chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Fatigue, Musculoskeletal stiffness, Myalgia
Clinical narrative: Extreme fatigue; Light dizziness; disorientation; Sore/stiff muscles, particularly lower extremities; Sore/stiff muscles, particularly lower extremities; This is a spontaneous report from a contactable consumer (Patient). A 44-year-old male patient received first dose of BNT162B2 (Pfizer COVID Vaccine, solution for injection, Lot# EN6202), via an unspecified route of administration, administered in left arm on 23Feb2021 at 05:00 AM (at the age of 44-years) as single dose for COVID-19 immunisation. Medical history included sleep apnea, headache and CALM supplement. The patient had no known allergies. Concomitant medication(s) included naproxen sodium for headache. On 23Feb2021 at 06:15 (1-hour and 15-minutes after vaccination), patient experienced extreme fatigue, light dizziness, disorientation, sore/stiff muscles, particularly lower extremities. The patient had not taken any other vaccine four weeks prior vaccination. The patient not had COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Lung disorder
Clinical narrative: face was flushed; At 15 minute waiting period, was feeling of opening up lungs, and that continued on drive home so about 30 minutes total.  Did not impede breathing but was like an "opening."; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old female patient (not pregnant) received the first dose of BNT162B2 (Pfizer Covid 19, solution for injection, lot number= EN6202) via an unspecified route of administration on 24Feb2021 at 09:15 AM on left arm as a single dose for COVID-19 immunization at a hospital. Medical history included atrial fibrillation, congestive heart disease. Patient received Latanoprost, Vitamins B12, Vitamin C, Vitamin D, Calcium and fish oil in two weeks. Patient did not receive any other vaccine in four weeks. Patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. At 15-minute waiting period (at 09:45), patient had feeling of opening up lungs, and that continued on drive home, so about 30 minutes total. It did not impede breathing but was like an "opening." When patient got home, so 45 minutes after the shot, patient's face was flushed but that went away in about another 15 minutes. So not particularly "adverse" but a reaction that you should knew about. No treatment was provided for the event. Outcome of the event was recovered.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Pfizer 2nd dose, batch EL3247. Period came again, 1 week after 2nd dose. Not as heavy, but only 2 weeks into regular cycle; This is a spontaneous reported from a contactable other health care professional reported for himself in response to health Care Professional letter sent in cross reference case which included that, A 31-years-old female patient received BNT162B2 (Covid-19 Vaccine; solution for injection; Batch/Lot Number: EL3247) via an unspecified route of administration on 13Jan2021 as single dose for covid-19 immunisation. Medical history included adrenogenital syndrome on Jun2020 vitamin d deficiency on unknown date in 2019, immune system disorder from 1994 and ongoing , gluten sensitivity from 2020 and ongoing , adrenogenital syndrome from 1994 and ongoing. Concomitant medication included colecalciferol (VITAMIN D) taken for vitamin d deficiency at a dose of 4000 IU per day via orally from on unknown date in 2019, methylprednisolone acetate (MEDROL) taken for adrenogenital syndrome at a dose of 3mg per day via orally from Jun2020. Historical vaccine included on 06Jan2021 BNT162B2 (Suspect Vaccine name and or/generic Name: Pfizer; Batch/Lot # and expiration date: EV0142; Prescribed dose, units and frequency: 1 Unit;Route of administration: Intramuscular; Start date: 06Jan2021; Time at vaccination: 17:30 hh: mm) for covid-19 immunisation and experienced early, heavy period on 14Jan2021. The patient reported that period came again, 1 week after 2nd dose. not as heavy, but only 2 weeks into regular cycle. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for SARS-Cov-2; tested positive for SARS-Cov-2; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient himself) reported a male patient of an unspecified age (also reported as: age: 71; unit: unspecified) who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. It was reported that patient received first dose on 30Jan2021 and tested positive for SARS-Cov-2 on 13Feb2021. Patient was asking how long to wait for the second shot. Outcome of events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: caller went to the dermatologist yesterday for eczema; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: unknown; Expiration Date: unknown), via an unspecified route of administration on 27Jan2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced eczema went to the dermatologist yesterday. Therapeutic measures were given, the patient was prescribed with prednisone. The patient was to receive her second dose of the vaccine on the day she reported and is inquiring on the use of the medication and receiving the vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: severe diarrhea; This is a spontaneous report from a contactable consumer or other non-health care professional via Pfizer-sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 17Feb2021, patient experienced severe diarrhea. Patient also took medication for his