chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Changes in my menstrual cycle have started. My menstrual cycle was ending as normal, but started back up as if it were starting all over again.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29May2021 11:00 (Lot number: EW0167) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies : Pencillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number=1, product=COVID 19, brand=Pfizer ,lot number=Ew0175, administration time=10:45 AM,, vaccine location=Right arm), administration date: 08May2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 22Jun2021 15:15, outcome "not recovered", described as "Changes in my menstrual cycle have started. My menstrual cycle was ending as normal, but started back up as if it were starting all over again.". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. The patient not been tested for COVID-19, Since the vaccination. No any product complaint to report. No medical information request.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bladder disorder, Chills, Fall
Clinical narrative: shivering; collapsing to the floor; losing control of her bladder; no strength; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 55 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OCREVUS; ATENOLOL. Past drug history included: Amoxicillin, reaction(s): "amoxicillin allergy"; Cipro, reaction(s): "Cipro allergy". The following information was reported: CHILLS (non-serious) with onset 14Apr2021, outcome "recovered" (2021), described as "shivering"; FALL (non-serious) with onset 14Apr2021, outcome "recovered" (2021), described as "collapsing to the floor"; BLADDER DISORDER (non-serious) with onset 14Apr2021, outcome "recovered" (2021), described as "losing control of her bladder"; ASTHENIA (non-serious) with onset 14Apr2021, outcome "recovered" (2021), described as "no strength".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site reaction
Clinical narrative: Severe chills; Left Deltoid administration site reaction; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 19Jan2021 (Lot number: EL1283, Expiration Date: 30Apr2021) at the age of 60 years as dose 2, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL, start date: 31Dec2020; IBUPROFEN, start date: 19Jan2021. Vaccination history included: Bnt162b2 (Dose: 1, Lot no: EJ1685, Expiry date: 31Mar2021, Dose: 0.3ml, Route of administration: Intramuscular, Anatomical location: Deltoid left), administration date: 31Dec2020, for Covid-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 20Jan2021, outcome "recovered" (Jan2021), described as "Severe chills"; VACCINATION SITE REACTION (non-serious) with onset 20Jan2021, outcome "unknown", described as "Left Deltoid administration site reaction". The action taken for bnt162b2 was unknown. Therapeutic measures were taken as a result of chills, vaccination site reaction.  Additional Information: Patient provided information to you regarding the reported adverse event with the use of the product. Patient considered the Pfizer product had a casual effect to the adverse event. Patient was willing to be contacted again by Pfizer on the reported adverse event. Did reaction recur on re-administration of product was yes; 24 hours after shot-10 hours of severe chills, injection site reaction. Additional vaccine administered on same date of Pfizer suspect was none. Family medical history relevant to AE was none Culture was not performed. Prior vaccinations (within 4 weeks) was none. There were no predisposing factors. Antipyretic use (around the date of vaccination) was Tylenol, Ibuprofen.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: but had a slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female 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: HEADACHE (non-serious), outcome "recovered", described as "but had a slight headache".  Additional Information: Patient stated that after the first dose had a little stronger side effects compared to what everyone was telling her. Patient did not have a fever but had a slight headache but it was minimum and went away in 10 hours and did not have it the next day.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: still having left arm pain; Sometimes when I carry heavy stuff, it feels bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 02May2021 (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), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "still having left arm pain"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Sometimes when I carry heavy stuff, it feels bad".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Skin discolouration
Clinical narrative: Have been getting darkening of skin/Spotting happened immediately, so the discoloration; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30May2021 (Lot number: EW0178) at the age of 22 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "Have been getting darkening of skin/Spotting happened immediately, so the discoloration". Therapeutic measures were taken as a result of skin discolouration.  Additional information: The patient wanted to report a side effect as the patient getting darkening of skin and was with dermatologist, right then nothing was working (medication unspecified). On 30May2021, the patient received vaccine on the left arm and stated that the expiration date was not available on the card. No other medical conditions and concomitant medication was reported. The patient stated that once this spotting had happened within, the spotting happened immediately, so the discoloration and seen by dermatologist and started treatment a cream with Triamcinolone acetonide ointment usp 0.1 percent for two weeks.  Follow-up attempts are completed. No further information is expected
