chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscular weakness, Off label use, Product use issue, Pyrexia
Clinical narrative: low grade fever; chills; muscle weakness; First dose received on 19Dec2020 second dose received on 08Jan2021; First dose received on 19Dec2020 second dose received on 08Jan2021; This is a spontaneous report from a contactable pharmacist (patient). A 43-year-old female patient not pregnant received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 08Jan2021 (unapproved schedule) as a single dose for COVID-19 immunization, lot number: EL3302. Medical history was reported as none. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 Intramuscular Left arm, lot number: EK5730. On 09Jan2021 patient experienced low grade fever, chills, muscle weakness. No treatment received for the events. Patient was tested for Covid post vaccination with Nasal Swab on 06Jan2021 result was negative. Patient was recovering from the events, at the time of the report.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: low grade fever; chills; muscle weakness; First dose received on 19Dec2020 second dose received on 08Jan2021; First dose received on 19Dec2020 second dose received on 08Jan2021; This is a spontaneous report from a contactable pharmacist (patient). A 43-year-old female patient not pregnant received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 08Jan2021 (unapproved schedule) as a single dose for COVID-19 immunization, lot number: EL3302. Medical history was reported as none. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 Intramuscular Left arm, lot number: EK5730. On 09Jan2021 patient experienced low grade fever, chills, muscle weakness. No treatment received for the events. Patient was tested for Covid post vaccination with Nasal Swab on 06Jan2021 result was negative. Patient was recovering from the events, at the time of the report.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Nausea
Clinical narrative: Flushed face; Severe nausea; This is a spontaneous report from a contactable consumer (patient).  A 65-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 11Jan2021 10:00 at single dose for COVID-19 immunisation. Medical history included hypertension and gastrooesophageal reflux disease. The patient previously took lisinopril and experienced drug hypersensitivity and anaphylactic reaction, diphenhydramine (BENADRYL) and experienced drug hypersensitivity and urticaria. Concomitant medication included propranolol hydrochloride (PROPRANOL), chlorthalidone (unknown manufacturer), rabeprazole sodium (ACIPHEX), vitamin c (unknown manufacturer). The patient experienced flushed face and severe nausea on 11Jan2021 13:00 with outcome of not recovered. It was unknown f treatment was performed. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.  Information on the Batch/Lot number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: inappropriate schedule of vaccine administered (first dose on 18Dec2020, second dose on 07Jan2021); Temp 102; body aches; chills; lymph node in right armpit swelling sz golf ball; vertigo all lasted 2.5 days; migraine pain >10 on pain scale; rash on hands and arms; nausea; blurred vision; Ongoing headache and body aches 5 days now; This is a spontaneous report from a contactable Nurse (patient).  A 50-year-old Female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 07Jan2020 at 09:00 a.m. intramuscular on right arm at single dose for COVID-19 immunization. Relevant medical history included hypothyroidism, post-traumatic stress disorder, anxiety and allergy to tetracycline. Concomitant medications included escitalopram oxalate (LEXAPRO), celecoxib (CELEBREX), levothyroxine, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]), colecalciferol (VITAMIN D [COLECALCIFEROL]) and paracetamol (TYLENOL). The patient received first dose of BNT162B2 on 18Dec2020 at 04:00p.m. intramuscular on right arm. On 07Jan2021 at 11:00 a.m. the patient experienced pyrexia with temperature of 102, body aches, chills, lymph node in right armpit swelling sz golf ball (as reported), nausea, migraine pain >10 on pain scale (as reported), rash on hands and arms, blurred vision and headache. On 08Jan2021 the patient underwent Nasal Swab SARS-CoV-2 test (Abbott) which resulted negative. No Treatment received for events. The patient recovered from vertigo on 09Jan2021. At the time of the reporting the patient had not yet recovered from headache and body aches, while was recovering from other reported events.   Information about Lot/Batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pain, Pain assessment, Pyrexia
