chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pruritus, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; feel itchy; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events in two patients (for her and her husband). This is the first of two reports. This is the report for the reporter (patient).  A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 69-years-old via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported; expiry date reported as 30Mar) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient reported that they, together with her husband received the vaccine on 09Mar2021 and then 5 days after they feel itchy, feel high fever, too much fever, it was going in and out; she does not want to eat and the report is positive. They went to the hospital and had a COVID-19 test and the reports were positive, her husband and herself was positive. The hospital gives services in hotel for 9 days after that, the 10 day is in the house, so the second vaccine is schedule on March but they did not go to there because they are under the isolation. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (Had a COVID-19 test and the reports were positive) on 14Mar2021. The outcome of the event was unknown  Information about lot/batch has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021441601 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Rash, Rash pruritic, Vulvovaginal pain, Vulvovaginal pruritus
Clinical narrative: She develops a little smaller on that her left arm with some pimples and a rash towards her back towards her the left arm/painful also itchy; She develops a little smaller on that her left arm with some pimples and a rash towards her back towards her the left arm/painful also itchy; developed a rash on her vagina; vagina is all red, itchy and also a little pain in her vagina; developed a rash on her vagina; vagina is all red, itchy and also a little pain in her vagina; developed a rash on her vagina; vagina is all red, itchy and also a little pain in her vagina; This is a spontaneous report received from a contactable consumer (Patient husband). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on an unspecified date (Lot Number: ER8727) as SINGLE DOSE for covid-19 immunisation.  Medical history included diabetic and high blood pressure. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (lot number: EN6206) as single dose for covid-19 immunisation. On her first shot that she had she developed small round rashes in the back like a four pimple that appear on 19Mar2021, and with the second vaccine, two days later she developed a little smaller on that her left arm with some pimples and a rash towards her back towards on the left arm and she visited her dermatologist today (15Apr2021) and she have been prescribed with some cream(Treatment) to alleviate the pain, the itching they actually they were painful also itchy and also she developed a rash on her vagina. When paraphrased the concern, reporter stated,  "Yes, it also in her vagina is all red, itchy and also a little pain in her vagina." The date 09Apr2021 that was when the second rash appeared. The first rash appeared on 19Mar2021. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vulvovaginal rash
Clinical narrative: She develops a little smaller on that her left arm with some pimples and a rash towards her back towards her the left arm/painful also itchy; She develops a little smaller on that her left arm with some pimples and a rash towards her back towards her the left arm/painful also itchy; developed a rash on her vagina; vagina is all red, itchy and also a little pain in her vagina; developed a rash on her vagina; vagina is all red, itchy and also a little pain in her vagina; developed a rash on her vagina; vagina is all red, itchy and also a little pain in her vagina; This is a spontaneous report received from a contactable consumer (Patient husband). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on an unspecified date (Lot Number: ER8727) as SINGLE DOSE for covid-19 immunisation.  Medical history included diabetic and high blood pressure. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (lot number: EN6206) as single dose for covid-19 immunisation. On her first shot that she had she developed small round rashes in the back like a four pimple that appear on 19Mar2021, and with the second vaccine, two days later she developed a little smaller on that her left arm with some pimples and a rash towards her back towards on the left arm and she visited her dermatologist today (15Apr2021) and she have been prescribed with some cream(Treatment) to alleviate the pain, the itching they actually they were painful also itchy and also she developed a rash on her vagina. When paraphrased the concern, reporter stated,  "Yes, it also in her vagina is all red, itchy and also a little pain in her vagina." The date 09Apr2021 that was when the second rash appeared. The first rash appeared on 19Mar2021. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Pain at injection site; arm pain; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 15Apr2021 15:00 (Batch/Lot Number: EP7534) at age of 55-years-old as single dose for covid-19 immunisation. Medical history included aplastic anemia from 2001, myelodysplastic syndrome (MDS) from 2009, graves disease 1970s diagnosis, past myocardial infarction (MI), antiphospholipid antibodies (APLA), stroke, seizure due to stroke, bone marrow transplant in 2009. Prior to vaccination, the patient was diagnosed with COVID-19. Known allergies included mostly antiseizure meds, dilantin, depakote, CT contrast. Concomitant medication in two weeks included levothyroxine sodium (SYNTHROID); lifitegrast (XIIDRA) taken; estrogens conjugated (PREMARIN); acetylsalicylic acid (ASPIRIN); vitamin d (VITAMIN D NOS). No other covid prior vaccination. The patient previously took first dose of bnt162b2 (Lot # EL3248) on 03Mar2021 16:30 in right arm for COVID-19 Immunization. The patient experienced pain at injection site on 15Apr2021 17:00 with outcome of recovering, arm pain on 15Apr2021 with outcome of unknown. No treatment received for event pain at injection site. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back disorder, Back pain, Condition aggravated
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 81-years-old male patient received bnt162b2 (COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 31Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunization. The patient medical history included lumbar problem. Concomitant medication included baclofen (BACLOFEN) taken for muscle relaxant therapy, start and stop date were not reported. The patient took the first bnt162b2 on 10Mar2021 in left arm for COVID-19 immunization and didn't feel anything. The second shot the patient took 21 days later, the first week the patient didn't feel anything but the second week, now the patient already suffered with lower back problem in the lumbar region of his back and since the patient took the second shot in the second week it seems like it got elevated that lower back problem from his back up to his neck and the patient was already taking a muscle relaxant tablet Baclofen 20 mg. It was supposed to relax muscle in his lower back/ lumbar region of his back. The first shot, it didn't affect the lower back but the second shot elevated the lumbar problem that the patient was having up to spine section of his back. The patient already had the lumbar problem but it seems like the second shot had elevated the pain up the whole back. The patient was having back problem with his whole back. The patient had taken the medication which was muscle relaxer and then the second shot had a muscle relaxer in it. The patient think that second shot was going to react with the bad numb body region that the patient had in his back and causing it to elevate up his back. The patient just feel that if you got a back problem the patient believed that the second shot seems like having a relaxer or something in it that would act with the tablet that you already were taking for the lumbar region of the back. The patient didn't have it going up his back, it was in one shot but now it went down the legs, the patient was having problem in his back. But the patient was concerned about the leg problem but since it was going up the back further than what the patient had at first. The patient had no problem with the first one. the patient think the first one was like 1 mg and the second one was 3 mg. 1 week from the date of shot. Around 06Apr2021 the patient began to have problem. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Vision blurred/ eyes to be blurred; This is a spontaneous report from a non-contactable consumer (patient's parent). A female patient of an unspecified age received second dose of BNT162B2 (Lot Number: Unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter informed reporter's daughter got a COVID Vaccine for Pfizer's second dose and her 'visual' (not clarified) vision is blurred, she went to all the eye doctor and they can't figure it out what was going on, so she need to understand what you guys have in that vaccine that was causing her eyes to be blurred and she can't understand, read or write or anything. Reporter stated they were dealing with serious things. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Swollen Lymph nodes (under right arm and neck); Nausea; Tiredness; Chills; Headache; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0150), via an unspecified route of administration in right arm on 10Apr2021 (at the age of 53-years-old) at 10:15 at single dose for COVID-19 immunization. The patient's medical history included sleep apnea, sulfonamide allergy and prediabetes. Concomitant medications included vitamin D and vitamin C. Prior to vaccination, the patient was not diagnosed with COVID-19 and was not pregnant. The patient experienced swollen lymph nodes (under right arm and neck), nausea, chills, headache, muscle pain, tiredness, and joint pain on 11Apr2021. The events were reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment of Naproxen 500mg. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was reported as recovering.  No follow-up attempts are possible; No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Swollen Lymph nodes (under right arm and neck); Nausea; Tiredness; Chills; Headache; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0150), via an unspecified route of administration in right arm on 10Apr2021 (at the age of 53-years-old) at 10:15 at single dose for COVID-19 immunization. The patient's medical history included sleep apnea, sulfonamide allergy and prediabetes. Concomitant medications included vitamin D and vitamin C. Prior to vaccination, the patient was not diagnosed with COVID-19 and was not pregnant. The patient experienced swollen lymph nodes (under right arm and neck), nausea, chills, headache, muscle pain, tiredness, and joint pain on 11Apr2021. The events were reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment of Naproxen 500mg. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was reported as recovering.  No follow-up attempts are possible; No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Movement disorder, Neuralgic amyotrophy, Pain in extremity
