chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Feeling hot, Insomnia, Mass
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 16Feb2021 at 17:15 (lot number and expiration date were not reported), as second dose, single for COVID-19 immunisation. Medical history included asthma, osteoarthritis (OA), rhuematoid factor positive, coagulation problem, high cholesterol, COVID prior vaccination and had known allergies: latex, peaches, and nuts. Concomitant medications included sertraline hydrochloride (ZOLOFT); omeprazole (PRILOSEC [OMEPRAZOLE]); montelukast; beclometasone dipropionate (QVAR); and diclofenac. The patient previously took morphine sulfate and experienced allergy and BNT162B2 dose 1 administered in left arm on 25Jan2021 for COVID-19 immunisation (vaccine in four weeks). On 18Feb2021, 35 hours after injection, at 4.15 AM, the patient had itching, burning, and redness at site, that woke her from sleep. By 17:40 the itching returned, more redness, ruby colour, more swelling with a lump beneath blue area given, and warm. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. The patient was not COVID tested post vaccination. The outcome of all the events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin discolouration, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 16Feb2021 at 17:15 (lot number and expiration date were not reported), as second dose, single for COVID-19 immunisation. Medical history included asthma, osteoarthritis (OA), rhuematoid factor positive, coagulation problem, high cholesterol, COVID prior vaccination and had known allergies: latex, peaches, and nuts. Concomitant medications included sertraline hydrochloride (ZOLOFT); omeprazole (PRILOSEC [OMEPRAZOLE]); montelukast; beclometasone dipropionate (QVAR); and diclofenac. The patient previously took morphine sulfate and experienced allergy and BNT162B2 dose 1 administered in left arm on 25Jan2021 for COVID-19 immunisation (vaccine in four weeks). On 18Feb2021, 35 hours after injection, at 4.15 AM, the patient had itching, burning, and redness at site, that woke her from sleep. By 17:40 the itching returned, more redness, ruby colour, more swelling with a lump beneath blue area given, and warm. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. The patient was not COVID tested post vaccination. The outcome of all the events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Feeling cold, Pain, Sinus headache
Clinical narrative: I got a sinus headache; body ached; Terrible feeling; lost all energy; was cold; This is a spontaneous report from a contactable consumer(patient). A 61-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN9581) via an unspecified route of administration, administered in right arm on 18Feb2021 12:00 as single dose for COVID-19 immunization. Patient medical history included Early Onset Alzheimers, high blood pressure, acid reflux, diverticulitis, and allergies to pollen and ragweed. Past drug event included Lipitor orifarm, amlodipine for allergies (Hypersensitivity). The patient concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via intramuscular, administered in arm Left on 28Jan2021 12:00 as single dose for COVID-19 immunization. Patient stated that on 19Feb2021 01:00 when she was in store, she had terrible feeling came over her. She lost all her energy, she got a sinus headache, she was cold, her body ached all over. She had to leave the store. Barely had enough energy to walk from the car into her house. The patient did not receive any other vaccines prior to the COVID vaccine in four weeks. Patient received other medications in two weeks after vaccination. Patient did not receive any treatment for AE. Patient was not tested covid prior vaccination or post vaccination. The clinical outcome of events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Migraine, Pyrexia
Clinical narrative: fever 101.1 to 102.2; migraine/headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced fever 101.1 to 102.2, slight headache and migraine. Patient called-in saying that she joined the clinical trial and there are some minor side effects such as fever 101.1 to 102.2 and slight headache which she considers normal because she is a migraine patient normally experiencing migraine every 20 to 25 days. She is also reporting that there is something today that happened wherein they are supposed to open the actual vaccination soon but they have opened today without her presence and this is very odd for her. A caller wants to understand the standard protocol because we are paying her. The event fever 101.1 to 102.2 was found to be medically significant. The patient underwent lab tests and procedures which included body temperature: 101.1 to 102.2 on unspecified date. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction to the Prevnar vaccine a couple of years ago; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) SINGLE DOSE for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the experienced allergic reaction to the Prevnar vaccine a couple of years ago. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Herpes virus infection
Clinical narrative: after the first dose, the patient had herpes outbreak,she had herpes before and after the vaccine; after the first dose, the patient had herpes outbreak,she had herpes before and after the vaccine; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 20Feb2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Feb2021 as a single dose for covid-19 immunisation. Medical history included herpes. Concomitant medications were not reported. On an unspecified date in 2021, after the first dose, the patient had herpes outbreak. Patient enquired whether she could take medication (Valaciclovir) because she had herpes before and after the vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Frustration tolerance decreased, Herpes simplex
