chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Heart rate, Heart rate increased
Clinical narrative: increased HR up to 130 bpm; shortness of breath; lightheadedness; fatigue; This is a spontaneous report from a contactable other healthcare professional (Nurse). A 63-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date (at the age of 63-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. One month after receiving the second dose of the vaccine, on an unspecified date, the patient experienced shortness of breath, increased heart rate up to 130 bpm, lightheadedness, fatigue. The patient underwent lab tests and procedures which included heart rate: 130 bpm. She wants to know if there any been any other reports of any cardiac issues one month after receiving the second dose of the vaccine. Outcome of the events was unknown. Response: Reviewed attached FACT SHEET FOR HCPs ADMINISTERING VACCINE and no information found regarding cardiac related events post vaccination. Spoke from attached FAQ-COVID-19 Vaccine-Pfizer Response to Reported Cases of Myocarditis in Recipients of COVID-19 Vaccine and Serious and Severe Adverse Events. Offered to send pdf document via email, caller declined. Referred to HCP Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, increased heart rate, Dizziness, Dyspnea, Fatigue cannot be completely ruled out. The impact of this report on 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 Regulatory Authorities, Ethic committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Eye haematoma
Clinical narrative: Hematoma in right eye; This is a spontaneous report from a contactable consumer (Patient). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EW0168), via an unspecified route of administration on 06May2021, at 16:15 hrs, on the right arm as single dose for COVID-19 immunization. No other vaccinations within four weeks prior to suspect vaccine. The patient's medical history and concomitant medications were not reported. No family medical history relevant to Adverse Event. No adverse events prior to vaccination. On 12May2021, the patient developed hematoma in her right eye after the first dose of the Covid Vaccine. Caller stated that the hematoma was barely visible now. Caller denies any medications, medical conditions, labs, testing, or treatments relevant to event. The patient did not visit any emergency room or physician office due to the events. The outcome of the event was resolving. Additional information requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis
Clinical narrative: tired feeling; cold; This is a spontaneous report from a non-contactable reporter other HCP reported for a unknown consumer. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization for which the patient had experienced sore arm on unspecified date. It was reported that Pfizer had 2 shots of vaccines. After the second shot, patient's arm didn't bother too much, but patient had like this kind of cold and tired on an unspecified date. That felt for about twenty four hours and patient was kind of just laid in bed most of the day. It went after twenty four hours. So, patient might know neither one of them was completely without symptoms. The outcome of events was recovered on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Tenderness
Clinical narrative: First dose: The day after receiving the first dose experiencing these lumps down the front of the arm; The lumps going down it and they are tender; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route, administered in left arm on 30Apr2021 as single dose for Covid-19 immunisation. The patient's medical history included ongoing atrial fibrillation (Afib) which was diagnosed five years ago and memory problems. No prior vaccinations (within 4 weeks). Concomitant medications were not reported. The day after receiving the first dose experiencing these lumps down the front of the arm on 01May2021. The lumps are all of them, all the way down the arm. The lumps are very tender, touchy and haven't gone away in 2021. It was the left arm after the first dose. The outcome of events was not recovered.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia, Rhinorrhoea
Clinical narrative: Fever; Runny nose; sick; This is a spontaneous report from a Pfizer program. A contactable consumer (patients Daughter) reported for her mother. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 04May2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced fever, runny nose and sick. The seriousness of the events was not specified by reporter. Provided  contact number. Unable to warm transfer , the call got disconnected while transferring the call. Created Manual AE form. Medical questions were addressed by this program and forwarded/referred to Medical Information. Reporter asked if she could get the second dose even if she was sick. The clinical outcome of the events was unknown.  Information regarding lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Illness, Vomiting
Clinical narrative: with the first Covid shot he got was sick and throwing up; with the first Covid shot he got was sick and throwing up; tired; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 53-yearsold male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0173), via unknown route of administration in left arm on 04May2021 as 1st dose, single dose for COVID-19 immunization. Medical history included amyotrophic lateral sclerosis from an unknown date and unknown if ongoing, patient has something like ALS or Lou Gehrigs disease, but has not been diagnosed. The patient's concomitant medications were not reported. The patient had no medical history. The patient states that with the first Covid shot he got was sick and throwing up for four days. He was worried about getting second shot because he heard it was stronger. He now feels sick, kind of, not throwing up. He did not file report after the first Covid shot. Confirmed details