Age: 22.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Skin discolouration
Clinical narrative: Have been getting darkening of skin/Spotting happened immediately, so the discoloration; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30May2021 (Lot number: EW0178) at the age of 22 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "Have been getting darkening of skin/Spotting happened immediately, so the discoloration". Therapeutic measures were taken as a result of skin discolouration.  Additional information: The patient wanted to report a side effect as the patient getting darkening of skin and was with dermatologist, right then nothing was working (medication unspecified). On 30May2021, the patient received vaccine on the left arm and stated that the expiration date was not available on the card. No other medical conditions and concomitant medication was reported. The patient stated that once this spotting had happened within, the spotting happened immediately, so the discoloration and seen by dermatologist and started treatment a cream with Triamcinolone acetonide ointment usp 0.1 percent for two weeks.  Follow-up attempts are completed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nasopharyngitis, Tremor
Clinical narrative: Cold; Shaking; Chills; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Jun2021 (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: NASOPHARYNGITIS (non-serious) with onset Jun2021, outcome "unknown", described as "Cold"; TREMOR (non-serious) with onset Jun2021, outcome "unknown", described as "Shaking"; CHILLS (non-serious) with onset Jun2021, outcome "unknown", described as "Chills"; HEADACHE (non-serious) with onset Jun2021, outcome "unknown", described as "Headache".  Additional information: I have a concern for my friend that got the shot yesterday so do you understand like why I am calling? Because somebody had an adverse reaction. Would you be able to give us the (incomplete sentence)? What's the guidelines? So her reaction was (incomplete sentence) and she's young, she's like 17 maybe, 110 pounds or something and she got cold last night she's shaking and then she's said like chills and then today her head is hurting really bad, really bad headache." Reporter stated, "No right now. I just want to know what's going on. Is that like a severe symptom, is that symptom that she really needs to go because she's saying that she's okay because she's having a headache and I'm telling her it's really up to you, you should probably go, you still have a headache anyway you have any kind of reaction that's not cool, just go to the doctor so, what's going down the grave, you got people turning purple and biting people and stuff (Further clarification was unknown), I mean what's coming down the pipe? What's weird for a typical young female to have a bad reaction, Is this serious? Is this bad, shaking because that freak me out? Shaking like that's like a seizure kind a thing like that's so bad (Reporter was unsure, hence not captured as event), you got to go, she's like Nah, nobody want to go to the doctor, I don't want to go and like I am fine and I'm like, you are not because your body just 'weirded' out. She probably go get it checked out because even though you feel better later something might happen, something might be going on and you are ignoring it and it's going to pick up again later and you won't even know what happened. So, right here right now somebody took the Pfizer shot young female, had headaches the next day, female, 120 pounds, shakes, and headaches the next day, what we are supposed to do?".  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: Cholecystectomy, Gout
Clinical narrative: Gall bladder removed; I never had gout before but was diagnosis & prescribed Meloxicam; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 11:45 (Lot number: EW0172) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gastritis" (unspecified if ongoing); "Gastroparesis" (unspecified if ongoing); "Chronic fatigue syndrome" (unspecified if ongoing); "Venous inefficacy" (unspecified if ongoing), notes: Venous inefficacy; "Type 2 diabetes" (unspecified if ongoing), notes: Type 2 diabetes; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient took concomitant medications. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin; Morphine, reaction(s): "Known allergies: Morphine", notes: Known allergies: Morphine; Demerol, reaction(s): "Known allergies: Demerol", notes: Known allergies: Demerol. The following information was reported: CHOLECYSTECTOMY (non-serious) with onset 21May2021, outcome "unknown", described as "Gall bladder removed"; GOUT (non-serious) with onset 2021, outcome "unknown", described as "I never had gout before but was diagnosis & prescribed Meloxicam". Therapeutic measures were taken as a result of cholecystectomy, gout. No follow-up attempts are possible. No further information is expected.  Additional information: Patient had gallbladder removed 21May2021 and surgery follow-up was 01Jun2021. Few days after surgery patient called the nurse to inquiry about scheduling 2nd injection. She stated after follow up appt. Patient had a good report but never had gout before but was diagnosis & prescribed Meloxicam. Symptoms on day of 2nd injections; temp of 102, fever blister, skin darken around mouth/chin, injection site sore, felt weak/nauseated' pain all over and thirsty. Symptoms lasted about a week except skin peeling around mouth/chin is on going. The 1st injection no symptoms. Ae treatment: Home remedy Tylenol, Hydrocodone, rest. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; buzzing sound in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jun2021 (Lot number: AW0181) at the age of 62 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE-1, Lot Number: AW0186.), administration date: 27May2021, when the patient was 62 years old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 22Jun2021, outcome "not recovered", described as "Tinnitus; buzzing sound in ears".  Additional information: The patient denied any medications, medical conditions, labs, testing, or treatments relevant to these events. No emergency room and no physician office. Prior vaccinations (within 4 weeks) and other vaccinations within four weeks prior to the first administration date of the suspect vaccines were none. Patients medical history (including any illness at time of vaccination), family medical history relevant to AE(s) and relevant tests were none.  No follow-up attempts are possible. No further information is expected.  Follow-Up (22Jul2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021783671 Same reporter/product/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Viral infection
Clinical narrative: She is now being prescribed an anti-viral Valacyclovir; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer-sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: VIRAL INFECTION (non-serious), outcome "unknown", described as "She is now being prescribed an anti-viral Valacyclovir".  Additional information: Swap from FC. She received both doses of COVID vaccine. She was now being prescribed an anti-viral valacyclovir and wondering if there are any documented interaction between medication and vaccine. Relayed PMI information and transferred. Faxed for AE. The caller did not provide any information other than 1st name.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Irritable bowel syndrome, Paraesthesia, SARS-CoV-2 test
Clinical narrative: mild Irritable Bowel Syndrome; A few hours after the first shot I had paresthesia in my legs, arms and back. After the second shot I immediately had paresthesia in my feet which eventually went away; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Mar2021 13:15 (Lot number: EP7534) 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: IRRITABLE BOWEL SYNDROME (non-serious) with onset 17Mar2021 17:00, outcome "not recovered", described as "mild Irritable Bowel Syndrome"; PARAESTHESIA (non-serious) with onset 17Mar2021 17:00, outcome "not recovered", described as "A few hours after the first shot I had paresthesia in my legs, arms and back. After the second shot I immediately had paresthesia in my feet which eventually went away". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Mar2021) negative. Therapeutic measures were not taken as a result of irritable bowel syndrome, paraesthesia.  Additional information: A few hours after the first shot had paresthesia in legs, arms, and back. A few days later had mild irritable bowel syndrome that went away after a few weeks. The event was not serious (no death, no life threatening, no caused/prolonged hospitalization, disabling/incapacitating and no congenital anomaly/birth defect). Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.  Follow-Up (22Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Irritable bowel syndrome, Paraesthesia, SARS-CoV-2 test
Clinical narrative: within a day the irritable bowel syndrome came back, no longer mild and I am still suffering from it; After the second shot I immediately had paresthesia in my feet which eventually went away; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 13:00 (Lot number: EW0151) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot: EP7534, Time: 01:15PM, Anatomical location: Right arm), administration date: 17Mar2021, when the patient was 48 years old, for COVID-19 immunization, reaction(s): "Paresthesia in my legs", "had mild irritable bowel syndrome". The following information was reported: IRRITABLE BOWEL SYNDROME (non-serious) with onset Apr2021, outcome "not recovered", described as "within a day the irritable bowel syndrome came back, no longer mild and I am still suffering from it"; PARAESTHESIA (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "After the second shot I immediately had paresthesia in my feet which eventually went away". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Mar2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of irritable bowel syndrome, paraesthesia.  Additional information: Other vaccine in four weeks and other medications in two weeks were no. After the second shot, immediately had paresthesia in feet which eventually went away. Unfortunately, within a day the irritable bowel syndrome came back, no longer mild, and still suffering from it. There was no way will risk getting a booster shot in a year. She can't imagine any worse. There was no treatment for IBS or paresthesia. No COVID prior vaccination. The patient tested COVID positive post vaccination. No known allergies and no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.  Follow-Up (22Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Ear pain, Facial pain, Fatigue