Clinical narrative: inappropriate schedule of vaccine administered (first dose on 18Dec2020, second dose on 07Jan2021); Temp 102; body aches; chills; lymph node in right armpit swelling sz golf ball; vertigo all lasted 2.5 days; migraine pain >10 on pain scale; rash on hands and arms; nausea; blurred vision; Ongoing headache and body aches 5 days now; This is a spontaneous report from a contactable Nurse (patient).  A 50-year-old Female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 07Jan2020 at 09:00 a.m. intramuscular on right arm at single dose for COVID-19 immunization. Relevant medical history included hypothyroidism, post-traumatic stress disorder, anxiety and allergy to tetracycline. Concomitant medications included escitalopram oxalate (LEXAPRO), celecoxib (CELEBREX), levothyroxine, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]), colecalciferol (VITAMIN D [COLECALCIFEROL]) and paracetamol (TYLENOL). The patient received first dose of BNT162B2 on 18Dec2020 at 04:00p.m. intramuscular on right arm. On 07Jan2021 at 11:00 a.m. the patient experienced pyrexia with temperature of 102, body aches, chills, lymph node in right armpit swelling sz golf ball (as reported), nausea, migraine pain >10 on pain scale (as reported), rash on hands and arms, blurred vision and headache. On 08Jan2021 the patient underwent Nasal Swab SARS-CoV-2 test (Abbott) which resulted negative. No Treatment received for events. The patient recovered from vertigo on 09Jan2021. At the time of the reporting the patient had not yet recovered from headache and body aches, while was recovering from other reported events.   Information about Lot/Batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test, Vertigo, Vision blurred
Clinical narrative: inappropriate schedule of vaccine administered (first dose on 18Dec2020, second dose on 07Jan2021); Temp 102; body aches; chills; lymph node in right armpit swelling sz golf ball; vertigo all lasted 2.5 days; migraine pain >10 on pain scale; rash on hands and arms; nausea; blurred vision; Ongoing headache and body aches 5 days now; This is a spontaneous report from a contactable Nurse (patient).  A 50-year-old Female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 07Jan2020 at 09:00 a.m. intramuscular on right arm at single dose for COVID-19 immunization. Relevant medical history included hypothyroidism, post-traumatic stress disorder, anxiety and allergy to tetracycline. Concomitant medications included escitalopram oxalate (LEXAPRO), celecoxib (CELEBREX), levothyroxine, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]), colecalciferol (VITAMIN D [COLECALCIFEROL]) and paracetamol (TYLENOL). The patient received first dose of BNT162B2 on 18Dec2020 at 04:00p.m. intramuscular on right arm. On 07Jan2021 at 11:00 a.m. the patient experienced pyrexia with temperature of 102, body aches, chills, lymph node in right armpit swelling sz golf ball (as reported), nausea, migraine pain >10 on pain scale (as reported), rash on hands and arms, blurred vision and headache. On 08Jan2021 the patient underwent Nasal Swab SARS-CoV-2 test (Abbott) which resulted negative. No Treatment received for events. The patient recovered from vertigo on 09Jan2021. At the time of the reporting the patient had not yet recovered from headache and body aches, while was recovering from other reported events.   Information about Lot/Batch number has been requested.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Dry mouth, Nausea, Pain in extremity
Clinical narrative: sore arm; lightheaded and kind of dizzy; Her stomach doesn't feel great ("stomach isn't the best"); Dry mouth; nausea; This is a spontaneous report from a contactable consumer (patient). This 88-year old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 09Jan2021 the patient experienced sore arm. Since an unspecified date in Jan2021 she was lightheaded and kind of dizzy, her stomach did not feel great, she had dry mouth and nausea. She was feeling as if she could get sick (further specified as nausea). She had not got sick but her stomach wasn't the best. Events outcome was unknown. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Photopsia
Clinical narrative: right eye has little shooting lightning bolts that are constant; This is a spontaneous report from a contactable other healthcare professional (patient) through the Medical Information Team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 11Jan2021 11:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that at 11:30am he received the Covid vaccine and now his right eye had little shooting lightning bolts that were constant. He wanted to know if that was a common side effect. Outcome of the event was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pain in extremity, Swelling face
Clinical narrative: lymph node under her tongue on the left side of her jaw that is swollen; sore throat; left jaw is swollen; arm is sore; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that her arm is sore on 10Jan2021, but everything else was fine until on 11Jan2021, she went into the bathroom and it felt a little funny under her tongue. Under her tongue, her left jaw is swollen, like visibly swollen on the left side and her lymph node under her tongue, but just on the left side. She reported that her throat is a little sore too. She was wondering if these are known side effects of the product, because she is trying to decide if she needs to just let it go or wait and see. Outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Illness