of being sick as: threw up a lot first day, slept for 17 hours straight, and stayed in bed a total three to four days. He doesnt remember the date on that first Covid shot. He didnt go to the doctor or anything. Two to three hours after he got the first shot the throwing up got to be violent. After that, he was just sick and tired for three to four days. Confirmed he was throwing up for one day only and that he fully recovered on that same day he got the Covid shot. Initially stated he doesnt remember the date he got the vaccine. He guesses it was three weeks before. Dont they say to wait three weeks to get second shot He recovered completely after 4th day and was back to normal self. Commented he has a sickness like does not feel well. No lab tests were done. The clinical outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Fever; Whenever she stand up she got dizzy; Headache; Body ache feel like somebody beat me up; This is a spontaneous report from a contactable consumer (patient herself). A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration, administered in Arm Right on 25May2021 as single dose for COVID-19 immunization. Medical history included constipation and arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had not received any other products. It was reported that on (yesterday) 25May2021 she received Pfizer COVID-19 vaccine and after that she had fever and whenever she stand up she got dizzy." Further it was stated that, "She also want to know if she could not put towel on her head something like that, she wanted some medical advice. She stated, she called because she had fever, headache and body ache feel like somebody beat her up. She inquired what could she do. She had the vaccination. She further stated, "All she wanted to know what she going to do with the pain, headache, body ache and fever. She was informed about Pfizer contact resources and informed about the timings as 8 AM to 8 PM from Monday to Friday and 9 AM to 3 PM Saturday and Sunday. Therapeutic measures were taken as a result of fever, she stand up she got dizzy headache, body ache feel like somebody beat me up as a Ibuprofen received yesterday (unknown date) about 12'o clock in the morning. There was not any investigation assessment. The outcome of all events was unknown.  Information on the lot/batch number has been requested. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Headache, Pain, Tremor
Clinical narrative: Whole body aches; Shaking; Face deep red, very hot; Face deep red, very hot; Bad headache; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother). 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 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took 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 1st dose, single for COVID-19 immunization and experienced side effects. On an unspecified date, the patient experienced whole body aches, shaking, face deep red, very hot, bad headache. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Euphoric mood, Tinnitus
Clinical narrative: I felt a little bit high, little bit of buzzy; I felt a little bit high, little bit of buzzy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient got this paperwork from Veterans Administration, patient was sitting there for 15 minutes, they want patient to sit and patient felt a little bit high, little bit of buzzy. Patient was just reporting a side effect. Patient stated that patient did not need anything, was just calling to tell as there were some side effects. Limited information was available over the call. The outcome of the events was unknown.  Information about batch/lot number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: mouth cold sores; This is a spontaneous report from a contactable pharmacist reported different events under the same suspect product for 10 patients via Medical information team. This is 1st report. A female patient (reporter's sister) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as unknown single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had 2 outbreaks of mouth cold sores. The outcome for the events was unknown.  Information about batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Outbreak of mouth cold sores; This is a spontaneous report from a contactable pharmacist reporting different events under the same suspect product for 10 patients via medical information team. This is 3rd report.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on an unknown date, as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient had an outbreak of mouth cold sores. The clinical outcome of the event was as unknown.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her son was vaccinated at the same time and he has absolutely no side effects other than a sore arm for a couple of days; This is a spontaneous report from a contactable Nurse. This Nurse (Patient's mother) reported that a male patient of an unspecified age received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE for covid-19 immunisation. The medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm for a couple of days. The outcome of the event was unknown.  Additional information about Batch no/ Lot no. has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: All died within the 5 weeks after there first shot; This is a spontaneous report from a contactable consumer. This consumer reported similar events for six patients.  This  is the sixth of six reports.  An elderly patient of unknown gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date of 2021, as single dose for covid-19 immunization. The patient' s medical history and concomitant medications were not reported. Patient was residential home with 5 other elderly residents patient. Reporter stated that they all got vaccinated with the first Pfizer shot (Confirmed as Covid 19 vaccine) and they all died within the 5 weeks after their first shot. By 18Mar2021 these residents in the house would have died. The reporter stated that they should not have died they just died. The reporter doesn' t know if it was a side effect, he knows if it was a reaction but all of the six residents that got vaccinated died within their first vaccination shot. Within the 5 weeks after the first vaccination. Reporter stated they died in their sleep supposedly. They died in their sleep.  Outcome of the event was fatal. It was unknown if an autopsy was done.  The information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021617030 same reporter/SD/AE, different  patients; Reported Cause(s) of Death: died within the 5 weeks after there first shot