Clinical narrative: Low libido; Vertigo; dizziness; fatigue; brain fog; headaches; dull pain on left cheek; Ear pain/ Jaw Pain; Ear pain/ Jaw Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 12:00 (Lot number: EW172) at the age of 24 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 (Dose1, single, Lot number:  EP7533, Administration time12:00 PM, Vaccine location Left arm), administration date: 04Apr2021, when the patient was 24 years old, for Covid-19 Immunisation. The following information was reported: VERTIGO (non-serious) with onset 03May2021, outcome "recovered" (06Jun2021), described as "Vertigo"; DIZZINESS (non-serious) with onset 03May2021, outcome "recovered" (06Jun2021), described as "dizziness"; FATIGUE (non-serious) with onset 03May2021, outcome "recovering", described as "fatigue"; FEELING ABNORMAL (non-serious) with onset 03May2021, outcome "recovering", described as "brain fog"; HEADACHE (non-serious) with onset 03May2021, outcome "recovering", described as "headaches"; FACIAL PAIN (non-serious) with onset 03May2021, outcome "recovering", described as "dull pain on left cheek"; EAR PAIN (non-serious), PAIN IN JAW (non-serious) all with onset 01May2021, outcome "unknown" and all described as "Ear pain/ Jaw Pain"; LIBIDO DECREASED (non-serious), outcome "not recovered", described as "Low libido". The events "vertigo", "dizziness", "fatigue", "brain fog", "headaches" and "dull pain on left cheek" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo, dizziness, fatigue, feeling abnormal, headache, facial pain.  Additional information: The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine (prior vaccination was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Libido decreased, Pain in jaw, Vertigo
Clinical narrative: Low libido; Vertigo; dizziness; fatigue; brain fog; headaches; dull pain on left cheek; Ear pain/ Jaw Pain; Ear pain/ Jaw Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 12:00 (Lot number: EW172) at the age of 24 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 (Dose1, single, Lot number:  EP7533, Administration time12:00 PM, Vaccine location Left arm), administration date: 04Apr2021, when the patient was 24 years old, for Covid-19 Immunisation. The following information was reported: VERTIGO (non-serious) with onset 03May2021, outcome "recovered" (06Jun2021), described as "Vertigo"; DIZZINESS (non-serious) with onset 03May2021, outcome "recovered" (06Jun2021), described as "dizziness"; FATIGUE (non-serious) with onset 03May2021, outcome "recovering", described as "fatigue"; FEELING ABNORMAL (non-serious) with onset 03May2021, outcome "recovering", described as "brain fog"; HEADACHE (non-serious) with onset 03May2021, outcome "recovering", described as "headaches"; FACIAL PAIN (non-serious) with onset 03May2021, outcome "recovering", described as "dull pain on left cheek"; EAR PAIN (non-serious), PAIN IN JAW (non-serious) all with onset 01May2021, outcome "unknown" and all described as "Ear pain/ Jaw Pain"; LIBIDO DECREASED (non-serious), outcome "not recovered", described as "Low libido". The events "vertigo", "dizziness", "fatigue", "brain fog", "headaches" and "dull pain on left cheek" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo, dizziness, fatigue, feeling abnormal, headache, facial pain.  Additional information: The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine (prior vaccination was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain
Clinical narrative: stomach ache; body is painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administration date 25Jun2021 (Lot number: EW2181) at the age of 15 years 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: ABDOMINAL PAIN UPPER (non-serious) with onset 25Jun2021, outcome "unknown", described as "stomach ache"; PAIN (non-serious) with onset 25Jun2021, outcome "unknown", described as "body is painful". Therapeutic measures were not taken as a result of abdominal pain upper, pain.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My son was vaccinated he just had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Jun2021 09:30 (Lot number: EW0150, Expiration Date: 31Jul2021) at the age of 12 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Autistic" (unspecified if ongoing), notes: Verbatim: Autistic. Concomitant medication(s) included: ZOLOFT taken for autism spectrum disorder. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My son was vaccinated he just had a sore arm".  Additional information: The reporter is the mother of the patient. The reporter stated, she got her kids vaccinated yesterday (26Jun2021), my oldest daughter who was 15 and she had blurry vision and lost her hearing briefly for few minute on the day of reporting morning, so the reporter just got like that it was a side effect that probably should be reported, and her hearing came back in to, lying on the couch right then.  The reporter stated that she was vaccinated, haven't side effect. The patient (reporter's son) was vaccinated he just had a sore arm, but her daughter had this blurred vision and lost her hearing this morning so she thought it was, and report it. When probed for vaccination and side effects details of patient, the reporter stated, yes, right, the patient had stop talking more about that and he had not complained about anything that the reporter knew. The reporter said the patient had no prior vaccination.   This LRN W2021388963 is cross linked with W2021388964. The report is cross referenced to report ID:   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Heart rate increased, Hypertension
