chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: helped her fibromyalgia; helped her fibromyalgia/ fibromyalgia symptoms were gone; bad chills; teeth were chattering; temperature of 102 point something; didn't feel good; 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 64 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Lot number: ER8733, Expiration Date: Jul2021) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia", start date: 2006 (unspecified if ongoing), notes: She states that she has had fibromyalgia since 2006. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot number: EM6202 , Expiry: Jun2021), administration date: 01Mar2021, when the patient was 64 years old, for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "helped her fibromyalgia"; PRE-EXISTING CONDITION IMPROVED (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "helped her fibromyalgia/ fibromyalgia symptoms were gone"; CHILLS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "bad chills"; CHILLS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "teeth were chattering"; PYREXIA (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "temperature of 102 point something"; MALAISE (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "didn't feel good". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, chills, pyrexia, malaise.  Additional information: She confirmed that he chills and fever ended on the following day, either 05Sep2021 or 06Sep2021 and that's also the same day that she noticed that her fibromyalgia symptoms were gone as well. She is still feeling good from not having her fibromyalgia symptoms. She busted her ass the following day which is usually a big mistake with fibromyalgia. Usually you are not going to do as good as you want and will overdo it and have a bad day for possibly weeks afterwards and she felt like shit even thought she had a great day, she felt crappy when she went to bed and then she woke up the next day in the same condition, she was feeling better and she finds that highly unusual with how her fibromyalgia works  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Peripheral swelling, Pyrexia
Clinical narrative: arm is swelling; fever; it is hot; 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), administration date 07Sep2021 (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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "arm is swelling"; PYREXIA (non-serious), outcome "unknown", described as "fever"; FEELING HOT (non-serious), outcome "unknown", described as "it is hot". Additional Information: NDC number of COVID vaccine: Not Provided. Reason for no lot number: of COVID vaccine: Complainant hung up abruptly/transfer incomplete. Expiry Date of COVID vaccine: Not Provided. Other Products: Not Provided. Patient History: Not Provided. Investigation Assessment: Not Provided. It was reported that, Caller said that she calling because she didn't know who to call really, yesterday she took the shot, clarified to the COVID vaccine, and when she came home she got stung in the same arm by a wasp and now her arm is swelling. It feels like it has a fever in, it is hot. When caller was informed that it is recommended for her to follow up with her primary care provider she purposefully ended the conversation and then disconnected the call. Unable to obtain further details.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: muscle pain; fever; tiredness; headache; injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection), administered in leg left, administration date 07Sep2021 09:00 (Lot number: FC3184) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if Covid prior vaccination: Yes. The patient's concomitant medications were not reported.  The following information was reported: MYALGIA (non-serious) with onset 07Sep2021 09:00, outcome "not recovered", described as "muscle pain"; PYREXIA (non-serious) with onset 07Sep2021 09:00, outcome "not recovered", described as "fever"; FATIGUE (non-serious) with onset 07Sep2021 09:00, outcome "not recovered", described as "tiredness"; HEADACHE (non-serious) with onset 07Sep2021 09:00, outcome "not recovered", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 07Sep2021 09:00, outcome "not recovered", described as "injection site pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, pyrexia, fatigue, headache, vaccination site pain.  Additional information: No other vaccine in four weeks. No other medications in two weeks. Adverse event: muscle pain, fever, tiredness, headache, injection site pain. COVID prior vaccination. COVID tested post vaccination.Covid test type post vaccination=Nasal Swab, Covid test name post vaccination=RT-PCR Priority, Covid test date=01Sep2021,Covid test result=Negative. No Known allergies. No other medical history.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: muscle pain; fever; tiredness; headache; injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection), administered in leg left, administration date 07Sep2021 09:00 (Lot number: FC3184) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if Covid prior vaccination: Yes. The patient's concomitant medications were not reported.  