chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Mar2021 (Lot number: EN6205, Expiration Date: 30Jun2021) at the age of 69 years as dose 1, single and administered in arm right, administration date 14Apr2021 (Lot number: ER8733, Expiration Date: 31Jul2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing), notes: Verbatim: MS. Concomitant medication(s) included: TYSABRI taken for multiple sclerosis (ongoing). Vaccination history included: Got flu shots way early this year, administration date: 21Sep2020, for Immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm".  Additional information: Physician was aware that she was going to get the shot, so she had correct time and stopped tysabri 2 weeks before she had to get it. Was right on target. The second dose was 2 weeks before going for the next stated that he was curious about the Pfizer Covid vaccine. He and his wife had gotten both of their shots. His wife had no side effects at all, just a sore arm where she got the shot. Caller was the original reporter and then handed phone to wife whom he was reporting on. Reporter details were updated to reflect that. Wife completed the report. The next morning when she woke up. It was a little like when you go to lift the elbow out, it just made the upper part of the arm a little sore. The second day, it was very light, then it was gone. Did not had any other problems and it was never red. It happened the same time with the first and the second. Time vaccination was given was around noon both times and event onset the next morning after both vaccines. No additional vaccines administered on same date of Pfizer suspect. The adverse event did not require to visit to Emergency Room/Physician's office. No prior vaccinations within 4 weeks. No relevant tests.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache
Clinical narrative: Tiredness; Headache; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea".  Additional information included: The report was not related to a study or programme. The patient received Pfizer vaccine on few days ago (Tuesday). The patient had been tired the last couple of days and diarrhoea was on another day. He asked how long would that last as he wanted to get the second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Sore throat; Runny nose; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 06May2021, outcome "unknown", described as "Sore throat"; RHINORRHOEA (non-serious) with onset 06May2021, outcome "unknown", described as "Runny nose"; HEADACHE (non-serious) with onset 06May2021, outcome "unknown", described as "Headache".  Additional information: The caller got his first dose on 16Apr2021 and will be getting the second dose by tomorrow, 07May2021. The caller currently has a sore throat, runny nose, and headache. The caller wants to know if it is okay to get the second dose tomorrow as scheduled?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional information: Caller reported that patient had a sore arm after receiving the Covid Shot. Patient could not lay on his side all night.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EWO183) at the age of 56 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Verbatim: High Blood Pressure; "COPD" (unspecified if ongoing), notes: COPD. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness". Therapeutic measures were not taken as a result of dizziness, fatigue. Additional information: Report was not related to a study or programme. Patient Ethnicity information is available, the patient was the reporter. Reporter consent was contact given. The COVID-19 Vaccine was a Pfizer product. Consumer stated, "He just has a question. He took the Pfizer first vaccine earlier today and He want to know, how long does the symptoms last from the vaccine. Consumer was informed about Pfizer Medical Information department and provided with the number LOT#: Consumer stated, "EW0183, it looks like a O, EWO183." Other medications: Consumer stated, "Yes, but He don't have all of it with me, He don't know". Treatment Consumer Stated, "No, He haven't took anything." No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Headache, Peripheral coldness
Clinical narrative: Tired; Headache; His hands and feet are very cold and he was worried about circulation issues; His hands and feet are very cold and he was worried about circulation issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. The mother was reporting for her son.  A 28 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tired"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PERIPHERAL COLDNESS (non-serious), ANXIETY (non-serious), outcome "unknown" and all described as "His hands and feet are very cold and he was worried about circulation issues".  Additional Information: It was reported that had a second Pfizer shot yesterday and he was nearly tired and it was not a big problem. He was not too worried it was just headache usual symptoms but he called us because he was worried that his hands and feet are very cold and he was worried about circulation issues.