chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: breaking out in welts on their face, but no itching after receiving the Pfizer vaccine/her symptoms resolved; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset Mar2021, outcome "recovered" (20Mar2021), described as "breaking out in welts on their face, but no itching after receiving the Pfizer vaccine/her symptoms resolved".  Additional information: Caller stated she received her 1st Pfizer vaccine dose on 15Mar2021 and was scheduled for her 2nd vaccine dose on 07Apr2021. The caller was asking If there was any data on a lot of people breaking out in welts on their face, but no itching after receiving the Pfizer vaccine. Caller stated her symptoms resolved by 20Mar2021.  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: Diarrhoea
Clinical narrative: she is having diarrhea; This is a spontaneous report received from contactable reporter (Consumer) from medical information team.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 13:00 (Lot number: EM9810) at the age of 71 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: DIARRHOEA (non-serious) with onset 29Mar2021, outcome "recovering", described as "she is having diarrhea".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling abnormal, Nausea
Clinical narrative: felt some nausea; he "felt off" / had a similar feeling, kind of off, he didn't feel all there; he also had some trouble with dinner; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Mar2021 (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: NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "felt some nausea"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "he "felt off" / had a similar feeling, kind of off, he didn't feel all there"; DECREASED APPETITE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "he also had some trouble with dinner".  Additional Information: The patient stated that he received the Pfizer COVID-19 vaccine last Tuesday (Mar2021). On Wednesday (Mar2021) during a 3 hour stretch, he felt some nausea, and he "felt off". He stated that he was more comfortable resting his head or laying down. On Thursday and Friday (Mar2021), he was okay. On Saturday (Mar2021), he had a similar feeling, kind of off, he didn't feel all there, and he also had some trouble with dinner. Yesterday (Mar2021), he had all 3 meals but still felt off. Today (Mar2021), his appetite was fine and he didn't feel so off. He wanted to know if there had been reports of lingering symptoms after 72 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the injection site; 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 27Mar2021 (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, single), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "soreness at the injection site".  Additional information: It was reported that she received the second dose of the Covid 19 vaccine 29 hours ago (at the time of report), it was reported that soreness at the injection site was the only symptom the patient was experiencing. Patient wanted to know if she should be worried about something and if it was okay to get her antibody titers in two weeks as suggested by her doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong technique in product usage process
Clinical narrative: she received the first dose of the Pfizer-BioNTech COVID-19 vaccine subcutaneously instead of intramuscularly; arm pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), subcutaneous, administered in arm, administration date 29Mar2021 (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), outcome "unknown", described as "she received the first dose of the Pfizer-BioNTech COVID-19 vaccine subcutaneously instead of intramuscularly"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain".Reporter asked if the second dose of the Pfizer-BioNTech COVID-19 vaccine induces more side effects than the first. She said she feels like she received the first dose of the Pfizer-BioNTech COVID-19 vaccine it was administered by a pharmacy technician and then she injects 2 'O' subcutaneously instead of intramuscularly, the present day. She explained the injection was too low. She specified she has arm pain. She asked if the efficacy of the vaccine would be impacted given this inadvertent administration. Putting up injection she believe on almost like triceps area; Did not give her in IM shot it was almost like a subcutaneous shot; Not into the muscle but more into the subcutaneous site. It was not about the quality of the product but it was about the wrong injection technique, that she was concerned. So, she was wondering if the vaccine was still being affective or she need a first dose again, like a total of 3 dose. She stated, she was a pharmacist herself, she knew that it was wrong when it was given. It did not feel right when it was given into the deltoid muscle but it was really there in her arm. She knew that the vaccine have the approval when looked at the prescription information it should IM but her injection was not given at the IM site. She stated it was given to her really low in her arm, it was like pretty much IM injection subcutaneously. Not into the muscle but more into the subcutaneous site. She would like to know if the vaccine was not given into the muscle whether it is effective or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased, Muscle spasms, Muscular weakness, Pain in extremity, Vaccination site pain
