chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: felt a little light headed; This is a spontaneous report from a non-contactable nurse (patient) via Regulatory Authority. . An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 06Jan2021 as dose 1, single for COVID-19 immunisation. The patient reported that she has thyroid disease, and she was taking levothyroxine. She was also taking hydroxychloroquine (PLAQUENIL) because she has a connected tissue disease. The patient also reported that she is at the age of menopause. On 06Jan2021, the patient received first dose of BNT162B2. She felt fine, she only felt a little light headed (on an unspecified date in Jan2021), nothing significant. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Influenza like illness
Clinical narrative: flu like symptoms/ tired/ aches; weak; This is a spontaneous report from a contactable consumer (patient) received via . An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: E19269), via an unspecified route of administration, administered in the right arm on 04Feb2021, at 15:30 as dose 1, single for COVID-19 immunisation. Medical history included known allergies: penicillin, etc. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. She did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 05Feb2021, at 07:00, the patient experienced flu like symptoms next two days; weak, tired, and ache. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. The patient recovered from the events on 07Feb2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: head cold; This is a spontaneous report from a non-contactable consumer (daughter-in-law) received. A female patient of an unspecified age 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 dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced, she just started coming down with a head cold on an unspecified date in Feb2021. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Chills, Feeling abnormal, Headache, Joint range of motion decreased
Clinical narrative: significant arm pain-with decrease ROM to less 90'; significant arm pain-with decrease ROM to less 90'; Chills; Brain fog; Felt agitated and unsettled; Headache-moderate; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EL3246; Expiration date was not reported), intramuscularly, administered in the left arm on 26Jan2021 (at the age of 55-years-old) as dose 1, single for COVID-19 immunisation at a hospital. Medical history included blood transfusion for lacerated liver repair in 1986, seasonal allergies and allergies to cats/dogs, various trees and various nuts. Concomitant medications included estradiol (ESTROGEN), progesterone and mesterolone (RESTORE); all taken for an unspecified indication, start and stop dates were not reported. The patient previously took acetylsalicylic acid, caffeine, phenacetin, promethazine hydrochloride (SYNALGOS) and cetirizine hydrochloride (ZYRTEC) and experienced drug allergy. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient experienced significant arm pain-with decrease ROM to less 90', chills, brain fog and felt agitated and unsettled, headache-moderate on 26Jan2021. No treatment was taken for the events. The outcome of the events was recovered on 29Jan2021 (Side effects lasted 3 days).  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: significant arm pain-with decrease ROM to less 90'; significant arm pain-with decrease ROM to less 90'; Chills; Brain fog; Felt agitated and unsettled; Headache-moderate; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EL3246; Expiration date was not reported), intramuscularly, administered in the left arm on 26Jan2021 (at the age of 55-years-old) as dose 1, single for COVID-19 immunisation at a hospital. Medical history included blood transfusion for lacerated liver repair in 1986, seasonal allergies and allergies to cats/dogs, various trees and various nuts. Concomitant medications included estradiol (ESTROGEN), progesterone and mesterolone (RESTORE); all taken for an unspecified indication, start and stop dates were not reported. The patient previously took acetylsalicylic acid, caffeine, phenacetin, promethazine hydrochloride (SYNALGOS) and cetirizine hydrochloride (ZYRTEC) and experienced drug allergy. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient experienced significant arm pain-with decrease ROM to less 90', chills, brain fog and felt agitated and unsettled, headache-moderate on 26Jan2021. No treatment was taken for the events. The outcome of the events was recovered on 29Jan2021 (Side effects lasted 3 days).  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain after first shot was only mild dull pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 26Jan2021 at 10:00 (at the age of 45-years-old) (Lot Number: EN5318) as dose 1, single for COVID-19 immunisation. Medical history included known allergies to ibuprofen and amoxicillin. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks. No other medications were received in two weeks.  The patient did not have COVID prior to vaccination and had not been tested for COVID post-vaccination.  On an unspecified date, the patient experienced pain after first shot was only mild dull pain at injection site. No treatment was received for the event. The outcome of the event was recovering/resolving.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Limb discomfort, Pain in extremity
