chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Feeling cold, Nervousness, Tremor, Vision blurred
Clinical narrative: feeling weak on 11 Apr a day after having the second shot; with the second one that she had blurred vision; the vaccine did something to her nervous system like shaking that she took it and for over 2 hours had chills. Later clarified that these side effects were from the second one; the vaccine did something to her nervous system like shaking that she took it and for over 2 hours had chills. Later clarified that these side effects were from the second one; woke up at 12:45 in the morning shaking and freezing for 2.5 hours and calmed down; This is a spontaneous report received from a contactable consumer (Patient). A 76-year-old patient of an unspecified gender received second dose BNT162B2 (Solution for injection) via an unspecified route of administration on 10Apr2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. It was stated that she wanted to report her side effects from the Pfizer Covid vaccine. Stated that she had Covid in December. Stated that that the vaccine did something to her nervous system like shaking that she took it and for over 2 hours had chills on an unspecified date in Apr2021. Later clarified that these side effects were from the second one. Stated that the pharmacist told her if she had antibodies not to get the shot. Stated she had it checked and had antibodies left. Stated that she had asked her doctor if she should get the vaccine since it was past 90 days since she had Covid and he stated yes. Stated that she took the first one. Stated she did not feel good the next day. Stated that it was like she had Covid, weak and had some shakes two days after. Stated that with the second one that she had blurred vision and woke up at 12:45 in the morning shaking and freezing for 2.5 hours and calmed down on an unspecified date in Apr2021. Stated that in the afternoon that she had another spell of this. Stated that she just felt better today. Stated that she had heard others that had Covid and then had reports of them getting sick. No further details provided. Declined to complete a report about the others. Stated that Pfizer should know that people should not take the vaccine if they have antibodies. Stated that her hair started coming out before the vaccine. Clarified that she had her antibodies checked three weeks before she had first shot. Stated that that one pharmacist stated not to have it until summer and then another stated to go ahead and take it. Stated that she had back and hip trouble and cannot get up the stairs good before the vaccine. Stated that the vaccine is supposed to protect you but who knows. Stated initially that she began feeling weak on 11Apr2021 a day after having the second shot. Stated that it had improved. Later clarified that she was weak from having Covid back in December prior to the vaccine. On an unspecified date in Apr2021, stated that the blurred vision lasted for 15 minutes. Outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Asthenia, Eating disorder, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: In pain; Could barely eat; feeling full; Taste buds are completely shot; muscles ache; can barely move when stand up; muscle weakness; really weak; This is a spontaneous report received from a contactable consumer (patient husband). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Lot number: ER8737, Expiration Date: Jul2021), via an unspecified route of administration on arm right on 02Apr2021 probably about 13:30 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were none. The patient had no family medical history. No additional vaccines administered on same date of the Pfizer Suspect. The patient did not visit to Emergency room or Physician office. The patient had no prior vaccinations (within 4 weeks) and no adverse events following prior vaccinations. It was reported that, the caller is a consumer reporting he and his wife had their first dose Pfizer Covid Vaccine on 02APR2021. Caller reports his wife experienced the same side effects as the caller. Caller's wife was really weak in Apr2021 and was experiencing all the same symptoms as the caller except no chills and no difficulty sleeping. Reports when the wife lays down, she was out cold asleep, and has no difficulty sleeping. The caller states the afternoon after receiving the Pfizer Covid Vaccine when leaving the administering facility, so far nothing bad had occurred. Caller reports he and his wife stopping to get something to eat on the way home from the Vaccination administering site, and in his case he could barely eat on 02Apr2021. This was the same for his wife. It was like it was not digesting on 02Apr2021. She has a feeling of feeling full and not being able to eat on 02Apr2021. Her taste buds are completely shot. Whenever she eats something it taste like cardboard. Mentioned his wife tries to eat because she needs to. She cold, barely finishes her food at the restaurant they went to after getting the first dose. It was like their food was so bland. Caller confirms some of the symptoms he reports are the same for caller's wife. Reports caller's wife is similar to him. She has muscle aches and can barely move when stand up in Apr2021. Caller explained his muscles ache like being beaten with a baseball bat and it's the same for his wife. Muscles ache constantly. Confirmed she was also having muscle weakness in Apr2021. Confirmed his wife was really weak. She can barely stand up. If she sits down on the chair or in a car in the drivers seat, its almost like caller was going to fall asleep. The outcome of the event was reported as unknown.  No follow-up attempts are needed; No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Taste disorder