diarrhea. The patient wanted to know if this was a possible side effect. The outcome of the event was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: little bit of a sore arm; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9266) via an unspecified route of administration, administered in left arm on 16Feb2021 at a single dose for COVID-19 immunization. Medical history included ongoing osteoporosis and Degenerative vertebrae and covid. Concomitant medication included calcium lactate and ubidecarenone (COQ-10). The patient experienced little bit of a sore arm on an unspecified date. Patient had Covid and she had no effect and showed no effect at all. The patient underwent lab tests and procedures which included covid-19 positive. The outcome of the event was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching since the injection.; This is a spontaneous report from a contactable consumer.   A 71-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 24feb2021 at 10:45 as single dose for covid-19 immunisation. Medical history included food allergy, Known allergies to Many foods. Apples, peaches,nectarines, cherries, snow peas, rawnuts. Swiss cheese, possible apricots,pears. Concomitant medication(s) included diphenhydramine hydrochloride (BENADRYL), calcium, famotidine (PEPCID (FAMOTIDINE). No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. 24Feb2021 at 11:00 AM, the patient experienced itching since the injection. The event assessed as non-serious with outcome of not recovered.    Information on the lot/batch number has been requested.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: Fever; Nausea; Extremely tired; This is a spontaneous report from a contactable consumer (patient's husband). An 85-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 17Feb2021 (lot number: EM9810; expiry date: unknown), at a single dose, for COVID -19 immunisation. The patient has no relevant medical history and was not taking concomitant medications. The patient previously received first dose of BNT162B2 for COVID-19 immunisation. Patient's husband reported that his wife had a reaction to second COVID shot. On 18Feb2021, the patient experienced fever, nausea and was extremely tired. The patient did not receive treatment for the events. Outcome of the events was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Mammogram, Nodule
Clinical narrative: I woke up with four nodules under my armpit and they were of different sizes; They were painful and one was almost the size of golf ball; This is a spontaneous report received from a contactable consumer (reporting on herself). A 56-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: solution for injection, lot number: EL9266 and Expiry date was not reported), via an unspecified route of administration on 16Feb2021 as single dose for COVID-19 immunization. Medical history included , hypothyroidism, blood cholesterol increased both from an un-known date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for hypothyroidism, and Some statin for High cholesterol both start and stop date were not reported. The historical vaccine includes first dose of BNT162B2 on 26Jan2021 for COVID-19 immunization. Patient got her second Pfizer Covid vaccine on (Tuesday) 16Feb2021. On 17Feb2021 (Wednesday) she went to get mammogram and Wednesday night she woke up with four nodules under her armpit and they were of different sizes. They were painful and one was almost the size of golf ball and today she got another one. Could be please tell because her doctor was not been here due to storm so she couldn't call her. So my question was to you how long is that going to last and is that typical. Patient did lab work. It was just a high cholesterol. It was routine done week before but she don't remember what it was, it was just regular blood work. The outcome of the event was not recovered.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Chills; nausea; body aches; headache; fatigue; This is a spontaneous report from a contactable consumer (patient, self-reported). A 23-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247 and expiration date was not reported), via an unspecified route of administration in left arm on 17Feb2021 at 10:15 AM, at single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. Historical vaccine included a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247 and expiration date was not reported) via an unspecified route of administration in left arm on 27Jan2021 at 10:30 am at single dose for COVID-19 immunisation. It reported that, on 18Feb2021 after receiving the vaccination the patient experienced Chills, nausea, body aches, headache, fatigue. Vaccination facility: Workplace clinic. The patient did not receive any of the vaccine in four weeks and any of the medications in two weeks. No COVID prior vaccination and no COVID tested post vaccination. The outcome of the patient's events was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: whopping headache; sore arm; This is a spontaneous report from contactable consumer (patient) via Pfizer sales representative. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 17Feb2021 (at the age of 66years (as reported)) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received her second dose of the Pfizer COVID-19 vaccine yesterday (17Feb2021). The patient reported a mild "sore arm" and "whopping headache" as adverse events on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: muscle spasms after the COVID Vaccine; She had soreness in her arm; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously had flu shot on an unspecified date for immunisation and experienced muscle spasms. On an unspecified date, the patient experienced muscle spasms after the covid vaccine. She felt like she did when she gets a flu shot. She had also soreness in her arm. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Headache