Clinical narrative: After the shot my heart rate went way up to 148; after the shot heart rate was high and blood pressure went crazy; After the shot my heart rate went way up to 148; after the shot heart rate was high and blood pressure went crazy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Feb2021 (Lot number: EN6198) at the age of 65 years as dose 1, single and administered in arm left, administration date 17Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Restless legs syndrome" (unspecified if ongoing), notes: Verbatim: Restless leg syndrome; "Surgery" (unspecified if ongoing), notes: Verbatim: Surgery on right arm; "high blood pressure" (unspecified if ongoing), notes: I take pills for that and it's very much control without the problem. Concomitant medication(s) included: ROPINIROLE; LOSARTAN taken for blood pressure measurement; HYDROCHLOROTHIAZIDE. The following information was reported: HYPERTENSION (non-serious) with onset 2021, outcome "unknown", HEART RATE INCREASED (non-serious) with onset 2021, outcome "recovered" (2021) and all described as "After the shot my heart rate went way up to 148; after the shot heart rate was high and blood pressure went crazy". The event "after the shot my heart rate went way up to 148; after the shot heart rate was high and blood pressure went crazy" and "after the shot my heart rate went way up to 148; after the shot heart rate was high and blood pressure went crazy" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypertension, heart rate increased.  Additional information: Patient had a reaction and happened to go to the Heart Doctor and everything after taking the Pfizer Covid-19 Vaccine. Consumer stated, It was the 3 days after the shot his heart rate went way up to 148 actually. He do have high blood pressure, take pills for that and it's very much control without the problem but after the shot heart rate was high and they gave me medicine for that and it lowered (Normal) his heart all over. Consumer stated, they put him on Metoprolol 25 mg twice a day and after that they put him on blood pressure medication that he was taking. Patient had no any prior vaccination. Consumer stated, After taking the vaccine his blood pressure went crazy. Consumer stated, he had blood test done before the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus Constant ringing in ears 24/7; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2021 09:45 (Lot number: EL9269) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Sulfur based products for Known allergies Sulfur based products. Vaccination history included: Bnt162b2 (dose number: 1, lot number: EL9261, administration time: 09:45 AM, vaccine location: Left arm), administration date: 26Jan2021, when the patient was 71 years old, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "Tinnitus Constant ringing in ears 24/7". Therapeutic measures were not taken as a result of tinnitus. Additional information: The patient was administered the most recent COVID-19 vaccine at Other Facility. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle twitching
Clinical narrative: Headache; Left Eye is Jumping; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Jun2021 (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 (1st DOSE), administration date: 14May2021, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 22Jun2021, outcome "not recovered", described as "Headache"; MUSCLE TWITCHING (non-serious) with onset 22Jun2021, outcome "unknown", described as "Left Eye is Jumping".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate irregular, Pain, Tinnitus, Vaccination site reaction
Clinical narrative: Tinnitus (moderate) unilateral on side of vaccine administration (left ear); moderate to severe injection site Rxn; Pain radiating through forearm and up to neck; rapid heart rate; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jun2021 11:00 (Lot number: EW0180) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tetracyclines, reaction(s): "Drug allergy: tetracyclines"; Quinolones, reaction(s): "Drug allergy: Quinolones". Vaccination history included: Bnt162b2 (DOSE 1, Product=COVID 19,, Brand=Pfizer, Lot number=EW0217,, Lot unknown=False,, Administration date=Jun2021,, Administration time=10:30 A.M., Anatomical Location =Left arm,), administration date: Jun2021, when the patient was 58 years old, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 27Jun2021 15:00, outcome "recovering", described as "Tinnitus (moderate) unilateral on side of vaccine administration (left ear)"; VACCINATION SITE REACTION (non-serious) with onset 27Jun2021 15:00, outcome "recovering", described as "moderate to severe injection site Rxn"; PAIN (non-serious) with onset 27Jun2021 15:00, outcome "recovering", described as "Pain radiating through forearm and up to neck"; HEART RATE IRREGULAR (non-serious) with onset 27Jun2021 15:00, outcome "recovering", described as "rapid heart rate"; FATIGUE (non-serious) with onset 27Jun2021 15:00, outcome "recovering", described as "Fatigue". Therapeutic measures were not taken as a result of tinnitus, vaccination site reaction, pain, heart rate irregular, fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Developed a metallic taste in my mouth/ Foul taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 18:45 (Lot number: EW0513) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Verbatim: High Blood Pressure. I do not know it has been couple of years.; "Cholesterol little elevated" (unspecified if ongoing), notes: I have a cholesterol little elevated but I am on medication for that. Concomitant medication(s) included: LIPITOR [ATORVASTATIN] taken for blood cholesterol increased; HYDROCHLORTHIAZID, start date: 2020. Vaccination history included: Bnt162b2 (First Shot, Lot number:LOT#: EP7534, Anatomical site of vaccine administration (first shot): Left arm, Time of Vaccination of first shot: 6:45 pm, No events reported.), administration date: 20Mar2021, when the patient was 61 years old, for Covid-19 Immunization. The following information was reported: DYSGEUSIA (non-serious) with onset 24May2021, outcome "not recovered", described as "Developed a metallic taste in my mouth/ Foul taste". The event "developed a metallic taste in my mouth/ foul taste" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of dysgeusia.  