Clinical narrative: In pain; Could barely eat; feeling full; Taste buds are completely shot; muscles ache; can barely move when stand up; muscle weakness; really weak; This is a spontaneous report received from a contactable consumer (patient husband). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Lot number: ER8737, Expiration Date: Jul2021), via an unspecified route of administration on arm right on 02Apr2021 probably about 13:30 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were none. The patient had no family medical history. No additional vaccines administered on same date of the Pfizer Suspect. The patient did not visit to Emergency room or Physician office. The patient had no prior vaccinations (within 4 weeks) and no adverse events following prior vaccinations. It was reported that, the caller is a consumer reporting he and his wife had their first dose Pfizer Covid Vaccine on 02APR2021. Caller reports his wife experienced the same side effects as the caller. Caller's wife was really weak in Apr2021 and was experiencing all the same symptoms as the caller except no chills and no difficulty sleeping. Reports when the wife lays down, she was out cold asleep, and has no difficulty sleeping. The caller states the afternoon after receiving the Pfizer Covid Vaccine when leaving the administering facility, so far nothing bad had occurred. Caller reports he and his wife stopping to get something to eat on the way home from the Vaccination administering site, and in his case he could barely eat on 02Apr2021. This was the same for his wife. It was like it was not digesting on 02Apr2021. She has a feeling of feeling full and not being able to eat on 02Apr2021. Her taste buds are completely shot. Whenever she eats something it taste like cardboard. Mentioned his wife tries to eat because she needs to. She cold, barely finishes her food at the restaurant they went to after getting the first dose. It was like their food was so bland. Caller confirms some of the symptoms he reports are the same for caller's wife. Reports caller's wife is similar to him. She has muscle aches and can barely move when stand up in Apr2021. Caller explained his muscles ache like being beaten with a baseball bat and it's the same for his wife. Muscles ache constantly. Confirmed she was also having muscle weakness in Apr2021. Confirmed his wife was really weak. She can barely stand up. If she sits down on the chair or in a car in the drivers seat, its almost like caller was going to fall asleep. The outcome of the event was reported as unknown.  No follow-up attempts are needed; No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Hypotension, Hypoxia
Clinical narrative: she ended up passing away in the hospital, her diagnosis there was hypoxia and acute CHF; she ended up passing away in the hospital, her diagnosis there was hypoxia and acute CHF; hypotensive; This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Mar2021 (Lot Number: EL9269; Expiration Date: 01May2021) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient sent to the ER hypoxic, hypotensive, short of breath, she ended up passing away in the hospital, her diagnosis there was hypoxia and acute CHF (Congestive heart failure). Serious: No. The patient died on an unspecified date.  It was not reported if an autopsy was performed.; Sender's Comments: Based on the information available, a causal association between BNT162B2 and the reported events cannot be excluded. However, details on the patent's age, medical history, drug-event temporal relationship, clinical course of the event and relevant test results would allow for a meaningful medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: she ended up passing away in the hospital, her diagnosis there was hypoxia and acute CHF; she ended up passing away in the hospital, her diagnosis there was hypoxia and acute CHF
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium decreased, Chest X-ray, Chest pain, Electrocardiogram, Prinzmetal angina