The following information was reported: MYALGIA (non-serious) with onset 07Sep2021 09:00, outcome "not recovered", described as "muscle pain"; PYREXIA (non-serious) with onset 07Sep2021 09:00, outcome "not recovered", described as "fever"; FATIGUE (non-serious) with onset 07Sep2021 09:00, outcome "not recovered", described as "tiredness"; HEADACHE (non-serious) with onset 07Sep2021 09:00, outcome "not recovered", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 07Sep2021 09:00, outcome "not recovered", described as "injection site pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, pyrexia, fatigue, headache, vaccination site pain.  Additional information: No other vaccine in four weeks. No other medications in two weeks. Adverse event: muscle pain, fever, tiredness, headache, injection site pain. COVID prior vaccination. COVID tested post vaccination.Covid test type post vaccination=Nasal Swab, Covid test name post vaccination=RT-PCR Priority, Covid test date=01Sep2021,Covid test result=Negative. No Known allergies. No other medical history.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding, Off label use, Product use issue, Rash
Clinical narrative: She is fine with the rash; She is breastfeeding; She is breastfeeding; She is breastfeeding; 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 27 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 (Lot number: FD8448) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), MATERNAL EXPOSURE DURING BREAST FEEDING (non-serious) all with onset 24Aug2021, outcome "unknown" and all described as "She is breastfeeding"; RASH (non-serious), outcome "recovered" (2021), described as "She is fine with the rash".  Additional information: Patient was breastfeeding and her 17 months old son, has developed a rash a week after her vaccination and the rash was worsening. Caller would like to know if she gives him Benadryl, would that affect his antibodies. No investigation assessment. She had talked to her pharmacist who had given her the vaccine about her son who was breast fed. He had gotten sick in Jan2021 and everyone around him tested positive for COVID. At the time they were not testing children in her area and he was not tested. He had a rash from head to toe at that time. Caller just got her vaccination on 24Aug2021. After a week, her son started developing a rash. Caller has called her pharmacist and her sons pediatrician. The doctor said it could be related. The pharmacist said it sounds like COVID rash and that caller should call and report it because there is not much research on how it reacts in breast fed patients. She was not too concerned about it, but she does not want another mom to get vaccinated and freak out thinking it is the Measles. Age adverse event started: 27 years or she might be 28 years old. Caller states that she doesn't take any medications and she has no underlying health conditions. No prior vaccinations (within 4 weeks). Could she give him Benadryl or will that effect the vaccine. Clearly he was getting the antibodies if he was getting a rash. She was fine with the rash. Would it be ok or would it interfere with it because it has been 2 weeks.  No follow-up attempts are possible. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101176985 child case
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on thigh, arms and stomach.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Sep2021 11:30 (Lot number: 7C 3184) at the age of 74 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Prostate cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 08Sep2021 07:30, outcome "recovering", described as "Rash on thigh, arms and stomach.". Therapeutic measures were taken as a result of rash.  Additional information: Facility type vaccine was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. Treatment included, Benadryl.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chills, Dysgeusia, Lip pain, Lip swelling
Clinical narrative: mouth taste like metal; lymph nodes swollen inside throat; sores on scalp like chicken pox; fevers; chills; jaw bone locked; inside mouth was full of blisters; lip was swollen and sore, for days she could hardly open her mouth; lip was swollen and sore, for days she could hardly open her mouth; 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), administration date 2021 (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: DYSGEUSIA (non-serious) with onset 2021, outcome "unknown", described as "mouth taste like metal"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "lymph nodes swollen inside throat"; BLISTER (non-serious) with onset 2021, outcome "unknown", described as "sores on scalp like chicken pox"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fevers"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; TRISMUS (non-serious) with onset 2021, outcome "unknown", described as "jaw bone locked"; ORAL MUCOSAL BLISTERING (non-serious) with onset 2021, outcome "unknown", described as "inside mouth was full of blisters"; LIP SWELLING (non-serious), LIP PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "lip was swollen and sore, for days she could hardly open her mouth".  