Clinical narrative: Sore arm; Lethargy; heavy-feeling limbs on full day 2; Fatigue on full day 2; This is a spontaneous report from a contactable consumer (patient) received. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm, on 22Feb2021 at 06:30 PM (Lot Number: EM9810) (at the age of 37 years old) as dose 1, single for COVID-19 immunisation. Medical history included insulin resistance, anxiety, depression, and generalized panic disorder, all from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medications included fluoxetine hydrochloride (PROZAC); lisdexamfetamine mesilate (VYVANSE); levocetirizine dihydrochloride (XYZAL); erenumab aooe (AIMOVIG); Montelukast sodium (SINGULAIR); cholecalciferol (VITAMIN D), all taken for an unspecified indication, start and stop date were not reported. The patient previously took sertraline (ZOLOFT) and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Feb2021 at 05:00 AM, the patient experienced sore arm , lethargy, heavy-feeling limbs on full day 2, and fatigue on full day 2. The patient did not receive any treatment for the events. The outcome of events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient) received. A 75 (unit not specified) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 22Feb2021 (Batch/Lot number: not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history included diabetes (notes "sugar spike") and atrial fibrillation (reported as AFIB). Concomitant medications included apixaban (ELIQUIS) taken for AFIB. On an unspecified date in 2021, the patient experienced a sore arm. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: fall; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received 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 dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that he was calling on the behalf of his neighbor who was scheduled to get her second dose of BNT162B2 on 24Feb2021 but would not be able to do so due to fall (on an unspecified date). The reporter asked if the second dose could be given later. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Nausea, Pain
Clinical narrative: flu like symptoms; headaches; nausea; body aches; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient 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) (at the age of 78 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. The patient experienced flu like symptoms including headaches, nausea and body aches that lasted for 4 days on an unspecified date in 2021. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Myalgia, Nausea
Clinical narrative: flu-like symptoms; nausea; headaches; muscle aches; chills; This is a spontaneous report from a non-contactable consumer (patient). A 74-year-old female patient 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 dose 1, single for COVID-19 immunisation. Medical history included shellfish allergy. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced flu-like symptoms, nausea, headache, muscle aches, and chills. The outcome of the events was recovered/resolved on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Investigation
Clinical narrative: no sense of taste/could 't taste anything; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), dose 2 via an unspecified route of administration on 26Feb2021 (at the age of 61-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was none. Concomitant medication included thyroid Pill (that's the only thing she take). Previously, the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. Reportedly, the patient received second dose of the Covid vaccine on 26Feb2021 (Friday), and the following Monday, on 01Mar2021 she had no sense of taste, and she lost her sense of taste and it's been about a week. The patient underwent lab work on 26Feb2021 and there was no issue with the results. No treatment received, just noticed that she could smell but she could 't taste anything, it's been about a week. That' the only side effect that she had. The patient asked if that was a normal side effect of the vaccine and if she should get a Covid test. Outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: muscle ache; low grade fever; chills; headache; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 33-year-old female patient received second 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 04Mar2021 as dose 2, single for COVID-19 immunisation (Age at vaccination: 33 years). The patient was not pregnant at the time of vaccination. Historical vaccine included 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, as dose 1, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient did not had allergies to medications, food, or other products. It was unknown that the facility where the most recent COVID-19 vaccine was administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The day after the vaccine was administered, on 05Mar2021, the patient experienced low grade fever, chills, headache, and muscle ache. The patient did not receive any treatment for the events. Outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: My feet were very red and itchy on the bottoms; My feet were very red and itchy on the bottoms; I had a rash on my lower legs and thighs on both legs; This is a spontaneous report from a contactable other hcp (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 08Mar2021 12:00 (Batch/Lot Number: EN6204) as dose 2, single (age at vaccination 71-year-old) for covid-19 