious) with onset 2021, outcome "recovering", described as "tachycardia"; PALPITATIONS (non-serious) with onset 07May2021, outcome "unknown", described as "racing heart was less"; ERYTHEMA (non-serious) with onset May2021, outcome "unknown", PRURITUS (non-serious) with onset May2021, outcome "not recovered" and all described as "itchy like under arm pit and breast that comes and goes/itchy arm, it was red, covid arm"; LYMPHOEDEMA (non-serious) with onset May2021, outcome "unknown", described as "lymphedema"; LYMPH NODE PAIN (non-serious) with onset May2021, outcome "recovered" (2021), described as "lymph node pain that was into the breast". The events "shortness of breath" and "tachycardia" 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 tachycardia.  Additional Information: Patient got Flu shot on Oct2021  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Product administered to patient of inappropriate age
Clinical narrative: Nose bleed; my 5 year old was given the injection and she had may be 4 hours afterward and then again may be 2 hour after that she had a nose bleed.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EPISTAXIS (non-serious), outcome "unknown", described as "Nose bleed"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "my 5 year old was given the injection and she had may be 4 hours afterward and then again may be 2 hour after that she had a nose bleed".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: a little achy feeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Sep2021 (Lot number: FF8839) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot: EL9264, Anatomical Location: left arm), administration date: 30Jan2021, for COVID-19 immunization; Bnt162b2 (Dose: 2, Lot: EN6205, Anatomical Location: left arm), administration date: 27Feb2021, for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "recovered" (2021), described as "a little achy feeling".  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Red mark three weeks after shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported.  The following information was reported: ERYTHEMA (non-serious), outcome "recovering", described as "Red mark three weeks after shot". Therapeutic measures were not taken as a result of erythema.  Additional information: The lot number was unknown as the reporter was unable to locate.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in her arm after the second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jan2021 (Lot number: EL1283) at the age of 57 years 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, SINGLE, Lot no: EH9899), administration date: 16Dec2020, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Soreness in her arm after the second vaccine".  Additional information: It felt like someone punched her. Then, her Booster dose was given on 23Dec2021 with lot number 33BOBA, and was given in her left arm and was given at 10 am. All three vaccines were given in her left arm.  No follow-up attempts are possible. No further information is expected.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Caller stated she asked the children this morning if they had any side effects and the reply was a little sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 6 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Dec2021 (Lot number: FK5127, Expiration Date: 30Apr2022) at the age of 6 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Autoimmune" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Dec2021, outcome "unknown", described as "Caller stated she asked the children this morning if they had any side effects and the reply was a little sore arm".  Additional information: Reporter stated the vial had the date of manufacture of Aug2021 instead of an expiration date. Reporter stated she asked the pharmacist what the expiration date was and the pharmacist showed her the print out of the 9 month expiration. Printed Manufacturing Date: 09 Month Expiry Date: Aug2021=30Apr2022. Patient did not have any history of all previous immunization with the Pfizer vaccine and not received any additional vaccines administered on same date of the Pfizer suspect. Family medical history relevant to adverse event was not reported. Relevant tests were none reported.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101885369 same product and event, different patient
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Hypersensitivity, Speech disorder, Tremor, Urticaria
