chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Supraventricular extrasystoles
Clinical narrative: Felt heart palpitations which doctor then defined as premature atrial complex (PAC). This hasn't happened to me before and started the day after getting the vaccine.; Felt heart palpitations which doctor then defined as premature atrial complex (PAC). This hasn't happened to me before and started the day after getting the vaccine.; This is a spontaneous report from a contactable consumer or other non hcp. A 27-years-old non-pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in arm right on 27Feb2021 13:00 (age at vaccination: 27-years-old) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing and food allergy from an unknown date and unknown if ongoing Known allergies: I think I'm allergic to eggs, but not confirmed. Patient did not received other vaccines within 4weeks prior to vaccination. The patient concomitant medications were not reported patient was not tested to post vaccination. On 28Feb2021, the patient experienced felt heart palpitations which doctor then defined as premature atrial complex (Pac). This had not happened to me before and started the day after getting the vaccine. Patient had physician office visit for the events and patient did not had any treatment for the events. The outcome of the events palpitations and supraventricular extra systoles was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Joint injury
Clinical narrative: I had put on compression sleeve for both my knees on Saturday. Sunday my left knee was bruised in two places where the sleeve was at.; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 59-year-old male patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Lot number: EN6201), via an unspecified route of administration in right arm on 12Mar2021 at 09:00 (at the age of 59-year-old) as single dose for COVID-19 immunisation. It was other facility type vaccine. The patient's medical history was hypertension and allergic to Penicillin. Concomitant medications in two weeks included Losartan and Tamsulosin from an unknown date. No other vaccine in four weeks. On 13Mar2021 at 09:00, the patient had put on compression sleeve for both my knees on Saturday. Sunday my left knee was bruised in two places where the sleeve was at. No covid prior vaccination. Post vaccination no covid tested was performed. No treatment was received for adverse event. The outcome of the adverse event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Palpitations
Clinical narrative: Heart palpitations; headache; dizziness; This is a spontaneous report from a contactable Consumer (patient herself). A 27-years-old non- pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, lot number: EN6208, expiry date: unknown) via unspecified route of administration, administered in right arm on 14Mar2021 15:15 (age at vaccination: 27-years) as DOSE 1, SINGLE for Covid-19 immunization. Facility type vaccine other was state organization. Medical history of patient included migraines and penicillin allergy from an unspecified date and unknown if ongoing. Concomitant medications were not reported. No other vaccine was administered in four weeks. The patient had surgery / general anesthesia on 09Mar2021 (in two weeks of vaccination). The patient experienced heart palpitations, headache, dizziness on 15Mar2021 12:00. Prior to and since vaccination the patient was not tested positive for covid. Treatment regimen was not given as a result of the adverse events. The outcome of the events was not recovered.   No follow-up attempts are possible.  No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Bundle branch block right, Electrocardiogram, Heart rate, Palpitations
Clinical narrative: heart palpitations; he has an incomplete right bundle branch; This is a spontaneous report from a contactable consumer or other non hcp. A 21-year-old male patient received (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration on 16Mar2021 (at the age of 21-year-old) as DOSE 1, single for covid-19 immunization. Patient medical history and concomitant medications were not reported. The patient received first dose of Pfizer vaccine on 16Mar2021 and within first 25 minutes developed heart palpitations. When he went home his heart rate was in the 110's. He went to the emergency room and had an EKG and his heart rate ranged from 88-110. The doctor said that he has an incomplete right bundle branch and he had to follow up with a cardiologist. The patient was asking whether this a dangerous side effect. Outcome of the events was unknown   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hypertension, Palpitations
Clinical narrative: Heart palpitation; pulse was over 100; blood pressure was high; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After first shot of Pfizer week ago and patient had a reaction after 4 hours with heart palpitation and his pulse was over 100 and blood pressure was very high. The patient underwent lab tests and procedures which included blood pressure measurement with result high and heart rate with result over 100 on an unspecified date. Patient wanted to know should receive a second shot. Patient was informed about Pfizer Medical Information Department. The outcome of the reported events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Heart rate increased, Palpitations
Clinical narrative: About an hour after the vaccine chest was pounding while vaccuuming/doing housework; Felt a fast heartbeat; Dizziness; Then skin felt hot as if I'd been running/ heat sensation in my skin.; This is a spontaneous report from a non-contactable consumer or other non hcp. A 36-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration, administered in left arm on 27Feb2021 (age at vaccination was 36-year-old) (Batch/Lot Number: EN6200) as single dose for COVID-19 immunization.  Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not taking any other medications prior two weeks. The patient had no known allergies. On 27Feb2021, about an hour after the vaccine the patient experienced chest was pounding while vacuuming /doing housework, felt a fast heartbeat and dizziness. The patient was recovered after sitting down for a moment. Then skin felt hot as if she had been running, but she had not been running. she recovered within a couple hours from the heat sensation in her skin. No treatment was received for the events. The outcome the events was recovered on 27Feb2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Discomfort, Lymphadenopathy, Myalgia, Pain in extremity
