chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dyspepsia, Nausea, SARS-CoV-2 test
Clinical narrative: The day after I received the vaccine, I got the common side effects, chills, loose stool, nausea. I also began having heartburn/indigestion.It has been 16 days since the first dose, and the loose stool and  heartburn/indigestion remain; The day after I received the vaccine, I got the common side effects, chills, loose stool, nausea. I also began having heartburn/indigestion.It has been 16 days since the first dose, and the loose stool and  heartburn/indigestion remain; The day after I received the vaccine, I got the common side effects, chills, loose stool, nausea. I also began having heartburn/indigestion.It has been 16 days since the first dose, and the loose stool and  heartburn/indigestion remain; The day after I received the vaccine, I got the common side effects, chills, loose stool, nausea. I also began having heartburn/indigestion.It has been 16 days since the first dose, and the loose stool and  heartburn/indigestion remain; This is a spontaneous report from a contactable healthcare professional (HCP [patient]). A 43-year-old male patient received first single dose of BNT162B2 (Pfizer, Solution for injection, lot number and exp date not reported), intramuscular (vaccine location: left arm) on 28Dec2020 for COVID-19 immunization. Facility type vaccine: Nursing Home/Senior Living Facility. Medical history included gastric sleeve and surgery. The patient had no known allergies. Patient did not have Covid prior vaccination. There was no other medical history. There were no concomitant medications. There were no other vaccine/s within four weeks. No other medications in two weeks. The day after patient received the vaccine, she got the common side effects on Jan2021: chills, loose stool, and nausea. She also began having heartburn/indigestion (Jan2021). It had been 16 days since the first dose, and the loose stool and heartburn/indigestion remain. Not sure if it's because of having the gastric sleeve done years ago, or not, as the surgery changed her metabolism and the like. No treatment was provided. Nasal Swab on 11Jan2021 was negative. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Hypertension, Tachycardia
Clinical narrative: Hypertension; Elevated HR; resting HR is tachy staying over 100 bpm; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1685), intramuscular in left arm, on 06Jan2021 at 12:00, at a single dose, for COVID-19 immunization. The patient's medical history included penicillin allergy. The patient's concomitant medication included lisinopril. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccines were administered in four weeks. On 08Jan2021 at 12 AM, the patient experienced hypertension and elevated heart rate (HR). Resting HR is tachycardic (reported as tachy) staying over 100 bpm. The adverse events resulted in doctor or other healthcare professional office or clinic visit. An additional medication was given as treatment to bring HR down. Post-vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Little aching in the shoulder part; Little soreness in the muscle; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from Jan2021 to Jan2021 at a single dose for COVID-19 immunization. Medical history included pain in her leg from a surgery; she said that she was taking Tylenol for it. It was reported that the patient just took the first dose of Covid 19 Vaccine yesterday and felt a little aching in the shoulder part, also Little soreness in the muscle; she wants to know as well if it's fine to take her daily medication Tylenol. She said that it is a little soreness in the muscle. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills; Body aches; Fevers; This is a spontaneous report from a contactable pharmacist. A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported), intramuscularly on the left arm on 11Jan2021 (10:45) at a single dose for COVID-19 immunization at the hospital. Medical history included hypothyroidism and allergy to sulfa drugs. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported), intramuscularly on the left arm on 21Dec2020 (when the patient was 26 years old) for COVID-19 immunization. On 12Jan2021 (02:00), the patient had fevers, chills and body aches. The patient had received an unspecified over-the-counter (OTC) pain reliever and an unspecified ointment as treatment for the reported events. The outcome of the events, 'fevers', 'chills' and 'body aches', was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: fast heartbeat/episode of rapid heartbeat; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at single dose Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced fast heartbeat/episode of rapid heartbeat after the second dose on an unspecified date. The outcome of event was unknown.  Information on the lot/ batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: A swollen armpit; Arm hurts; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's daughter) reported that a 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration in right arm on 08Jan2021 at a single dose for COVID-19 immunization. The patient has no medical history. There were no concomitant medications. The patient's arm hurts on 08Jan2021 and developed a swollen armpit on 10Jan2021. The outcome of swollen armpit was not recovered while arm hurts recovered on 10Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Decreased appetite, Diarrhoea