Clinical narrative: headache; gastro intestinal problems; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 18Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Feb2021, the patient experienced side effects such as gastro-intestinal problems that started on Tuesday (23Feb2021) and headache started on Sunday (28Feb2021). She was asking as she was unsure if this side effects are related to her getting the covid vaccine or she is just sick. The events assessed as non-serious. Outcome of the events was unknown.  Information on lot/batch number has been requested  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 17 days letter was tested positive for Covid; 17 days letter was tested positive for Covid; This is a spontaneous report for initial and Follow-up 1 from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number-unknown, Expiration date unknown) via an unspecified route of administration on 24-JAN-2021 at SINGLE DOSE for COVID -19immunization. Patient medical history and concomitant medication were not reported. Patient received first dose of Covid vaccine 24Jan2020 and tested positive for Covid 17 days later. She had never took second dose of vaccine and is wondering if she can do that now. The outcome of the event was unknown  Follow-up (25Feb2021):This is a follow-up spontaneous report from a Pfizer Sponsored Program CEP 159558. Information about lot/batch number has been requested.  .
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: fell sick; was positive for covid; was positive for covid; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. A 64 years old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 27Jan2021 as SINGLE DOSE for covid-19 immunisation. Patient medical history and concomitant medications were not reported. On an unspecified date the patient fell sick and was positive for covid on 16Feb2021. The reporter was concerned about when is the right time to receive the second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Feb2021. Outcome of the events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Swollen lymph node in right arm the size of a grapefruit; Some soreness; This is a spontaneous report from a contactable consumer.  A 70-year-old female patient (non-pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN5318), via an unspecified route of administration on arm right on 23Feb2021 09:30 AM at single dose for COVID-19 immunization. The patient medical history included diabetics and asthma from an unspecified date and allergies to sulphuric from an unspecified date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, it was unknown, whether the patient had been tested for COVID-19. The patient received Insulin and paraxitone medications in two weeks. The patient did not receive any other vaccines in 4 weeks. The patient Concomitant medications was not reported. On 24Feb2021 12:00 PM, the patient experienced Swollen lymph node in right arm the size of a grapefruit and had some soreness. The patient did not receive any treatment for the events. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, COVID-19, Drug ineffective, Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: tested positive for Coronavirus after both doses of vaccine; tested positive for Coronavirus after both doses of vaccine; Exposed to Covid; This is a spontaneous report from a contactable nurse. This nurse reported for a 78-year-old female patient (reporter's friend). A 78-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration Date: unknown), dose 2 via an unspecified route of administration on 16Feb2021 and dose 1 via an unspecified route of administration on an unspecified date (Lot number: unknown), both as single dose for COVID-19 immunization. Medical history included pacemaker (got it within the last 3 years for an arrhythmia). There were no concomitant medications. On 18Feb2021, the patient was exposed to COVID and started feeling unwell. On 19Feb2021, the patient was experiencing symptoms. On 22Feb2021, the patient was tested positive for coronavirus after both doses of vaccine. The patient underwent lab tests and procedures which included body height: 5 foot 8 inches or 5 foot 9 inches on an unspecified date and sars-cov-2 test: positive on 22Feb2021. The outcome of the events was unknown. The patient's doctor advised her to have antibody infusion because she didn't tell that she got the vaccine. The reporter did some research and read that it was not advised as the antibodies would compete with each other. The reporter wants to know if the patient should do the antibody infusion after getting the vaccine or not.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, A possible contributory role of the suspect product to the development of the event cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Gait inability, Vertigo