immunisation. Medical history included Hypothryroid, High Blood Pressure, depression from an unknown date and unknown if ongoing Other medical history: Depression, Complete Hysterectomy(Need hormone replacement), Known allergies: Penicillin from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for thyroid disorder, start and stop date were not reported; estradiol (ESTRADIOL) taken for hysterectomy, start and stop date were not reported; amlodipine (AMLODIPINE) taken for hypertension, start and stop date were not reported; lisinopril (LISINOPRIL) taken for hypertension, start and stop date were not reported; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported; gabapentin (GABAPENTIN) taken for depression, start and stop date were not reported. Historical vaccine information included bnt162b2 (COMIRNATY) 1st dose on 15Feb2021, administration site (Left arm,), administered at 12:00 PM, lot number EM9809 for COVID-19 immunization. On 08Mar2021 23:45, the patient experienced my feet were very red and itchy on the bottoms, i had a rash on my lower legs and thighs on both legs. It was reported that patient had a reaction last night. patient got her shot at 12 noon yesterday her second vaccination (unspecified medication), patient went to bed around 10.30. patient was awoken around midnight with itching on the bottom of her feet and rest of my leg but it wasn't on her arm, it didn't appear to be on her arm or on rest of her body just her legs and her feet so patient got up and stayed up for couple for hours. patient was worried that it was an allergic reaction, patient wanted to make sure. it didn't get worsened surprisingly the rash faded and went away. patient did not have the rash near the injection site, but her feet were very red. The outcome for all event was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Lymphatic disorder, Pain, Paraesthesia
Clinical narrative: some pain in shot site/Where the shot was given hurt very much; tingling down her arm, pain in her back and top of shoulder; Feel like a stinging and tingling down my arm; swollen lymph node in the back of her ear and back of her throat area; I had some pain in my back shoulder on the same side for a couple of days on the top of my shoulder; congestion of the lymph node/ most probably from the neck area to the ear; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A female patient (Patient Age: 66: unit not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 03Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Consumer stated, "she was just calling because she had a shot last week/last Wednesday on 03Mar2021. She did not have any major reaction, but she was having some reaction, but she wanted to (incomplete sentence). She means she have kind of read after that it sounds like it was not totally abnormal but she just wants to make sure that she won't have (incomplete sentence) you know should she definitely get the second shot. Consumer stated, "So, immediately when she got the shot (In 03Mar2021), she did feel like a stinging and tingling down her arm and she have continued to have like the actual where the shot was given hurt very much/some pain in shot site. In Mar2021, she had some pain in her back shoulder on the same side for a couple of days on the top of her shoulder and now she have got like, in the past few days she developed sort of on the same side, it feels like her lymph node was some kind of swollen in the back of her ear and back of her throat area almost like inside but not a swollen throat all on the same side where she got the vaccine, but it feels, she mean inside like she do not feel it was like externally, she feel like there was some problem with like may be like the congestion of the lymph node on that side according to her view, most probably from the neck area to the ear. Serious: No. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: some pain in shot site/Where the shot was given hurt very much; tingling down her arm, pain in her back and top of shoulder; Feel like a stinging and tingling down my arm; swollen lymph node in the back of her ear and back of her throat area; I had some pain in my back shoulder on the same side for a couple of days on the top of my shoulder; congestion of the lymph node/ most probably from the neck area to the ear; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A female patient (Patient Age: 66: unit not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 03Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Consumer stated, "she was just calling because she had a shot last week/last Wednesday on 03Mar2021. She did not have any major reaction, but she was having some reaction, but she wanted to (incomplete sentence). She means she have kind of read after that it sounds like it was not totally abnormal but she just wants to make sure that she won't have (incomplete sentence) you know should she definitely get the second shot. Consumer stated, "So, immediately when she got the shot (In 03Mar2021), she did feel like a stinging and tingling down her arm and she have continued to have like the actual where the shot was given hurt very much/some pain in shot site. In Mar2021, she had some pain in her back shoulder on the same side for a couple of days on the top of her shoulder and now she have got like, in the past few days she developed sort of on the same side, it feels like her lymph node was some kind of swollen in the back of her ear and back of her throat area almost like inside but not a swollen throat all on the same side where she got the vaccine, but it feels, she mean inside like she do not feel it was like externally, she feel like there was some problem with like may be like the congestion of the lymph node on that side according to her view, most probably from the neck area to the ear. Serious: No. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Hypersensitivity, Pruritus