Clinical narrative: aches and pain in hips; very lethargic/lethargy was worse; sore throat; chills; head pain/headaches; nauseous; had no appetite; had horrible diarrhea; stomach cramps; slept 13 hours which my normal is max 8 hours/Slept 15 hours straight Sun. To Mon; This is a spontaneous report received from a contactable consumer (patient). An adult female patient of an unspecified age (reported as 63, no unit provided, pending clarification) received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), via an unspecified route of administration in right arm, on 08Jan2021 12:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included known allergies to penicillin and mango. Concomitant medication included probiotics, colecalciferol (D3), cyanocobalamin (B12), lysine and elderberry (ELDERBERRY [SAMBUCUS NIGRA]). The patient did not receive other vaccines in 4 weeks. The patient did not have COVID-19 prior to vaccination. The patient is not pregnant. The patient received her first vaccine on 08Jan2021, Friday. On 09Jan2021 at 16:30, Saturday or next day after the vaccine, the patient got nauseous late in the afternoon and had no appetite, so she ate some Jasmine rice and Peppermint tea. Within 3 hours, she had horrible diarrhea and stomach cramps. She went to bed early and slept for 13 hours which her normal is max 8 hours. She woke up on 10Jan2021, Sunday, and was very lethargic and had sore throat, chills and head pain across the back of her head, she never had headaches. She slept for 15 hours straight from Sunday To Monday (10Jan2021-11Jan2021). She woke up with the same symptoms on 11Jan2021, Monday (same as Sunday), but lethargy was worse. She had the same diet & care on Sunday, Monday and Tuesday (10Jan2021-12Jan2021) hot tea and hot showers letting hot water beat on her head and body. The patient still had chills, sore throat, head pain and was lethargic. On 21Jan2021 (Tuesday evening by 19:30), head pain was gone, was not as lethargic & throat was not as sore. The patient only drank hot peppermint tea, 3 liters warm lemon filtered water and soup. The patient was gargling with warm salt water & took 800 mg MOTRIN daily. On 13Jan2021 (Wednesday, the patient was back at work Wednesday but started to experience aches and pain in hips and sore throat but better. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Lethargy, Nausea, Oropharyngeal pain
Clinical narrative: aches and pain in hips; very lethargic/lethargy was worse; sore throat; chills; head pain/headaches; nauseous; had no appetite; had horrible diarrhea; stomach cramps; slept 13 hours which my normal is max 8 hours/Slept 15 hours straight Sun. To Mon; This is a spontaneous report received from a contactable consumer (patient). An adult female patient of an unspecified age (reported as 63, no unit provided, pending clarification) received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), via an unspecified route of administration in right arm, on 08Jan2021 12:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included known allergies to penicillin and mango. Concomitant medication included probiotics, colecalciferol (D3), cyanocobalamin (B12), lysine and elderberry (ELDERBERRY [SAMBUCUS NIGRA]). The patient did not receive other vaccines in 4 weeks. The patient did not have COVID-19 prior to vaccination. The patient is not pregnant. The patient received her first vaccine on 08Jan2021, Friday. On 09Jan2021 at 16:30, Saturday or next day after the vaccine, the patient got nauseous late in the afternoon and had no appetite, so she ate some Jasmine rice and Peppermint tea. Within 3 hours, she had horrible diarrhea and stomach cramps. She went to bed early and slept for 13 hours which her normal is max 8 hours. She woke up on 10Jan2021, Sunday, and was very lethargic and had sore throat, chills and head pain across the back of her head, she never had headaches. She slept for 15 hours straight from Sunday To Monday (10Jan2021-11Jan2021). She woke up with the same symptoms on 11Jan2021, Monday (same as Sunday), but lethargy was worse. She had the same diet & care on Sunday, Monday and Tuesday (10Jan2021-12Jan2021) hot tea and hot showers letting hot water beat on her head and body. The patient still had chills, sore throat, head pain and was lethargic. On 21Jan2021 (Tuesday evening by 19:30), head pain was gone, was not as lethargic & throat was not as sore. The patient only drank hot peppermint tea, 3 liters warm lemon filtered water and soup. The patient was gargling with warm salt water & took 800 mg MOTRIN daily. On 13Jan2021 (Wednesday, the patient was back at work Wednesday but started to experience aches and pain in hips and sore throat but better. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever to 102.8; This is a spontaneous report from a contactable (patient).  This 32-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 18Dec2020 at single dose for COVID-19 immunisation. The patient was vaccinated at Pharmacy or Drug Store. Age at vaccination was 32-years-old. No other vaccine was received in four weeks. Medical history and concomitant medications were unknown. About 20 hours after the first vaccine (Dec2020), the patient ran a fever to 102.8, lasted about 12 hours. Information on the Lot/Batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: Disequilibrium, very mild; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249), via an unspecified route of administration in the right arm on 13Jan2021 08:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced disequilibrium, very mild on 13Jan2021 09:00. No treatment was received for the event. Outcome of the event was recovering.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Headache