Clinical narrative: Prinzmetal Angina; Chest pain; This is a spontaneous report from a contactable other health professional (patient).  A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 08:00 (Lot Number: EM9810) at the age of 58-year-old as single dose for covid-19 immunisation. Medical history included ongoing High BP that was under control with medication from 2016, ongoing low Thyroid from 2017, Low Potassium 3.1 on 06Feb2021. The patient's concomitant medication was none. The patient previously received the first dose of BNT162B2 on 18Jan2021 11:45 am (lot number: EL3247) with Anatomical Site of injection: Left at the age of 58 years old for covid-19 immunisation and experienced Chest Pain on 22Jan2021 15:00 which required visit to Physician Office, Chest Pain 06Feb2021 (Several days) which required visit to Emergency Room. Vaccination facility type was hospital. No Prior Vaccinations. The patient experienced chest pain on 26Feb2021. The event required visit to Emergency Room. Event Outcome reported as "Prinzmetal Angina". Relevant Tests includes: Covid-19 on 23Dec2020 with Result: (-); Covid-19 on 18Jan2021 with Result: (-); Covid-19 on 21Jan2021 with Result: (-); X- Ray Chest on 06Feb2021 with Result: (-); EKG on 06Feb2021 with Result: (-); Low Potassium on 06Feb2021 with Result: 3.1. The outcome of the events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Prinzmetal Angina; Chest pain; This is a spontaneous report from a contactable other health professional (patient).  A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 08:00 (Lot Number: EM9810) at the age of 58-year-old as single dose for covid-19 immunisation. Medical history included ongoing High BP that was under control with medication from 2016, ongoing low Thyroid from 2017, Low Potassium 3.1 on 06Feb2021. The patient's concomitant medication was none. The patient previously received the first dose of BNT162B2 on 18Jan2021 11:45 am (lot number: EL3247) with Anatomical Site of injection: Left at the age of 58 years old for covid-19 immunisation and experienced Chest Pain on 22Jan2021 15:00 which required visit to Physician Office, Chest Pain 06Feb2021 (Several days) which required visit to Emergency Room. Vaccination facility type was hospital. No Prior Vaccinations. The patient experienced chest pain on 26Feb2021. The event required visit to Emergency Room. Event Outcome reported as "Prinzmetal Angina". Relevant Tests includes: Covid-19 on 23Dec2020 with Result: (-); Covid-19 on 18Jan2021 with Result: (-); Covid-19 on 21Jan2021 with Result: (-); X- Ray Chest on 06Feb2021 with Result: (-); EKG on 06Feb2021 with Result: (-); Low Potassium on 06Feb2021 with Result: 3.1. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: 1st dose on 15JAN2021 but tested positive of Covid-19 Virus on 25JAN2021; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number and expiry dates: UNKNOWN), via an unspecified route of administration on 15Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 25Jan2021, the patient tested positive of COVID-19 Virus. She was not able to continue with the 2nd dose. Patient want to know if she should continue with the 2nd dose or repeat the dosing back to 1st dose.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid Illness; This is a spontaneous report received from a contactable consumer (on behalf of her boss) via a Pfizer sponsored program and also via Medical Information Team. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Lot number and expiration date was not reported), via an unspecified route of administration on 26Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that, the patient did not feel well on 28Mar2021, and then tested positive for Covid Illness on 31Mar2021. The reporter also stated that the patient was still feeling tired, not 100%. The outcome of the event was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program.   An unspecified aged female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 08Apr2021 as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The Consumer(patient) stated that she received her first dose of Covid-19 vaccine on 08Apr2021 and tested positive for Covid last on 10Apr2021 and her(consumer) roommate, received the first dose of Covid-19 vaccine on 10Apr2021 and tested positive for Covid today (13Apr2021). Consumer wanted to know if they need to wait to get the second dose of the vaccine. The patient underwent lab test and procedure which included SARS-CoV-2 test: positive on 10Apr2021. The Outcome of the event 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-2021416341 same drug/reporter, different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: tested positive for Covid; This is a spontaneous report from a contactable consumer via. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 10Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that her roommate, received the first dose of Covid-19 vaccine on 10Apr2021 and tested positive for Covid today on 13Apr2021. Reporter asked if they need to wait to get the second dose of the vaccine. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021416340
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: lightheadedness; shortness of breath; tightness in the chest; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration on 05Apr2021 (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 previously being allergic to "a lot of antibiotics", cortisone, and prednisone. She also reports that she "cannot take the flu shot because then I get the flu". Because of her medical history, she consulted with all of her HCPs and they all told her it was safe to get the Covid19 vaccine. patient received her first dose of the Pfizer-Biontech Covid19 vaccine on 05Apr2021. She has since been experiencing lightheadedness, shortness of breath, and tightness in the chest in Apr2021. She tested negative for Covid19 illness this past Sunday (11Apr2021), and her cardiologist ruled out any heart conditions as the cause. The 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: Pain, Pain assessment, Systemic lupus erythematosus