Clinical narrative: shoulder pain at the injection site; decreased mobility in left arm; not so much weakness as soreness and I find that I'm guarding my arm because of the soreness; not so much weakness as soreness and I find that I'm guarding my arm because of the soreness; Charlie Horses; This is a spontaneous report received from a contactable reporter (Nurse) from medical information team.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 09Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single, MANUFACTURER UNKNOWN (Lot # not provided)), for COVID-19 Immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "shoulder pain at the injection site"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "decreased mobility in left arm"; MUSCULAR WEAKNESS (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "not so much weakness as soreness and I find that I'm guarding my arm because of the soreness"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "Charlie Horses".  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-2021289893 same reporter/drug, different patient
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 (Lot number: EN6207) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Obsessive-compulsive disorder" (unspecified if ongoing). Concomitant medication(s) included: PAXIL taken for obsessive-compulsive disorder. The following information was reported: DIZZINESS (non-serious) with onset 24Mar2021, outcome "unknown", described as "Dizziness". Therapeutic measures were not taken as a result of dizziness. Additional Information: Patient was wondering, he got the first dose exactly one week ago today and he had no side effects until today, patient noticed one symptom and his job requires to climb up onto trailers and then walk around on trailers and he just noticed today that he had some slight dizziness throughout the day when he was doing that activity and he also do a lot of driving, he did not notice any issues with driving but only when he was climbing up onto trailers which are about 6 feet high off the ground only or get up suddenly from a chair patient noticed dizziness which he never have normally. he was wondering if this is a possible side effect." Consumer stated, he didn't see an expiration date. Consumer stated, he has excellent health.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Tinnitus
Clinical narrative: headache; ringing in ear; upset stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date Mar2021 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "recovering", described as "headache"; TINNITUS (non-serious) with onset Mar2021, outcome "recovering", described as "ringing in ear"; ABDOMINAL DISCOMFORT (non-serious) with onset Mar2021, outcome "recovering", described as "upset stomach". Additional information: Clinical course: The patient experienced headache, ringing in ear, and upset stomach on the evening of first BNT162B2 vaccine. Felt better by morning.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal pain, Rhinorrhoea
Clinical narrative: pain in sigmoid colon; nose had been running; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (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: GASTROINTESTINAL PAIN (non-serious), outcome "unknown", described as "pain in sigmoid colon"; RHINORRHOEA (non-serious), outcome "unknown", described as "nose had been running". Additional information: The patient got the asked if it's okay to take pain reliever (Advil) for pain in her sigmoid colon. She also asked if it was ok for her to take daily antihistamine (Zyrtec) after receiving her first dose of Pfizer- Biontech Covid19 vaccine. She stated that her nose had been running since she had not been taking her Zyrtec.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Vaccination site pain
Clinical narrative: arm pain in muscle at injection site; nausea; headache; body ache; chills; This is a spontaneous report received from a contactable consumer via a Pfizer colleague. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date Mar2021 (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, Batch/Lot number: unknown), administration date: Mar2021, for COVID-19 immunisation, reaction: "axillary pain". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "arm pain in muscle at injection site"; NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "nausea"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "headache"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "body ache"; CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills".  Additional information: The events took place 10 hours after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Oropharyngeal pain, Vaccination site pain
Clinical narrative: Headache (mild); Sore throat (mild); Fatigue (moderate); Injection site soreness (mild); Muscle aches (moderate); 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 received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Lot number: EL3247, Expiration Date: May2021) 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: HEADACHE (non-serious), outcome "unknown", described as "Headache (mild)"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat (mild)"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue (moderate)"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site soreness (mild)"; MYALGIA (non-serious), outcome "unknown", described as "Muscle aches (moderate)".  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: a little injection sore pain; a little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 48 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Mar2021, outcome "unknown", described as "a little injection sore pain"; FATIGUE (non-serious) with onset 26Mar2021, outcome "unknown", described as "a little tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Erythema, Limb mass, Pain in extremity