Clinical narrative: Herpes Simplex; Caller expressed her frustration; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 06Feb2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had herpes simplex and frustration. Outcome of the events was unknown. The patient was due for her 2nd dose on 27Feb2021.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Feeling abnormal, Malaise
Clinical narrative: had mild foggy head; upset tummy; diarrhea; just not feeling right; This is a spontaneous report received from a contactable consumer (Patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection and Lot Number: EN6201) via an unspecified route of administration in Arm Left on 08Feb2021 16:45 (age at vaccination: 67 years) as single dose for COVID-19 immunization. Medical history included Reiters syndrome and mild food allergy to turkey. Concomitant medications were reported as none. Patient did not received other vaccines in four weeks. Patient did not had other medications in two weeks. Patient did not had COVID prior vaccination. She was not tested for COVID post vaccination. On 09Feb2021 24 hours after receiving vaccine she had mild foggy head, upset tummy, diarrhea and just not feeling right. Lasted about 36 hours. All the events were considered as non-serious. No treatment was received for the events. The outcome of events was recovered on an unspecified date in 2021.  Follow-up (24May2021): Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: lost taste and smell; lost taste and smell; This is a spontaneous report from a contactable consumer (patient) or other non hcp reported. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration on 28Jan2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation (the patient works for Doctor's office). The patient received the first dose of BNT162B2 on 06Jan2021, and had headache and was tired. The patient medical history and concomitant medications were not reported. The patient experienced lost taste and smell on an unknown date in Jan2021 (3 days after she lost taste and smell and are still gone. The patient feel fine. The patient just wish she could taste food and smell the perfume). She was wondering if we have any information on how long this might last. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Hypoacusis
Clinical narrative: loss of smell; lost his sense of taste; difficulties listening; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration as first dose on 13Jan2021 and second dose on 3Feb2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced loss of smell, lost his sense of taste and difficulties listening. The events assessed as non-serious. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Heart rate increased, Rash, Rash macular
Clinical narrative: Her heart was beating faster; Part of her face was flushed; Her chest and arms had a rash; Blotches all over; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; batch/lot number was not reported), via an unspecified route of administration on 23Feb2021 (at the age of 75-years-old) as 1st dose, single dose for COVID-19 immunization. Medical history included family history of Bell's palsy (her mother had it). The patient's concomitant medications were not reported. The patient got the first dose of BNT162B2 on 23Feb2021. After 15 minutes, the patient noticed her heart was beating faster. She didn't know whether it was because she was nervous or what. When she got home, she happened to look in the mirror for some reason and she saw that part of her face was flushed, her chest and arms had a rash, and had blotches all over. The patient called and explained it to her doctor, the doctor told her that she could take an antihistamine before the second dose or skip it. The patient reported that she looked online, and she read that one should not take antihistamine as it could affect the efficacy of the vaccine. The patient was scheduled for the second dose on 16Mar2021. The patient will be 76-years-old in a couple of weeks, she lives alone and doesn't know what to do if she should she take an antihistamine before the second dose. In reading some literature, the patient saw that there's a slight possibility for Bell's palsy, her mother had Bell's palsy and she watched her face get worse and worse. The patient mentioned that she may not go back to get the second dose, and wonders what the efficacy of the first dose alone is. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Condition aggravated, Stress
Clinical narrative: she had arthritis/shoulder problems and pain/that her shoulder got so bad "I couldn't move my shoulder"; she had arthritis/shoulder problems and pain; Worsening shoulder pain with need for cortisone injection following administration of her first vaccine dose/it got significantly worse after her first dose; I'm very stressed; This is a spontaneous report from a contactable consumer (patient) reported for herself. An 80-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller asked whether a Cortisone shot that she just got in her shoulder would interfere or interact with the second dose of the vaccine she will be getting tomorrow. The caller reported that she received her first vaccine dose about 3 weeks ago, specific date unknown at the time of this call. She reported that she had been having shoulder problems and pain but it got significantly worse after her first dose, although she stated that she don't think the shoulder had anything to do with the shot. The caller reported that her shoulder got so bad, she couldn't move her shoulder and she was told she had arthritis and was administered a Cortisone shot to the shoulder for pain. The caller now reported, she was very stressed because she doesn't know if she messed up the effectiveness of the vaccine by getting the cortisone shot in her shoulder. The caller reported that she spoke with the doctor who said there shouldn't be an issue but she worried about her second dose tomorrow. Worsening shoulder pain with need for cortisone injection following administration of her first vaccine dose. The caller asked whether there was any difference in effectiveness if the second dose was given later than 3 weeks. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: lost his smell for 2 weeks; This is a spontaneous report from a contactable consumer (patient) or other non HCP. A male patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. On unspecified date, after the second dose, patient lost his smell for 2 weeks. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: lost my sense of taste; I lost my sense of smell; This is a spontaneous report from a Non contactable Consumer. This 31-Years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL9264, Expiry date 31Aug2021)(At the age of 31 years-old), via an unspecified route of administration into left arm on 03Feb2021 at 14:00 PM as a single dose for COVID-19 immunisation. Medical history included Migraines. The patient's concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Post vaccination, patient was not tested for COVID-19 Patient did not receive any other medications within four weeks. Patient stated that 2 days after receiving the first dose , On 05Feb2021 at 17:00 PM, I lost my sense of smell. On the 3rd day, I lost my sense of taste. My taste was gone for 5 days.No treatment was given for the events. The outcome of the events was reported as recovered on unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fibromyalgia, Headache, Pain, Pyrexia
Clinical narrative: made us ill like we had covid; had an increase in her fibromyalgia pain; high fever; body ache; no energy; headache; This is a spontaneous report from a contactable consumer (patient's husband) via Medical Information Team. A female patient (Age: 63; Unit: Unknown) (reporter's wife) received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Solution for injection) via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunisation. The patient's medical history included Covid-19 in Oct2020 and Covid infection turned into pneumonia in Oct2020. Concomitant medications were not reported. Caller (male, age 64 will be 65 in (birth month withheld)) stated, "his wife (female, age 63) and he received their first dose of the Pfizer vaccine on Friday and it made them ill like they had Covid. They had Covid in Oct. We had high fever, body ache, no energy and headache. There was no way he was going to take the second shot. He felt like the dickens. Everything was fine. The storm hit Friday night, lasted all day yesterday. He had the headache and weakness, low energy. He was a stage 4 lung cancer survivor. For both, the Covid infection turned into pneumonia. That shot made them feel like we got Covid like we did in Oct. His wife also had an increase in her fibromyalgia pain. He heard people who had Covid have real bad reactions after the second dose than the first. If it did not make him feel like he had Covid then he would take the second dose. It was terrible." Caller wanted information regarding efficacy of 1 dose. No PQC present. Seriousness was reported as no. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: made us ill like we had covid; had an increase in her fibromyalgia pain; high fever; body ache; no energy; headache; This is a spontaneous report from a contactable consumer (patient's husband) via Medical Information Team. A female patient (Age: 63; Unit: Unknown) (reporter's wife) received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Solution for injection) via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunisation. The patient's medical history included Covid-19 in Oct2020 and Covid infection turned into pneumonia in Oct2020. Concomitant medications were not reported. Caller (male, age 64 will be 65 in (birth month withheld)) stated, "his wife (female, age 63) and he received their first dose of the Pfizer vaccine on Friday and it made them ill like they had Covid. They had Covid in Oct. We had high fever, body ache, no energy and headache. There was no way he was going to take the second shot. He felt like the dickens. Everything was fine. The storm hit Friday night, lasted all day yesterday. He had the headache and weakness, low energy. He was a stage 4 lung cancer survivor. For both, the Covid infection turned into pneumonia. That shot made them feel like we got Covid like we did in Oct. His wife also had an increase in her fibromyalgia pain. He heard people who had Covid have real bad reactions after the second dose than the first. If it did not make him feel like he had Covid then he would take the second dose. It was terrible." Caller wanted information regarding efficacy of 1 dose. No PQC present. Seriousness was reported as no. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Chest pain
Clinical narrative: chest pains; It scared me; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer Sponsored Program. A female patient of an unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as an unknown, single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced developed chest pains and it scared her. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Drug hypersensitivity, Eye discharge, Pruritus, Rhinorrhoea