Sex: M
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: neurological reaction; This is a spontaneous report from contactable Physician. This physician reported for a consumer (patient).   A male patient of unspecified age received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller reported his 32-year-old female wife was hospitalized after a neurological reaction from the first dose of the Pfizer-BioNTech COVID-19 vaccine. He asked if neurological reactions have been reported following the receipt of the COVID-19 vaccine. The caller explained the only similar case he was able to find was regarding an adult male patient who was in his forties or fifties, experienced neurological reaction, after getting a COVID-19 vaccine on an unknown date. The caller stated he has to attend to a patient and could not stay on the line. He explained he won't need a call back if the information was sent to him by email. The caller asked was the second dose of the Pfizer-BioNTech COVID-19 vaccine recommended following a serious adverse reaction from the first dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: metal taste in her mouth; This is a spontaneous report from a Pfizer sponsored Program received from consumer (patient herself) reported that a 60-year-old female received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient mentioned that she has received both of the Pfizer Covid 19 Vaccines. With the first vaccine on an unspecified date, she experienced a metal taste in her mouth as soon as she received the vaccine. With the second vaccine she experienced a little soreness in her arm and the metal taste continued. Caller stated it was like I ate hot soup. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Pain in extremity
Clinical narrative: A little soreness in her arm; Metal taste; This is a spontaneous marketing program report from a contactable consumer or other non hcp (patient herself). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient's medical history included Multiple sclerosis from an unknown date patient taking Immunosuppressant Ocrevus. Historical vaccination included the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for Covid-19 immunization.The patient's concomitant medications were not reported. On an unspecified date the patient experienced with A little soreness in her arm, Metal taste patient state that it was like I ate hot soup. The patient enquired about the information about the individuals with MS or taking immunosuppressants who received the vaccination. The outcome of the event Metal taste patient state that it was like I ate hot soup was not resolved and while   "A little soreness in her arm was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: This is a spontaneous report was received from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, while reporting on herself caller mentioned that she was talking to 2 girls in her office who also just had the second Pfizer Covid vaccine and are having extended menstrual bleeding. They are not having it to the extent she is they are just having spotting. She wanted to call about that. The outcome of the event was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021618011 same reporter/drug/AE, different patients
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date, as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced little headache after the second dose. The outcome of the event was reported as unknown.   The report is cross referenced to report ID: 9FHZJM4R.  Follow-up attempts are needed. Further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pneumonia
Clinical narrative: Pneumonia; received his first dose of the Pfizer COVID-19 vaccine on 22March2021 and then was diagnosed with COVID-19; received his first dose of the Pfizer COVID-19 vaccine on 22March2021 and then was diagnosed with COVID-19; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration on 22Mar2021 as 1st dose single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 22Mar2021, the patient received first dose of the Pfizer COVID-19 vaccine and then was diagnosed with COVID-19. On 04April2021, the patient was hospitalized. The patient also developed Pneumonia, The patient received Remdesivir treatment and the patient was doing well now. The outcome of the events were resolved on an unspecified date.  Follow-up attempts are needed. Further information is expected.; Sender's Comments: Based on the information currently available and close temporal association the lack of efficacy of the vaccine BNT162B2, the causal association of the reported events COVID-19 and pneumonia with the usage of the vaccine BNT162B2 cannot be excluded. 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.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Rash macular