Clinical narrative: Diarrhea; Lump on arm is a little red; discovered it was red and had swelling; arm was hurting; Chills; swelling on arm/describe it as the shape of half of a walnut shell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Mar2021 08:00 (Lot number: EN2607) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Crohn's disease", start date: 1995 (ongoing), notes: in 1997 she ruptured, referring to her Crohn's; "Arthritis" (ongoing), notes: since the 1980's; "Nausea" (unspecified if ongoing); "Pain" (unspecified if ongoing). Concomitant medication(s) included: IMURAN [AZATHIOPRINE] taken for crohn's disease (ongoing); CELEBREX taken for arthritis (ongoing); PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL] taken for pain (ongoing); CITRACAL + D3 taken for crohn's disease (ongoing); FOLIC ACID, start date: 1997 (ongoing); ONDANSETRON taken for nausea (ongoing). Past drug history included: Humira. Vaccination history included: Covid-19 vaccine (dose 1, Lot number: EL9266, Expiry date: unknown , Location: left arm, route: injection), administration date: 01Mar2021, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 23Mar2021, outcome "recovered" (23Mar2021), described as "Chills"; DIARRHOEA (non-serious) with onset 24Mar2021, outcome "recovered" (24Mar2021), described as "Diarrhea"; PERIPHERAL SWELLING (non-serious) with onset 22Mar2021, outcome "not recovered", described as "swelling on arm/describe it as the shape of half of a walnut shell"; LIMB MASS (non-serious) with onset 23Mar2021, outcome "not recovered", described as "Lump on arm is a little red"; ERYTHEMA (non-serious) with onset 23Mar2021, outcome "unknown", described as "discovered it was red and had swelling"; PAIN IN EXTREMITY (non-serious) with onset 23Mar2021, outcome "unknown", described as "arm was hurting". Therapeutic measures were taken as a result of diarrhoea. Additional information: It was reported that patient has been taking Imuran probably from the beginning of her diagnosis with Crohn's, since 1996 or 1997, taking Celebrex for about 20 years, Percocet for about 2 years, multivitamin (1 tab daily) (unspecified) for about 15 years to stay healthy. It was also reported that her physician recommended she take Citracal +D3 because of her Crohns and has been taking it for 2 years because of the calcium citrate, began taking Folic Acid probably about 1997 because the Crohn's doctor said it was good for the patient. It was reported that the label stated ondansetron ODT and has been taking ondansetron as needed for nausea for 2 years.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Diarrhea; Lump on arm is a little red; discovered it was red and had swelling; arm was hurting; Chills; swelling on arm/describe it as the shape of half of a walnut shell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Mar2021 08:00 (Lot number: EN2607) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Crohn's disease", start date: 1995 (ongoing), notes: in 1997 she ruptured, referring to her Crohn's; "Arthritis" (ongoing), notes: since the 1980's; "Nausea" (unspecified if ongoing); "Pain" (unspecified if ongoing). Concomitant medication(s) included: IMURAN [AZATHIOPRINE] taken for crohn's disease (ongoing); CELEBREX taken for arthritis (ongoing); PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL] taken for pain (ongoing); CITRACAL + D3 taken for crohn's disease (ongoing); FOLIC ACID, start date: 1997 (ongoing); ONDANSETRON taken for nausea (ongoing). Past drug history included: Humira. Vaccination history included: Covid-19 vaccine (dose 1, Lot number: EL9266, Expiry date: unknown , Location: left arm, route: injection), administration date: 01Mar2021, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 23Mar2021, outcome "recovered" (23Mar2021), described as "Chills"; DIARRHOEA (non-serious) with onset 24Mar2021, outcome "recovered" (24Mar2021), described as "Diarrhea"; PERIPHERAL SWELLING (non-serious) with onset 22Mar2021, outcome "not recovered", described as "swelling on arm/describe it as the shape of half of a walnut shell"; LIMB MASS (non-serious) with onset 23Mar2021, outcome "not recovered", described as "Lump on arm is a little red"; ERYTHEMA (non-serious) with onset 23Mar2021, outcome "unknown", described as "discovered it was red and had swelling"; PAIN IN EXTREMITY (non-serious) with onset 23Mar2021, outcome "unknown", described as "arm was hurting". Therapeutic measures were taken as a result of diarrhoea. Additional information: It was reported that patient has been taking Imuran probably from the beginning of her diagnosis with Crohn's, since 1996 or 1997, taking Celebrex for about 20 years, Percocet for about 2 years, multivitamin (1 tab daily) (unspecified) for about 15 years to stay healthy. It was also reported that her physician recommended she take Citracal +D3 because of her Crohns and has been taking it for 2 years because of the calcium citrate, began taking Folic Acid probably about 1997 because the Crohn's doctor said it was good for the patient. It was reported that the label stated ondansetron ODT and has been taking ondansetron as needed for nausea for 2 years.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: Tiredness; Sore arm; Chills; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 70 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 24Mar2021 12:00 (Lot number: ER8730) at the age of 70 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: FATIGUE (non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "Tiredness"; PAIN IN EXTREMITY (non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "Sore arm"; CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "Chills".  