chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Weight
Clinical narrative: 2-3days after the first dose a rash appeared on his leg/ rash on my forearm too and it looks like Poison ivy; This is a spontaneous report received from a contactable consumer (patient himself) via a 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EK9231), via an unspecified route of administration on 13Jan2021 at 01.30 (at the age of 59-years-old and weight: 230 or 235 lbs) as 1st, dose single for COVID-19 immunization. Patient's medical history and concomitant medication were not reported. It was reported that, the patient had his first shot 2 days ago the first Pfizer shot and within two days he developed a rash on his leg that was about may be six inches long and two or three inches wide. Patient had a rash on her forearm too and it looks like Poison ivy, but he lives in the north and it was Feb now so he don't think it was Poison ivy but the rash has been gone way since he got the rash couple days after the shot. The patient just put Calamine and he had no medical treatment. The outcome of the event was recovered in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: 2-3days after the first dose a rash appeared on his leg/ rash on my forearm too and it looks like Poison ivy; This is a spontaneous report received from a contactable consumer (patient himself) via a 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EK9231), via an unspecified route of administration on 13Jan2021 at 01.30 (at the age of 59-years-old and weight: 230 or 235 lbs) as 1st, dose single for COVID-19 immunization. Patient's medical history and concomitant medication were not reported. It was reported that, the patient had his first shot 2 days ago the first Pfizer shot and within two days he developed a rash on his leg that was about may be six inches long and two or three inches wide. Patient had a rash on her forearm too and it looks like Poison ivy, but he lives in the north and it was Feb now so he don't think it was Poison ivy but the rash has been gone way since he got the rash couple days after the shot. The patient just put Calamine and he had no medical treatment. The outcome of the event was recovered in 2021.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache
Clinical narrative: shortness of breath; headaches; This is a spontaneous report from a contactable Consumer (Patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient 's medical history and concomitant medications were not reported. Consumer stated that consumer had the COVID Vaccine on Friday and had some bad side effects. Consumer had shortness of breath and a headache and consumer had to use his inhaler. Consumer wanted to know if consumer was a candidate for the second dose of the vaccine after having a "bad reaction" to the first? The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Limb discomfort, Pain in extremity
Clinical narrative: toe pain/A week later her toes are improving but is still tender to touch; redness on both feet; Her great toe on her right foot and the second toe on the left foot were red and inflamed; minor arm discomfort; This is a spontaneous report from a non-contactable consumer (patient herself) received via a sales representative. A 52-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date: Not reported), dose 2 via an unspecified route of administration on 06Jan2021 as 2nd dose, single for COVID-19 immunisation. The patient previously received first dose of BNT162B2 for COVID-19 immunization. Medical history included diagnosed with COVID-19 on Oct2020 with mild symptoms and recovered with no sequelae. Patient reported she has no underlying conditions and occasionally takes vitamins, she is quite active and walks several miles a day, she had not injured her feet nor purchased new shoes. This is the first time this has ever occurred. She has no history of autoimmune diseases or Raynaud's. On 06Jan2021, after vaccination patient had some minor arm discomfort but no other issues. On 28Jan2021, Patient started to experience toe pain and redness on both feet, her great toe on her right foot and the second toe on the left foot were red and inflamed (she has pictures). A week later her toes are improving but is still tender to touch. The outcome of minor arm pain was unknown and for other events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Condition aggravated, Feeling hot, Lymphadenopathy, Pain in extremity
Clinical narrative: I had a UTI; My ears feel hot./she feels her neck and ears feel different; worst last night; she still feels full; my glands when I would swollen would be super sharp. I have swollen lymph nodes; soreness in arm/I had injection pain; soreness in arm/I had injection pain; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 08Feb2021 11:00(age at vaccination: 65 years) as 1st dose, single for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient stated that she had her first dose of vaccine at 11 AM yesterday. On 08 Feb2021, the patient experienced soreness in arm. The patient reported that throat doesn't feel sore and her ears feel hot. On 09Feb2021 at noon, the patient experienced her glands was swollen and when she swallows she had a sharp pain on one side, so right way, she ate chicken noodle soup and hot tea, and made it feel a lot better, she had swollen lymph nodes that have been a side effect as she saw it on the list, had a UTI (urinary tract infection) but was felt better and was taking a Macrobid 100mg capsule by mouth twice daily for UTI, so she thought maybe that would help, but her pharmacist said it would not help with swollen glands, but she did not know if it came from a UTI, her ears feel hot/she feels her neck and ears feel different, soreness in arm/I had injection pain, worst last night and she still feels full when she feels her neck and ears feel different. She was a massage therapist, she iced, and rubbed over it and can lift-up, last night it hurt to lift-up, she moved it around, now she can barely feel it, not like last night. It was reported that patient had no longer sharp pain. She had no thermometer, so unknown if she had a temperature, her face feels warm, but she was hot all the the time being 65. Patient was recovering from the events my glands when I would swollen would be super sharp. Patient had not recovered from the event still feels full. The outcome of the events UTI, my ears feel hot/she feels her neck and ears feel different and worst last night was reported as unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Vaccination site pain