Clinical narrative: nosebleed; noticed a spot on her arm, not quite a rash, but like a circle; This is a spontaneous report from a Pfizer sponsored program. A contactable 31-years-old female other HCP reported for herself.  A 31-years-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 19May 28May2021 at 14:13:37  as a 2nd dose single for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on unknown date as a 1st dose single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date patient (yesterday as reported) started experiencing nose bleeds and noticed a spot on her arm, not quite a rash, but like a circle.  She asked if, nose bleeds been reported.  and What should she do about it. Patient stated she had been having it since yesterday and today (dates unspecified). She was sent home from work and is going to an Urgent Care clinic. The outcome of the events were unknown.  Information on the lot/ batch number has been requested.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site reaction
Clinical narrative: Felt the pinch of the needle; She hasn't had anything happen, she has not felt different what so ever; This is a spontaneous report from a contactable consumer (patient herself). This 90-year-old healthy female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0185), via an unspecified route of administration on 26May2021 10:00 (this past Wednesday) (age at vaccination: 90 years) as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0179) on 05May2021 for COVID-19 immunization. On 26May2021, the patient experienced felt the pinch of the needle, she hasn't had anything happen, she has not felt different whatsoever. She keeps waiting for the other shoe to drop. She wants to know if this has been reported before. Patient said that she got the shot Wednesday morning and now it is Friday morning and she has not had anything happen, she has not felt different what so ever and she wondered if this is normal because she has not felt anything, nothing at all. She said that was so complicated she just wants to know if this is normal. The outcome of the events was unknown.   Follow up needed, further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: shortness of breath; raising of heartbeat; This is a spontaneous report from a contactable consumer (mother). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration on 27May2021 as 2nd dose, single dose for covid-19 immunization (he got it yesterday at around 5PM, time zone unspecified). The patient medical history and concomitant medications were not reported. Historical vaccine included first dose BNT162B2 for COVID-19 immunization. States that about an hour ago, her son started experiencing shortness of breath and raising of heartbeat on 28May2021 (started an hour to 17 hours (and running)) and they were not sure if this was normal; and it was after getting the 2nd dose of the Pfizer Covid-19 vaccine shot (he got the it yesterday at around 5PM). She was seeking answers to help decide if her son needs to go the ER. Outcome of the events was unknown.   Information about lot/batch number requested.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's husband). 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 an unspecified date as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications. On unspecified date, the patient received the first dose of the Pfizer COVID-19 vaccine. She was heaving heavy cramps because of her menstrual cycle and her husband wanted to know whether she can get the second dose and her husband was got response as, patient should not get the Pfizer-BioNTech COVID-19 Vaccine if patient had a severe allergic reaction after a previous dose of the vaccine or if patient had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer patient to speak to healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The patient healthcare provider knows patient health situation and has access to information that can better help inform this decision. Outcome of event was unknown.  Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Considerable pain; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on 05May2021 (Lot number: not reported) as second dose, single for covid-19 immunisation. Patient previously had his first dose of BNT162B2 on 14Apr2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient felt considerable pain on an unspecified date in May2021, a few weeks after he got second dose of the vaccine. The patient stated he was feeling better now. The outcome of event was recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: a blood that came out of the injection site/ bled a little; This is a spontaneous report received from a contactable consumer (Patient). A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported that on his first dose he saw that there was a blood that came out of the injection site. On his second dose, he unsure if he got the vaccine as he didn't see a blood come out. He didn't feel anything in his arms. Patient went to take the second vaccine today, but he doesn't know if he got it or not. He got the first one and it bled a little, but with the second one he felt nothing. Did they give it to him. Patient was unsure if he got the second dose vaccine. The outcome of the event was unknown.   Information about batch/Lot number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory disorder, SARS-CoV-2 test
Clinical narrative: upper respiratory sickness; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8736), via intramuscular, administered in right arm on 26Apr2021 at 13:00 (age at vaccination 63-year-old) as 1st dose, single for COVID-19 immunization. Medical history included covid-19 in early December for 3 weeks. The patient's concomitant medications were not reported. Patient had no prior vaccinations within 4 weeks and had no adverse event following prior vaccinations. Patient had no additional vaccines administered on same date of the pfizer suspect. Patient had no history of all previous immunization with the pfizer vaccine considered as suspect. On 08May2021 the patient experienced upper respiratory sickness. Patient did not have any reaction, but 2 weeks later, she got a upper respiratory sickness and hasn't gotten better. She was nearing the 6 week mark but her infection was still lingering. She was told not to get the second vaccine until she was feeling better. She said that she knows you are supposed to get the second dose within 6 