Clinical narrative: Lupus; Pain; This is a spontaneous report received from a Pfizer-sponsored program from a non-contactable consumer (patient's mother). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Mar2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported.  On an unspecified date the patient experienced lupus and pain. It was reported that patient had lupus and she received her first dose of the vaccine on 20Mar2021. Patient experienced pain. She also verified that her daughter took paracetamol (TYLENOL) and benproperine phosphate (NORCOL) (Further clarification unknown) and now she wanted to know if it was ok for patient to receive second dose the day after the report (reported as tomorrow) and if she will experience pain again. Reported wanted also to know if it Is it ok to take Norcol or Tramadol. Reporter stated that her daughter is going to get a second shot tomorrow, Pfizer. Now, on the first shot she had lupus and she guesses this is the problem. She has like pain of 9.8. Patient's mother almost brought patient to the emergency room (ER) again and then she said that may be due to COVID shot. Patient is going to get the second shot this time and patient's mother does not want to have her pain. Patient's mother just wants to be sure that it is okay for her because of her lupus. Patient's mother read it that you are not supposed to take any Tylenol or Advil before. It was reported that specially, in the morning, when patient wakes up, she is under pain. She tries not to take this but she does not have a choice. Patient's mother has told her to tolerate that pain if either she can take Norcol or Tramadol. Now, patient is scheduled tomorrow for her second shot at 2 o'clock, for Pfizer. Patient's mother wanted to know if it is safe to take in the morning. Always patient is in pain, all the time if either Tramadol or Norcol. Patient's mother wanted to know if it is safe to take it even though she is going to get COVID shot at 2 o'clock. Outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Feeling hot, Taste disorder, Throat tightness
Clinical narrative: tightening sensation in throat air way restricting; tightening sensation in throat air way restricting; Taste in mouth followed by burning sensation throughout my body; Taste in mouth followed by burning sensation throughout my body; Turned red skin hot to touch; Turned red skin hot to touch; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received BNT162B2 (Brand: Pfizer), dose 2 via an unspecified route of administration, administered in arm right on 13Apr2021 (Lot Number: EW0158) as single dose for COVID-19 immunisation. Medical history included asthma and high blood pressure. Known allergies: Sulfa drugs. If Covid prior vaccination: No. If Covid tested post vaccination: No. The patient was not pregnant. The patient's concomitant medications were not reported. If other vaccine in four weeks: No. The patient previously received first dose of BNT162B2 on 23Mar2021 01:15 PM (Lot number: ER5732), in left arm, at the age of 56-year-old for COVID-19 immunization. 1st shot hot spot red swelling at injection area. 2nd shot severe instant adverse reaction. The patient experienced taste in mouth followed by burning sensation throughout her body. Turned red skin hot to touch. Immediately followed by tightening sensation in throat air way restricting on 13Apr2021 at 01:45 AM. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment was received for the events which included Medics treated oxygen Dr administered Benadryl. The patient was recovering from the events.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Upper airway obstruction
Clinical narrative: tightening sensation in throat air way restricting; tightening sensation in throat air way restricting; Taste in mouth followed by burning sensation throughout my body; Taste in mouth followed by burning sensation throughout my body; Turned red skin hot to touch; Turned red skin hot to touch; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received BNT162B2 (Brand: Pfizer), dose 2 via an unspecified route of administration, administered in arm right on 13Apr2021 (Lot Number: EW0158) as single dose for COVID-19 immunisation. Medical history included asthma and high blood pressure. Known allergies: Sulfa drugs. If Covid prior vaccination: No. If Covid tested post vaccination: No. The patient was not pregnant. The patient's concomitant medications were not reported. If other vaccine in four weeks: No. The patient previously received first dose of BNT162B2 on 23Mar2021 01:15 PM (Lot number: ER5732), in left arm, at the age of 56-year-old for COVID-19 immunization. 1st shot hot spot red swelling at injection area. 2nd shot severe instant adverse reaction. The patient experienced taste in mouth followed by burning sensation throughout her body. Turned red skin hot to touch. Immediately followed by tightening sensation in throat air way restricting on 13Apr2021 at 01:45 AM. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment was received for the events which included Medics treated oxygen Dr administered Benadryl. The patient was recovering from the events.