Clinical narrative: I had a UTI; My ears feel hot./she feels her neck and ears feel different; worst last night; she still feels full; my glands when I would swollen would be super sharp. I have swollen lymph nodes; soreness in arm/I had injection pain; soreness in arm/I had injection pain; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 08Feb2021 11:00(age at vaccination: 65 years) as 1st dose, single for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient stated that she had her first dose of vaccine at 11 AM yesterday. On 08 Feb2021, the patient experienced soreness in arm. The patient reported that throat doesn't feel sore and her ears feel hot. On 09Feb2021 at noon, the patient experienced her glands was swollen and when she swallows she had a sharp pain on one side, so right way, she ate chicken noodle soup and hot tea, and made it feel a lot better, she had swollen lymph nodes that have been a side effect as she saw it on the list, had a UTI (urinary tract infection) but was felt better and was taking a Macrobid 100mg capsule by mouth twice daily for UTI, so she thought maybe that would help, but her pharmacist said it would not help with swollen glands, but she did not know if it came from a UTI, her ears feel hot/she feels her neck and ears feel different, soreness in arm/I had injection pain, worst last night and she still feels full when she feels her neck and ears feel different. She was a massage therapist, she iced, and rubbed over it and can lift-up, last night it hurt to lift-up, she moved it around, now she can barely feel it, not like last night. It was reported that patient had no longer sharp pain. She had no thermometer, so unknown if she had a temperature, her face feels warm, but she was hot all the the time being 65. Patient was recovering from the events my glands when I would swollen would be super sharp. Patient had not recovered from the event still feels full. The outcome of the events UTI, my ears feel hot/she feels her neck and ears feel different and worst last night was reported as unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Atrial tachycardia
Clinical narrative: Atrial tachycardia condition; This is a spontaneous report from a Pfizer-sponsored program a non-contactable consumer (patient, self-reported). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date in Jan2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date, she had an atrial tachycardia condition, and she got the 1st vaccine 3 and a half weeks ago. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Headache, Lethargy, Migraine, Nausea
Clinical narrative: Lethargic; aches and pains, soreness; migraine for three days; nausea; weakness; left side of head hurt and was swollen; left side of head hurt and was swollen; This is a spontaneous report received from a contactable consumer (Patient) via a sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced lethargic, aches and pains, soreness, migraine for three days, nausea, weakness, left side of head hurt and was swollen. The outcome of events was unknown.    Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Lethargic; aches and pains, soreness; migraine for three days; nausea; weakness; left side of head hurt and was swollen; left side of head hurt and was swollen; This is a spontaneous report received from a contactable consumer (Patient) via a sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced lethargic, aches and pains, soreness, migraine for three days, nausea, weakness, left side of head hurt and was swollen. The outcome of events was unknown.    Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Vaccination site pain
Clinical narrative: lingering headache; fatigue; soreness around injection site; chills; fever; This is a spontaneous report from a contactable other hcp (patient). A 26-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL8982 and Expiration date: unknown), via an unknown route of administration, in left arm on 03Feb2021 at 08:30 (at the age of 26-year-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took bnt162b2, administered in left arm on 13Jan2021 at 09:45 (Lot number: EL8982) and experienced soreness around injection site. Patient did not receive any other vaccine within 4 weeks prior to the covid-19 vaccine. Prior to vaccination, patient was not diagnosed with covid-19. Patient has no allergies to medications, food or other products. Since the vaccination, patient has not been tested for COVID-19. On 03Feb2021 at 21:00, the patient experienced soreness around injection site, chills/fever approx. 12 hours post-injection. On 04Feb2021, the patient experienced lingering headache and fatigue even 24 hours post-injection. The case was assessed as non-serious by the reporter. Patient did not received treatment for events. Outcome of events was recovering.  Follow-up attempts are completed. No further information is expected. .