Clinical narrative: experience arm pain; weakness; difficulty moving his arm; pain under his shoulder; Parson Turner Syndrome (neuritis); This is a spontaneous report from a contactable physician. A 21-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm pain followed by difficulty moving his arm. He was requiring a sling at the time of the report, had been prescribed ketorolac tromethamine (TORADOL) and steroids but was not doing any better. He was having continued weakness and pain under his shoulder. Physician was asking for documentation or studies that had been done to determine if the vaccine had any relationship with Parson Turner Syndrome (neuritis) and recommendations for management. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021438381 Same reporter/drug/AE, different patient
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Was really tired after the first vaccine; This is a spontaneous report received from a contactable consumer (patient). A 53-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on left deltoid single dose for COVID-19 immunization on 29Mar2021, 11:30am, at 53-year old. Medical history included: bipolar disorder, breast cancer, slightly high blood pressure. Concomitant medications included: ongoing letrozole 2.5mg tablet once daily from 2017; ongoing omeprazole 20mg once daily for constant heartburn; ongoing propranolol (PROPANOLOL) 20mg twice daily from 2016; ongoing clonazepam 0.5mg twice a day for anxiety from 2016; ongoing venlafaxine hydrochloride (EFFEXOR) 75mg for bipolar disorder. The patient previously received flu shot (vaccines, unspecified) a couple of years ago. The patient was really tired after the first vaccine. Outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pruritus, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; itchy; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients. This is the second of two reports.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6O04, expiry date: 30Mar, as reported), via an unspecified route of administration, on 09Mar2021, as single dose, for COVID-19 immunisation, at a hospital. The patient's medical history and concomitant medications were not reported. The reporter and her husband received the vaccine on 09Mar2021 and then 5 days after (14Mar2021) they feel itchy, feel high fever, too much fever, it was going in and out; and the report is positive. They went to the hospital and had a COVID-19 test and the reports were positive, her husband and herself was positive. The hospital gave services in hotel for 9 days after that, the 10 day is in the house, so the second vaccine is schedule in March but they did not go to there because they are under the isolation. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (Had a COVID-19 test and the reports were positive) on 14Mar2021. The outcome of the events was unknown  Information about lot/batch has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021440584 same reporter, drug, event; different patient
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: This is a spontaneous report received from a contactable consumer (the patient). A 68-year-old non-pregnant female patient received BNT162B2 (COVID-19 VACCINE), dose 1 on 24Feb2021 11:30 AM(Lot Number: EL8982), dose 2 on 17Mar2021 11:30 AM (Lot Number: ER2613), both via an unspecified route of administration in left arm at the age of 68-year-old at singe dose for COVID-19 immunisation. Medical history included mildly high blood pressure, last year had kidney cancer (resolved with surgery), allergies: cefalexin monohydrate (KEFLEX) (antibiotic). Concomitant medications included cholecalciferol (D3), acetylsalicylic acid (BABY ASPIRIN), ubidecarenone (COQ10), and cetirizine hydrochloride (ZYRTEC), all taken for an unspecified indication from an unspecified date. No COVID prior vaccination. No COVID tested post vaccination. The patient continued to have muscle/joint pain in her legs. It was mild after the first injection, but more bothersome after the second injection and has remained for several weeks. The events onset date after the first dose was not specified (2021), the events onset date after second dose was reported as 25Mar2021 09:00 AM. No treatment received for the events. The outcome of the events was not recovered. The events were non-serious. No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Hypersensitivity, Pain, Rash