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Transient ischaemic attack
Clinical narrative: This is a spontaneous report received from a contactable consumer via a Pfizer-sponsored program COVAX US SUPPORT. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had stroke like symptoms and he may have had a TIA or a migraine stroke. He was in hospital for 2 to 3 days. His second shot is scheduled. No lab test were reported. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: died yesterday due to blood clots; This is a spontaneous report from a contactable consumer.   A 55-year-old female patient (mother) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and the patient's concomitant medications were not reported.  The patient experienced blood clots and died due to the event. It was not reported if an autopsy was performed.   Information on the lot/batch number has been requested. ; Reported Cause(s) of Death: died yesterday due to blood clots
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: he was tested Covid-19 positive; he was tested Covid-19 positive; This is a spontaneous report from a Pfizer sponsored program, reported by contactable consumer (patient self-reported). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date in 2021, as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not provided. It was reported that patient had his first dose of Pfizer Covid-19 vaccine a week from today in 2021 and scheduled to get his second dose next Tuesday (20Apr2021) however he was tested Covid-19 positive in 2021 and wanted to know if he can still get the second dose. Outcome of the events was unknown.  Follow-up actions are needed. Information about lot and batch number has been requested.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: got a rash on the other forearm; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 27-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: Unknown), via unspecified route of administration on 13Apr2021, (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 13Apr2021, at night (as reported) the patient experienced rash on the other forearm, the patient also wanted to know if rash and COVID-19 Immunization are related to each other. Also, patient asks if it was okay to get the second dose after this symptom. The outcome of the event was reported as unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a Pfizer sponsored program.   A contactable male consumer (patient) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1st  via an unspecified route of administration on 22Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient had the first dose 22MAR2021 and due for the second dose on 12APR2021. Patient tested positive for COVID-19 and got released from quarantine. The outcome of the event was unknown.    No follow up attempts are possible. Information on lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disturbance in attention, Insomnia
Clinical narrative: ringing in the ear; I have difficulty sleeping and functioning during the daytime.; That was interfered with his concentration and sleep; 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 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 11Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 11Apr2021, In the evening his ear had started ringing. It has gotten worst since Sunday to Tuesday. Since Tuesday to till now the level of severity was the same. Patient had difficulty in sleeping and functioning during the daytim. He could not turn it off. He stated that was really started affected his life in a negative way. He was heard that as he was talked. That was interfered with his concentration and sleep. That was a noise which most people called it ringing in the ear. He stated that was both high and low pitch and it was very detrimental to his life. He could be in an ambient noisy area such a coffee shop, he will hear it. In a quiet place he was heard. Patient wanted to know he put his hands on the ear or he heard that. On an unspecified date, the patient experienced ringing in the ear, I have difficulty sleeping and functioning during the daytime, it interferes with my concentration. The outcome of the events was unknown.   No Follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Sleep disorder, Tinnitus
Clinical narrative: ringing in the ear; I have difficulty sleeping and functioning during the daytime.; That was interfered with his concentration and sleep; 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 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 11Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 11Apr2021, In the evening his ear had started ringing. It has gotten worst since Sunday to Tuesday. Since Tuesday to till now the level of severity was the same. Patient had difficulty in sleeping and functioning during the daytim. He could not turn it off. He stated that was really started affected his life in a negative way. He was heard that as he was talked. That was interfered with his concentration and sleep. That was a noise which most people called it ringing in the ear. He stated that was both high and low pitch and it was very detrimental to his life. He could be in an ambient noisy area such a coffee shop, he will hear it. In a quiet place he was heard. Patient wanted to know he put his hands on the ear or he heard that. On an unspecified date, the patient experienced ringing in the ear, I have difficulty sleeping and functioning during the daytime, it interferes with my concentration. The outcome of the events was unknown.   No Follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive on 01Apr2021; tested positive on 01Apr2021; This is a spontaneous report from a contactable consumer (himself). A 69-years-old male patient received the first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution of injection) via an unspecified route of administration on 19Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Apr2021, the patient had tested positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Apr2021. The timeframe between vaccination and starting of symptoms was 13 days. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Headache, SARS-CoV-2 test