Clinical narrative: allergic reaction with runny eyes and nose; allergic reaction with runny eyes; allergic reaction with runny nose; itchy face; sore left shoulder muscle; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 74-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: en6205), via an unspecified route of administration, in the right arm on 05Mar2021 at 09:15 (age at the time 74-year-old) at a 2nd dose, as single dose for covid-19 immunisation. The patient's medical history included esophagitis, possibly reacting to dairy (dairy intolerance), and left breast cancer. The patient had known allergies included very minor dairy allergy. Concomitant medication included levothyroxine, unspecified eye drops-cataract surgery and unspecified statin. The patient previously received of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: em9809), via an unspecified route of administration, in the left arm on an unknown date in Feb2021, at a 1st dose, as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient experienced allergic reaction with runny eyes and nose, itchy face, sore left shoulder muscle on 07Mar2021 at 07:30 AM. Therapeutic measures were taken as a result of the events included benadryl (1 at 4pm, 2nd at 7pm). The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First dose soreness in arm (left); This is a spontaneous report from a contactable consumer reporting for herself. A 52-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN5318, expiration date not reported), via an unspecified route of administration, in Arm Left on an unknown date in Feb2021 (01:00 PM, as reported) (at the age of 52-years-old), as SINGLE DOSE for COVID-19 immunization. Medical history included high blood pressure, known allergies to sulfa. Concomitant medications included lisinopril; elderberry [sambucus nigra]; vitamin D NOS; ascorbic acid (VIT C). Patient did not receive other vaccines in four weeks of Covid vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On unknown date in Feb2021, the patient experienced first dose soreness in arm (left). Patient did not received treatment for adverse event. Outcome of the event was recovered approximately on unknown date in 2021 (that lasted more than two weeks, as reported).  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Food intolerance, Nausea, Parosmia
Clinical narrative: Nausea; Food intolerance; Smell also affected-lingering 10 days after vaccine admin; This is a spontaneous report from a contactable other Health Professional. A 18-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered in left arm on 25Feb2021 at 10:00 am (at the age of 18-year-old) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history includes Polycystic ovarian syndrome (PCOS), obesity and COVID-19, the patient had covid prior vaccination. The patient not tested covid post vaccination. No known allergies reported. concomitant medications includes Metformin and Oral contraceptive, which were received by patient in two weeks. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered in left arm on 04Feb2021at 04:00 pm (at the age of 18-year-old) as 1st dose, single dose for COVID-19 immunisation. The facility type for vaccine was Hospital. The patient was not received other vaccine in four weeks. On 01Mar2021, the patient experienced nausea and food intolerance. Smell also affected-lingering 10 days after vaccine administration. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events with antiemetics. The outcome of the events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Headache
Clinical narrative: experiencing headaches; Also short memory lapses; This is a spontaneous report from a contactable consumer. A 66-year-old female (same age at vaccination) non-pregnant patient received first dose of bnt162b2 (BNT162B2, Solution for injection, lot: EN6200) via unspecified route of administration on 22Feb2021 at 02:30 PM as single dose in arm right for COVID-19 immunization. Medical history reported was allergies to Sulfa. Concomitant medications reported was citalopram hydrobromide (CITALOPRAM HBR, tablet) as 20 mg and Lisinopril Tablet as 2.5mg. Patient did not receive any other vaccine in four weeks. Patient didnt have covid prior vaccination nor tested post vaccination. On 07Mar2021, patient was experiencing headaches daily since Sunday and also short memory lapses. No treatment was received by patient in response to the events. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: She is worried; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20Feb2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced she is worried. Patient mentioned that she was scheduled to get the second dose on saturday. She was worried that she might not get it since they mixed up names and showed up her in another location that is a 5h drive from her home, in the other cost. She wanted to know what happened if she do not get it in 21 days, do she have to repeat the doses. She sentenced that if she do not get the second dose in time, she would get another vaccine from another manufacturer and wanted to know if she was going to have stock within 42 days (away from the date she got the first dose) in the location she was going to go for the second dose. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, Swelling
Clinical narrative: Slightly swelling; Pain; This is a spontaneous report from a contactable consumer (reported for himself). A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration, administered in Arm Right on 15Feb2021 (at the age of 72-year-old) 10:15 as 1st dose, single dose for covid-19 immunization. Medical history included hypothyroidism. patient had allergic to Pollen, variety of food. Concomitant medications included levothyroxine sodium (SYNTHROID); fluoxetine hydrochloride (PROZAC); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); calcium (CALCIUM); docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3 [DOCOSAHEXAENOIC ACID; EICOSAPENTAENOIC ACID; TOCOPHEROL]). It was reported that, 45 minute later the patient experienced slightly swelling, pain on 15Feb2021 11:00 . He was exposed 24 hours a day for 10 days to his husband 8 days after he had the vaccine. He (Husband) had a positive Covid test on 22Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 01Mar2021. Patient did not receive any treatment for events. On an unspecified date in 2021, the patient had recovered from the events.