Clinical narrative: This consumer (patient's daughter) reported that a 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown) at single dose for COVID-19 immunization on 13Apr2021 at 4:45-4:50pm. Relevant history and concomitant drugs were unknown. The consumer reported on Wednesday morning (14Apr2021), her mom woke up with the rash. It continued to worsen. The patient was on an antiviral, narcotic pain medication for the pain, and a lidocaine patch.  They took the patient to the emergency room Saturday. They said it wasn't a side effect. They first thought it was just a rash, but it continued to get worse and painful. It turned out to be shingles since 17Apr2021. They originally thought her mom was just having an allergic reaction so they gave her Benadryl. When they called in to report it on Friday, they told her to take her mom to the Emergency room. The patient went to the Emergency room Saturday morning. The outcome of event rash, and shingles was not resolved, the outcome of other events was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable consumer (patient).  A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in deltoid right on 19Feb2021 12:30 (Batch/Lot Number: EL9266) as single dose for covid-19 immunisation. Medical history included allergies: dogs, cats, pollen, dust, feathers, erythromycin. Historical vaccine included tetanus shot with flu like symptoms: fever. Concomitant medication included loratadine (CLARITINE) taken for allergies from an unspecified start date and ongoing. The patient experienced sore arm on 19Feb2021 14:00 with outcome of recovered.  Patient received treatment Ibuprofen for the event.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in her shoulder; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2, via an unspecified route of administration on 13Apr2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain in her shoulder on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fever; This is a spontaneous report from a contactable consumer or other non hcp (patient's sister). This case refers to third of third. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, Solution for injection) via an unspecified route of administration on 13Apr2021 (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced low grade fever on an unspecified date. The outcome of the event was reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: chills; possibly fever; headache; This is a spontaneous report from a contactable Other HCP (patient). This 46-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm at the same age on 20Apr2021 08:30 AM (lot number: ER8731) as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 30Mar2021 08:00 AM (lot number: ER8733) as single dose for Covid-19 immunisation. About 12 hours after the 2nd dose, the patient got the chills, and possibly fever on 20Apr2021 at 08:00 PM. The patient woke up next morning with fever and headache. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Cold sweat, Diarrhoea
Clinical narrative: fever of 103deg; stomach cramps; cold sweats; nausea; diarrhea; extreame cold chills; headaches; indigestion; This is a spontaneous report from a contactable consumer. A adult 43 year old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 14Apr2021 09:00 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunisation. The patient medical history included overweight. Concomitant medication(s) included valacyclovir [valaciclovir] (VALACYCLOVIR [VALACICLOVIR]), paracetamol (TYLENOL), loratadine (CLARITINE) and multivitamins taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 administered in Arm Left on 24Mar2021 09:00 (Lot Number: ER8727). The reporter stated that the day after the second dose he had a fever of 103deg, stomach cramps, cold sweats, nausea, diarrhea, extreme cold chills and headaches on 15Apr2021 18:00 and indigestion on 15Apr2021. These lasted until the fourth day. he started feeling better but almost every night since the vaccine I have had a little headache, and nausea. he thought it was going away until last night 20Apr2021 the headache has returned worse and he had a low grade fever along with indigestion. As he was writing this he have cold sweats and a headache. The patient did not receive any treatments for the events. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks and prior to the COVID-19 vaccine. The outcome of the events fever of 103deg, stomach cramps, cold sweats, nausea, diarrhea, extreame cold chills, headaches was reported as not recovered and indigestion was reported as unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Headache, Nausea, Pyrexia
Clinical narrative: fever of 103deg; stomach cramps; cold sweats; nausea; diarrhea; extreame cold chills; headaches; indigestion; This is a spontaneous report from a contactable consumer. A adult 43 year old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 14Apr2021 09:00 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunisation. The patient medical history included overweight. Concomitant medication(s) included valacyclovir [valaciclovir] (VALACYCLOVIR [VALACICLOVIR]), paracetamol (TYLENOL), loratadine (CLARITINE) and multivitamins taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 administered in Arm Left on 24Mar2021 09:00 (Lot Number: ER8727). The reporter stated that the day after the second dose he had a fever of 103deg, stomach cramps, cold sweats, nausea, diarrhea, extreme cold chills and headaches on 15Apr2021 18:00 and indigestion on 15Apr2021. These lasted until the fourth day. he started feeling better but almost every night since the vaccine I have had a little headache, and nausea. he thought it was going away until last night 20Apr2021 the headache has returned worse and he had a low grade fever along with indigestion. As he was writing this he have cold sweats and a headache. The patient did not receive any treatments for the events. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks and prior to the COVID-19 vaccine. The outcome of the events fever of 103deg, stomach cramps, cold sweats, nausea, diarrhea, extreame cold chills, headaches was reported as not recovered and indigestion was reported as unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Back disorder