Clinical narrative: fever; tiredness; muscle pain; chills/shaking in bed with blanket on; still get wet/sweat; headache; nausea; feeling unwell; Felt "very sick"; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on 06Jan2021, at 76 years of age, at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 06Jan2021, 45 minutes after shot, the patient felt "very sick" and was on bed for 4 days; moreover the patient reported he had "a big reaction" as, on an unspecified date, he felt fever, tiredness, muscle pain, chills (reported as "shaking in bed with blanket on"), still get wet/sweat, headache, nausea and feeling unwell. All the reported events were assessed as non-serious. At the time of the report the events "felt very sick", "tiredness", "muscle pain", "chills/shaking in bed with blanket on" and "still get wet/sweat" had resolved on an unspecified date, the events "fever", "headache" had not resolved yet and outcome of the events "nausea" and "feeling unwell" was unknown. The patient asked whether or not to take the 2nd shot in 3 weeks.  Information on the lot/batch number has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: fever; tiredness; muscle pain; chills/shaking in bed with blanket on; still get wet/sweat; headache; nausea; feeling unwell; Felt "very sick"; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on 06Jan2021, at 76 years of age, at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 06Jan2021, 45 minutes after shot, the patient felt "very sick" and was on bed for 4 days; moreover the patient reported he had "a big reaction" as, on an unspecified date, he felt fever, tiredness, muscle pain, chills (reported as "shaking in bed with blanket on"), still get wet/sweat, headache, nausea and feeling unwell. All the reported events were assessed as non-serious. At the time of the report the events "felt very sick", "tiredness", "muscle pain", "chills/shaking in bed with blanket on" and "still get wet/sweat" had resolved on an unspecified date, the events "fever", "headache" had not resolved yet and outcome of the events "nausea" and "feeling unwell" was unknown. The patient asked whether or not to take the 2nd shot in 3 weeks.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Lymphadenopathy
Clinical narrative: chest and axillary adenopathy; Tender clavicular; This is a spontaneous report from contactable healthcare professional (patient). This 45-year-old female patient (non-pregnant) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot 9231) intramuscular, in left arm, on 30Dec2020 at 17:45, for COVID-19 immunization. No other vaccine was given in 4 weeks. Medical history included allergy to sulfamethoxazole (BACTRIM). The patient had no COVID19 prior vaccination and was not tested after vaccination. Concomitant medication included ethinylestradiol, levonorgestrel (DAYSEE) 0.15-0.03 (unspecified unit and frequency). On 02Jan2021 the patient experienced chest and axillary adenopathy and tender clavicular. No treatment was given. The events had not yet resolved at the time of report.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dyspnoea exertional, SARS-CoV-2 test positive
Clinical narrative: positive Covid test the day before second dose of vaccine; positive Covid test the day before second dose of vaccine; This is a spontaneous report from a Pfizer-sponsored program, by  contactable physician reported for herself.  This 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EK5730), intramuscular at single dose in the left deltoid on 22Dec2020 11:00 for Covid-19 immunisation. Medical history included was none. There were no concomitant medications. The patient experienced positive Covid test the day before second dose of vaccine on 11Jan2021 with outcome of not recovered. On an unspecified date, she can't smell or taste and has some shortness of breath on exertion with outcome of unknown. No further treatments given. Did not have any antibody testing recently and had history of negative antibodies prior to everything, receiving the first vaccine. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient received first vaccine on 22Dec2020 and went for Covid testing on Saturday, 09Jan2021. Found out results were positive on 11Jan2021. She was scheduled to have the second Covid vaccine on 12Jan2021. Patient  then asks if there is a problem with her getting the second dose vaccine 10 days later than originally scheduled due to her results.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported "positive Covid test the day before second dose of vaccine".