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Eye swelling, Flushing, Pain in extremity
Clinical narrative: Extremely flushed skin; Fever; chills; Swelling in face, under eyes; Swelling in face, under eyes; Sore arm/aching extremities; Extreme joint pain; This is a spontaneous report from a contactable consumer (patient). A patient of (Age: 26, Unit: Unknown) and unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date: Not reported) via an unspecified route of administration on 04Feb2021 as 2nd dose, single for COVID-19 immunization. The patient previously took first dose of BNT162B2 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 04Feb2021, after 1hour of vaccination, the patient experienced extremely flushed skin, fever, chills, sore arm, swelling in face, under eyes and 12hours after vaccination, patient had Extreme joint pain/ aching extremities. Fever and chills changed over time. Mild following the dose, increased in intensity overnight. Mild again this morning. Extreme joint pain/aching extremities which has decreased in severity but is still ongoing.   The outcome of the events Swelling in face, under eyes were recovered on an unspecified date in Feb2021 and rest of the events was not recovered.  Information on the lot/ batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Swelling face
Clinical narrative: Extremely flushed skin; Fever; chills; Swelling in face, under eyes; Swelling in face, under eyes; Sore arm/aching extremities; Extreme joint pain; This is a spontaneous report from a contactable consumer (patient). A patient of (Age: 26, Unit: Unknown) and unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date: Not reported) via an unspecified route of administration on 04Feb2021 as 2nd dose, single for COVID-19 immunization. The patient previously took first dose of BNT162B2 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 04Feb2021, after 1hour of vaccination, the patient experienced extremely flushed skin, fever, chills, sore arm, swelling in face, under eyes and 12hours after vaccination, patient had Extreme joint pain/ aching extremities. Fever and chills changed over time. Mild following the dose, increased in intensity overnight. Mild again this morning. Extreme joint pain/aching extremities which has decreased in severity but is still ongoing.   The outcome of the events Swelling in face, under eyes were recovered on an unspecified date in Feb2021 and rest of the events was not recovered.  Information on the lot/ batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node abnormalities; This is a spontaneous report from a non-contactable Consumer. This consumer reported for a patient that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It is reported that reporter came across the below news today, on 04Feb2021, which was about suspected side effect after vaccination with Comirnaty product. Lymph node abnormalities (on an unspecified date) after COVID vaccine. Outcome of event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: sore arm; chills; sweating; tired; achy; This is a spontaneous report received from a contactable consumer and a non-contactable consumer (patient). These consumers (patient and patient's friend) reported for a patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. On an unspecified date, the patient reported that post second Pfizer vaccine experienced sore arm, at about 14 hours post vaccine (while sleeping) chills, no fever (at least not when I checked overnight), sweating (still no fever or else I just checked it when no fever) and woke up feeling ok. Maybe a little tired and achy but could be from how the patient slept overnight. It was better than covid. The outcome of the events was unknown.  Information about lot/batch number has been requested.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling fatigued; This is a spontaneous report received from a non-contactable consumer (patient).  A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, batch/lot number and Expiration date was not reported), via an unspecified route of administration, on 03feb2021, as a single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. On 04Feb2021, the patient had reported feeling fatigued. Outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain in extremity, Pyrexia, Tension headache
Clinical narrative: tension head aches; fatigue; sore arm; Following second dose - low grade fever 99.9 - 100.2 12 hours after the shot that went away on it's own within 24 hours; This is a spontaneous report from a contactable Other Healthcare Professional (patient herself). A 25-year-old female patient (Non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection,), dose 2 intramuscularly administered in the Left Arm on 09Jan2021 at 09:15 (at the age of 25-years-old) as a 2ND DOSE, SINGLE DOSE for COVID-19 immunization, at Hospital. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/Lot Number: Unknown) dose 1 intramuscularly administered in the Left Arm on 19Dec2020 at 11:30 AM as a 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Patient did not receive any other vaccine in four weeks. Other medications received in two weeks were none. Patient did not have covid prior vaccination. She did not have any known allergies and other medical history. On 09Jan2021 at 21:15 following second dose, patient experienced, low grade fever 99.9 - 100.2 12 hours after the shot that went away on it's own within 24 hours. She experienced, sore arm on 10Jan2021, arm for 3 days after vaccination and fatigue, tension headaches on 16Jan2021, for 7 days after vaccination. The patient underwent lab tests and procedures which included body temperature, 99.9 - 100.2, on 09Jan2021. Patient did not receive any treatment for the events. She had not been tested for covid post vaccination. Outcome of the low-grade fever 99.9 - 100.2 12 hours after the shot was recovered on 10Jan2021 and rest of the events were recovered on an unspecified date.