Clinical narrative: really big sharp headache; lots of vowel movements (Diarrhea); Chills; dizziness; This is a spontaneous report from a contactable healthcare professional. A 38-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (right arm, second dose) from 12Jan2021 17:00 to 12Jan2021 17:00 at a single dose for COVID-19 vaccination. Medical history included UTI. Concomitant medication included sulfamethoxazole, trimethoprim (BACTRIM). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020 (first dose). It was reported by the patient that she was awaken in the middle of the night because of a really big sharp headache also with lots of bowel movements (Diarrhea). The patient also had Chills and dizziness; all on 13Jan2021. There was no treatment for the events. The outcome of the events was not recovered. Information on the Lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nausea, Oropharyngeal pain
Clinical narrative: nausea; sore throat/ throat hurt; feeling unwell; fatigue/extra tired; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EI1686; expiry date: unknown) intramuscular in the right arm, on 04Jan2021 at 12:00 at a single dose, for COVID-19 immunization. Medical history included diabetic/ diabetes diagnosed in 2015, high blood pressure, and high cholesterol, all prior vaccination. The patient has no relevant family history. The patient has no concomitant medications. Patient has no previous immunization with the Pfizer vaccine. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient received the first shot of the vaccine 04Jan2021 at 12:00, and she started feeling unwell during the weekend (Saturday; 09Jan2021). She's still experiencing these symptoms: fatigue, nausea, sore throat, and she's feeling worse. She called the COVID hotline because she was having fatigue and nausea. They told her to call her PCP and call Pfizer to report. After first dose on 04Jan2021, she felt ok over the weekend. She was just fatigued last night and had nausea and her throat hurts. She wanted to know about getting her second shot that is scheduled for 26Jan2021, if it is recommended or not. There was no prescriber. She received the vaccine through work clinic. She was extra tired this weekend, so Saturday would have been the start for that. She went to bed early and that was when the nausea started. It woke her up. Her throat hurt off and on through winter. But last night, it was worse than it has been. It comes and goes without any medication or anything. She was sure it was given in the muscle. NO emergency room (ER) or physician's office required. She called COVID hotline and they are making her go to the doctor before she can return to work. She has not gone yet. Outcome of the events was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives; Itchiness; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration from 04Jan2021 to 04Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing prediabetic and hyperlipidemia. Concomitant medication included metformin for prediabetic and pravastatin for hyperlipidemia; both ongoing. The nurse reports that the patient developed hives and itchiness 48 hours after the administration of the first dose. The patient received Benadryl and it is getting better with Benadryl. The outcome of the events was recovering.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: fatigue; headache; injection site soreness; This is a spontaneous report from a contactable other health care professional. A 36-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0140), via an unspecified route of administration on 12Jan2021 16:00 at SINGLE DOSE at left arm for COVID-19 immunization.  Medical history included Idiopathic intracranial hypertension. On 12Jan2021 20:00, the patient experienced Fatigue, Headache, Injection site soreness. The patient did not receive treatment for the events. The outcome of the events was recovering.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Chills; Fever (up to 101.8ºF ); Headache; Nausea; Fatigue; Body Aches; Swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the left arm on 07Jan2021 08:00 at single dose for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included ibuprofen (ADVIL), paracetamol (TYLENOL), calcium carbonate (TUMS), citalopram and birth control (unspecified medication). The patient previously took first dose of bnt162b2 (lot number: EJ1685, expiry date not reported), via an unspecified route of administration in the left arm on 20Dec2020 11:00 at single dose for COVID-19 immunisation. On 07Jan2021 18:30, the patient experienced chills, fever (up to 101.8ºF), headache, nausea, fatigue, body aches and swollen lymph nodes. The patient underwent lab tests and procedures which included aars-cov-2 test: negative on 08Jan2021 COVID test result=Negative. No treatment was received for the adverse events. Clinical outcome of the events recovered on an unspecified date.