Clinical narrative: I was unable to walk; I was completely out of balance; This dizziness continued until today and gradually got better day by day; It was like I was light headed or had Vertigo; It was like I was light headed or had Vertigo; This is a spontaneous case is received from a contactable consumer. A 69-year-old female patient received BNT162B2 (Batch/Lot Number: EL9262) dose 2 via an unspecified route of administration, administered in Arm Right on 14Feb2021 09:30 as SINGLE DOSE for covid-19 immunisation. Medical history included atrial fibrillation, hypertension, hypothyroidism. Concomitant medications included amlodipine besilate (AMLODIPINE BESILATE); apixaban (ELIQUIS) ; clobetasol (CLOBETASOL) ; levothyroxine sodium (LEVOTHYROXINE SODIUM). On 17Feb2021 07:30, the patient experienced i was unable to walk (gait inability), i was completely out of balance (balance disorder) , this dizziness continued until today and gradually got better day by day (dizziness), it was like i was light headed or had vertigo (dizziness) , it was like i was light headed or had vertigo (vertigo). The outcome for the events was recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: It was red, the injection site is big round circle and it's hot; It was red, the injection site is big round circle and it's hot; It was red, the injection site is big round circle and it's hot; This is a spontaneous report from a contactable consumer . A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EN5318), via an unspecified route of administration on an unspecified date in Feb2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, Consumer stated, "Its two weeks ago today that I have my first vaccine and after two days ago I noticed that it was red, the injection site is big round circle and it's hot and I did not have this before when I first got the shot. I did not get it. Now all of sudden I have this the reaction. Should I do something about it".  The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: feeling feverish; tired; This is a spontaneous report from a contactable other healthcare professional. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not provided), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that she was feeling feverish and tired the day after receiving her 2nd COVID vaccination. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: Pain at the site of Injection; Feeling unwell; This is a spontaneous report from a contactable other health care professional (patient). A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL3247) via an unspecified route of administration in the left arm on 18Feb2021 at 09:15 and the patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247) via an unspecified route of administration in left arm on 27Jan2021 at 10:30 as a single dose for COVID-19 immunization. The patient medical history included mild seasonal allergies. The patient not had COVID prior vaccination. The patient had no known allergies. Concomitant medication received in two weeks was included loratadine (CLARITINE). The patient did not receive any other vaccine in four weeks. On 18Feb2021 at 20:30, patient experienced Pain at the site of Injection and feeling unwell. The patient was not tested COVID post vaccination. Therapeutic measures were taken as a result of events and included treatment with Tylenol. The outcome of the events is recovering.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This is a spontaneous report received from a contactable consumer (Patient). A 74-year-old non pregnant female patient received first dose of BNT162B2 (COVID 19, Formulation: solution for injection, Lot number: EN6201, Expiry date: unknown) via an unspecified route of administration in right arm on 12Feb2021 at 12:00 AM as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. There was no other vaccine in four weeks. On 15Feb2021, the patient experienced severe muscle pain for over a week now. The patient took Ibuprofen for the event. The outcome of the event was unknown. The outcome of the events was not recovered
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Swollen tongue, Tongue discomfort
Clinical narrative: my tongue & the roof of my mouth started burning; my tongue & the roof of my mouth started burning; My tong also swelled enough that I bite the side of my tongue at night; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN9581) second dose via an unspecified route of administration, administered in left arm on 19Feb2021 13:45 as SINGLE DOSE for covid-19 immunisation. Medical history included burning tongue reaction when prescribed Zoloft, Buspiron, Effexor, so immediately stopped and burning subsided within 24 hours and also get a burning tongue reaction to walnuts and fresh pineapple, all from an unknown date and unknown if ongoing. Patient did not test positive for Covid prior to or post vaccination. Concomitant medications included ATORVASTIN, GABAPENTIN and METHENAMINE. On 27Jan2021 at 11:30 AM patient received first dose of Bnt162b2 (lot number=EL9265 in left arm). On 19Feb2021 after receiving 2nd vaccine shot patient stated that my tongue and the roof of my mouth started burning. My tongue also swelled enough that I bite the side of my tongue at night, enough to break the skin of my tongue. It has been 6 days since the 2nd shot and the burning has not diminished. Almost impossible to sleep at night. Doctor gave some prednisone yesterday to see if the auto immune reaction would diminish. The burning did not diminish. The patient was very fearful to take a booster shot in 6 months and no one was able to assure her. Patient was given Prednisone and lidocaine rinse as therapeutic measure for the events. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills until about noon today; This is a spontaneous report from a contactable consumer(Patient herself). A female patient of an unspecified age received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection ) via an unspecified route of administration on 18Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 19Feb2021, the patient experienced chills until about noon today. The caller was asking if she could take tylenol. The outcome of event was not recovered.    Information about lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: slight arm soreness; This is a spontaneous report from This is a spontaneous a report by contactable female consumer (patient) reported from a Pfizer-sponsored program . A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced slight arm soreness. The outcome of the event was unknown.  Information of lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cortisol, Gastrointestinal disorder, Vomiting
Clinical narrative: unpleasant GI issues; unpleasant GI issues made her vomit like crazy; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on an unknown date (at the age of 47-years-old), as a single dose for COVID-19 vaccination. Patient's medical history included active Epstein-Barr virus and had high cortisol levels. The concomitant medications were not reported. The patient reported that when she received BNT162B2, she experienced unpleasant GI issues and she also stated that unpleasant GI issues made her vomit like crazy. The patient has not had this in over 20-25 years. The outcome of the events was unknown.   No follow-up attempts are possible.   Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: she's experiencing shoulder sore and feeling achy after she had her second dose; This is a spontaneous report from a contactable female consumer (Patient) via Pfizer sponsored program .   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), dose 2 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced shoulder sore and feeling achy after she had her second dose. The patient asked by the caller if it is okay to take Tylenol since she's experiencing shoulder sore and feeling achy after she had her second dose of Covid-19 vaccine. The outcome of the event was unknown.  Information about Lot/Batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: Flu-like symptoms; pain; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection), dose 1 via an unspecified route of administration on 18Feb2021 (Batch/Lot number was not reported) at the age of 75 years old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown If other vaccine in four weeks. The patient experienced Flu-like symptoms and pain on an unspecified date. Patient went to the emergency department where he was evaluated and then released. Adverse events resulted in Emergency room/department or urgent care. It was unknown if treatment received. It was unknown if covid prior vaccination and if covid tested post vaccination. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed. Information about lot/ batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Asthenia, Body temperature, Chills
Clinical narrative: Milder form of weakness; Dizziness; Fever of 102 degrees; Horrible headache; Body aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6201, Expiration Date: 30Jun2021), via an unspecified route of administration in left arm, on 21Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history included blood pressure, cholesterol, thyroid, use of sleeping pill (sleeping pill at night and drinks 2-3 oz of Vodka; falls asleep immediately), and alcoholic (doctor is convinced but patient denies; drinks 2-3 oz of Vodka every night). The patient's concomitant medications included hydrochlorothiazide/ lisinopril (LISINOPRIL HCT) for blood pressure, atorvastatin for cholesterol, liothyronine sodium for thyroid from 1970, and liothyronine sodium (CYTOMEL) for thyroid, all were ongoing; and a sleeping pill. The patient previously took the first dose of BNT162B2 (Lot Number: EL3247, Expiration Date: May2021) on 31Jan2021 at the age of 74 years for COVID-19 immunization (left arm) and experienced severe weakness, dizzy and lightheaded, felt like she was going to pass out, tightness in chest, heavy breathing, electrocardiogram (EKG) showed irregular with elongated T waves (09Feb2021), and liver enzymes (ALT and AST) jumped significantly (09Feb2021). On 21Feb2021, the patient had a fever of 102 degrees, a horrible headache, body aches, and chills. After the second dose (22Feb2021), the patient had a milder form of weakness and dizziness. All events resulted in physician office visit. The patient asked if the vaccine could throw a blood test off. The patient read in the newspaper that the vaccine could cause temporary irregularities in breast mammograms. The patient was recovering from "Milder form of weakness". The patient recovered from "Dizziness" on 25Feb2021 but with sequel. The patient recovered from the remaining events on 22Feb2021.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Headache, Pain, Pyrexia