Clinical narrative: I read that swollen lymph nodes is a possible side effect.; It's uncomfortable its not like painful but its very uncomfortable and tender.; tender; like a ball under my arm, swollen under my arm and in my armpit and down into like my breast tissue.; I couldn't even lay that way.; That evening my arm was sore; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (Solution injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she went Tuesday afternoon and got her first covid shot. That evening her arm was sore and yesterday it continued to hurt and last night when she went to bed it was like there was something like a ball under her arm, swollen under her arm and in her armpit and down into like in her breast tissue. She couldn't even lay that way. She read that swollen lymph nodes was a possible side effect. It's uncomfortable it was not like painful but it was very uncomfortable and tender. Caller asked, is that what she was experiencing a swollen lymph node and should she get it checked out. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: I read that swollen lymph nodes is a possible side effect.; It's uncomfortable its not like painful but its very uncomfortable and tender.; tender; like a ball under my arm, swollen under my arm and in my armpit and down into like my breast tissue.; I couldn't even lay that way.; That evening my arm was sore; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (Solution injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she went Tuesday afternoon and got her first covid shot. That evening her arm was sore and yesterday it continued to hurt and last night when she went to bed it was like there was something like a ball under her arm, swollen under her arm and in her armpit and down into like in her breast tissue. She couldn't even lay that way. She read that swollen lymph nodes was a possible side effect. It's uncomfortable it was not like painful but it was very uncomfortable and tender. Caller asked, is that what she was experiencing a swollen lymph node and should she get it checked out. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased, Oxygen saturation, Oxygen saturation abnormal
Clinical narrative: Irregular heartbeat, resting heart rate at least 20 bpm higher than normal; Severe fluctuations in oxygen levels, feeling out of breath and unable to take a deep breath in; Severe fluctuations in oxygen levels, feeling out of breath and unable to take a deep breath in; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: El3302), dose 1 via an unspecified route of administration, administered in arm left on 17Mar2021 at 10:00 as (at the age of 33-years-old) single for COVID-19 immunisation. Medical history included rheumatoid arthritis and known allergies: coconut. The patient's concomitant medications were not reported. 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 19Mar2021 at 08:00, the patient experienced irregular heartbeat, resting heart rate at least 20 bpm higher than normal and severe fluctuations in oxygen levels, feeling out of breath and unable to take a deep breath in. The patient did not receive any treatment for the events. The patient assessed the events as non-serious. The outcome of all the events was resolved.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Urticaria
Clinical narrative: itchy hives; feeling hot; This is a spontaneous report from a contactable consumer or other non-health care professional.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced itchy hives and feeling hot on an unspecified date. The outcome of the events was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: Dizziness; Palpitations; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 03Mar2021 11:30 (at the age of 77-years-old) as dose 1, single for COVID-19 immunisation. Medical history included breast cancer from Aug2019 to an unknown date (Has had a Mastectomy, she doesn't know if the cancer is still there or not), Microbacterial infection in the lungs from Sep2018 and ongoing. Concomitant medications included alprazolam (XANAX) taken for anxiety from Jun2020 and ongoing; omeprazole (PROTONIX [OMEPRAZOLE]) taken as her stomach is a huge problem for her (Stomach Acid) and ongoing. The patient asked if she could get her second scheduled vaccine while having symptoms of palpitations and dizziness. She stated she has had palpitations before but these palpitations after the vaccine started on 10Mar2021 (7 days after receiving vaccine). She said she had been a little bit dizzy since her shot but a little bit more today. She had her first shot on 03Mar2021 and her second is scheduled for 24Mar2021. She would like to change her appointment for her second dose and see how she feels. She clarified the dizziness started yesterday and she does not think it's getting worse. Caller stated she had an ultrasound in Jul2020. She had treatment for palpitations prior but confirms she has not had treatment for the palpitations she experienced after the vaccine. Additional vaccines were not administered on Same Date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks) were taken. The adverse events did not required visit to emergency room nor physician office. The outcome of the events was not recovered.  No follow-up attempts are Possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Euphoric mood, Feeling abnormal, Flushing, Malaise