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills; Fever (up to 101.8ºF ); Headache; Nausea; Fatigue; Body Aches; Swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the left arm on 07Jan2021 08:00 at single dose for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included ibuprofen (ADVIL), paracetamol (TYLENOL), calcium carbonate (TUMS), citalopram and birth control (unspecified medication). The patient previously took first dose of bnt162b2 (lot number: EJ1685, expiry date not reported), via an unspecified route of administration in the left arm on 20Dec2020 11:00 at single dose for COVID-19 immunisation. On 07Jan2021 18:30, the patient experienced chills, fever (up to 101.8ºF), headache, nausea, fatigue, body aches and swollen lymph nodes. The patient underwent lab tests and procedures which included aars-cov-2 test: negative on 08Jan2021 COVID test result=Negative. No treatment was received for the adverse events. Clinical outcome of the events recovered on an unspecified date.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: swollen lymph nodes around left clavicle and close to armpit and neck, that happened 5 days after the first dose of COVID vaccine and they are very painful; Swollen lymph nodes around left clavicle and close to armpit and neck; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in left arm on 17Dec2020 08:00 at single dose for COVID-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took oxycodone and experienced allergy. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The 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. Since the vaccination, the patient has not been tested for COVID-19. On 23Dec2020 07:00 PM, the patient experienced swollen lymph nodes around left clavicle and close to armpit and neck, that happened 5 days after the first dose of COVID vaccine and they are very painful. The outcome of the events was recovering. No treatment was given to the patient for the events.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; Chills; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1685), via an unspecified route of administration in left arm, on 23Dec2020 at 17:45, at a single dose, for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. On 24Dec2020 at 6 AM, the patient experienced fever, chills, and fatigue lasting 36 hours. No treatment was received for the events. Post vaccination on an unspecified date, the patient underwent COVID-19 nasal swab test that was negative. The patient recovered from the events on 25Dec2020 (18:00).
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test positive
Clinical narrative: 6 days after the first dose he received a diagnostic with a positive test for COVID-19; 6 days after the first dose he received a diagnostic with a positive test for COVID-19; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient called that he was administered with the first dose of Pfizer's COVID-19 vaccine on 28Dec2020 and 6 days after (03Jan2021) the first dose, he received a positive result for a COVID-19 laboratory test. He started with symptoms of COVID-19 between 4 to 6 days after the administration of the vaccine and he had scheduled the second dose of the vaccine in 2 days (at the time of report). He had been quarantined appropriately after being diagnosed. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I developed a rash at the injection site after my second dose (both of which were given in my left arm), which made me wonder if I should have alternated injection sites.; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient asked if it would it be beneficial to recommend that the two doses of the Covid vaccine be given in different arms for each patient. On an unspecified date, the patient developed a rash at the injection site after the second dose (both of which were given in the left arm), which made the patient wonder if she should have alternated injection sites. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: ringing in both of my ears got worse started slightly after the first dose and gotten worse after the second dose; ringing in both of my ears got worse started slightly after the first dose and gotten worse after the second dose; This is a spontaneous report from a non-contactable nurse.  A 32-year-old male patient receive d BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose , via an unspecified route of administration to Jan2021 at SINGLE DOSE for COVID-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  On an unknown date, the patient experienced ringing in both of ears got worse started slightly after the first dose and gotten worse after the second dose. Patient stated that it kind off went away toward right before the second dose, was ok for a day or two 5th or 6th getting worse again. Patient stopped two of her meds that could cause this. The vaccine was the only thing that has changed. The second dose was administered on unknown date in Jan2021 (5th or 6th of Jan2021). The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 76.