Additional information: Caller states she has some questions and concerns, states she is also a medical personnel, states she is a scientist, states she took the Pfizer Covid vaccine three weeks ago, due for second tomorrow and she is concerned, states she is devastated and does not want to get the second one. Caller declines to provide any further personal information and does not consent to follow up. Caller states the minute after taking it her whole mouth taste like metal, states two or three hours after her lymph nodes swollen inside the throat, so swollen she could hardly see the tonsils, states her scalp had sores like chicken pox, jaw bone locked, states she had fevers and chills, states inside mouth was full of blisters, her lip was swollen and sore, for days she could hardly open her mouth. Caller declines to file the report, states she does not want to be a lab rat, does not want to be contacted about this and that. Caller wants to know if it is safe to get the second vaccine. Caller states she is allergic to some nuts. Confirms she got the Pfizer Covid vaccine, no NDC LOT and Expiration number provided, declined report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oral mucosal blistering, Pyrexia, Trismus
Clinical narrative: mouth taste like metal; lymph nodes swollen inside throat; sores on scalp like chicken pox; fevers; chills; jaw bone locked; inside mouth was full of blisters; lip was swollen and sore, for days she could hardly open her mouth; lip was swollen and sore, for days she could hardly open her mouth; 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), administration date 2021 (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: DYSGEUSIA (non-serious) with onset 2021, outcome "unknown", described as "mouth taste like metal"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "lymph nodes swollen inside throat"; BLISTER (non-serious) with onset 2021, outcome "unknown", described as "sores on scalp like chicken pox"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fevers"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; TRISMUS (non-serious) with onset 2021, outcome "unknown", described as "jaw bone locked"; ORAL MUCOSAL BLISTERING (non-serious) with onset 2021, outcome "unknown", described as "inside mouth was full of blisters"; LIP SWELLING (non-serious), LIP PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "lip was swollen and sore, for days she could hardly open her mouth".  Additional information: Caller states she has some questions and concerns, states she is also a medical personnel, states she is a scientist, states she took the Pfizer Covid vaccine three weeks ago, due for second tomorrow and she is concerned, states she is devastated and does not want to get the second one. Caller declines to provide any further personal information and does not consent to follow up. Caller states the minute after taking it her whole mouth taste like metal, states two or three hours after her lymph nodes swollen inside the throat, so swollen she could hardly see the tonsils, states her scalp had sores like chicken pox, jaw bone locked, states she had fevers and chills, states inside mouth was full of blisters, her lip was swollen and sore, for days she could hardly open her mouth. Caller declines to file the report, states she does not want to be a lab rat, does not want to be contacted about this and that. Caller wants to know if it is safe to get the second vaccine. Caller states she is allergic to some nuts. Confirms she got the Pfizer Covid vaccine, no NDC LOT and Expiration number provided, declined report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Pruritus
Clinical narrative: back itches; stated that both eyes are extremely dry; 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) (Lot number: EW0182) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "back itches"; DRY EYE (non-serious), outcome "unknown", described as "stated that both eyes are extremely dry".  Additional Information: Caller stated that she got the Pfizer vaccine a few months ago and back itches uncontrollably all day long and both eyes are extremely dry. Further question that Is for the Pfizer Covid 19 vaccine and Is for the second dose. Also wanted to know if there are any suggestions to do for her back to stop itching.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; 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) (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), for COVID-19 immunisation. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Caller wanted to know the amount of polyethylene glycol in each dose of the Comirnaty vaccine as she is allergic to it and because her allergist informed her that she might have more problem with the second dose than the first dose".  Additional information: Reporter wanted to know the amount of polyethylene glycol in each dose of the Comirnaty vaccine as patient was allergic to it and because her allergist informed her that she might have more problem with the second dose than the first dose.  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: Pain, Pruritus, Urticaria