Clinical narrative: itching; dry skin; allergy; This is a spontaneous report from a contactable consumer via Regulatory Authority. An elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer experienced dry skin and itching/itchy, allergy. Consumer has recently changed soaps. Consumer said its subsiding. Patient has dry skin anyways. Was this from soap or injection? Consumer stated that she was a little itchy. At first she was not. However, now she was. She did not have any spots or anything. Her skin was dry. She was trying to see if this was due to possibly changing soaps as well. Normally she does not. Stated she used some at her brother's house and then she bought some where she is now. She did not use any of the soap at all yesterday. Consumer asked if she should get 2nd dose? She was just trying to see if these are side effects or could be from the vaccine. The outcome of event itching was recovering, for dry skin not recovered and for allergy was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue, Rash, Vaccination site bruising, Vaccination site pain, Weight
Clinical narrative: red patch on my arm and black and black; nurse put it in below the muscle; Little sore but I still have patch of red on my arm and black and blue; Little sore but I still have patch of red on my arm and black and blue; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 69 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 (Batch/Lot Number: EL8982) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing Verbatim: High cholesterol. Concomitant medication(s) included atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient experienced red patch on her arm and black and black rash on an unspecified date with outcome of unknown, nurse put it in below the muscle causing product use issue on an unspecified date with outcome of unknown, little sore but she still have patch of red on her arm and black and blue causing vaccination site bruising on an unspecified date with outcome of unknown, vaccination site pain on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included weight:of about 185 Pounds.  Upon Follow-up (09Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that: The patient has high cholesterol, Batch/LOT number was updated, concomitant medications included Atorvastatin 40mg taken once a day. The patient weight and adverse events were added.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Myalgia, Pain, Pyrexia
Clinical narrative: fever; chills; muscle aches; where I had the shot (arm) it's really really sore; one lymph node under my arm is swollen; body aches; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN5318; Expiration date: Unknown) via an unspecified route of administration (age at vaccination 39-year) in arm on either 11Feb or 12Feb2021 as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from Jan2021 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date the patient experienced fever, chills, muscle aches, where she had the shot (arm) it's really really sore, one lymph node under her arm was swollen, body aches. Caller reported her experience after first dose of Pfizer-BioNTech COVID-19 Vaccine: "woke up with severe symptoms; having fever, chills, muscle aches, one lymph node under her arm was swollen, body aches, fever, chills, and where she had the shot (arm) it's really really sore. She asked if she should get tested for COVID-19." The patient underwent lab tests and procedures which included SARS-COV-2 antibody test: positive on an unspecified date in Jan2021. It was reported that the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN6198; Expiration date: Unknown) on 08 MAR 2021 for COVID-19 immunization. Description of product complaint: Caller had her second shot of the COVID-19 Vaccine yesterday. Caller states that she woke up at 3AM this morning and she had every symptom. Caller was wondering what the chances are that she could have COVID-19 again, or if these symptoms were all from the shot. Caller previously had COVID-19 in Jan2021. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021273646 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: fever; chills; muscle aches; where I had the shot (arm) it's really really sore; one lymph node under my arm is swollen; body aches; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN5318; Expiration date: Unknown) via an unspecified route of administration (age at vaccination 39-year) in arm on either 11Feb or 12Feb2021 as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from Jan2021 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date the patient experienced fever, chills, muscle aches, where she had the shot (arm) it's really really sore, one lymph node under her arm was swollen, body aches. Caller reported her experience after first dose of Pfizer-BioNTech COVID-19 Vaccine: "woke up with severe symptoms; having fever, chills, muscle aches, one lymph node under her arm was swollen, body aches, fever, chills, and where she had the shot (arm) it's really really sore. She asked if she should get tested for COVID-19." The patient underwent lab tests and procedures which included SARS-COV-2 antibody test: positive on an unspecified date in Jan2021. It was reported that the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN6198; Expiration date: Unknown) on 08 MAR 2021 for COVID-19 immunization. Description of product complaint: Caller had her second shot of the COVID-19 Vaccine yesterday. Caller states that she woke up at 3AM this morning and she had every symptom. Caller was wondering what the chances are that she could have COVID-19 again, or if these symptoms were all from the shot. Caller previously had COVID-19 in Jan2021. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021273646 similar report from same reporter
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Swelling, Urticaria
Clinical narrative: sore throat; swollen neck; hives; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 15:45 (at the age of 55-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included pulmonary issues, asthma issues and allergies. The patient had no other medical history. The patient's concomitant medications included unspecified asthma medications, nothing that would affect the vaccine. The patient had no history of previous immunizations with the Pfizer vaccine. The patient had no additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccinations within 4 weeks. The patient had no adverse events (AEs) following prior vaccinations. It was reported that, the caller on the line calling about the COVID 19 Vaccine. The patient received her first one yesterday on 08Mar2021 and she had some different side effects than she was expecting. She mentioned she had swelling in the neck, hives, and a sore throat. She did not have any trouble breathing, talking or swallowing. She was calling because she wants to know if she can take Benadryl ahead before getting the second shot. She stated she was hoping to avoid this reaction. Caller did not have full contact details for HCP to provide. The swelling in the neck started to swell an hour after getting the vaccine. Treatment: Placed ice over the area. The swelling in neck went away over night because it was not there when she woke up this morning. For Hives: She applied a Benadryl topical solution. She mentioned she has allergies, and it was not unusual for her to get hives. That was why she wants to know if she can take Benadryl before getting the second shot to try and get ahead of it. Sore throat: This started four hours after getting the vaccine. The adverse events not required visit to the Emergency Room and Physician's Office. The patient had no relevant test. The outcome of the event swollen neck was recovered on 08Mar2021. The outcome of the events hives and sore throat was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: armpit was swollen and painful; swelling is closer to the top of his ribs/left armpit is swollen; This is a spontaneous report from a contactable consumer. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6199), dose 1 via an unspecified route of administration, administered in Arm Left on 07Mar2021 at 12:00 as dose 1, single for COVID-19 immunisation. Medical history included pain and knee operation. Concomitant medication(s) included ongoing mometasone furoate (FLONASE [MOMETASONE FUROATE]); hydrocodone bitartrate, paracetamol (VICODIN) taken for pain from 19Feb2021 to 01Mar2021; marijuana (MARIJUANA). Consumer stated, on 09Mar2021 at 03:00 that a day and a half later, he noticed that his left armpit was swollen and painful/ hurts. He stated that the swelling was closer to the top of his ribs on the left side versus the bottom of the left arm, and says it looks like an oval and a "big ol' puff." Caller would like to know if this has been reported as a common side effect experienced by others. Consumer further added that it seemed to be getting better until he got up to do his morning routine, isting at the same level now. He was planning to receive the second dose of the vaccine on 28Mar2021. Mentions predating the vaccine he had surgery on his knee two weeks ago, and he was taking Vicodin daily until 01Mar2021. Added last night he drank a beer and he smokes medical marijuana. Adds there was nothing different from this daily routine going on except the Pfizer COVID 19 vaccine. AE(s) did not require a visit to physician or ER. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: noticed a rash/rash on her back; bumpy/bumpy on her back; itchy/itchy on her back; This is a spontaneous report from a contactable consumer (patient). A 87-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9202 and Expiration date was unknown), via an unspecified route of administration in left arm on 16Feb2021 at 10:00AM (at the age of 87-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included cholesterol. There was no family medical history. History including any illness at time of vaccination was none. Concomitant medications included Cyanocobalamin (B12), ongoing Rosuvastatin (5mg; take once daily by mouth) taken for Cholesterol, One a Day Vitamin. There was no other vaccines received prior vaccinations (within 4 weeks). History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. There was no additional vaccines administered on same date of the Pfizer suspect. On 23Feb2021, the