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Fatigue; mild soreness/arm sore/soreness in the arm; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 04Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation, naproxen sodium (ALEVE), via an unspecified route of administration on 04Jan2021 at an unspecified dose and frequency for an unspecified indication. Medical history included blood pressure abnormal, blood uric acid abnormal, hypersensitivity, blood cholesterol abnormal, all from an unknown date and unknown if ongoing. Concomitant medication included alopurinol (ALOPURINOL), 300mg take once daily by mouth for Uric acid, amlodipine besilate (AMLODIPINE BESILATE) 10mg; take once daily by mouth for blood pressure, atorvastatin calcium (ATORVASTATIN CALCIUM) 20mg; take one half daily by mouth for cholesterol, cetirizine (CETIRIZINE) 10mg take once daily as needed for allergy, omeprazole (OMEPRAZOLE) 20mg; take one twice daily by mouth for uric acid, losartan (LOSARTAN), 100mg; take once daily by mouth for Blood pressure. The patient called regarding the Pfizer COVID 19 vaccine. He received his first dose of the vaccine at the a Hospital. He added he had just taken Aleve before the vaccination. Then he was reading in his heart magazine and it said it could effect the efficacy of the shot if you take aspirin or ibuprofen. He was asking for more information about that and was it okay that he took Aleve. He clarified he received the first dose of the Pfizer COVID 19 vaccine on 04Jan2021 at 15:00 PM in the left arm. He took the Aleve at 08:00 04Jan2021. He reports he had no pain the first day, no soreness in the arm or anything. The next day he had mild soreness in arm like the flu or pneumonia shot. On the third day he was a little fatigued. But by the fourth day he was able to take his usual walk of three or four miles without being winded and he was fine. He was planning for the second dose 25Jan2021 at 15:00. The outcome of the event pain in extremity was recovered on 06Jan2021 and the event fatigue was recovered on 07Jan2021.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills; Fevers; minor body aches/severe body aches; small headache/severe headaches; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration in the left arm on 12Jan2021 10:30 at a single dose for COVID-19 immunization. The patient's medical history included sub clinical hyperthyroidism and diagnosed with COVID prior to vaccination. The patient had no known allergies to medications, food, or other products. The patient was not pregnant. Concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in the left arm on 21Dec2020 11:45 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. On 12Jan2021 20:00, the patient experienced minor body aches and a small headache. She went to bed and woke up at approx. 13Jan2021 00:15 with severe body aches, severe headaches, chills, and fevers. Therapeutic measures were taken as a result of the adverse events and included treatment with ibuprofen and diphenhydramine (BENADRYL). Outcome of the events was not recovered.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Throwing up, violently; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration in right arm on 12Jan2021 11:30 AM at for COVID-19 immunization. Medical history included breast cancer, heart valve problem, asthma, and allergies. The patient's concomitant medications were not reported. The patient experienced throwing up, violently on 12Jan2021 11:30 AM. Patient dose not have COVID prior vaccination. Patient was not tested for COVID post vaccination. No treatment was received for the adverse event. The outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever; Very tired; Arm pain; This is a spontaneous report from a non-contactable consumer (patient). A adult female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 09Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 19Dec2020 for COVID-19 immunization. On 09Jan2021, the patient had low grade fever; was very tired; and had arm pain. The patient had not received any treatment for the reported events. The outcome of the events, 'low grade fever', 'very tired' and 'arm pain', was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to the vaccination, and it was unknown if she had been tested post-vaccination.  No follow-up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Middle insomnia, Myalgia, Paraesthesia
Clinical narrative: a flood of heat throughout my body; pain in my calf muscle; tingling; Woke me up all night; super dizzy; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration in the left arm on 12Jan2021 10:00 at a single dose for COVID-19 immunization. There were no medical history. The patient is not pregnant. Concomitant medication included amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced super dizzy on 12Jan2021 10:06, a flood of heat throughout her body, pain in her calf muscle, tingling, and it woke her up all night on 12Jan2021 12:00. Outcome of the events was recovering.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Jaundice, Pain
Clinical narrative: Chills; Bone aches; Minor HA; Diarrhea; Violent vomiting; A jaundice color of skin; This is a spontaneous report from a non-contactable pharmacist. A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3246), intramuscular on 12Jan2021 at a single dose for COVID-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. On 12Jan2021, the evening after the vaccine was administered, the patient experienced chills, bone aches, and minor HA that then worsened to explosive diarrhea and violent vomiting with a jaundice color of skin. The events resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Chills; Bone aches; Minor HA; Diarrhea; Violent vomiting; A jaundice color of skin; This is a spontaneous report from a non-contactable pharmacist. A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3246), intramuscular on 12Jan2021 at a single dose for COVID-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. On 12Jan2021, the evening after the vaccine was administered, the patient experienced chills, bone aches, and minor HA that then worsened to explosive diarrhea and violent vomiting with a jaundice color of skin. The events resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: menstrual cycle started 4 days early with heavier than usual flow; Myalgias; Chills; Tmax 100.7; This is a spontaneous report from a contactable physician reported for herself. A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0142), intramuscular in the right arm on 08Jan2021, 15:00 at a single dose for covid-19 immunisation. The patient's medical history was not reported. The patient did not have Covid prior to vaccination. Patient did not have other vaccine in four weeks. Concomitant medications included multivitamin. The patient previously took amoxicillin and experienced hypersensitivity (reported as known allergies to amoxicillin). The patient received the first dose of bnt162b2 (lot:EK5730), intramuscularly in the right arm on 18Dec2020 at 11:00AM at a single dose for covid-19 immunization. The patient experienced myalgias, chills, tmax 100.7 on 09Jan2021 09:00. It was also reported that patient's menstrual cycle started 4 days early with heavier than usual flow on 09Jan2021 11:00. Patient did not received treatment for the events. The outcome of the event myalgia, chills and pyrexia, was recovered on 09Jan2021, 21:00 and recovered on an unknown date for the event menstrual cycle abnormal. Patient was not tested positive for Covid-19 post vaccination.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen and tender left neck lymph node; Swollen and tender left neck lymph node; Headache; Tiredness; This is a spontaneous report from a contactable other health professional (HCP). A 35-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176), intramuscular on left arm, on 12Jan2021 at 09:15, at a single dose for COVID-19 immunization. Medical history included anxiety and migraine from an unknown date and unknown if ongoing. Concomitant medication included escitalopram. The patient received the first dose of BNT162B2 (lot number: EH9899), intramuscularly on left arm at 23Dec2020, 03:30 PM. The patient experienced swollen and tender left neck lymph node, headache and tiredness; all on 12Jan2021 at 17:30. There was no treatment given for the events. The outcome of the events was not recovered.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pain in extremity, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Sore arm; a little tired; second dose was due 25Jan2021; Tested positive for COVID-19 on 03Jan2021/congestion and cough; Tested positive for COVID-19 on 03Jan2021/congestion and cough; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). This 39-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via intramuscular at left deltoid on 28Dec2020 11am at single dose for COVID-19 immunization. Medical history included non-smoker with no other illness. Concomitant medication was none. The patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. Patient reported after receiving her first dose of the COVID-19 vaccine on 28Dec2020, she had sore arm and a little tired, other than that felt fine. She stated second dose was due 25Jan2021. She was tested positive for COVID-19 (Rapid Covid testing) on 03Jan2021. She already decided going to wait the 90-day-period to get the second dose of the vaccine. Since she was quarantined she wanted to what she should do. She stated her having testing positive for Covid did not have anything to do with the vaccine. She still had some lingering symptoms, congestion and cough. Nothing had worsened, but just wouldn't go away. She did not receive any other vaccines the same day or 4 weeks prior. No history of problems with vaccines in past. She had not had antibodies checked yet. It was reported no AE required a visit to emergency room/physician office. The patient was not hospitalized. The patient received no additional therapies for COVID-19. Patient's outcome with COVID-19 was recovering, and the rest of events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported  tested positive for COVID-19 (Rapid Covid testing), which is considered ineffective of BNT162B2, and the administration of BNT162B2.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: mild swelling and tenderness of corresponding vaccine site arm in armpit lymph nodes; mild swelling and tenderness of corresponding vaccine site arm in armpit lymph nodes; This is a spontaneous report from a contactable pharmacist. A 44-year-old female patient received bnt162b2 (BNT162B2), the first dose (lot number: EH9899, expiry date: not reported), intramuscularly, on 18Dec2020 04:00 PM, at a single dose, on the left arm; and the second dose (lot number: EL1284, expiry date: not reported), intramuscularly, on 07Jan2021 11: 00 AM, at a single dose, on the right arm, both for COVID-19 immunization. The vaccine was administered in a hospital. The patient was not pregnant. Medical history included COVID. It was reported that patient was diagnosed with COVID prior to vaccination and was not tested for COVID post vaccination. The patient had no known allergies. Concomitant medications included ethinylestradiol, levonorgestrel (JOLESSA), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), ergocalciferol (VIT D); these are the other medications she received in two weeks. The patient did not receive any other vaccine within four weeks. The patient experienced mild swelling and tenderness of corresponding vaccine site arm in armpit lymph nodes the evening following both covid 19 vaccine doses 1 and 2. This lasted 48-72 hours and then resolved. The first dose was received on 18Dec2020 with reaction occurred on 19Dec2020. The second dose was received on 07Jan2021 with reaction occurred on 08Jan2021 06:00 PM (also reported as "09Jan2021"). The patient did not receive any treatment for the reported adverse events. Outcome of the events was recovered on an unspecified date.