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Nausea; Moderate to Severe myalgia and arthralgia; Moderate to Severe myalgia and arthralgia; Low grade fever; This is a spontaneous report from a contactable other Health Care Professional reported (Patient). A 47-year-old non- pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9264), via intramuscular route of administration, administered in Arm Left on 23Feb2021 at hospital (at the age of 47-year-old) as second single dose for COVID-19 immunisation. The patient medical history was not reported. No known drug allergy was reported. Concomitant medications received in two weeks of vaccination included escitalopram 5mg once a day taken for an unspecified indication, start and stop date were not reported. Patient previously received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261), via intramuscular route of administration, administered in Arm Left on 03Feb2021 at 10:15 (at age of 47 Year of age), as a single dose for COVID-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. On 02Mar2021, the patient experienced moderate to severe myalgia and arthralgia, low grade fever, nausea. It was reported that adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events included muscle relaxers. On 03Mar2021, the patient underwent Covid test (Covid tested post vaccination) which included, Covid test type post vaccination: nasal swab/ COVID 19 PCR (Polymerase chain reaction) with result: negative. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Swelling face
Clinical narrative: my face started swelling in my lower right cheek and a little bit on my upper neck. Then within 15-20 min my left lower cheek started swelling slightly; right side of my tongue started to tingle; This is a spontaneous report from contactable consumers (one of them was patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot Number: EN6260), dose 1 via an unspecified route of administration, administered in right arm on 05Mar2021 16:45 (at the age of 39-year-old) as single dose for COVID-19 immunization. The patient medical history included allergic to shellfish and iodine. Concomitant medications included levothyroxine, colecalciferol (VITAMIN D 3) and prenatal vitamins; all the concomitant medications were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 Vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 05Mar2021 16:45, the patient received first dose of the vaccine within 5 minutes her face started swell and she had tingling on her tongue. The patient stated that "I received my first does of the vaccine and within 5 min my face started swelling in my lower right cheek and a little bit on my upper neck. Then within 15-20 min my left lower cheek started swelling slightly. The right side of my tongue started to tingle as well". From the onset of the reaction to the when it started to go away was around an hour. She stated that they observed her and she didn't got into anaphylactic shock or need emergent care. She stated that she filed an online report and wanted to speak to someone in person regarding her reaction and whether or not she should get the second vaccine. She stated that her physician didn't know whether she should or not and did not give her guidance on getting the second dose. The patient wanted to know if she can get the second dose. No treatment was received for the events. Outcome of the events was reported as resolved.  No follow-up attempts are needed. No further information is expected
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling, Swelling face
Clinical narrative: my face started swelling in my lower right cheek and a little bit on my upper neck. Then within 15-20 min my left lower cheek started swelling slightly; right side of my tongue started to tingle; This is a spontaneous report from contactable consumers (one of them was patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot Number: EN6260), dose 1 via an unspecified route of administration, administered in right arm on 05Mar2021 16:45 (at the age of 39-year-old) as single dose for COVID-19 immunization. The patient medical history included allergic to shellfish and iodine. Concomitant medications included levothyroxine, colecalciferol (VITAMIN D 3) and prenatal vitamins; all the concomitant medications were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 Vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 05Mar2021 16:45, the patient received first dose of the vaccine within 5 minutes her face started swell and she had tingling on her tongue. The patient stated that "I received my first does of the vaccine and within 5 min my face started swelling in my lower right cheek and a little bit on my upper neck. Then within 15-20 min my left lower cheek started swelling slightly. The right side of my tongue started to tingle as well". From the onset of the reaction to the when it started to go away was around an hour. She stated that they observed her and she didn't got into anaphylactic shock or need emergent care. She stated that she filed an online report and wanted to speak to someone in person regarding her reaction and whether or not she should get the second vaccine. She stated that her physician didn't know whether she should or not and did not give her guidance on getting the second dose. The patient wanted to know if she can get the second dose. No treatment was received for the events. Outcome of the events was reported as resolved.  No follow-up attempts are needed. No further information is expected
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nasal congestion, Oropharyngeal pain
Clinical narrative: Sore throat; fatigue; head ache; head congestion; Diarrhoea; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient(non-pregnant) received unknown dose of BNT162B2 (PFIZER-BOTECH COVID-19 VACCINE, solution or injection, Batch/Lot number was not reported), via an unspecified route of administration on 06Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown whether patient had other vaccine in four weeks, other medications in two weeks. The patient was not tested covid positive prior vaccination. The patient did not have covid prior vaccination. It was reported that on 08Mar2021 the patient experienced sore throat, fatigue, headache, head congestion, diarrhea. outcome of the events was not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Throat irritation, Urticaria