Additional information: The patient had no relevant family medical history. The patient had no prior vaccinations (within 4 weeks). The patient did not receive additional administered vaccines. The events did not result to emergency or physician office visit. The patient did not undergo relevant tests.    No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness at injection site; swelling in left arm; fever in left arm; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 20Mar2021 13:30 (Lot number: EP7534) at the age of 78 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 1, Single, Administration Site: left arm, Lot No.: EN6200), administration date: 01Mar2021, when the patient was 78 years old, for Covid-19 immunization, reaction(s): "No adverse event". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 23Mar2021, outcome "recovering", described as "redness at injection site"; VACCINATION SITE SWELLING (non-serious) with onset 23Mar2021, outcome "recovering", described as "swelling in left arm"; PYREXIA (non-serious) with onset 23Mar2021, outcome "recovering", described as "fever in left arm". Additional Information: The patient has not taken any other products and has no history. The patient received both doses of the COVID-19 Vaccine. She read the information in the pamphlet that they gave her. She has not been to her physician. She received the second dose of the vaccine on 20Mar2021, given in her left arm. Since getting the second dose, she had redness, swelling and fever in her left arm. She received the first dose on 01Mar2021. It was administered in her left arm. Lot: EN6200. She was worried because she didn't know since both were given in the left if that is why she experienced this. The patient has no history of all previous immunization with the COVID-19 Vaccine and has no additional vaccines administered on same date of the COVID-19 Vaccine. The adverse events did not require emergency room nor physician office visit. The patient has no medical history (including any illness at time of vaccination), has no family medical history relevant to adverse events and no relevant tests done.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Continuous upper arms muscle pain when raise arms overhead; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID. Vaccination history included: Bnt162b2 (in left arm as dose 1, single), for COVID-19 immunisation, reaction(s): "Thyroid gland swelling", "upper arms muscle pain when raise arms overhead", "left lateral upper arm (with pain)", "Hard swelling below injection site on left lateral upper arm approximately 3inches long by 1/2-inch-wide". The following information was reported: MYALGIA (non-serious), outcome "recovering", described as "Continuous upper arms muscle pain when raise arms overhead". Therapeutic measures were not taken as a result of myalgia.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. It was reported that continuous upper arms muscle pain when raise arms overhead was experienced day after both shots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain in extremity
Clinical narrative: Mild soreness on left arm within a few hours of receiving the shot; Felt chilled that evening and again in the morning, although there was no fever; General ill feeling reminiscent of the feeling experienced after a fever breaks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 14:00 (Lot number: EP6955) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Erectile dysfunction" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3; TADALAFIL; FISH OIL; GARLIC EXTRACT [ALLIUM SATIVUM BULB]. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Mar2021 14:30, outcome "recovering", described as "Mild soreness on left arm within a few hours of receiving the shot"; CHILLS (non-serious) with onset 24Mar2021 14:30, outcome "recovering", described as "Felt chilled that evening and again in the morning, although there was no fever"; MALAISE (non-serious) with onset 24Mar2021 14:30, outcome "recovering", described as "General ill feeling reminiscent of the feeling experienced after a fever breaks". Therapeutic measures were not taken as a result of pain in extremity, chills, malaise.  Additional information: COVID-19 vaccine was administered at the facility of workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of other medications the patient received within 2 weeks of vaccination include fish oil, vitamin D3, multi-vitamin, tadalafil, garlic extract. No known allergies. Patient had no allergies to medications, food, or other products. 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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Loss of personal independence in daily activities, Vaccination site pain, Vaccination site swelling