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 54-year-old female patient (not pregnant) received the 2nd dose of BNT162B2 (Comirnaty), at the age of 54, in left arm, on Aug 22, 2021, single dose, for COVID-19 immunisation. No medical history reported. Concomitant medication(s) included sertraline, start date: Aug 22, 2021; and rosuvastatin. Vaccination history included the 1st dose of the COVID-19 vaccine (manufacturer unknown), for COVID-19 immunisation. The patient had pruritus (patient started itching), urticaria/hives and pain, all onset Aug 28, 2021, at 06:00, with outcome of not recovered. The events were evaluated at a physician office visit and emergency room visit. No therapeutic measures taken as a result of pruritus, urticaria and pain. Additional information: No other vaccine in four weeks. Other medications in two weeks: sertraline, rosuvastatin, Adverse event: Patient started itching and got hives. Nothing even touched this itching and pain she had. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No COVID-19 detected prior to vaccination. COVID-19 tested post vaccination. No known allergies. Other medical history: none. Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Impaired healing, Osteoarthritis, Pruritus, Wound
Clinical narrative: Burning; I have bunch of fresh ones and they appears on my thighs, on my legs, on my arms, on my back, all over my body except my face and they itch like crazy and I continue having fresh ones; Rounded wounds and they are swollen and itchy like crazy, they itching me; Rounded wounds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old patient received bnt162b2 (BNT162B2), administration date 17Aug2021 (Lot number: FC3182) at the age of 62 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: BURNING SENSATION (non-serious), outcome "recovering", described as "Burning"; IMPAIRED HEALING (non-serious), outcome "unknown", described as "I have bunch of fresh ones and they appears on my thighs, on my legs, on my arms, on my back, all over my body except my face and they itch like crazy and I continue having fresh ones"; PRURITUS (non-serious), outcome "recovering", described as "Rounded wounds and they are swollen and itchy like crazy, they itching me"; WOUND (non-serious), outcome "recovering", described as "Rounded wounds". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of burning sensation, pruritus, wound.  Additional Information: Consumer stated, got fever at worst from working till hours, end up missing both of knees so ended up having on knees, test osteoarthritis (not clarified on the call). Consumer was taking the Allegra but run out of it (further clarification was unknown) and the doctor gave this medication for itching, it is called Hydroxyzine, it's 25 mg.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Cough, Fatigue
Clinical narrative: Caller was audibly coughing while on the phone; Feeling wore out; No energy; Loss of equilibrium; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 14:30 (Lot number: FC3181) at the age of 62 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "COPD" (ongoing), notes: Diagnosed about 5-6 years ago; "Heart stents" (unspecified if ongoing), notes: Received them about 6 years ago. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 01Sep2021 15:30, outcome "not recovered", described as "Feeling wore out"; ASTHENIA (non-serious) with onset 01Sep2021 15:30, outcome "not recovered", described as "No energy"; BALANCE DISORDER (non-serious) with onset 01Sep2021 15:30, outcome "not recovered", described as "Loss of equilibrium"; COUGH (non-serious), outcome "unknown", described as "Caller was audibly coughing while on the phone".  Additional information: Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. Adverse events following prior vaccinations was none. Family medical history relevant to adverse events was none. Caller was a consumer that reported that he got the Pfizer Covid-19 vaccine on 01Sep2021 and ever since then he was feeling wore out, has no energy, and has a loss of equilibrium. He said that he could not work. He said that he has to be able to lay down. He stated that it has to be side effects from the vaccine. Caller was audibly coughing while on the phone. Vaccination facility type was pharmacy. Adverse events do not require a visit to emergency room and physician office. Relevant tests were none. Caller said that he wanted to get in to see the doctor, but they told him that he had to call us before they would see him. No statement needed-f/u will be conducted.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: My hands itch a lot/ it's a little each day/ is very itchy for hours/ my arms also itch.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 62-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 13:00 (Lot number: EW0171) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood pressure" (unspecified if ongoing); "known allergies: Nuts" (unspecified if ongoing). Concomitant medication(s) included: METHIMAZOLE; VALSARTAN. Vaccination history included: Bnt162b2 (product: COVID 19, brand: Pfizer, lot number: ER8737, lot unknown: False, administration date: 01Apr2021, administration time: 12:30 PM, dose number: 1, vaccine location: Right arm), administration date: 01Apr2021, when the patient was 62 years old, for COVID-19 Immunisation. The following information was reported: PRURITUS (non-serious) with onset 04May2021, outcome "not recovered", described as "My hands itch a lot/ it's a little each day/ is very itchy for hours/ my arms also itch.". Therapeutic measures were not taken as a result of pruritus. Additional information Covid vaccine details: Lot unknown: False If other vaccine in four weeks: No Other medications in two weeks: Valsartan, Methimazole. The patient did not have Covid prior vaccination. The patient had not Covid tested post vaccination. Adverse events start date: 04May2021   Adverse event: My hands itch a lot. Sometimes it's a little each day. Sometimes is very itchy for hours. Sometimes my arms also itch. Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Ear pain, Eating disorder, Feeling abnormal