Clinical narrative: I had felt sick when I received the first dose; severe brain fog; body high; dilated pupils; flushed skin; acting "silly" for lack of a better word; This is a spontaneous report received from a contactable female consumer (patient). A 27-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 19Mar2021 09:00 (at age of 27-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included allergic to kiwi fruits and had a severe allergic reaction to an unknown dye found in Lo Loestrin Fe. The patient previously took valium and experienced extremely hyper. The patient was not pregnant at the time of this report. Concomitant medications included naproxen sodium (ALEVE) and ethinylestradiol, norethisterone acetate (JUNEL FE 1/20) taken for an unspecified indication. The patient felt like she had eaten a very strong marijuana edible a few hours after vaccination. No one have talked to her has had an effect like this. This was around the time that she had felt sick when she received the first dose. This dose did not make her feel sick, just high. Her father said he had the same reaction, though. Symptoms included severe brain fog, body high, dilated pupils/flushed skin, acting "silly" for lack of a better word on unspecified date in Mar2021. The patient received no treatment for adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the patient received Aleve, Junel 1/20 within 2 weeks of vaccination. The patient had not diagnosed with COVID-19 prior to vaccination, the patient had not been tested for COVID-19 since the vaccination. The outcome of events was recovered with sequel on an unspecified date in 2021.       No follow-up attempts are needed. No further information expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Mydriasis
Clinical narrative: I had felt sick when I received the first dose; severe brain fog; body high; dilated pupils; flushed skin; acting "silly" for lack of a better word; This is a spontaneous report received from a contactable female consumer (patient). A 27-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 19Mar2021 09:00 (at age of 27-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included allergic to kiwi fruits and had a severe allergic reaction to an unknown dye found in Lo Loestrin Fe. The patient previously took valium and experienced extremely hyper. The patient was not pregnant at the time of this report. Concomitant medications included naproxen sodium (ALEVE) and ethinylestradiol, norethisterone acetate (JUNEL FE 1/20) taken for an unspecified indication. The patient felt like she had eaten a very strong marijuana edible a few hours after vaccination. No one have talked to her has had an effect like this. This was around the time that she had felt sick when she received the first dose. This dose did not make her feel sick, just high. Her father said he had the same reaction, though. Symptoms included severe brain fog, body high, dilated pupils/flushed skin, acting "silly" for lack of a better word on unspecified date in Mar2021. The patient received no treatment for adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the patient received Aleve, Junel 1/20 within 2 weeks of vaccination. The patient had not diagnosed with COVID-19 prior to vaccination, the patient had not been tested for COVID-19 since the vaccination. The outcome of events was recovered with sequel on an unspecified date in 2021.       No follow-up attempts are needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Joint injury, Limb injury
Clinical narrative: broken right wrist; broken right foot; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: ER2613; Expiration date was not reported), via an unspecified route of administration on 22Mar2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced broken right wrist, broken right foot on an unspecified date. For lot number, caller stated the only numbers she sees on the card is ER2613 and DGM4. Caller stated she received the COVID vaccine yesterday and she had a question. Caller stated the nurse kept saying she could not take Advil and she had broken her right wrist and right foot. Caller stated it helped to take Advil in between taking Percocet. Caller stated her pharmacist said she could take Advil. Caller wants to know if she could take Advil or not. Caller stated her COVID 19 vaccine card was in her purse and she had to go get it but will also need her glasses. Caller apologized as she was slower than normal because of her broken foot. Caller stated so this agent was telling her that she has been on hold for 45 minutes and she had to be on hold again since this agent cannot answer her question. Caller declined to complete report at this time wished to be transferred for her question. Caller unwilling to complete the report. Clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Concussion, Dizziness, Feeling abnormal, Head injury, Headache
Clinical narrative: Concussion; blurred vision; Nausea; dizzy/dizziness; felt a fogginess and cloudiness; head injury; Headache; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 23Mar2021 09:45 (age at vaccination is 63years old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. On 23May2021 Caller states I noticed after my first shot I felt like I had a concussion. I felt dizzy. As I was driving back home the concussion symptoms aggravated. I had a blurred vision, nausea and dizzy. I feel the same way today. Is this normal. Received an auto call back 2021-03-24 9:39 Outbound call attempted #1 2021-03-24 9:43Outbound disclaimer provided. Informed caller dizziness and nausea has been reported post vaccine. But blurred vision has not been associated with the vaccine. However, these may not be all the possible side effects of the Pfizer BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer BioNTech COVID-19 Vaccine is still being studied in clinical trials. Please speak to your HCP if these symptoms persist. I am afraid to get second dose. Can I get the second shot despite all the symptoms I had, Informed caller to monitor the symptoms. The eligibility of the second dose would depend on the severity of the symptoms. Please discuss this with your HCP. Caller states he got Pfizer Covid vaccine around 9:45AM on 23Mar2021, states he waited the 15 minutes and as he was sitting in the chair he felt a fogginess and cloudiness, states when he was driving home he felt like he had a concussion, not sure what is going on, felt fine until the shot, states it was like a head injury or something, with some nausea and dizziness, states he is still feeling it today Product Details: unable to locate NDC, Lot or Expiration Date on patient cared, states the following number is listed and either reads: PAA165969 or PAAL65969 States his main reason for calling is he is trying to figure out if there is something he should do for this concussion feeling, and should he forgo the second dose as he is not doing so well with this first dose. Communication: The caller was provided with phone number of (PHONE NUMBER), option 3, and business hours prior to transfer to queue, hold times are longer than normal. Outcome of events was recovered on 28Mar2021.   Follow-up(24Mar2021) This is a Follow-up spontaneous report received from a contactable consumer (patient). This male patient reported for himself added   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vision blurred