Clinical narrative: Right arm soreness and swelling after first injection; Right arm soreness and swelling after first injection; Weak and tired and stayed in bed after first injection; Weak and tired and stayed in bed after first injection; She had a difficult time sleeping on that side of the right arm after the first injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 24Feb2021 (Lot number: EN6202) at the age of 76 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. The concomitant medications included blood pressure medication all the time and had for years. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 24Feb2021, outcome "recovering" and all described as "Right arm soreness and swelling after first injection"; FATIGUE (non-serious), ASTHENIA (non-serious) all with onset 24Feb2021, outcome "recovering" and all described as "Weak and tired and stayed in bed after first injection"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "She had a difficult time sleeping on that side of the right arm after the first injection". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She received the vaccine at the hospital. She takes blood pressure medication all the time and had for years so it was not relevant. She did not have time to complete vaccine supplemental form. She feels awful and did with the first one. She felt weak and tired and just stayed in bed the rest of the day. She had a difficult time sleeping on that side of the right arm after the first injection and had to put cold packs on it.   No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: Right arm soreness and swelling after first injection; Right arm soreness and swelling after first injection; Weak and tired and stayed in bed after first injection; Weak and tired and stayed in bed after first injection; She had a difficult time sleeping on that side of the right arm after the first injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 24Feb2021 (Lot number: EN6202) at the age of 76 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. The concomitant medications included blood pressure medication all the time and had for years. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 24Feb2021, outcome "recovering" and all described as "Right arm soreness and swelling after first injection"; FATIGUE (non-serious), ASTHENIA (non-serious) all with onset 24Feb2021, outcome "recovering" and all described as "Weak and tired and stayed in bed after first injection"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "She had a difficult time sleeping on that side of the right arm after the first injection". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She received the vaccine at the hospital. She takes blood pressure medication all the time and had for years so it was not relevant. She did not have time to complete vaccine supplemental form. She feels awful and did with the first one. She felt weak and tired and just stayed in bed the rest of the day. She had a difficult time sleeping on that side of the right arm after the first injection and had to put cold packs on it.   No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Discomfort, Dizziness, Feeling abnormal, Headache
Clinical narrative: Pain; Discomfort; I haven't been feeling well; Dizzy/I was so dizzy that my eyes were turning all over; Headaches; Weakness; Feeling very bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 19Mar2021, outcome "not recovered", described as "Dizzy/I was so dizzy that my eyes were turning all over"; HEADACHE (non-serious) with onset 19Mar2021, outcome "not recovered", described as "Headaches"; ASTHENIA (non-serious) with onset 19Mar2021, outcome "not recovered", described as "Weakness"; FEELING ABNORMAL (non-serious) with onset 19Mar2021, outcome "not recovered", described as "Feeling very bad"; PAIN (non-serious), outcome "unknown", described as "Pain"; DISCOMFORT (non-serious), outcome "unknown", described as "Discomfort"; MALAISE (non-serious), outcome "unknown", described as "I haven't been feeling well". Therapeutic measures were taken as a result of dizziness, headache, asthenia, feeling abnormal, pain, discomfort, malaise.  Additional information: The patient had no additional vaccines administered on same date of BNT162B2. The patient had not received any other vaccines within 4 weeks prior vaccination. The events did not result to ER visit. The patient took TYLENOL as treatment of the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: Pain; Discomfort; I haven't been feeling well; Dizzy/I was so dizzy that my eyes were turning all over; Headaches; Weakness; Feeling very bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 19Mar2021, outcome "not recovered", described as "Dizzy/I was so dizzy that my eyes were turning all over"; HEADACHE (non-serious) with onset 19Mar2021, outcome "not recovered", described as "Headaches"; ASTHENIA (non-serious) with onset 19Mar2021, outcome "not recovered", described as "Weakness"; FEELING ABNORMAL (non-serious) with onset 19Mar2021, outcome "not recovered", described as "Feeling very bad"; PAIN (non-serious), outcome "unknown", described as "Pain"; DISCOMFORT (non-serious), outcome "unknown", described as "Discomfort"; MALAISE (non-serious), outcome "unknown", described as "I haven't been feeling well". Therapeutic measures were taken as a result of dizziness, headache, asthenia, feeling abnormal, pain, discomfort, malaise.  Additional information: The patient had no additional vaccines administered on same date of BNT162B2. The patient had not received any other vaccines within 4 weeks prior vaccination. The events did not result to ER visit. The patient took TYLENOL as treatment of the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: injection site pain; body aches; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Mar2021 15:00 (Lot number: EN6203), expiration date Jun2021) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hair loss" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE taken orally for alopecia, start date: 2018 (ongoing). Vaccination history included: Bnt162b2 via intramuscular route, On left shoulder), administration date: 03Mar2021 at 9:00 AM (Lot number: EN6203), expiration date Jun2021), when the patient was 30 years old, for Covid-19 Immunisation. The following information was reported: PAIN (non-serious) with onset 24Mar2021 08:00, outcome "recovered" (24Mar2021), described as "body aches"; FATIGUE (non-serious) with onset 23Mar2021 21:00, outcome "recovered" (24Mar2021 16:00), described as "fatigue"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "injection site pain". Therapeutic measures were not taken as a result of pain, fatigue.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hot flush, Pain, Rhinorrhoea