Clinical narrative: Still feels bad; Feeling horrible; Short of breath; Coughing; Sneezing; Can't eat; Itching; Congestion; Cold symptoms; Ears hurting; Slept the majority of the day yesterday; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 28-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Sep2021 (Lot number: EW0185) at the age of 28 years as dose 1, 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: FEELING ABNORMAL (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Feeling horrible"; DYSPNOEA (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Short of breath"; COUGH (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Coughing"; SNEEZING (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Sneezing"; EATING DISORDER (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Can't eat"; PRURITUS (non-serious) with onset 08Sep2021, outcome "unknown", described as "Itching"; NASAL CONGESTION (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Congestion"; NASOPHARYNGITIS (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Cold symptoms"; EAR PAIN (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Ears hurting"; SOMNOLENCE (non-serious) with onset 08Sep2021, outcome "unknown", described as "Slept the majority of the day yesterday"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Still feels bad".  Additional Information: Patient's Medical History (including any illness at time of vaccination): None. States that she got the vaccine yesterday and ever since yesterday has been short of breath, coughing, she cannot eat, it is making her feel horrible. She started itching last night, but has no rash. She's been having congestion, cold symptoms, sneezing, her ears hurt. States that she can still taste and smell. Caller states she is still feeling bad, her symptoms all began yesterday. History and Investigations: Denies any other medications, medical conditions, labs, testing, or treatments relevant to these events. No Emergency Room or Physician Office visit required.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Pruritus, Sneezing, Somnolence
Clinical narrative: Still feels bad; Feeling horrible; Short of breath; Coughing; Sneezing; Can't eat; Itching; Congestion; Cold symptoms; Ears hurting; Slept the majority of the day yesterday; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 28-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Sep2021 (Lot number: EW0185) at the age of 28 years as dose 1, 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: FEELING ABNORMAL (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Feeling horrible"; DYSPNOEA (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Short of breath"; COUGH (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Coughing"; SNEEZING (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Sneezing"; EATING DISORDER (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Can't eat"; PRURITUS (non-serious) with onset 08Sep2021, outcome "unknown", described as "Itching"; NASAL CONGESTION (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Congestion"; NASOPHARYNGITIS (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Cold symptoms"; EAR PAIN (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Ears hurting"; SOMNOLENCE (non-serious) with onset 08Sep2021, outcome "unknown", described as "Slept the majority of the day yesterday"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Still feels bad".  Additional Information: Patient's Medical History (including any illness at time of vaccination): None. States that she got the vaccine yesterday and ever since yesterday has been short of breath, coughing, she cannot eat, it is making her feel horrible. She started itching last night, but has no rash. She's been having congestion, cold symptoms, sneezing, her ears hurt. States that she can still taste and smell. Caller states she is still feeling bad, her symptoms all began yesterday. History and Investigations: Denies any other medications, medical conditions, labs, testing, or treatments relevant to these events. No Emergency Room or Physician Office visit required.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Magnetic resonance imaging, Vaccination site pain
Clinical narrative: Left arm soreness, Within two hours/Her arm was sore and she noticed it a few hours after the injection.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Jan2021 (Lot number: EL1284) at the age of 74 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXIN.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Jan2021, outcome "unknown", described as "Left arm soreness, Within two hours/Her arm was sore and she noticed it a few hours after the injection.". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: Patient arm was sore, and she noticed it a few hours after the injection. She also noticed this with each one. She had no other symptoms with the first vaccine. Left arm soreness- Within two hours of getting each shot. She had no other symptoms after first shot.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: U