weeks, but with having Covid, she was advised to have a antibody test to see how many antibodies she has. Patient enquired, should she have take antibody test and how long she can go between getting the first and second dose. Patient does not know if her upper respiratory sickness was related to the vaccine or not, but does not think it was, she was just concerned that it was lingering so long. She has not really felt well since she had Covid. She said that she had no side effects or anything, but was hesitant on the 2nd vaccine because she has not felt good. Patient was coughing while reporting. As therapeutic measure patient was taking a Z-Pac, it has not helped, she said that she guess it has, but not great. The event resulted patient to visit physician office. The outcome of the event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Disorientation, Fall, Gait disturbance, Ill-defined disorder
Clinical narrative: disoriented; not walking well and was saying peculiar things; not walking well and was saying peculiar things; chemical imbalance; fell in the garage and almost froze; This is a spontaneous report from a contactable consumer (patient's friend) communicated to a medical information team. A 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 10May2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced disoriented, not walking well and was saying peculiar things, chemical imbalance, fell in the garage and almost froze. It was reported that the patient was hospitalized for all events for 6 days. Reported that patient received treatment with rehab facility trying to get her memory and walking abilities back to where they were. Also reported that reporter took her 87 year old friend/older neighbour to get the first dose of the Pfizer Covid 19 vaccine on 10May2021. After the vaccine, the neighbour was disoriented, fell in the garage and almost froze. The ambulance came and took her to the hospital. She was hospitalized for 6 days. She was not walking well and was saying peculiar things. The hospital tests were negative and her son in law was told she had a chemical imbalance. Prior to this she was completely functionable and able to do everything on her own. She was in a rehab facility at that time and trying to get her memory and walking abilities back to where they were. Reporter wanted to know that, She get the second dose of the vaccine which was scheduled for 4 June or not and also about the chemical imbalance. Reported that the risks of the PFIZER-BIONTECH COVID-19 VACCINE. Reporter reffered to neighbour's physician or hospital physician to determine if she had a severe allergic reaction or not and if she should take the second dose of the vaccine. Reported that no information about a chemical imbalance being reported as a side effect. Reporter tried many ways to report, like spoke to DSU, attached fact sheet and website but unabled to do as mail was not correct then also reported that Pfizer online complain site was not reliable and it kicked them out. It didn't work and the other one they gave us didn't work either (email). The patient received the treatment for all events. The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Investigation
Clinical narrative: disoriented; not walking well and was saying peculiar things; not walking well and was saying peculiar things; chemical imbalance; fell in the garage and almost froze; This is a spontaneous report from a contactable consumer (patient's friend) communicated to a medical information team. A 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 10May2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced disoriented, not walking well and was saying peculiar things, chemical imbalance, fell in the garage and almost froze. It was reported that the patient was hospitalized for all events for 6 days. Reported that patient received treatment with rehab facility trying to get her memory and walking abilities back to where they were. Also reported that reporter took her 87 year old friend/older neighbour to get the first dose of the Pfizer Covid 19 vaccine on 10May2021. After the vaccine, the neighbour was disoriented, fell in the garage and almost froze. The ambulance came and took her to the hospital. She was hospitalized for 6 days. She was not walking well and was saying peculiar things. The hospital tests were negative and her son in law was told she had a chemical imbalance. Prior to this she was completely functionable and able to do everything on her own. She was in a rehab facility at that time and trying to get her memory and walking abilities back to where they were. Reporter wanted to know that, She get the second dose of the vaccine which was scheduled for 4 June or not and also about the chemical imbalance. Reported that the risks of the PFIZER-BIONTECH COVID-19 VACCINE. Reporter reffered to neighbour's physician or hospital physician to determine if she had a severe allergic reaction or not and if she should take the second dose of the vaccine. Reported that no information about a chemical imbalance being reported as a side effect. Reporter tried many ways to report, like spoke to DSU, attached fact sheet and website but unabled to do as mail was not correct then also reported that Pfizer online complain site was not reliable and it kicked them out. It didn't work and the other one they gave us didn't work either (email). The patient received the treatment for all events. The outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Sore throat; Felt tired; Ache; This is a spontaneous report received via contactable consumer or other non-health care professional (parent).A 20-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration administered in Arm Left on 26May2021 16:00 as single dose for COVID-19 immunization.Medical history included irritable bowel syndrome from an unknown date and unknown if ongoing from two years. The patient concomitant medications were not reported.The patient experienced felt tired, ache on 27May2021 and sore throat on 28May2021. Clinical course reported as stated that the caller is calling about her 20 year old daughter who received the first dose of the Pfizer Biontech COVID- 19 vaccine on 26May2021, felt tired and achy. This morning she woke up with a sore throat. She would like to know if this was a reported side effect with the Pfizer Biontech COVID-19 vaccine. Caller also added that she would like to know if the symptoms with the second dose of the Pfizer Biontech COVID-19 vaccine are more important than the ones with the first dose of the Pfizer Biontech COVID-19 vaccine. The events were assessed as non-serious. The daughter is planning to receive the next dose on 18JUN2021.The outcome of the event felt tired and ache was reported as recovering while for sore throat it was reported as not recovered.  