Clinical narrative: cold chills; hot flashes; body aches; runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old 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 (first dose), for Covid-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "cold chills"; HOT FLUSH (non-serious), outcome "unknown", described as "hot flashes"; PAIN (non-serious), outcome "unknown", described as "body aches"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Myalgia, Pain in extremity
Clinical narrative: muscle and leg pains soon after the 2nd dose; muscle and leg pains soon after the 2nd dose; She has more difficulty on one side, has to drag her leg; All I want to know is if this is normal and will the weakness go back to normal?; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 03Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN, (Lot number: Not provided)), for covid-19 immunization, reaction: "headache for one day". The following information was reported: MYALGIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "muscle and leg pains soon after the 2nd dose"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "She has more difficulty on one side, has to drag her leg"; ASTHENIA (non-serious), outcome "unknown", described as "All I want to know is if this is normal and will the weakness go back to normal?".  Additional information: Caller stated that she received her 2nd Pfizer vaccine dose on 03Feb2021 in her  right arm. She began having muscle and leg pains soon after the 2nd dose. She has more difficulty on one side, has to "drag her leg." Caller stated that after her first Pfizer vaccine dose she "had a headache for one day and that was it." She wanted to know is if this was normal and would the weakness go back to normal.   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-2021335652 Same patient and product; different dose and event
Sex: U
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain, Pain in extremity
Clinical narrative: sore arm; chills; flu-like symptoms; body ache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (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 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; CHILLS (non-serious), outcome "unknown", described as "chills"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms"; PAIN (non-serious), outcome "unknown", described as "body ache".  Additional information: Patient had second COVID-19 shot at 10 am. Patient experienced sore arm. Overnight patient had chills and flu-like symptoms. The next morning the patient had body ache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: experienced a metallic taste in her mouth; This is a spontaneous report received from contactable reporter (Physician) from a sales representative. The reporter is the patient.  A 56-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Lack of food cravings" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "experienced a metallic taste in her mouth".  Additional Information: The patient experienced a metallic taste in her mouth almost immediately. She did not mention if this was after the first dose, the second dose, or both. She also experienced a lack of food cravings that she used to have prior to being vaccinated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Feeling worse; This is a spontaneous report received from non-contactable reporter (Consumer). The reporter is the patient.  A 61-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, administration date 12Mar2021 (Batch/Lot number: unknown) at the age of 61 years 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: FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "recovering", described as "Feeling worse".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had the typical reaction of having sore arm after vaccination; 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 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's 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) with onset 2021, outcome "recovered" (2021), described as "had the typical reaction of having sore arm after vaccination". Clinical course: The patient got the two doses of the Pfizer COVID-19 vaccine. However, she didn't really think she received the first dose of the Pfizer COVID-19 vaccine. When she received the first dose of the vaccine, the vaccination provider slipped around and pulled away from the patient. The patient did not feel the liquid coming into her arm. She asked her vaccination provider if the vaccine was given and the vaccination provider said yes. She did not have any adverse event following vaccination with first dose. When she got the second dose of the vaccine, she felt the liquid coming in and it strengthen her belief that she did not receive the first dose of the vaccine. She had the typical reaction of having sore arm after vaccination for half a day. She wanted to now if there is any way to asses if she got the first dose of the vaccine.  No follow-up attempts are possible. No further information is expected.