Vaccine: COVID19
Symptoms: Biopsy, Condition aggravated, Rash, Rash macular
Clinical narrative: Rash; The day after dose 2, it increases dramatically; to the point it looks like bock shot scars all over body below neck. Some spots are scarring; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent in response to consumer letter sent via follow-up letter and follow up received from a contactable consumer (patient).  A 22-year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 13Aug2021 16:00 (Lot number: FD8448F) at the age of 22 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, single; lot number: FA7484; via intramuscular route in arm; at 16:00), administration date: 23Jul2021, when the patient was 22 years old, for COVID-19 immunization, reaction(s): "Pityriasis Rosea". The following information was reported: RASH (non-serious) with onset 14Aug2021, outcome "not recovered", described as "Rash"; CONDITION AGGRAVATED (non-serious) with onset 14Aug2021, outcome "not recovered", described as "The day after dose 2, it increases dramatically"; RASH MACULAR (non-serious) with onset 14Aug2021, outcome "not recovered", described as "to the point it looks like bock shot scars all over body below neck. Some spots are scarring". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: patient received any other vaccine within 4 weeks, prior to the vaccination was reported as none. Patient medical history (including any illness at time of vaccination) reported as none. Not allowed to continue cream. Rash continues to grow exponentially. Clinical course: (with held) had 1 red spot of unknown nature 4 week before dose 1st of Pfizer. Within 2days these spots Increased dramatically. Diagnosed as Pityriasis Rosea. Started to subside in intensity before the week of 2nd dose. The day after dose 2 it increased dramatically in nature to the point it looks like bock shot scars all over body below neck. Some spots are scarring. Not good. It has not started to decrease in intensity at this point in time. Unfortunately, there was fear for any further vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Days after I got the first shot I got a bruise on my right foot. Went away.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 03Jun2021 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: food intolerance" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CONTUSION (non-serious) with onset 2021, outcome "recovered" (2021), described as "Days after I got the first shot I got a bruise on my right foot. Went away.". The event "days after i got the first shot i got a bruise on my right foot. went away." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of contusion. Additional information: The patient was not pregnant at vaccination. Facility type vaccine was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Adverse event: Days after I got the first shot, I got a bruise on my right foot. Went away. Within like 2 days after I got my second shot I got the same bruise in the same spot. Since then, I started getting them on my arms as well, back on my foot, feeling of restlessness and a lump first on one leg that went away in about 4 days and then another around pelvic area also took about 4 days. One Dr said I do have something vascular going on. Blood and urine test came out ok. Doctors did not rule out that it could a reaction. I got several opinions, and nothing explains why.  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-202101186410 same reporter/patient/product, different dose/event.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Investigation, Polymerase chain reaction, Respiratory gas exchange disorder
Clinical narrative: Chest pain; difficulty breathing; gas exchange in lungs is decreated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 24Apr2021 15:15 (Lot number: EW0170) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto hypothyroidism" (unspecified if ongoing); "Known allergies: sulfa drug" (unspecified if ongoing), notes: Known allergies: sulfa drug. Concomitant medication(s) included: LEXAPRO; SYNTHROID. Vaccination history included: Bnt162b2 (Dose 1, lot number: ER8734, administration time: 10:45 AM), administration date: 27Mar2021, when the patient was 31 years old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 27May2021 19:00, outcome "not recovered", described as "Chest pain"; DYSPNOEA (non-serious) with onset May2021, outcome "not recovered", described as "difficulty breathing"; RESPIRATORY GAS EXCHANGE DISORDER (non-serious) with onset May2021, outcome "not recovered", described as "gas exchange in lungs is decreated". The events "chest pain", "difficulty breathing" and "gas exchange in lungs is decreated" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of chest pain, dyspnoea, respiratory gas exchange disorder.  Additional Information: The patient age group was an adult. The patient did not received any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient had been tested for covid post vaccination. The patient tested for nasal swab test (PCR) on 07Sep2021, resulted for negative. Adverse event: Chest pain, difficulty breathing. Starting about 2 weeks after receiving the second dose, developed a significant amount of difficulty breathing with any exertion. Testing shows gas exchange in lungs is decreated.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Eating disorder, Fatigue, Head discomfort