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: a swollen lymph node on my left clavicle; other vaccine same date vaccine date 12Apr2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 (Lot number: EW0173) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "migraines due to traumatic brain injury (TBI)", start date: 2014 (unspecified if ongoing), notes: migraines due to traumatic brain injury, (TBI) in 2014; "hypertension" (unspecified if ongoing), notes: hypertension. Concomitant medication(s) included: DEPAKOTE; LAMICTAL; OXYTROL FOR WOMEN; LISINOPRIL; CHANTIX. Vaccination history included: Bnt162b2 (lot number=EW0151, lot unknown=False, administration date=12Apr2021 administration time=04:15 PM, dose number=1, Vaccine location=Left arm), administration date: 12Apr2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 08May2021, outcome "not recovered", described as "a swollen lymph node on my left clavicle"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08May2021, outcome "not recovered", described as "other vaccine same date vaccine date 12Apr2021". The events "a swollen lymph node on my left clavicle" and "other vaccine same date vaccine date 12apr2021" were evaluated at the physician office visit.  Additional information:  It was reported that after second dose, noticed a swollen lymph node on my left clavicle (08May21). Have seen a doctor (05May21), and are still keeping track of my ongoing symptoms. Patient did not receive other vaccine in four weeks. Did not have covid prior vaccination and not tested covid post vaccination. No allergies were reported.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder
Clinical narrative: sinuses just started and her sinuses are really bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Lot number: EW0169) as dose 1, single for covid-19 immunisation. Relevant medical history included: "has sinus issues because she just moved " (ongoing). The patient's concomitant medications were not reported.  The following information was reported: SINUS DISORDER (non-serious), outcome "unknown", described as "sinuses just started and her sinuses are really bad".  Additional information: Caller states her sinuses just started and her sinuses are really bad and she took the 1st dose of the Pfizer shot and has an appointment to take the 2nd dose of the Pfizer shot on the 11th of the month. does not have permission to do that and she herself is just sick with her sinuses and that has nothing to do with the vaccine and she has sinus issues because she just moved; States she herself is in otherwise good health and this is just her sinuses and she thought she was calling the location of the facility that gave her the Pfizer COVID vaccine and wanted to ask them how to go about her situation and did not know she was calling Pfizer.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Limb operation, Pain, Pain in extremity
Clinical narrative: Pain and soreness; pain in her Left arm; Having problems with the soreness and moving her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Apr2021, outcome "not recovered", described as "Pain and soreness"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "not recovered", described as "pain in her Left arm"; LIMB OPERATION (non-serious) with onset Apr2021, outcome "not recovered", described as "Having problems with the soreness and moving her arm".  Additional Information: The caller is calling about the Pfizer BioNtech vaccine. The caller and his wife had their first dose on 28Apr2021. The patient experienced some soreness where she took the shot, in the left arm. The patient is really having problems with the soreness and moving her arm. Is this natural or something to worry about it. It has been like 10 days since receiving the vaccine. The patient is still experiencing pain. Does the patient need to see a doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021514567 Same reporter/product/event, different patient
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: since receiving the shot all his allergy symptoms have went away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Lot number: EN6200) at the age of 73 years as dose 1,single and administration date 18Mar2021 (Lot number: 6198) as dose 2,single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 19Mar2021, outcome "unknown", described as "since receiving the shot all his allergy symptoms have went away".  Additional information: Patient who has taken the second COVID vaccine shot, and since receiving the shot all his allergy symptoms have gone away. The transfer agent states that the patient currently has several respiratory issues right now and has immune system challenges. The transfer agent states that the patient did take the two vaccines with no symptoms. Caller confirmed information provided by transfer agent as correct. Caller states that his regular ongoing symptoms have been reduced by 99 percent. His runny/stuffed up nose, itchy eyes, asthma, all was reduced to 0 after taking the two vaccines. Caller states that he wants to be in a Pfizer 3rd shot trial. Caller confirms that after receiving the vaccine that his symptoms went away. He states that he lives in (privacy) and it has a very large (privacy) community and he is significantly afraid of getting the variant. He states that the virus is already in (privacy). Caller states that's how the original virus started in (privacy). He states that a man went to a conference in (privacy) and then went back to (privacy) and they determined that he and everyone around him were carrying the virus. Caller states that he does not want to get the virus because he has had friends that died from the virus in April of last year. He states that he is interested in any possibility of a Pfizer 3 trial. He states that he does take allergy shots every week. He is on maintenance which means they don't increase the dose any further, which means he sufferers all week. He states Pfizer which is a great company should have a way of checking mRNA of people who have allergies and that may be the way to go. Caller states that he got better. He was taking Tylenol 3000 mg a day for sinus headaches. He states that his Tylenol usage has dropped almost to zero.  He says that every possible symptom of the sinus problem the eye itching, nose, throat problems, and nose have almost disintegrated. He states its almost amazing.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: her mother is very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). A female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine - manufacturer unknown (Dose: 01), for Covid-19 immunization, reaction(s): "No reaction on previous exposure to vaccine".  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "her mother is very sick".   Additional information: Patient does not have covid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus headache, Weight, Weight decreased