Clinical narrative: Concussion; blurred vision; Nausea; dizzy/dizziness; felt a fogginess and cloudiness; head injury; Headache; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 23Mar2021 09:45 (age at vaccination is 63years old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. On 23May2021 Caller states I noticed after my first shot I felt like I had a concussion. I felt dizzy. As I was driving back home the concussion symptoms aggravated. I had a blurred vision, nausea and dizzy. I feel the same way today. Is this normal. Received an auto call back 2021-03-24 9:39 Outbound call attempted #1 2021-03-24 9:43Outbound disclaimer provided. Informed caller dizziness and nausea has been reported post vaccine. But blurred vision has not been associated with the vaccine. However, these may not be all the possible side effects of the Pfizer BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer BioNTech COVID-19 Vaccine is still being studied in clinical trials. Please speak to your HCP if these symptoms persist. I am afraid to get second dose. Can I get the second shot despite all the symptoms I had, Informed caller to monitor the symptoms. The eligibility of the second dose would depend on the severity of the symptoms. Please discuss this with your HCP. Caller states he got Pfizer Covid vaccine around 9:45AM on 23Mar2021, states he waited the 15 minutes and as he was sitting in the chair he felt a fogginess and cloudiness, states when he was driving home he felt like he had a concussion, not sure what is going on, felt fine until the shot, states it was like a head injury or something, with some nausea and dizziness, states he is still feeling it today Product Details: unable to locate NDC, Lot or Expiration Date on patient cared, states the following number is listed and either reads: PAA165969 or PAAL65969 States his main reason for calling is he is trying to figure out if there is something he should do for this concussion feeling, and should he forgo the second dose as he is not doing so well with this first dose. Communication: The caller was provided with phone number of (PHONE NUMBER), option 3, and business hours prior to transfer to queue, hold times are longer than normal. Outcome of events was recovered on 28Mar2021.   Follow-up(24Mar2021) This is a Follow-up spontaneous report received from a contactable consumer (patient). This male patient reported for himself added   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Swelling, Throat tightness
Clinical narrative: face started burning,swelling,turning red,throat started to close up, approx 30 min after injection.; face started burning,swelling,turning red,throat started to close up, approx 30 min after injection.; face started burning,swelling,turning red,throat started to close up, approx 30 min after injection.; face started burning,swelling,turning red,throat started to close up, approx 30 min after injection.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Right on 08Mar2021 14:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included multiple sclerosis, emphysema, sulfonamide allergy. Patient received other medications within 2 weeks of vaccination. The patient previously took Keflex and experienced drug allergy. The patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Mar2021 at 15:00, the patient experienced face started burning, swelling, turning red, throat started to close up, approx. 30 min after injection. Patient received treatment as Benadryl for the events. The clinical outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Oxygen saturation, Oxygen saturation abnormal
Clinical narrative: Low grade fever (98.5); fatigue; muscle ache; oxygen of 97-98; This is a spontaneous report from a contactable consumer (Patient) reporting herself.  A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: So-lution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 at 14:15 (at the age of 52-years-old) as dose 1, single for covid-19 immunisation and levothyroxine (batch/lot number and not reported) for an unspecified indication. Medical history included none. Patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. On 23Mar2021 at 13:45, the patient experienced low grade fever (98.5), fatigue, muscle ache and oxygen of 97-98. The patient underwent lab tests and procedures which included body temperature: 98.5, oxygen saturation: 97-98. The events were reported as non-serious as none of the events met the criteria for seriousness. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment was not given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events were recovered in Mar2021.  Follow-up (30Mar2021): This is a Follow-up spontaneous report received from a Pfizer collegue in response to a query which asked for confirmation of the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines and explained about the awareness date.   No follow-up attempts are needed. No further information is expected