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: so tired she slept for 12 hours; This is a spontaneous report from a contactable consumer via medical information team. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, it was reported that the reporter knew someone who got the shot and said they were so tired she slept for 12 hours (2nd AE by same caller logged on different interaction). The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: he can undergo a dental procedure for toothache before the second dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as a first dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that caller wants to know if he can undergo a dental procedure for toothache before the second dose. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Her arm was sore and really hurt; This is a spontaneous report from a Pfizer-sponsored program via a contactable female consumer (patient reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 05Feb2021, as a single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced her arm was sore and really hurt on 05Feb2021.It was reported that she received Pfizer COVID-19 vaccine first dose 'today' on (05Feb2021) and her arm was sore, and it hurts really bad. She wanted to know if she can safely take any pain relievers. The outcome of the event was reported as unknown.  Information about lot/batch number has been requested.  Follow-up attempts have been completed and no further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Tooth infection, Toothache
Clinical narrative: some infection under the tooth; severe tooth ache; This is a spontaneous report from a contactable Consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, Expiry Date: Unknown), dose 1 via an unspecified route of administration on 29Jan2021 (at the age of 75 years old) as a 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, patient had received the first dose of the Covid vaccine on 28Jan2021 and was scheduled to receive the second dose on 17Feb2021. This past Friday (On 07Feb) she developed a severe tooth ache, in which she went to the dentist and they concluded that she needed a root canal. She had a toothache since, there was some infection under the tooth that was hurting. The dentist prescribed her penicillin (Batch/lot number: Unknown) to take for a possible infection. They recommended an endodontist, they thought that there was some infection under the tooth that was hurting. Patient wanted to know if it is ok for her to take penicillin, after she have had the Covid shot. Also, she was advised from her physician to stop taking methotrexate for 7 days after receiving the vaccine and How is penicillin going to affect her Covid shot. Outcome of the event was unknown.  QR Comment: 'I had a toothache; There was some infection under the tooth that was hurting'- captured as event since further clarifications were unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Dizziness, Fall, Illness
Clinical narrative: he got sick 11 days later after he got the 1st dose; he got sick and wasn't sure if it is the flu; slipped off in the bathroom; went into the shower and had a fall; experienced some leg pain; felt light-headed; blood pressure is high but today his blood pressure went down; This is a spontaneous report from a contactable consumer reporting for himself from a Pfizer-sponsored Program. An 85-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration on Jan2021 (at the age of 85-years-old) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced he got sick 11 days later after he got the 1st dose, he got sick and wasn't sure if it is the flu, slipped off in the bathroom; went into the shower and had a fall, experienced some leg pain, felt light-headed, blood pressure is high but today his blood pressure went down on an unspecified date. Upon follow-up on 05Feb2021, the caller said he had his first dose last 9th of Feb. 11 days after the first dose, the caller said he got sick and wasn't sure if it is the flu, mentioned that he slipped off in the bathroom and experienced some leg pain, and felt light-headed since yesterday and is getting better now. The caller said his blood pressure is high but today his blood pressure went down, main concern is if he should get the second dose. Upon additional follow-up on 05Feb2021, no new event was reported however patient had two questions and had been on the phone all day. Caller stated that he had the first dose of the COVID vaccine in the latter part of January, and since then, he went into the shower and had a fall. Caller stated that he also has gotten sick. Caller was wondering, if there was a recommendation for getting the second dose, after experiencing what he had, or was the three weeks still the recommendation. Caller was wondering because he was due for his second dose on Tuesday. Caller was also wondering if it was possible to get a side effect from a product, 11 days after that person gets the product. Caller stated that he had already completed two reports about this, and he was just trying to get his question answered. Clinical outcome of the events was unknown.  Follow-up (05Feb2021): New follow-up report received from a Pfizer-sponsored Program from a contactable consumer included: No new event however patient had called upon trying to get his questions answered.   Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: he got sick 11 days later after he got the 1st dose; he got sick and wasn't sure if it is the flu; slipped off in the bathroom; went into the shower and had a fall; experienced some leg pain; felt light-headed; blood pressure is high but today his blood pressure went down; This is a spontaneous report from a contactable consumer reporting for himself from a Pfizer-sponsored Program. An 85-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration on Jan2021 (at the age of 85-years-old) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced he got sick 11 days later after he got the 1st dose, he got sick and wasn't sure if it is the flu, slipped off in the bathroom; went into the shower and had a fall, experienced some leg pain, felt light-headed, blood pressure is high but today his blood pressure went down on an unspecified date. Upon follow-up on 05Feb2021, the caller said he had his first dose last 9th of Feb. 11 days after the first dose, the caller said he got sick and wasn't sure if it is the flu, mentioned that he slipped off in the bathroom and experienced some leg pain, and felt light-headed since yesterday and is getting better now. The caller said his blood pressure is high but today his blood pressure went down, main concern is if he should get the second dose. Upon additional follow-up on 05Feb2021, no new event was reported however patient had two questions and had been on the phone all day. Caller stated that he had the first dose of the COVID vaccine in the latter part of January, and since then, he went into the shower and had a fall. Caller stated that he also has gotten sick. Caller was wondering, if there was a recommendation for getting the second dose, after experiencing what he had, or was the three weeks still the recommendation. Caller was wondering because he was due for his second dose on Tuesday. Caller was also wondering if it was possible to get a side effect from a product, 11 days after that person gets the product. Caller stated that he had already completed two reports about this, and he was just trying to get his question answered. Clinical outcome of the events was unknown.  Follow-up (05Feb2021): New follow-up report received from a Pfizer-sponsored Program from a contactable consumer included: No new event however patient had called upon trying to get his questions answered.   Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: vaccine itch; This is a spontaneous report from a non-contactable consumer via Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as UNKNOWN,SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient experienced vaccine itch on an unspecified date. The outcome of the event itchy was unknown.  No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: An unspecified age female patient received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number and Expiration date: Unknown), dose 1 via an unspecified route of administration on 05Feb2021 as 1st dose, single for an COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 05Feb2021, the patient had experienced arm pain. She wants to know if she can take Tylenol. The outcome of event was unknown.  Information on Lot /Batch Number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm soreness from the vaccine; This is a spontaneous report from a contactable consumer (patient) received via Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on 04Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Feb2021, the patient stated that he received his 1st dose yesterday, due to arm soreness from the vaccine, he took Naproxen 200mg. According to him, he already spoke to 2 nurses and they were unable to provide him an information regarding interaction of the vaccine and medicine. The outcome of the event was unknown.  Information about Batch/Lot number has been requested.  Follow-up attempts are completed. No further information was expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: hip pain; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program. A 67-years-old female Non-Pregnant patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EL8982), via an unspecified route of administration, in Arm Right on 19Jan2021 12:15 as 1st dose single, for a covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included naproxen (NAPROXEN) taken medications in two weeks, the patient did not receive any other vaccine in four weeks. The patient had not known allergies. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported, on 19Jan2021 12:15 The patient experienced hip pain. Patient had taken Tylenol before and after 1st dose. She also had some hip pain but according to her it's not because of her 1st dose. She took naproxen the day of vaccination she asking Does this decrease the amount of antibodies that I gave. No Treatment received. The outcome of event was recovered on unknown date of 2021.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Candida infection
Clinical narrative: experiencing thrush since taking it.; This is a spontaneous report from a contactable other hcp from a Pfizer-sponsored program.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced "experiencing thrush since taking it." No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. It was reported that the patient took the Covid Vaccine and has been experiencing thrush since taking it.  The outcome of the event was unknown.    Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Gait inability, Pyrexia