Clinical narrative: Patient reports she was lost weight and her weight was somewhere between 125 lbs. and 130 lbs; sinus headache around her eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 70-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 (Lot number: EW0182) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "seasonal allergies" (ongoing), notes: Verbatim: seasonal allergies. Concomitant medication(s) included: BENADRYL taken for hypersensitivity (ongoing); ALLEGRA-D [FEXOFENADINE; PSEUDOEPHEDRINE HYDROCHLORIDE] taken for hypersensitivity (ongoing). The following information was reported: SINUS HEADACHE (non-serious) with onset 07May2021, outcome "unknown", described as "sinus headache around her eyes"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Patient reports she was lost weight and her weight was somewhere between 125 lbs. and 130 lbs". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She is calling to ask if she can take her seasonal allergy medication. She usually takes Benadryl or Allegra D. She has taken these medications for quite some time. She has seasonal allergies. She is asking if taking her Benadryl or Allegra-D will affect the Covid 19 vaccine she received. she is lost weight, and her weight is somewhere between 125 lbs. and 130 lbs. She reports her family all got the Covid 19 vaccine. She reports she was hesitant about getting the Covid 19 vaccine, but she started listening to reports about the vaccine and none of her family members had side effects after receiving their Covid 19 vaccines. She has not taken any of her allergy medication today. She also did not take her allergy medication yesterday, 06May2021, prior to receiving her Covid 19 vaccine. She is starting to get a sinus headache around her eyes right now. She usually gets a sinus headache with her seasonal allergies.  are her worst seasons because of the flower budding.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: I feel my weakness came back again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old patient received bnt162b2 (BNT162B2), administration date 17Apr2021 (Batch/Lot number: unknown) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "HIV" (unspecified if ongoing); "I am a weak person on my left side because of neurological part " (unspecified if ongoing), notes: Seriously I am a weak person on my left side because of neurological part. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), administration date: 27Mar2021, for Covid-19 Immunization. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "I feel my weakness came back again".  Additional information: Patient reported of being a weak person on his left side and was better first but after the vaccination (Pfizer Covid Vaccine), he felt his weakness came back again. Patient also reported that he was immune compromised person and had HIV and he took the medicine the vaccination. He reported of being a weak person on his left side because of neurological part so, he was getting better of weakness was on his left side. He reported of being fine first but after the vaccination (Pfizer Covid Vaccine), he felt that his weakness came back again. He had followed up with (Privacy) so his neurons contempt probably and he had to go back to (Privacy) to report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: first dose: sore arm; first dose: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 07Apr2021 15:45 (Lot number: EW0153, Expiration Date: Jul2021) at the age of 56 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Apr2021, outcome "unknown", described as "first dose: sore arm"; HEADACHE (non-serious) with onset 07Apr2021, outcome "recovered" (08Apr2021), described as "first dose: headache". Therapeutic measures were taken as a result of headache.  Additional information: After first dose she had sore arm. She went back to work the next day and the sore arm lasted for 2 to 4 days. She also developed headache which started about an hour after the first dose. With the first she had a headache all night. She took Aleve and went to bed and fell asleep. The headache was gone when she woke up.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea, SARS-CoV-2 test
Clinical narrative: first vaccine- my period came more a week early; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: POLYMENORRHOEA (non-serious), outcome "not recovered", described as "first vaccine- my period came more a week early". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of polymenorrhoea  Patient did not receive other vaccine in four weeks. Other medications in two weeks were none. Patient had not received covid vaccine prior to vaccination. The patient had not received any other vaccines ,The patient had covid test date: 29Apr2021, The patient had Nasal Swab test with result Negative. Patient sates period came more a week early, 2nd vaccine patient still waiting to start period over 2 weeks  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 59-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown) for COVID-19 Immunisation. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea".  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain
Clinical narrative: Side is hurting; its like a pressure in what caller guesses is her uterus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (Formulation: Solution for injection), administered in arm right, administration date 07May2021 (Lot number: EL10170, Expiration Date: 31Aug2021) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 07May2021, outcome "recovering", described as "Side is hurting"; FEELING ABNORMAL (non-serious) with onset 07May2021, outcome "recovering", described as "its like a pressure in what caller guesses is her uterus".  Additional information: Caller is a consumer inquiring if anybody has ever reported any side effects like caller is presenting. Caller's side is hurting.  Caller got the first dose Pfizer Covid Vaccine this morning, 07May2021. Side is hurting: Caller states its like a pressure in what caller guesses is her uterus.  It is making caller feel like she has to go to the bathroom.  Caller reports she has been drinking a lot of water.  Caller is in pain on her side all of a sudden and the pain is not going away. Caller reports her side hurting is ongoing and has improved. Caller wanted to see if anyone reported this event.  Caller wants to go lay down.  Caller declines to complete l Form.  Caller states she wants to go lay down.  Caller would like to speak with medical information.  No further information is provided.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm, after first vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 19Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm, after first vaccine".  Additional information:She is concerned about the potential side effects from the second dose being much worse and would like to know if she delayed her second dose beyond the recommended 3 week interval would it lessen the chance of having side effects from the second dose. caller know that the recommended interval is 3 weeks and that there is no data to suggest that potential side effects would be lessened if the second dose is delayed.Caller wants to know more information about taking medications like Tylenol or Ibuprofen either before or after the Pfizer COVID-19 vaccine to help with potential side effects. and if people should take antihistamines to help prevent an allergic reaction to the Pfizer COVID-19 vaccine.Reporter seriousness for Sore arm, after first vaccine: Unspecified.Reporter seriousness for At risk: for not taking second vaccine, or as scheduled:   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear discomfort, Fatigue, Headache, Pain
Clinical narrative: pain at injection site; Chills; Headache; Fatigue; body aches; woke with a clogged ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for COVID-19 immunization, reaction(s): "pain at the injection site". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at injection site"; CHILLS (non-serious), outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; PAIN (non-serious), outcome "unknown", described as "body aches"; EAR DISCOMFORT (non-serious), outcome "unknown", described as "woke with a clogged ear".  Additional Information: Is Pfizer Covid-19 vaccine a Pfizer product: Unspecified. Pfizer Covid-19 vaccine manufacturer was unspecified. Dates for Pfizer Covid-19 vaccine were Unspecified. NDC number and Expiry Date of Pfizer Covid-19 vaccine was not Provided. Reason for no lot number: of Pfizer Covid-19 vaccine: Caller unwilling to complete the report. Other Products were not Provided. Investigation Assessment was not Provided. Dates for pain at injection site, Chills, Headache, Fatigue, body aches, woke with a clogged ear was provided as unspecified. Additional Context: Caller is reporting that she experienced a reaction after getting the Pfizer Covid-19 vaccine. Declines to provide email address. She reports that on Monday morning, she received the second dose. Like the first time she had pain at the injection site. The pain did go away. She also had chills, headache, fatigue and body aches. She went to bed on Tuesday and yesterday she woke with a clogged ear on the side that she received the shot. She didn't make a big deal out of it or relate it to the vaccine. She researched and realized her ear clogging could be a side effect of the vaccine. She read that others had this. She is asking if we have heard this? What needs to be done? Does she need to see an ENT? Does anyone at Pfizer have an explanation or suggestion? Reporter seriousness for pain at injection site, Chills, Headache, Fatigue, body aches, woke with a clogged ear was provided as unspecified.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at injection site; Chills; Headache; Fatigue; body aches; woke with a clogged ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for COVID-19 immunization, reaction(s): "pain at the injection site". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at injection site"; CHILLS (non-serious), outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; PAIN (non-serious), outcome "unknown", described as "body aches"; EAR DISCOMFORT (non-serious), outcome "unknown", described as "woke with a clogged ear".  