patient experienced rash on her back, itchy on her back and bumpy on her back. It was reported that patient received the first dose of the Pfizer COVID vaccine on 16Feb2021. Stated that she noticed a rash a week later that was itchy and bumpy on half of her back and it is still there today. She is scheduled for the second dose of the vaccine this Friday at 10 AM. Consumer stated that she thought before she goes for the second shot, she should consult with someone about the rash on her back mostly. She didn't connect it with the shot at first but now she is concerned about whether she should get the second dose. She would like to know if she should receive the second the dose of the vaccine since she had the rash after the first dose. AEs does not require a visit to physician or ER. There was no relevant test done. There was no investigation assessment. Outcome of the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Skin lesion
Clinical narrative: the caller's arm was itching and was sore with a little red circle around it; the caller's arm was itching and was sore with a little red circle around it; she had a lump on her skin that is pink and red; redness; This is a spontaneous report from a contactable consumer reported for herself. An 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 04Mar2021 as DOSE 2, SINGLE for COVID-19 immunization. Reason for no lot number: of COVID shot: Patient unwilling to complete the report. The patient medical and concomitant medication history were reported. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) as dose 1, single on 04Mar2021 for COVID-19 immunization. Patient never had a problem with the first one. Other products, patient history and investigation assessment were not provided. It was mentioned that patient never had a reaction to shots, but arm was tender but arm seems like its getting better, patient never had a problem with flu shots, other people have had worse problems. On Mar2021, after the second dose of the vaccine, patient sat there for 15 minutes and everything was fine. The patient went home and put alcohol on arm. The next day (on 05Mar2021), the arm was itching and was sore with a little pink and red circle around it where patient got the vaccine. Patient wonders if that shot was stronger than the other one? Patient did not have fever or sickness. There was a little lump on arm which was pink and had some redness. Was it normal for it to did this? Patient mentions that the redness was gone but there was still a lump and itching, patient was keeping alcohol on it. The outcome of the events were unknown.  No follow-up attempts are possible. No further information are expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dysphagia, Dyspnoea, Feeling abnormal, Paraesthesia oral
Clinical narrative: funny taste in her mouth; tingling in her tongue; swelling; shortness breath; her chest was tight; she was not feeling 100%; difficulty swallowing; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine; Formulation: Solution for injection; Lot number and expiration date was not reported; NDC number and manufacturer: unspecified), dose 1 via an unspecified route of administration on 02Mar2021 (age at the time of vaccination 65 years old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that she had the Pfizer shot on 02Mar2021. She was wondering because right after, she did not have a severe reaction, but she did have a reaction. She had a funny taste in her mouth and her tongue was tingling on an unknown date in 2021 and that lasted for a few days, she felt okay but she had that feeling. She was sensitive to medicines, so she thought maybe it was just that but then Thursday morning (unspecified date in 2021) she had shortness of breath and difficulty swallowing and that lasted until Sunday and she thought she had a mild reaction and she was nervous about getting the second Pfizer shot. She wanted to know if she does not get the second shot, can she wait and get the Johnson and Johnson or if she doesn't get the second shot would she be protecting she just doesn't what to do with the first shot would she be okay if she did not get the second shot. She would really like to find out if she only got the first shot is that enough coverage for her. She had the funny taste sensation; it came and went since Tuesday morning. On Thursday morning, she woke up and didn't feel good, she had some swelling, shortness breath, her chest was tight. She went to the doctor, because she was not feeling 100%. On Sunday she felt better, she is much better than she was, but still has periods with "short of breath". She wanted to know how long will this last. Her doctor said she probably shouldn't take the 2nd shot. She is wondering if she can get the Johnson & Johnson vaccine instead of Pfizer's second dose. The outcome of the events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Taste disorder