Clinical narrative: headache; Exposure 07Apr2021 to someone who tested positive; This is a Spontaneous report from a contactable consumer (herself) to a Pfizer Sponsored Program COVAX US support. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller, called to say 25Mar2021 was her first covid vaccine dose. She had exposure 07Apr2021 to someone who tested positive for covid 19. She was not experiencing any symptoms right now; she was still in quarantine and is wondering if she can get her second dose on 15Apr2021. She experienced a headache for half a day on 10Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test was she does not had any results on 12Mar2021. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Polymerase chain reaction
Clinical narrative: had a PCR test and yesterday test came back positive; had a PCR test and yesterday test came back positive; This is a spontaneous case received from a female consumer. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: unknown) and second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: unknown), both via an unspecified route of administration on an unspecified date at a single dose, for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had a pcr test and yesterday test came back positive. The patient underwent lab tests and procedures which included PCR test was positive on 13Apr2021.The outcome of the events was unknown.  Follow-up actions are closed.Further information cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, SARS-CoV-2 test
Clinical narrative: Diagnosed as Guillain-Barre syndrome; This is a spontaneous report from a contactable consumer (patient himself). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 16Feb2021 12:00 (Batch/Lot number was not reported) at the age of 50-year-old as single dose for covid-19 immunisation. The patient was health and had no medical history. The patient had no known allergy. Concomitant medication included finasteride (PROSCAR); lorazepam; hydroxyzine.  There was no other vaccine in four weeks. The patient was diagnosed as Guillain-Barre syndrome on 24Feb2021 16:00. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient was in hospitalization for 8 days. The patient had no COVID prior vaccination and had been tested post vaccination. The patient underwent lab tests and procedures which included covid (blood test): negative on 01Mar2021. Outcome of event was recovered with sequel in 2021. The patient received IVIG Infusion therapy for 5 days for event.   Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Vomiting
Clinical narrative: vomiting; shortness of breath; coughing spell; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 15Apr2021 as SINGLE DOSE for covid-19 immunization. Patient medical history and concomitant medications were not reported. After taking the 1st dose of the Pfizer Covid 19 vaccine on 15Apr2021, the patient experienced shortness of breath and vomiting, and wanted to know if this a common side effect and how long would it last. While reporting the events via phone she was unable to continue talking and hold phone due to coughing spell. Outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID test after the COVID vaccine; This is a spontaneous report from a contactable consumer. A male patient (consumer) of an unspecified age received BNT162B2 (COMIRNATY; Formulation: Solution for injection, Lot number: Unknown) via unspecified route of administration at single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient reported that he received his first Covid vaccine dose on 27Mar2021 and 7 days later "he thought he was having allergy symptoms, every year he gets a stuffy head and headache's, symptoms that he gets with allergies every year". patient reports that he went to the convenient care center and received a prescription for allergies, he also "got a steroid pump for his nasal symptoms". While he was there, he was tested for covid and 2 days later the test came back positive. He was advised to quarantine for 10 days but his second covid vaccine dose is scheduled for Saturday, but his quarantine doesn't end until Monday. He asks, should I end my quarantine early and go for the second shot or can I get it later than 3 weeks?  Patient reports that his symptoms are gone and he doesn't want to miss his second dose. Outcome of the event was unknown.  Followup#1 (PRD 15Apr2021/SRD 15Apr2021) This is a Follow-up spontaneous report from a contactable consumer. Confirmed COVID vaccine received on 27Mar2021, patient went to the doctor and had a COVID test on 03Apr2021 and the results came back positive on 05Apr2021. Patient said now next Thursday his 10 days quarantine will be up and then he can go back and go retake the test again. On 19Apr2021, Monday, that will be the 10 days mark and then the following Thursday of that same week it will be his visit to follow up with the doctor. Patient reported product complaint says that he went down to get his first COVID vaccine on 27Mar2021 and it was 7 days later that he thought he had spring allergies that were kind of surfacing and starting to take place. When he had went to the doctor to get allergy medication the doctor gave him a prescription pill and a nasal spray and while the caller was there they gave him a COVID test and 2 days later it came back positive. Confirmed COVID vaccine received on 27Mar2021, he went to the doctor and had a COVID test on 03Apr2021 and the results came back positive on 05Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident, Hemiparesis, Magnetic resonance imaging