Clinical narrative: really bad headache; extreme chills; extreme fatigue/exhausted; she wasn't able to eat; feel like pressure in her head; cough/ outcome of the cough persistent; soreness in my arm, right after/left arm was sore where she received the injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) (patient) from medical information team for a Pfizer sponsored program.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Aug2021 10:45 (Lot number: FC3180) at the age of 49 years as dose 2, single for covid-19 immunisation. Family history included: "high blood pressure" (unspecified if ongoing), notes: her mom has high blood pressure but patient's blood pressure is fine. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot: FA7485, Dose: Unknown strength/volume/dose injection to left arm at 15:25), administration date: 08Aug2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29Aug2021, outcome "recovered" (31Aug2021), described as "soreness in my arm, right after/left arm was sore where she received the injection"; HEADACHE (non-serious) with onset 07Sep2021, outcome "recovered" (Sep2021), described as "really bad headache"; CHILLS (non-serious) with onset 07Sep2021, outcome "not recovered", described as "extreme chills"; FATIGUE (non-serious) with onset 07Sep2021, outcome "recovering", described as "extreme fatigue/exhausted"; EATING DISORDER (non-serious) with onset 07Sep2021, outcome "unknown", described as "she wasn't able to eat"; HEAD DISCOMFORT (non-serious) with onset 07Sep2021, outcome "unknown", described as "feel like pressure in her head"; COUGH (non-serious) with onset 07Sep2021, outcome "not recovered", described as "cough/ outcome of the cough persistent". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: Consumer administered 2nd dose Pfizer-BioNTech Covid-19 Vaccine 29Aug2021.Onset of side effects 07Sep2021: slight headache, extremely fatigued. Took COVID test 07Sep2021 which came back negative.08Sep2021 onset of extreme chills, still had extreme fatigue and sometimes when would stand up would feel like pressure in head; gets this cough every now again that just shows up, unknown if it's from the chills or sweating; but the cough is not constant, it just comes out of nowhere. Cough started when started getting chills-cough persistent, kind of the same.    No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, SARS-CoV-2 test
Clinical narrative: really bad headache; extreme chills; extreme fatigue/exhausted; she wasn't able to eat; feel like pressure in her head; cough/ outcome of the cough persistent; soreness in my arm, right after/left arm was sore where she received the injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) (patient) from medical information team for a Pfizer sponsored program.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Aug2021 10:45 (Lot number: FC3180) at the age of 49 years as dose 2, single for covid-19 immunisation. Family history included: "high blood pressure" (unspecified if ongoing), notes: her mom has high blood pressure but patient's blood pressure is fine. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot: FA7485, Dose: Unknown strength/volume/dose injection to left arm at 15:25), administration date: 08Aug2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29Aug2021, outcome "recovered" (31Aug2021), described as "soreness in my arm, right after/left arm was sore where she received the injection"; HEADACHE (non-serious) with onset 07Sep2021, outcome "recovered" (Sep2021), described as "really bad headache"; CHILLS (non-serious) with onset 07Sep2021, outcome "not recovered", described as "extreme chills"; FATIGUE (non-serious) with onset 07Sep2021, outcome "recovering", described as "extreme fatigue/exhausted"; EATING DISORDER (non-serious) with onset 07Sep2021, outcome "unknown", described as "she wasn't able to eat"; HEAD DISCOMFORT (non-serious) with onset 07Sep2021, outcome "unknown", described as "feel like pressure in her head"; COUGH (non-serious) with onset 07Sep2021, outcome "not recovered", described as "cough/ outcome of the cough persistent". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: Consumer administered 2nd dose Pfizer-BioNTech Covid-19 Vaccine 29Aug2021.Onset of side effects 07Sep2021: slight headache, extremely fatigued. Took COVID test 07Sep2021 which came back negative.08Sep2021 onset of extreme chills, still had extreme fatigue and sometimes when would stand up would feel like pressure in head; gets this cough every now again that just shows up, unknown if it's from the chills or sweating; but the cough is not constant, it just comes out of nowhere. Cough started when started getting chills-cough persistent, kind of the same.    No follow-up attempts are possible. No further information is expected.