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Tiredness/Exhaustion; Chills; Low grade fever; Muscle aches; Weakness; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) via an unspecified route of administration, on an unspecified date in Jan2021 at 15:30, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received first dose of the Pfizer BioNTech Covid-19 vaccine on Monday at 3:30 P.M. He woke up yesterday morning with exhaustion, tiredness, chills, low grade fever, muscle aches, and just weakness that hasn't stopped since yesterday morning. All these lasted for 48 hours. Patient then asked how long he will experience these. Outcome of the events was not recovered.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disorientation, Dizziness, Dysphagia, Ear discomfort, Feeling abnormal
Clinical narrative: numbing on right side of face/numbness in my right arm; hard time swallowing; dizziness; fogginess; disorientation; hard of hearing; right ear felt very clogged; This is a spontaneous report from a contactable healthcare professional. A male patient of an unspecified age (reported as 43 with unspecified units) received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE and also reported as covid vaccine; unknown lot number and expiration date), via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunization. The patient's concomitant medications and medical history were not reported. The patient reported that he received the covid vaccine on Monday late afternoon on 11Jan2021. He reported side effects of numbing on right side of face, hard time swallowing and numbness in his right arm on Jan2021. On Jan2021, he had initial symptoms of dizziness, fogginess and disorientation and then went to bed and woke up with additional symptoms (what he mentioned earlier). The patient added that his right ear felt very clogged and was hard of hearing at the time, but now it has resolved (that was the last thing that went away). The patient inquired if he should get the second dose. He mentioned that all the symptoms cleared up and he inquired as to what are the recommendation. The outcome of the events was recovered on Jan2021.  The following information on the batch/lot number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoacusis, Hypoaesthesia
Clinical narrative: numbing on right side of face/numbness in my right arm; hard time swallowing; dizziness; fogginess; disorientation; hard of hearing; right ear felt very clogged; This is a spontaneous report from a contactable healthcare professional. A male patient of an unspecified age (reported as 43 with unspecified units) received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE and also reported as covid vaccine; unknown lot number and expiration date), via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunization. The patient's concomitant medications and medical history were not reported. The patient reported that he received the covid vaccine on Monday late afternoon on 11Jan2021. He reported side effects of numbing on right side of face, hard time swallowing and numbness in his right arm on Jan2021. On Jan2021, he had initial symptoms of dizziness, fogginess and disorientation and then went to bed and woke up with additional symptoms (what he mentioned earlier). The patient added that his right ear felt very clogged and was hard of hearing at the time, but now it has resolved (that was the last thing that went away). The patient inquired if he should get the second dose. He mentioned that all the symptoms cleared up and he inquired as to what are the recommendation. The outcome of the events was recovered on Jan2021.  The following information on the batch/lot number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disorientation, Dizziness, Dysphagia, Feeling abnormal, Hypoaesthesia
Clinical narrative: numbing on right side of face/numbness in my right arm; hard time swallowing; dizziness; fogginess; disorientation; hard of hearing; right ear felt very clogged; This is a spontaneous report from a contactable healthcare professional. A male patient of an unspecified age (reported as 43 with unspecified units) received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE and also reported as covid vaccine; unknown lot number and expiration date), via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunization. The patient's concomitant medications and medical history were not reported. The patient reported that he received the covid vaccine on Monday late afternoon on 11Jan2021. He reported side effects of numbing on right side of face, hard time swallowing and numbness in his right arm on Jan2021. On Jan2021, he had initial symptoms of dizziness, fogginess and disorientation and then went to bed and woke up with additional symptoms (what he mentioned earlier). The patient added that his right ear felt very clogged and was hard of hearing at the time, but now it has resolved (that was the last thing that went away). The patient inquired if he should get the second dose. He mentioned that all the symptoms cleared up and he inquired as to what are the recommendation. The outcome of the events was recovered on Jan2021.  The following information on the batch/lot number has been requested.