Clinical narrative: stroke; R sided weakness; expressive aphagia; This is a spontaneous report from a contactable other health professional (patient). A non-pregnant 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 05Feb2021 (at age of 68 years old, no pregnant, Lot Number: EN5318) as single dose for covid-19 immunization. Medical history included type 1 diabetes, hypertension (HTN). The patient not had COVID prior vaccination also not had COVID tested post vaccination. No known allergies. Concomitant medication included insulin, lisinopril and Multi vitamin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 15Jan2021 at 03:00 P.M. (at age of 68 years old, Batch/Lot number unknown) as single dose for covid-19 immunization. The patient received 2nd Covid shot on 05Feb2021. Had a stroke on 14Feb2021 at 08:00 AM with R sided weakness and expressive aphagia. Stroke noted on MRI in L hemisphere, speech area. The patient had no idea if this was related to the Pfizer Covid vaccine. AE resulted in: Emergency room/department or urgent care, Hospitalization (1 day), Life threatening illness (immediate risk of death from the event). Treatment received for events included observation, Lovenox. The outcome of the events was recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Stroke, Weakness left or right side, and Expressive aphasia cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to  Committees and Investigators, as appropriate.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Malaise, Sleep disorder
Clinical narrative: really being tired/ overly tired; Caller stated yesterday was worse; she had to go back to bed after she got up and was up a couple of times during the night; not feeling well; This is a spontaneous report from a contactable consumer or other non healthcare profesional via Medical Information Team. An 85-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on 13Apr2021 as single dose for COVID-19 immunization. The patient took Tylenol 600mg before the vaccine for knee pain. The patient's concomitant medications were not reported. Historical vaccine included dose 1 BNT162B2 for COVID-19 immunization. On an unspecified date, caller stated that after second dose had them really being tired and yesterday was worse. Patient also stated she was overly tired and everything so the vaccine must be protecting her immune system. She had to go back to bed after she got up and was up a couple of times during the night. Patient stated her husband had a headache. Patient postponed her knee surgery but HCP until she had the vaccines as per HCP sugesstion. Patient mentioned she read not to take Tylenol before the vaccine. Patient wanted to know if she was still protected even though she took the Tylenol before the vaccine. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: Fatigue, mild fever, chills, body ache on , 4/24, the day after vaccination. Slight pain on the site of injection.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Urticaria, Vomiting
Clinical narrative: I was told to wait 30 min instead of 15 because I've had allergic reactions before, and to let them know if I was having side effects. After 5 min I had a headache and 5-10 min later I was very nauseous. I let the EMT's know and the asked me questions to make sure I could breath ok and wasn't going into anaphylactic shock (I could breath fine). After 30 min I left and threw up on my way home and 3-4 more times after I got home. I took ibuprofen for my headache and took a nap, an hour or so later I woke up and had hives all over my arms and some on my neck and back. I called the advice nurse on my insurance card and she directed me to Teledoc (they do video/phone app's) to make a Dr. appointment. I made my app for 4/23/21. Even though my hives were pretty much all cleared up by then(2 days later) I still wanted to ask the Dr. If I should get the second shot or look into another vaccine. He told me to not get the second Pfizer dose and it was up to me if I wanted to get another one like the Moderna or J&J one. He said I was 50-60% immune instead of the full 95% and that was better than nothing. I'm glad I got the vaccine but will not be getting any more in the future.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Hypertension, Irritability
Clinical narrative: High blood pressure and heart rate elevated  tired and very irritable  this lasted 4 days with the 2nd and 3rd days being very bad.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: approx. 3 hours post injection patient woke with whole body pruritis, MD paged, topical benedryl ordered for itching. Lotion applied, awaiting results.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth, Rash erythematous
Clinical narrative: ?Covid arm?  Approx 2.5? oblong,  raised, reddish, itchy patch at injection site.  Warm, sore to touch.   1x topical cortisone
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: ?Covid arm?  Approx 2.5? oblong,  raised, reddish, itchy patch at injection site.  Warm, sore to touch.   1x topical cortisone
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Headache (4 days) , Body Aches (5 days), Fatigue (8 days)
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling hot, Pruritus
Clinical narrative: Got very hot. Light-headed.  Couldn?t breathe with minutes of vaccine. Felt like I was gonna  faint. Waited it out until it passed. Later, like two days later, started itching all over.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Dizziness, Fatigue, Nausea, Pain
Clinical narrative: Super Dizzy (2 days), nausea (4 days), tingling throughout body (5 days), fatigue (10 days), Severe body aches.  Felt like every bone in my body was broken (4 days)
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Super Dizzy (2 days), nausea (4 days), tingling throughout body (5 days), fatigue (10 days), Severe body aches.  Felt like every bone in my body was broken (4 days)
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Non-cardiac chest pain
Clinical narrative: Mild shingles on left anterior costal margin. Started as soreness like a pulled muscle then 3 clusters of vesicles appeared 1 week later. At that time, PCP contacted through telehealth. Picture sent. Shingles diagnosed. Valtrex rx given. Symptoms resolved 1-2 weeks later. ghost