Clinical narrative: Milder form of weakness; Dizziness; Fever of 102 degrees; Horrible headache; Body aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6201, Expiration Date: 30Jun2021), via an unspecified route of administration in left arm, on 21Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history included blood pressure, cholesterol, thyroid, use of sleeping pill (sleeping pill at night and drinks 2-3 oz of Vodka; falls asleep immediately), and alcoholic (doctor is convinced but patient denies; drinks 2-3 oz of Vodka every night). The patient's concomitant medications included hydrochlorothiazide/ lisinopril (LISINOPRIL HCT) for blood pressure, atorvastatin for cholesterol, liothyronine sodium for thyroid from 1970, and liothyronine sodium (CYTOMEL) for thyroid, all were ongoing; and a sleeping pill. The patient previously took the first dose of BNT162B2 (Lot Number: EL3247, Expiration Date: May2021) on 31Jan2021 at the age of 74 years for COVID-19 immunization (left arm) and experienced severe weakness, dizzy and lightheaded, felt like she was going to pass out, tightness in chest, heavy breathing, electrocardiogram (EKG) showed irregular with elongated T waves (09Feb2021), and liver enzymes (ALT and AST) jumped significantly (09Feb2021). On 21Feb2021, the patient had a fever of 102 degrees, a horrible headache, body aches, and chills. After the second dose (22Feb2021), the patient had a milder form of weakness and dizziness. All events resulted in physician office visit. The patient asked if the vaccine could throw a blood test off. The patient read in the newspaper that the vaccine could cause temporary irregularities in breast mammograms. The patient was recovering from "Milder form of weakness". The patient recovered from "Dizziness" on 25Feb2021 but with sequel. The patient recovered from the remaining events on 22Feb2021.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Oxygen saturation decreased
Clinical narrative: Shortness of breath; coughing; low oxygen; This is a spontaneous report from a contactable consumer (patient). A 34-years-old female patient received first dose of BNT162B2 (Pfizer COVID 19, Solution for injection, lot number: unknown) via an unspecified route of administration on 20Feb2021 at 12:30 PM on left arm as a single dose for COVID-19 immunization. The patient is not pregnant. Medical history included COVID-19 (prior to vaccination). Concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID-19 since the vaccination. On 21Feb2021 at 12:30 PM, patient experienced shortness of breath, low oxygen and coughing which resulted in emergency room/department or urgent care. Patient received morphine for pain. Outcome of the events was not recovered.  Information on lot and batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Indicates "got sick" after a week, wife SARs-Cov-2 positive.  He was tested, also positive.; Indicates "got sick" after a week, wife SARs-Cov-2 positive.  He was tested, also positive.; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Wife) that of A unspecified age female patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown, Expiration date; unknown), via unspecified route of administration on unspecified at a single for COVID-19 immunization. The patient medical history and patient's concomitant medications were not reported. Contactable consumer first dose on 03FEB2021, after a week Indicates "got sick", and SARs-Cov-2 positive. Contactable consumer was kind of sick for a whole week and I run a test, mine came out to be positive on unspecified date. Contactable consumer wife got sick for different reason she went to the hospital and one of the case came on was Covid 19 case and she end up being positive and the same time after that one week when she went she had positive (further clarification unknown). The outcome of events unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021185205 same reporter, product and AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling sensation on lip; This is a spontaneous report from a contactable other-HCP. A 44-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, allergy to fish. Concomitant medication(s) included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) taken for blood pressure abnormal and vitamins daily from an unspecified start date and ongoing. The patient previously took compazine [prochlorperazine edisylate], reglan [metoclopramide hydrochloride], gabapentin, dilaudid. On 28Jan2021, the patient experienced tingling sensation on lip (not serious). Therapeutic measures were taken as a result of tingling sensation on lip (paraesthesia). The outcome of the event recovered  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program.  A contactable physician (patient, reported a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 13Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for covid-19 immunisation. She got the second dose of the Covid19 vaccine last 13Feb2021 and then Monday she was having back ache in Feb2021. Until now she was still experiencing mid back (as reported). The outcome of the event was not recovered.  Follow-up attempts are completed. Information about lot/ batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: I became pregnant in between my first and second dose of the series; This is a spontaneous from a contactable consumer. This female consumer reported that a female patient of an unspecified age received first and second dose of BNT162B2 (solution for injection) both doses via an unspecified route of administration as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that became pregnant in between my first and second dose of the series. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: Excruciating muscle pain; This is a spontaneous report from a contactable consumer or other non hcp. An 84-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: 610247; Expiration Date: Aug2022), dose 2 via an unspecified route of administration, in Arm Right on 11Feb2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. 5 days after vaccination, the patient experienced Excruciating muscle pain in right thigh. Her daughter-in-law had Pfizer COVID-19 Vaccine and had the same symptoms of excruciating muscle pain for two weeks. The patient took acetaminophen 250mg, aspirin (two pills q5hours), caffeine: 85mg. The outcome of the event was unknown.   No follow-up attempts are possible, and no information is required.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021208189 same drug/event, different patients.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Mild fever; body aches; This is a spontaneous report from a contactable consumer (patient). A 31-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number and expiration date were not reported) via an unspecified route of administration in left arm on 24Feb2021 (age at vaccination 31 years old) as single dose for COVID-19 immunization. Medical history included kidney disease. No known allergies were reported. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (lot unknown reason Misplaced/discarded, administration date was 28Jan2021 at 12:30 PM, vaccine location was Left arm) for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID-19. On 25Feb2021 at 04:00, patient experienced mild fever and body aches. Patient did not receive treatment for events. The outcome of events was recovered.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained. .
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site warmth, Pruritus
Clinical narrative: Redness; itching; warm to touch at injection site. About the size of a dollar; This is a spontaneous report from a contactable Nurse. A 93-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN9581), via intramuscular route of administration on 19Feb2021 as SINGLE DOSE in Arm Left for covid-19 immunization. Medical history included HTN, atrial fib, renal cell carcinoma, arthritis, osteopenia. The patient received first dose of BNT162B2 (Lot number: EL9264) via intramuscular route of administration on 29Jan2021 as SINGLE DOSE (at the age of 93-years) in Arm Left for covid-19 immunization. The patient had known allergies to: Ace inhibitors, valsartan, penicillins, azithromycin. The patient did not receive any other vaccine in four weeks. The concomitant medications included: warfarin, latanoprost, phosphatidyl, selenium, triamcinolone acetonide (Kenalog [triamcinolone acetonide]) ointment, curcuma longa (turmeric root extract), vitamin b, Echinacea C complete, amlodipine, vitamin c [ascorbic acid], atorvastatin, biotin, carvedilol, cefdinir, vitamin d3, vaccinium macrocarpon (cranberry extract), docosahexaenoic acid, fish oil, green tea extract, probiotic. Prior to the vaccination the patient was not diagnosed with COVID-19. On 25Feb2021, the patient experienced redness, itching, warm to touch at injection site, about the size of a dollar bill. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. Since the vaccination the patient had not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: This is a spontaneous report from a contactable consumer. A 66-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection,Lot Number: EN6200) via an unspecified route of administration, administered in left arm on 19Feb2021 09:00 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No covid prior to vaccination. No covid diagnosed post vaccination. No known allergies. No pregnant at the time of vaccination. The patient experienced blisters on hands and feet on 21Feb2021. Cream to use on infected as treatment. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Between the first one and the second one I got Covid; Between the first one and the second one I got Covid; This is a spontaneous report from a contactable consumer (Patient) and follow-up received on 20Feb2021 from same reporter via Pfizer-sponsored program was processed together with initial information. A female patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration on 03Feb2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient wanted to reschedule second vaccine because between the first one and the second one patient got Covid and patient haven't get 10 days of Covid yet and patient can't get the negative for  test can patient reschedule vaccine through you or no because not then patient have to call somebody else and hold for another 25-30 minutes." Patient received her first dose 3Feb2021, 9 days ago, she contracted COVID-19, she is due to her 2nd dose on the 23rd. The patient underwent lab tests and procedures which included sars-cov-2 test: covid on Between the first one and the second one I got Covid. Patient have been on hold and have been on phone for now 45 minutes, she trying to work. The outcome of the event was unknown.   Information on the lot/batch number has been requested.