Clinical narrative: fever; light-headedness; unable to walk; chills; This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program Pfizer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 for covid-19 immunization. The patient experienced fever, light-headedness, unable to walk, chills on an unspecified date. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable female consumer (patient) via Pfizer-sponsored Program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 29Jan2021 as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included formoterol fumarate, mometasone furoate (DULERA), montelukast and fluticasone propionate (FLONASE, formulation: nasal spray). It was reported that the patient received vaccine last Friday on 29Jan2021, she is on immunosuppressants and antihistamines, 2 steroids nasal spray fluticasone (FLONASE), DULERA inhaler and Montelukast. She is now wondering if using this will interfere with the efficacy of the vaccine. She did have sore arm on an unspecified date after the vaccine. She is asking how long will side effects last. She also wants to know how long until these medications are cleared from her system. The patient wants to know if the side effects stop after 7 days. The outcome of the event was unknown.  Information on lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Carpal tunnel syndrome
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program via a contactable female consumer (Patient reported for herself). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that she was going to receive the second dose of the Pfizer COVID vaccine on Feb 18, 2021. She was scheduled for carpel tunnel surgery on Feb 23, 2021. The pain medication that she was going to use is nonsteroidal like an ibuprofen. She did not want to blunt the Pfizer COVID vaccine response, so she will gladly delay the surgery, if Pfizer thinks it was more appropriate. She asked if she could take the nonsteroidal pain medication that soon after the second dose of the Pfizer COVID vaccine or should she delay the surgery? She stated she can delay it if needed. Clarification of which nonsteroidal product she was to use not provided. The patient was unwilling to complete report. The outcome of the event was reported as unknown. Information on the lot/batch number has been requested. Follow-up attempts have been completed and no further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: little bit of chills; soreness in the muscle; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 05Feb2021, this case now contains all required information to be considered valid. A contactable consumer reported that a 74-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9269, expiration date: Not reported), via an unspecified route of administration, administered in Arm Right on 03Feb2021 14:00 as (At the age of 74-years) 1ST DOSE, SINGLE for covid-19 immunisation. The patient had no Prior Vaccinations within 4 weeks. The patient medical history was not reported. The concomitant medications included blood thinner medications. The patient family history was none. It was reported that she has had her first dose of the Pfizer COVID 19 vaccine 03Feb2021 at 14:00PM in the right arm. She felt good, came home and took a Tylenol two hours later. She had a little soreness in the muscle. She had a little bit of chills but she normally has some chills with her blood thinner medication. She is going to schedule for the second dose on 25Feb2021 but it has not opened up yet. Patient mention she keeps shrinking due to natural aging. The outcome of the event chills was not recovered and other event was recovered on 04Feb2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder pain after getting the 1st dose of the Pfizer Covid-19 Vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration on 04Feb2021 as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced shoulder pain after getting the 1st dose of the Pfizer COVID-19 vaccine on an unspecified date. Clinical outcome for event was unknown.  Information about Batch/Lot number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: after the 1st dose she felt a little sore in her arm.; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose bnt162b2 (BNT162B2,Solution for injection,Batch/Lot number was not reported) via an unspecified route of administration on 21Jan2021 as FIRST DOSE,SINGLE for covid-19 immunisation.The patient medical history and  concomitant medications were not reported.The patient experienced after the 1st dose she felt a little sore in her arm on an unspecified date. The outcome of the event little sore in her arm was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: Bladder infection; This is a spontaneous report received from a non-contactable consumer (reported for mother) via Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced bladder infection. The reporter called on behalf of her Mom, her mom had the Covid 19 Vaccine on 14Jan. and then 01Feb. Mom had a Bladder infection, reporter was not sure if the Doctor already asked her to take antibiotics yet. But just wanted us to know about this situation, if possible, they would cancel and reschedule the 2nd dose for today. The outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rhinitis, Sinus disorder
Clinical narrative: Callers done with the first dose 3 weeks ago next schedule will be on 16Feb; infection of the nose; Steroids for the sinus; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number unknown), via an unspecified route of administration in Jan2021 as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was done with the first dose 3 weeks ago; next schedule would be on 16Feb2021. On 02Feb2021, patient had infection of the nose and sinus. The reporter started to take treatment last Tuesday, Levaquin for the infection of the nose and Steroids for the sinus. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.