Additional Information: Is Pfizer Covid-19 vaccine a Pfizer product: Unspecified. Pfizer Covid-19 vaccine manufacturer was unspecified. Dates for Pfizer Covid-19 vaccine were Unspecified. NDC number and Expiry Date of Pfizer Covid-19 vaccine was not Provided. Reason for no lot number: of Pfizer Covid-19 vaccine: Caller unwilling to complete the report. Other Products were not Provided. Investigation Assessment was not Provided. Dates for pain at injection site, Chills, Headache, Fatigue, body aches, woke with a clogged ear was provided as unspecified. Additional Context: Caller is reporting that she experienced a reaction after getting the Pfizer Covid-19 vaccine. Declines to provide email address. She reports that on Monday morning, she received the second dose. Like the first time she had pain at the injection site. The pain did go away. She also had chills, headache, fatigue and body aches. She went to bed on Tuesday and yesterday she woke with a clogged ear on the side that she received the shot. She didn't make a big deal out of it or relate it to the vaccine. She researched and realized her ear clogging could be a side effect of the vaccine. She read that others had this. She is asking if we have heard this? What needs to be done? Does she need to see an ENT? Does anyone at Pfizer have an explanation or suggestion? Reporter seriousness for pain at injection site, Chills, Headache, Fatigue, body aches, woke with a clogged ear was provided as unspecified.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Paranasal sinus discomfort
Clinical narrative: This morning he woke up with the pain again in his left temple.; His temples felt squeezed in a vice.  It lasted 2 days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Lot number: EWD150, Expiration Date: 31Jul2021) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARANASAL SINUS DISCOMFORT (non-serious) with onset 01May2021, outcome "recovered" (03May2021), described as "His temples felt squeezed in a vice.  It lasted 2 days."; PAIN (non-serious) with onset 06May2021, outcome "unknown", described as "This morning he woke up with the pain again in his left temple.".  Additional information: Caller stated he was watching his diet these days. This morning he woke up with the pain again in his left temple. It was the pain he had the day after the vaccine. The same as the first time, but not as severe, only on one side. Caller has heard of reports about blood clots and was concerned. Caller stated someone that he had a blood clot in his brain that was causing the pain in his temple. Caller asked was this necessary, if not, he would have to go to the Emergency Department. Caller asked does the pain in the temple 5 days after the vaccine, something to be alarmed about. If he could not have this answered he was going to the Emergency Department. Caller stated he does not want his brain to explode. He does not want to have a stroke.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: felt like someone hit his arm; fatigued a little; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "felt like someone hit his arm"; FATIGUE (non-serious), outcome "unknown", described as "fatigued a little".  Additional information: The caller had a friend who had their second Pfizer shot. The patient was older than the caller. The patient was fine, he said it felt like someone hit his arm and was fatigued a little. The caller declines to file a safety report, no further information or details were captured at this time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Fall, Vertigo
Clinical narrative: Vertigo; fell on our dog cage because he lost his balance; fell on our dog cage because he lost his balance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 13:00 (Lot number: ER8732) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious) with onset 01May2021 23:30, outcome "unknown", described as "Vertigo"; FALL (non-serious), BALANCE DISORDER (non-serious) all with onset 01May2021 23:30, outcome "unknown" and all described as "fell on our dog cage because he lost his balance". The event "fell on our dog cage because he lost his balance" and "fell on our dog cage because he lost his balance" was evaluated at the physician office visit.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Rash macular
Clinical narrative: which was given halfway down the right arm, closer to elbow than the shoulder; She had a red spot where she got the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1 in right arm), administration date: 01Apr2021, for COVID-19 Immunization.  The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 22Apr2021, outcome "unknown", described as "which was given halfway down the right arm, closer to elbow than the shoulder"; RASH MACULAR (non-serious) with onset Apr2021, outcome "unknown", described as "She had a red spot where she got the shot".  Additional information: Caller stated that her daughter is 16 years old and received her second Pfizer vaccine dose on 22Apr2021, which was given halfway down the right arm, closer to elbow than the shoulder. She had a red spot where she got the shot, so knew it was the wrong area on her arm. It was not given into the muscle like it should have been given. Caller queried will this shot be effective if it was not given into the muscle and were going to take patient for an antibody test to see if she has any antibodies from the 2 vaccine doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: feeling tired; had like flu-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "feeling tired"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "had like flu-like symptoms".  Additional information: Reporter had 2 friends that also had the Pfizer vaccination and they just were feeling tired, nothing of such like he is having, they had like flu-like symptoms. It was unknown if patient received other vaccine within 4 weeks (prior).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021526487 same reporter/vaccine/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: feeling tired; had like flu-like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "feeling tired"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "had like flu-like symptoms". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021526486 same reporter/vaccine/event, different patient