Clinical narrative: Itchiness on the throat, core of the body, and scalp; Hives on the throat; Itchiness on the throat, core of the body, and scalp; This is a spontaneous report from a contactable other hcp (patient). A 37-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 04Mar2021 12:15 (Batch/Lot Number: EN6199) as single dose for COVID-19 immunisation. Medical history included Subclinical hypothyroidism. Known allergies of various foods but not top 8. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM); ashwagandha (ASHWAGANDHA); ergocalciferol (VIT D); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The patient had no Covid prior vaccination. Since 05Mar2021 02:30 AM, the patient experienced Itchiness on the throat, core of the body, and scalp. Hives on the throat. AE resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment. The patient had not tested Covid post vaccination. Outcome of the events was recovering.  No follow-up attempts are Possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Exposure via partner
Clinical narrative: after being intimate with him, she started to have sore knee joints; after being intimate with him, she started to have sore knee joints; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that her fiance received both doses of Pfizer COVID vaccine and stated that after being intimate with him, she started to have sore knee joints. First she thought her knees were just acting up, but then it started being more sore. The patient asked why she was more sore and did she have the vaccine in her body now. The patient further asked what was the duration of immunity of the vaccine and if the next round of shots would be given next year. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Malaise, Nasal discomfort, Rhinalgia, Swelling
Clinical narrative: painful sensation on her nose; swelling on the left part of the nose; inhaled she feel everything irritated within; malaise; She had her throat dry; This is a spontaneous report from a contactable consumer. This female consumer reported for herself.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number was not reported), dose 1 via an unspecified route of administration on 25Feb2021 as 1 ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 03Mar2021 the patient experienced painful sensation on her nose, swelling on the left part of the nose and it began to drop liquid out of it, she had her throat dry and when she inhaled she feel everything irritated within and also she had malaise. On the day of report (09Mar2021), the patient did not have the symptoms anymore, but her nose ended up a little sensitive. The patient mentioned that she had the same pain on the same side of the nose cartilage. She would like to know if this might be caused by the vaccine. The patient was scheduled to get the second dose on 18Mar. The patient was recovered from the events in Mar2021 where as painful sensation on her nose was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache that started the following day and had proceeded to get worse; This is a spontaneous report from a contactable consumer (reporting on herself). A 50-years-old Non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number: EN6205 and Expiration Date was not reported), via an unspecified route of administration in Arm Right on 04Mar2021 13:00, as 1st dose, single dose for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19, and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that headache that started the following day (on 05Mar2021 at 07:00) and has proceeded to get worse. Adverse event was resulted in Doctor or other healthcare professional office/clinic visit. Patient did not received any treatment. Patient did not tested covid post vaccination. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Paraesthesia
Clinical narrative: Severe right burning thigh pain; Severe right burning thigh pain; Severe right burning thigh pain and paresthesia; This is a spontaneous report from a contactable Physician. This Physician reported for a 65-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL92666) via intramuscularly, administered in arm right on 14Feb2021 14:45 as single dose for covid-19 immunisation. Medical history included graves disease and prediabetes. The patient had known allergies to Penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and metformin were received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient experienced severe right burning thigh pain and paresthesia on 20Feb2021, this resulted in clinical visit (Physician office visit). The patient did not receive the treatment for the events. The patient did not underwent COVID test post vaccination. The outcome of events was resolving.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Myalgia, Ocular hyperaemia, Skin discolouration
Clinical narrative: redness of the eyes; blurred vision; headache; muscle pain; body chills; blueish discoloration in hands; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on 03Mar2021 as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Mar2021, the patient experienced redness of the eyes with blurred vision, headache, muscle pain, body chills & blueish discoloration in hands. Caller asked if she should receive the second Pfizer Covid vaccine The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: redness of the eyes; blurred vision; headache; muscle pain; body chills; blueish discoloration in hands; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on 03Mar2021 as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Mar2021, the patient experienced redness of the eyes with blurred vision, headache, muscle pain, body chills & blueish discoloration in hands. Caller asked if she should receive the second Pfizer Covid vaccine The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.