Additional information: Patient already went to his primary care physician for consultation. Patient wanted to know if anything was being reported that any other, any side effects coming up after a week. Patient took Hydrochlorthia 12.5 mg tablet once a day (not clarified further, hence not captured in tab), Patient was trying to see if it is related to the vaccine because like I said, it happened almost a month or two months after I received it.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: My cycle is very early; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (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: MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "My cycle is very early".  Additional information: The patient was reported her in country. The patient did not reported other vaccine in four weeks. Their was no COVID prior vaccination and no COVID tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Soreness of the arm; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Jun2021 08:00 (Lot number: EW017A) at the age of 69 years 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: PAIN IN EXTREMITY (non-serious) with onset 25Jun2021, outcome "recovering", described as "Soreness of the arm"; HEADACHE (non-serious) with onset 25Jun2021, outcome "recovered" (26Jun2021), described as "Headache". Therapeutic measures were taken as a result of headache.  Additional information: Caller states patient is calling about the Pfizer COVID vaccine with lot number EW017A. Patient wanted to report that her husband and herself had the shot on Friday 25Jun2021. patient had soreness in her arm and her husband had low back pain. Patient states his back pain became so severe he could hardly walk and stuff. Patient states Patient took him to the ER and they gave him a muscle relaxer and a pain pill, which didn't help at all. Patient states they were there for about 4 hours and sent home with some more pain pills and that was still not helping, when he left the hospital he was still in pain. Patient was wondering if this was common with the Pfizer vaccine; he has never had the back pain before with the pain in the muscle. Caller states this was in his muscles and it was not me concerning. HCP declined to provide Patient states Patient called Saturday 26Jun2021 and the call was disconnected but Patient was given the option for number 3 to call back before it disconnected. Patient states the nurse told us after the shot to take Tylenol and the headache would go away and Patient was fine. Caller mentions Patient still has the soreness in the arm but it isn't bad. Patient states the second shot is scheduled for 16Jul2021. indication They hesitated for a while before taking the shot. No Prior Vaccinations (within 4 weeks) If applicable, No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.No AE(s) following prior to vaccinations. No Patient's Medical History (including any illness at time of vaccination). No family Medical History Relevant to AE(s). No relevant Tests.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Decreased immune responsiveness
Clinical narrative: The antibodies in my body is just dropping more than half, 50% after six months.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 20Jan2021 (Lot number: EL3247) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN B COMPLEX. Vaccination history included: Bnt162b2 (Dose:1, Lot/batch: EL0142), administration date: 30Dec2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: DECREASED IMMUNE RESPONSIVENESS (non-serious), outcome "unknown", described as "The antibodies in my body is just dropping more than half, 50% after six months.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was healthy. Patient reported six months ago on 20Jan, she got the second shot from Pfizer and after a couple of weeks, when she got the blood work for her primary care, she tested antibody cells was as coming, that was 298. Thats the number and then after six months like, last week, not even six months, she got back to the routine checkup and she also had test on antibody test, it was about to 127. It was further reported that she used to take vitamin C vitamin B, multi vitamins and Lipitor (not further clarified) thats for her cholesterol 10mg and then after that for couple of month she was not taking any vitamin. On 21Feb2021, she had the antibodies 293 and got the blood work on 17Jun, her antibodies were going down to 127.  Follow-Up (23Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle twitching
Clinical narrative: Headaches; Left eye jumping/ eye jumping other than its something like a twitching; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Jun2021 (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), administration date: 14May2021, for COVID-19 immunization, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: HEADACHE (non-serious) with onset 22Jun2021, outcome "not recovered", described as "Headaches"; MUSCLE TWITCHING (non-serious) with onset 22Jun2021, outcome "not recovered", described as "Left eye jumping/ eye jumping other than its something like a twitching".  Additional Information: Reporter unable to clarify further on eye jumping other than its something like a twitching. States has lots of health problems. Asking for more information on her side effects including duration and whether it is related to the vaccine.   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: arm pain after injection; This is a spontaneous report received from a non-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 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 "arm pain after injection".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.