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Vaccination site pain, Vaccination site warmth
Clinical narrative: headache; arm pain; arm was warm at the site; really tired; body was aching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Apr2021 (Lot number: ER8732) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 02Apr2021, outcome "recovered" (Apr2021), described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 02Apr2021, outcome "recovered" (Apr2021), described as "arm pain"; VACCINATION SITE WARMTH (non-serious) with onset 02Apr2021, outcome "recovered" (Apr2021), described as "arm was warm at the site"; FATIGUE (non-serious) with onset 02Apr2021, outcome "recovered" (Apr2021), described as "really tired"; PAIN (non-serious) with onset 02Apr2021, outcome "recovered" (Apr2021), described as "body was aching".  Additional information: The next day, 02Apr2021, she started to feel these symptoms. She confirms by the fourth day, she started to feel better. She recovered completely from these symptoms. Emergency Room: No, Physician Office: No. Patient had no prior Vaccinations (within 4 weeks): No AE(s) following prior vaccinations. Patient's Medical History (including any illness at time of vaccination): No Concomitant products: She had not been on any medicines. Relevant Tests: No.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: very tired; second dose: sore arm; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 28Apr2021 15:45 (Lot number: EW0153, Expiration Date: Jul2021) at the age of 56 years as dose 2, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Suspect: Pfizer covid vaccine , First Dose, Time of Vaccination: 3:45 PM, Vaccine Lot number: EW0153, Vaccine lot expire date: Jul2021, Anatomical location of Administration: Right deltoid (0.3ml)), administration date: 07Apr2021, when the patient was 56 years old, for Covid-19 immunization, reaction(s): "Headache". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28Apr2021, outcome "recovered" (30Apr2021), described as "second dose: sore arm"; HEADACHE (non-serious) with onset 28Apr2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 28Apr2021 18:00, outcome "unknown", described as "very tired". Therapeutic measures were taken as a result of headache.  Additional information: Reporter took her mother for both doses of Pfizer COVID19 vaccine. Second dose was on 28Apr2021. She had the first on 07Apr2021. They had the same vial number for both doses. Caller asked the pharmacist about it. It is caller's understanding that the vials are supposed to be kept at a certain temperature and not used again. She thinks it is weird it is the same vial 3 weeks later. Caller wants to make sure that is correct. She wants to make sure her mom is vaccinated appropriately. She didn't really have any side effects. She did have a sore arm after both doses. She had a headache after both doses. She was very tired mostly with the second dose. It was not as bad as most people have had. Second Dose Headache: started maybe three hours after vaccination. With the second one, she took Ibuprofen because the headache was a bit worse and she works using her arms and her arms were sore. She went to sleep after the Ibuprofen and woke up better.   Very tired: that occurred mostly with the second dose. She had vaccine around 3:45PM and got home around 5PM. Around 6PM, she felt extremely tired and didn't really wake up until the next day. She was tired throughout the night. Patient reported no AE following prior vaccinations.   No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Paraesthesia
Clinical narrative: my right arm had tingling effect feeling; was really wired I couldn't get the sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Apr2021 (Lot number: EW0150) at the age of 55 years as dose 1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset Apr2021, outcome "unknown", described as "my right arm had tingling effect feeling"; INSOMNIA (non-serious) with onset Apr2021, outcome "unknown", described as "was really wired I couldn't get the sleep".  Additional information:Patient got first she already got second shot but when she got the first one the lady that gave me first shot and told me that if you had like after effect so call and let you know this about you know. The side effect this side effect she never heard with anybody say anything people say they got  got chills, fatigue or may be flu symptoms but  the side effect she had was Okay she got the shot both the shot she got in left arm but the side effect she had both the time first shot and second shot that my right arm had tingling effect feeling  and wired she couldn't get the sleep, the first time tingling feeling first she think  just laying on her arm how she thought fall asleep she felt like just laying wrong side she felt sleep. Treatment in response to event:  consumer stated, " First time she didn't did anything but the second time  she put some oil on her arm; Just Tylenol."  No follow-up attempts are possible. No further information is expected.