Clinical narrative: funny taste in her mouth; tingling in her tongue; swelling; shortness breath; her chest was tight; she was not feeling 100%; difficulty swallowing; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine; Formulation: Solution for injection; Lot number and expiration date was not reported; NDC number and manufacturer: unspecified), dose 1 via an unspecified route of administration on 02Mar2021 (age at the time of vaccination 65 years old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that she had the Pfizer shot on 02Mar2021. She was wondering because right after, she did not have a severe reaction, but she did have a reaction. She had a funny taste in her mouth and her tongue was tingling on an unknown date in 2021 and that lasted for a few days, she felt okay but she had that feeling. She was sensitive to medicines, so she thought maybe it was just that but then Thursday morning (unspecified date in 2021) she had shortness of breath and difficulty swallowing and that lasted until Sunday and she thought she had a mild reaction and she was nervous about getting the second Pfizer shot. She wanted to know if she does not get the second shot, can she wait and get the Johnson and Johnson or if she doesn't get the second shot would she be protecting she just doesn't what to do with the first shot would she be okay if she did not get the second shot. She would really like to find out if she only got the first shot is that enough coverage for her. She had the funny taste sensation; it came and went since Tuesday morning. On Thursday morning, she woke up and didn't feel good, she had some swelling, shortness breath, her chest was tight. She went to the doctor, because she was not feeling 100%. On Sunday she felt better, she is much better than she was, but still has periods with "short of breath". She wanted to know how long will this last. Her doctor said she probably shouldn't take the 2nd shot. She is wondering if she can get the Johnson & Johnson vaccine instead of Pfizer's second dose. The outcome of the events was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash on arms and legs began the next day; itch; This is a spontaneous report from a contactable consumer (patient). A 73-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, in the left arm on 19Feb2021 at 12:30 (at the age of 73-years-old) as dose 1, single for covid-19 immunisation. Medical history included breast cancer, knee arthroplasty, hypothyroid, GERD (gastrooesophageal reflux disease), gallbladder removed all from an unknown date and unknown if ongoing. Allergies to medications, food, or other products; known allergies reported penicillin allergy. Concomitant medications included losartan; armodafinil; levothyroxine sodium (SYNTHROID); multi-vitamins; colecalciferol, ubidecarenone, (CoQ1) (COQ10 + D3) all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination patient was not diagnosed with covid-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 20Feb2021, the patient experienced rash on arms and legs began the next day and itch. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient had received treatment for event was taking Benadryl orally and topically.  Outcome of the events was recovering.  Additional information has been requested.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Body temperature, Chills, Fatigue
Clinical narrative: headaches; tiredness; muscle and joint pain; muscle and joint pain; Taste is gone- he cannot taste anything; fever; Injection site is red- big red mark; couldn't walk; chills; not feeling well and really hurting; not feeling well and really hurting; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   An 81-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 06Mar2021 11:30 (Batch/Lot number and Expiration date was not reported) (at the age of 81-years-old) as dose 1, single for covid-19 immunisation. Medical history included atrial fibrillation (Verbatim: A-fib, had that for 30 years, reported just a little bit of a heart condition) and covid-19 (reported that he had the covid in September, but he healed and got over it. No additional information provided). Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)); furosemide (LASIX [FUROSEMIDE]), Start, stop date and dosing regimen details of concomitant medications were not reported (reports he is on so many medications. He clarified he is on 19 different medications. And mentioned Aspirin and Lasix. No additional information was provided). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no adverse events reported prior to previous vaccinations. There was no relevant family history reported. On 08Mar2021, when he woke up (exact time unknown), the patient experienced headaches, tiredness, muscle and joint pain, taste gone, fever, chills, Injection site is red- big red mark and couldn't walk. On an unspecified date in 2021, the patient experienced not feeling well and really hurting. The reporter called for guidance about what to do after he experienced symptoms for the administration of the Pfizer's COVID-19 vaccine. It was reported that he was administered with the Pfizer's COVID-19 vaccine on Saturday 06Mar2021, and he experienced headaches, tiredness, muscle and joint pain, the taste gone, fever and chills and redness in the injection site. Laboratory tests on an unspecified date included body temperature: unknown results (fever). The events did not result in emergency room or physician office visit. The patient reported that he goes to the doctor every month and he has blood tests done every month to see what's going on with his body. Also reported that he waited on the phone for a half hour, and he was not feeling well and really hurting, and wants his question answered. There were no relevant tests performed. The clinical outcome of the event not feeling well and really hurting was unknown and all other events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.