Follow -up attempts are needed. Information on the lot/batch number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic stroke, SARS-CoV-2 test
Clinical narrative: Acute ischemic stroke; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 04May2021 08:00 (at age 49-years-old) (Batch/Lot Number: ER8735) as 2nd dose, single for covid-19 immunisation. The first dose was received on 13Apr2021 (lot number: ER8735) on the left arm at age 49-years-old. Medical history included high cholesterol and penicillin allergy. Concomitant medication included rosuvastatin. No other vaccine was received within 2 weeks of vaccination. The patient experienced acute ischemic stroke which started afternoon of 05May2021 13:00. Patient visited ER on 06May2021 at 07:00 and was hospitalized for stroke from 06May2021 to 07May2021. He started physical therapy to rebuild strength and coordination in left arm and leg. Treatment atorvastatin 40,aspirin 81,Hydrochlorothiazide 25 was given. Patient was not diagnosed with covid prior to vaccination and has been tested on 06May2021 (nasal swab): negative. Outcome of the event was recovering.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Four days after taking the vaccine, the patient tested positive for COVID-19; This is a spontaneous report from a contactable pharmacist. A 29-year-old (age at vaccination) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on 23Apr2021 as 1st dose, single for COVID-19 immunisation. The patient medical history was and concomitant medications were not reported. It was reported that four days after taking the vaccine, the patient tested positive for COVID-19 on Tuesday 27Apr2021. The clinical course of the event was reported as: the patient had the first dose of the COVID-19 vaccine and four days after taking the vaccine, the patient tested positive for COVID-19. The reporter wanted guidance on the second dose of the vaccine. The reporter also wanted to know if there were reactions if a person who had COVID-19 and had the COVID-19 vaccine. It was also reported that "vaccination of people with known current SARS-CoV-2 infection should be deferred until the person has recovered from the acute illness (if the person had symptoms) and they had met criteria to discontinue isolation." "Participants were excluded if they had a clinical or microbiological diagnosis of COVID-19 before entry into the trial." No investigation assessment provided. The outcome of the event was unknown.   Information on lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness transient, Computerised tomogram, Confusional state, Feeling abnormal, Hallucination, visual
Clinical narrative: started seeing strange things- saw things that weren't there. The yellow wall in his bedroom came up but had all kinds of art work on it, the ceiling and doors too; couldn't remember things; Weird things happened in my brain; lost his vision while driving; CT scan  it did show hardening of the arteries in his brain ,was told had a TIA (Transient Ischemic Attack) or some kind of a stroke; had issues with confusion as well; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 06Apr2021 as 2nd dose, single dose (at the age of 78-year-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 as 1st dose for COVID-19 immunization. On 02May2021 (26 days later), patient lost his vision while driving and it came back good enough to drive within a half hour (medically significant) and when it recovered on 02May2021, patient started seeing strange things, saw things that were not there. The yellow wall in his bedroom came up but had all kinds of artwork on it, the ceiling and doors too (medically significant), patient couldn't remember things, had weird things happened in his brain. Patient stated that it didn't go away entirely until about 10 days later. Patient also had issues with confusion as well. Patient stated that he thinks he was back to normal now. A computed tomography (CT) scan was completed a week or so earlier and it did show hardening of the arteries in his brain. Patient saw his primary care physician and was referred to a neurologist. On unspecified date of May-2021, patient was told he had a transient ischemic attack (TIA) or some kind of a stroke (medically significant). Patient had a Magnetic resonance elastography (MRE) (like a Magnetic resonance imaging (MRI) of the brain) yesterday (27May2021), but it had not been read yet. Patient asked if he was the only one that had done this or had other people had this problem, even two or three people or he was an isolated case and in response it was stated that, unable to find information about his symptoms in resources and the Product Information (PI) for the vaccine does not contain information reporting his symptoms (vision loss, memory loss, confusion, hallucinations) as side effects of the vaccine. The outcome of had a TIA (Transient Ischemic Attack) or some kind of a stroke was unknown, for lost his vision while driving was recovered on 02May2021 while recovered for rest of the events on May2021.  Information about lot/batch number is requested.