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fever (98.5); fatigue; muscle ache; oxygen of 97-98; This is a spontaneous report from a contactable consumer (Patient) reporting herself.  A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: So-lution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 at 14:15 (at the age of 52-years-old) as dose 1, single for covid-19 immunisation and levothyroxine (batch/lot number and not reported) for an unspecified indication. Medical history included none. Patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. On 23Mar2021 at 13:45, the patient experienced low grade fever (98.5), fatigue, muscle ache and oxygen of 97-98. The patient underwent lab tests and procedures which included body temperature: 98.5, oxygen saturation: 97-98. The events were reported as non-serious as none of the events met the criteria for seriousness. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment was not given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events were recovered in Mar2021.  Follow-up (30Mar2021): This is a Follow-up spontaneous report received from a Pfizer collegue in response to a query which asked for confirmation of the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines and explained about the awareness date.   No follow-up attempts are needed. No further information is expected
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Chills, Dizziness
Clinical narrative: Pain at the injection site immediately; Weakness; dizziness; chill; Increased HR and Blood Pressure; Increased HR and Blood Pressure; This is a spontaneous report from a contactable consumer or non-healthcare Professional. A 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 28732, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 09:00 (age at vaccination 80 years) as dose 1, single for covid-19 immunisation. Medical history included Myelodysplastic Syndrome, AFIB (Other medical history: Myelodysplastic Syndrome, AFIB). Concomitant medication was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 09:00 the patient experienced pain at the injection site immediately, weakness, dizziness, chill, increased hr and blood pressure, increased hr and blood pressure. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement was increased, heart rate was increased.  Patient received treatment of 60 mg Solumerdol, 25 mg Benadryl, 500 msg NS. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Vaccination site pain
Clinical narrative: Pain at the injection site immediately; Weakness; dizziness; chill; Increased HR and Blood Pressure; Increased HR and Blood Pressure; This is a spontaneous report from a contactable consumer or non-healthcare Professional. A 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 28732, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 09:00 (age at vaccination 80 years) as dose 1, single for covid-19 immunisation. Medical history included Myelodysplastic Syndrome, AFIB (Other medical history: Myelodysplastic Syndrome, AFIB). Concomitant medication was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 09:00 the patient experienced pain at the injection site immediately, weakness, dizziness, chill, increased hr and blood pressure, increased hr and blood pressure. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement was increased, heart rate was increased.  Patient received treatment of 60 mg Solumerdol, 25 mg Benadryl, 500 msg NS. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Heart rate, Heart rate increased, Hypertension
Clinical narrative: Mild dizziness then increased heart rate; Mild dizziness then increased heart rate; tachycardia; high blood pressure; rash on face; This is a spontaneous report from a contactable consumer or other non hcp (herself). A 64-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection,Batch/Lot Number: EN6204, expiry date not reported), via an unspecified route of administration, administered in Arm Right on 18Mar2021 12:45 as dose 1, single (age at vaccination 64-year-old) for covid-19 immunisation. Medical history included breast cancer metastatic and Known allergies: Sulfur antibiotics from an unknown date. Concomitant medication(s) included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 12:45, the patient experienced mild dizziness then increased heart rate, tachycardia, high blood pressure, rash on face. The patient received treatment for the events includes Benadryl injection, steroid injection, EPI pen inj. The patient underwent lab tests and procedures which included blood pressure measurement: high on 18Mar2021, heart rate: increased on 18Mar2021. The clinical outcome for all events was Recovered with lasting effects on an unknown date in 2021.  No follow up attempts are possible. No further information is expected
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tachycardia
Clinical narrative: Mild dizziness then increased heart rate; Mild dizziness then increased heart rate; tachycardia; high blood pressure; rash on face; This is a spontaneous report from a contactable consumer or other non hcp (herself). A 64-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection,Batch/Lot Number: EN6204, expiry date not reported), via an unspecified route of administration, administered in Arm Right on 18Mar2021 12:45 as dose 1, single (age at vaccination 64-year-old) for covid-19 immunisation. Medical history included breast cancer metastatic and Known allergies: Sulfur antibiotics from an unknown date. Concomitant medication(s) included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 12:45, the patient experienced mild dizziness then increased heart rate, tachycardia, high blood pressure, rash on face. The patient received treatment for the events includes Benadryl injection, steroid injection, EPI pen inj. The patient underwent lab tests and procedures which included blood pressure measurement: high on 18Mar2021, heart rate: increased on 18Mar2021. The clinical outcome for all events was Recovered with lasting effects on an unknown date in 2021.  No follow up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date, the patient experienced shortness of breath. The patient did not receive any treatment for the reported events. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event shortness of breath. The clinical outcome of the event shortness of breath was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Narrative "The patient did not receive concomitant medications." updated as "Concomitant medications were not reported". 2. Concomitant Therapy leave blank. 3. Narrative "from a non-contactable consumer" updated to "from a contactable consumer".