Clinical narrative: Got a real back problem; This is a spontaneous report from a contactable consumer report for self. This 74-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated between his first and second dose of the vaccine he got a real back problem and took drugs and is on the final course of prednisone. He stated today (as of 21Apr2021) is day 41 after the first dose so he has 24 hours to get the second shot. The event outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: anxiety everyday soon after waking up; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 at single dose for COVID-19 immunisation. Medical history included anxiety and panic attacks. Patient had been free of anxiety/panic attacks for 6 years. The patient's concomitant medications were not reported. Patient previously received the first dose of Pfizer Covid vaccine on 16Mar2021. The first week he felt fine, then the second week he began to feel his panic and anxiety increase and he had a panic attach in which he was admitted to the emergency department. The patient experienced anxiety everyday soon after waking up after the second vaccination. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She became symptomatic for Covid 19 two days later and tested positive 4 days later; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.   The patient's concomitant medications were not reported.  It was reported that the patient received dose 1 of COVID vaccine and then two days later (08Apr2021) she got COVID with outcome of unknown.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 08Apr2021. Patient's dose 2 was scheduled for Monday and inquired if she should take it or reschedule.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: sleepy; tired; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiry date unknown), via an unspecified route of administration on 15Feb2021 as a SINGLE DOSE for COVID-19 immunisation and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiry date unknown), via an unspecified route of administration on 08Mar2021 as a SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was sleepy and tired the next 2 days after the first and second shots and were the only effects patient had. Outcome of the all the events were reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Mouth haemorrhage
Clinical narrative: There was some bleeding in his mouth; he tasted the blood on his tongue; blood is coming from the mouth continuously and I can taste the blood; Had a nose bleed but that happened one time; This is a spontaneous report from a contactable consumer (patient). This 37- year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EW0171), via an unspecified route of administration, on 20Apr2021 (at the age of 37-years-old) as a single dose for COVID-19 vaccination. Patient has no relevant medical history or concomitant medications. He got the 1st dose of Pfizer COVID vaccine yesterday around 12, and had "normal swelling and stuff like that, nothing major but today from the morning, blood is coming from the mouth continuously and I can taste the blood like as if the sensation that you get in your mouth when you have a blood in your mouth and usually when I spit I found it a bit more and sometimes a bit less but it is there, every time I spit, it was once I got from the nose but from the mouth I am not sure what is the source of that bleeding, is it gums or coming out from where I do not know."  No treatment was received. The clinical outcome of the events was unknown.   Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast pain, Dyspnoea, Product administered at inappropriate site
Clinical narrative: was given the vaccine behind my deltoid in the fatty part of my arm; had severe left breast pain radiating to my back accompanied; shortness of breath; had severe left breast pain radiating to my back accompanied; This is a spontaneous report from a contactable consumer (nurse and patient herself). This female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on an unspecified Sunday at 12:00 as single dose behind her deltoid in the fatty part of her arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The question is the patient received the second shot of the Pfizer vaccine Sunday at 12:00, was given the vaccine behind her deltoid in the fatty part of her arm. She had severe left breast pain radiating to her back accompanied with shortness of breath since Tuesday morning. Patient wanted to know if that side effect has been reported