Clinical narrative: Issues with Speech; Issues with vision; Issues with ability to stand; shakes; hives; had an allergic reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) at the age of 48 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HYPERSENSITIVITY (medically significant) with onset 02Apr2021, outcome "recovered" (2021), described as "had an allergic reaction"; SPEECH DISORDER (medically significant), outcome "unknown", described as "Issues with Speech"; VISUAL IMPAIRMENT (medically significant), outcome "unknown", described as "Issues with vision"; DYSSTASIA (medically significant), outcome "unknown", described as "Issues with ability to stand"; TREMOR (medically significant), outcome "unknown", described as "shakes"; URTICARIA (non-serious), outcome "unknown", described as "hives". The events "had an allergic reaction", "issues with speech", "issues with vision", "issues with ability to stand" and "shakes" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of hypersensitivity.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Issues with Speech; Issues with vision; Issues with ability to stand; shakes; hives; had an allergic reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) at the age of 48 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HYPERSENSITIVITY (medically significant) with onset 02Apr2021, outcome "recovered" (2021), described as "had an allergic reaction"; SPEECH DISORDER (medically significant), outcome "unknown", described as "Issues with Speech"; VISUAL IMPAIRMENT (medically significant), outcome "unknown", described as "Issues with vision"; DYSSTASIA (medically significant), outcome "unknown", described as "Issues with ability to stand"; TREMOR (medically significant), outcome "unknown", described as "shakes"; URTICARIA (non-serious), outcome "unknown", described as "hives". The events "had an allergic reaction", "issues with speech", "issues with vision", "issues with ability to stand" and "shakes" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of hypersensitivity.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Angiopathy, Poor peripheral circulation
Clinical narrative: vascular issues; limited circulation on her lower extremities on her feet; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "She was told by her allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANGIOPATHY (non-serious), outcome "unknown", described as "vascular issues"; POOR PERIPHERAL CIRCULATION (non-serious), outcome "unknown", described as "limited circulation on her lower extremities on her feet".  Additional information: Reporter also mentioned that she had called in before for herself to inquire about the Pfizer BioNtech covid-19 Vaccine because she had some vascular issues however it was not mentioned if this brought about an AE after getting the dose/doses. She was told by her allergies, cardiologist and vascular doctor to kind of wait because she had limited circulation on her lower extremities on her feet and she had blown all the vessels on her feet.   Follow-up (08Nov2021): The initial case was missing the following minimum criteria: Adverse events. Upon receipt of follow-up information on (08Nov2021), this case now contains all required information to be considered valid. Added AEs, RMH information.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue
Clinical narrative: Extreme fatigue; 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 88 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 04Mar2021 (Lot number: EN6202, Expiration Date: 30Jun2021) at the age of 87 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "thyroid doesn't work well" (unspecified if ongoing), notes: thyroid doesn't work well. Concomitant medication(s) included: IRON taken for thyroid disorder, start date: Dec2021; PRILOSEC [OMEPRAZOLE]; VITAMIN C [ASCORBIC ACID]. Vaccination history included: Bnt162b2 (1st dose:, Lot Number / Expiry Date: EL8982/ 31May2021, Route, Anatomical Location: Left Deltoid), administration date: 27Jan2021, when the patient was 87 years old, for COVID-19 immunization; Flu shot, administration date: Oct2021. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Extreme fatigue". The event "extreme fatigue" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had extreme fatigue that was lasted several months after receiving her Pfizer Covid 19 Vaccine. The caller had been advised to reach out to HCP and that Pfizer can't provided medical advise. Caller was asking if Pfizer had any additional information on fatigue to provide or guidance on what she can do. The caller was calling in regards to the COVID vaccine. The caller wants to know what could Pfizer do for the extreme fatigue that seems to be coming from the COVID vaccine. She had it for several months. She had been to her healthcare professional and they haven't given her any help. The caller received both shots and then a couple of months may be 3 months after that, she started experiencing fatigue. Her bloodwork seems to be okay. The fatigue hadn't improved, it's probably a little worse, she didn't remember exactly when it started. The caller stated that her thyroid doesn't work well. This was diagnosed years and years ago. She takes iron and just recently in the last week, she started taking Prilosec and Vitamin C. She stated that she saw 2 different doctors and neither one helped. She believed that the doctors didn't know what to do either. They did bloodwork and that was it. She just had the regular blood work taken from her arm so whatever they did from that was what she had. She mentioned that she had the flu shot in the fall, clarified as Oct2021. The patient did not received other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s).  No follow-up attempts are possible. No further information is expected.