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: palpitations for about 5 minutes; This is a spontaneous report from a contactable consumer (patient's husband) via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on 29Mar2021 as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 29Mar2021, the patient experienced palpitations for about 5 minutes. Reporter wanted to know if that was okay or just normal. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dysuria, Prostatomegaly, Semen volume decreased
Clinical narrative: Enlarged prostate; Difficult urination; lack of semen; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the arm right on 18Mar2021 at 09:30 (at the age of 47-year-old) as a dose 1, single for COVID-19 immunisation. The patient's medical history included penicillin allergy. The patient's concomitant medication included omeprazole (OMEPRAZOL). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced enlarged prostate, urination difficulty and lack of semen (semen volume low). No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events enlarged prostate, urination difficulty and lack of semen (semen volume low) were not recovered at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained  Amendment: This follow-up report is being submitted to amend previously reported information: "The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care" Deleted from narrative since it not provided in source document.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: Injection site pain; Fatigue; Headache; Muscle aches; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER 8730) via an unspecified route of administration in the left arm on 01Apr2021 at 14:30 (at the age of 42-years-old) as dose 2, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration, on an unknown date as dose 1, single (age at vaccination: 42 years), for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, the patient experienced injection site pain, fatigue, headache, muscle aches and chills. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events injection site pain, fatigue, headache, muscle aches and chill. The clinical outcome of the events injection site pain, fatigue, headache, muscle aches and chill were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.  Follow up (21Jul2021) via Amendment: This follow-up report is being submitted to amend previously reported information: Other relevant history for dose 1 age and unit updated; Ending sentence update to 'No follow-up attempts are possible. No further information is expected.'
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Very sore arm; Lightheaded; Feverish; Tired; Loss of appetite; This is a spontaneous report from a non-contactable consumer (patient, self-reporting). A 30-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 30Mar2021 at 15:45(at the age of 30-year-old), as a dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 11:00, the patient experienced very sore arm, lightheaded, feverish, yuck, tired, loss of appetite. The patient did not receive any treatment for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events very sore arm, lightheaded, feverish, yuck, tired, loss of appetite was not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Dose description updated to "DOSE NUMBER UNKNOWN, SINGLE".
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Vertigo
Clinical narrative: Maternal Exposure During Pregnancy, third trimester; Severe vertigo; This is a spontaneous report from a contactable consumer, the patient. A 35-years-old pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via an unspecified route of administration, in the right arm on 31Mar2021 at 16:45 (maternal exposure during pregnancy, third trimester) as a single dose for COVID-19 immunization (at the age of 35-years). The patient's medical history reported as none. Patient's concomitant medications were not reported. The last menstrual date of the patient was on 04Aug2020, gestation period was 34 weeks, and delivery date was on 09May2021. The patient had no known allergies. The patient received other vaccine within 4 weeks prior to the COVID vaccine which included tdap (tetanus-diphtheria- pertussis vaccine toxoid) (MANUFACTURER UNKNOWN) on 24Feb2021 for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in left arm on 10Mar2021 at 16:30 (at the age of 35-years-old) as a single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 03Apr2021, after 2.5 days of vaccination the patient experienced severe vertigo and it was ongoing and it was fourth day of vaccination at the time of report. On an unspecified date, she had maternal exposure during pregnancy, third trimester. No therapeutic measures were taken as a result of the reported events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event severe vertigo was not recovered, while outcome of another event was unknown.