with vaccine. Was the vaccine given this way considered to be effective? Response included Off label disclaimer provided. Pfizer is unable to make recommendations for individual patients who received an invalid vaccine dose; clinical judgment based on the medical history and the clinical status of a specific patient should dictate the appropriate actions to be taken. As per CDC guidelines if the vaccine was given via an incorrect route (e.g., subcutaneous) Do not repeat dose. Inform the recipient of the potential for local and systemic adverse events. Informed caller the only side effects that has been reported with the vaccine is difficulty breathing but that's secondary to a severe allergic reaction which generally occur within few minutes to an hour post vaccination. Reporter asked if Pfizer refund medical expenses, response included Program program that has been created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of certain medical countermeasures. Events were reported as non-Serious. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling, Swelling
Clinical narrative: swollen lymph nodes; her arm started swelling and it progressed to her neck, chest and head, the swelling persist; her arm started swelling and it progressed to her neck, chest and head, the swelling persist; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 as single dose for COVID-19 immunization. Medical history included HAE hereditary edema. Concomitant medication included steroids. The patient received the first dose of the PFIZER-BIONTECH on 23Mar2021 within 8 minutes her arm started swelling and it progressed to her neck, chest and head, the swelling persist. On 24Mar2021, she went to ER they treated her first with Benadryl and anti-inflammatory drugs and then with steroids, she's been taking steroids for a month; she was diagnosed with HAE hereditary edema. She also experienced swollen lymph nodes on unspecified date. Patient stated she hadn't had a facial surgery and the swelling persist and it's been a month, she hasn't received the second dose of the vaccine. Patient would like to know when this was expected to go away and how protected she was from the first dose of the vaccine because she's also taking steroids. The outcome of the events was unknown. This report was assessed as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the first dose of BNT162B2 (COVID-19 VACCINE, lot number: ER8727) via an unspecified route of administration on 05Apr2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient had the first shot on Aril 5th and he had a little outbreak of shingles. He had a little reaction, a single outbreak across his chest. Patient asked if he should continue to take the second dose. Patient stated that he was just curious about the dose and whether to take second dose. The reaction was minor and he went to see his primary doctor and it was not serious, just 5 little dots. Outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vascular injury
Clinical narrative: the Pfizer covid vaccine hit the blood vessel; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for Covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced the Pfizer Covid vaccine hit the blood vessel on an unspecified date. Outcome of event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: This is a spontaneous report received from a non-contactable consumer reported for himself. This male patient with unspecified age received NT162B2 (COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications were none. The patient experienced a herpes spot pop out on his lip after the COVID vaccine. The outcome of event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of BNT162B2 (COVID-19 VACCINE), via an unspecified route of administration on 12Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fall on an unspecified date with outcome of unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia, Urine analysis abnormal
Clinical narrative: Having dark urine, concentrated urine; Having dark urine, concentrated urine; This is a spontaneous report from a contactable consumer (patient). This male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Apr2021 as single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as single dose for covid-19 immunisation. On 19Apr2021 evening, the patient had been having dark urine, concentrated urine, no matter how much water drink. 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: Headache, Illness, Tinnitus
Clinical narrative: headache; ringing in head; being sick; This is a spontaneous report from a contactable consumer(patient).  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced a headache she went through a stage of being sick, there was ringing in head, all on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness, Pain in extremity, Vaccination site pain
Clinical narrative: his arm is sore and tight; his arm is sore and tight; specifically soreness where the shot was.; This is a spontaneous report from a contactable consumer reported for himself. This 26-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the first dose of the Pfizer covid 19 vaccine on 20Apr2021 and his arm was sore and tight, specifically soreness where the shot was. Event outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue
Clinical narrative: Ear ache; Tiredness; This is a spontaneous report from a contactable consumer (patient's daughter) via Medical information Team. An 88-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 20Apr2021 (at the age of 88-year-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed an ear ache and tiredness since receiving the vaccine on 20Apr2021. The consumer asked these are normal side effects and how long will they last. Outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hot flush, Hyperhidrosis, Insomnia, Joint contracture
Clinical narrative: Felt a warm rush come over her entire body; Felt faint; Sweating and beads of sweat came out of her entire body; Nauseous; Both of her hands locked in a claw-like position and couldn't move them; Both of her hands locked in a claw-like position and couldn't move them; Nerve pain in both of her hands that keeps her up at night; Nerve pain in both of her hands that keeps her up at night; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0171), via an unspecified route of administration in left arm, on 19Apr2021 at 09:30 AM, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included escitalopram oxalate (LEXAPRO), probiotics, magnesium, fish oil, and silicon dioxide (SILICA). The patient previously took the first dose of BNT162B2 (Lot Number: EP6955) on 22Mar2021 at 09:30 AM at the age of 38 years for COVID-19 immunization (left arm); and erythromycin and experienced allergies. The patient had no other vaccine in four weeks. The most recent vaccine was administered in a pharmacy or drug store facility. On 19Apr2021 at 09:45 AM (also reported as about 20 minutes after the dose), the patient felt a warm rush come over her entire body and felt faint. The patient had to sit down. The patient started sweating and beads of sweat came out of her entire body. The patient felt nauseous, both of her hands locked in a claw-like position and she couldn't move them. The patient felt an intense rush - almost like a fullness in both of her hands. This lasted about 30 to 45 minutes. Later that day (19Apr2021; unspecified time) and still, the patient now had nerve pain in both of her hands that keeps her up at night. The patient recovered but with lasting effects. No treatment was received for the adverse events. The patient had not been tested for COVID-19 post vaccination. The patient had not recovered from "Nerve pain in both of her hands that keeps her up at night". The patient recovered from the remaining events on 19Apr2021 but with sequelae.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Nausea, Neuralgia
Clinical narrative: Felt a warm rush come over her entire body; Felt faint; Sweating and beads of sweat came out of her entire body; Nauseous; Both of her hands locked in a claw-like position and couldn't move them; Both of her hands locked in a claw-like position and couldn't move them; Nerve pain in both of her hands that keeps her up at night; Nerve pain in both of her hands that keeps her up at night; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0171), via an unspecified route of administration in left arm, on 19Apr2021 at 09:30 AM, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included escitalopram oxalate (LEXAPRO), probiotics, magnesium, fish oil, and silicon dioxide (SILICA). The patient previously took the first dose of BNT162B2 (Lot Number: EP6955) on 22Mar2021 at 09:30 AM at the age of 38 years for COVID-19 immunization (left arm); and erythromycin and experienced allergies. The patient had no other vaccine in four weeks. The most recent vaccine was administered in a pharmacy or drug store facility. On 19Apr2021 at 09:45 AM (also reported as about 20 minutes after the dose), the patient felt a warm rush come over her entire body and felt faint. The patient had to sit down. The patient started sweating and beads of sweat came out of her entire body. The patient felt nauseous, both of her hands locked in a claw-like position and she couldn't move them. The patient felt an intense rush - almost like a fullness in both of her hands. This lasted about 30 to 45 minutes. Later that day (19Apr2021; unspecified time) and still, the patient now had nerve pain in both of her hands that keeps her up at night. The patient recovered but with lasting effects. No treatment was received for the adverse events. The patient had not been tested for COVID-19 post vaccination. The patient had not recovered from "Nerve pain in both of her hands that keeps her up at night". The patient recovered from the remaining events on 19Apr2021 but with sequelae.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: 102° fever; chills; headache; This is a spontaneous report from a contactable other hcp. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), lot number EN5318, via Intramuscular, administered in Left arm on 02Feb2021 13:00 at single dose for COVID-19 immunization and the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number PAA156057, via Intramuscular route, administered in Arm Left on 12Jan2021 12:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced 102° fever, chills and headache. No treatment was received for the events.The outcome of events was resolved in unspecified date.  No follow-up attempts are needed. No further information is expected.