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Oedema peripheral
Clinical narrative: lymphadenopathy at her bilateral axilla.; This is a spontaneous report from a contactable pharmacist (patient). This pharmacist reported similar events for 2 patients. This is the first report out of 2 patients. Only this case is serious, medically significant.  A 33-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730, expiry date: 31Mar2021, NDC number: 59267-1000-1), intramuscular in the left deltoid on 21Dec2020 17:32 at 0.3ml single, for Covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced lymphadenopathy at her bilateral axilla and got worse on 07Jan2021. She reported that it was painful and swollen. The events was reported as serious medically significant. She wanted to know if she should have the 2nd dose of the vaccine. The outcome of the event was not recovered.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported lymphadenopathy cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : 2021025446 same reporter and drug/similar event/different patients
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Flushing, Hyperacusis, Hypoaesthesia oral, Immediate post-injection reaction
Clinical narrative: a mild anaphylactic reaction; tongue numbness/lips and tongue started to get numb; throat swelling; she was getting a migraine; she was flushed and her head got sick, and she got congested; she was flushed and her head got sick, and she got congested; she was flushed and her head got sick, and she got congested; This is a spontaneous report from a contactable other health professional (patient).   This female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EK5730, Expiry Date Mar2021), via an unspecified route of administration at single dose in the left arm on 28Dec2020 for Covid-19 immunisation. Medical history included allergies to beestings. There were no concomitant medications. On an unspecified date, the patient experienced a mild anaphylactic reaction, tongue numbness, she was getting a migraine, throat swelling, she was flushed and her head got sick, and she got congested. No treatment required. The outcome of the events was recovered. The events were described as follows: Patient stated that she took the first dose of the Pfizer vaccine on 28Dec2020. She had an immediate reaction where she was thinking that she was getting a migraine; those symptoms included that the room got loud, she was flushed and her head got sick, and she got congested. She works at a hospital, and she got the vaccine at that hospital where she works. She waited the standard 15 minutes after the injection and then she walked back to her office. After 25 minutes had passed after getting the vaccine, her lips and tongue started to get numb and she could feel like her throat was starting to swell. Se did not take Benadryl, although in hindsight, she should have. She does have allergies to beestings, but the people administering the product did not know that. The primary care physician said that he did not think that she should take the second dose.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of mild anaphylactic reactions cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Pharyngeal swelling, Respiratory tract congestion
Clinical narrative: a mild anaphylactic reaction; tongue numbness/lips and tongue started to get numb; throat swelling; she was getting a migraine; she was flushed and her head got sick, and she got congested; she was flushed and her head got sick, and she got congested; she was flushed and her head got sick, and she got congested; This is a spontaneous report from a contactable other health professional (patient).   This female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EK5730, Expiry Date Mar2021), via an unspecified route of administration at single dose in the left arm on 28Dec2020 for Covid-19 immunisation. Medical history included allergies to beestings. There were no concomitant medications. On an unspecified date, the patient experienced a mild anaphylactic reaction, tongue numbness, she was getting a migraine, throat swelling, she was flushed and her head got sick, and she got congested. No treatment required. The outcome of the events was recovered. The events were described as follows: Patient stated that she took the first dose of the Pfizer vaccine on 28Dec2020. She had an immediate reaction where she was thinking that she was getting a migraine; those symptoms included that the room got loud, she was flushed and her head got sick, and she got congested. She works at a hospital, and she got the vaccine at that hospital where she works. She waited the standard 15 minutes after the injection and then she walked back to her office. After 25 minutes had passed after getting the vaccine, her lips and tongue started to get numb and she could feel like her throat was starting to swell. Se did not take Benadryl, although in hindsight, she should have. She does have allergies to beestings, but the people administering the product did not know that. The primary care physician said that he did not think that she should take the second dose.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of mild anaphylactic reactions cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: developing "hives" 36 hours post injection; This is a spontaneous report from a contactable pharmacist. A female patient (Age: 38; unit: unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 08Jan2021 at a single dose for covid-19 immunization. Medical history included COVID-19 o 30Oct2020, developing "rashes anytime [she] gets ill" and she therefore believes that her reaction was her immune system's response. The patient's concomitant medications were not reported. The patient developed "hives" 36 hours post injection on Jan2021 with outcome of unknown. She asked if such "delayed" reaction was reported as a side effect of the vaccine. mentioned that she would like to receive the second dose, although her PCP is reluctant to it.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: developing "hives" 36 hours post injection; This is a spontaneous report from a contactable pharmacist. A female patient (Age: 38; unit: unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 08Jan2021 at a single dose for covid-19 immunization. Medical history included COVID-19 o 30Oct2020, developing "rashes anytime [she] gets ill" and she therefore believes that her reaction was her immune system's response. The patient's concomitant medications were not reported. The patient developed "hives" 36 hours post injection on Jan2021 with outcome of unknown. She asked if such "delayed" reaction was reported as a side effect of the vaccine. mentioned that she would like to receive the second dose, although her PCP is reluctant to it.  Information about Lot/Batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: hives; rash on her neck, largely on her chest across both breasts and some going down her belly, near her belly button and upper back; This is a spontaneous report from a contactable pharmacist reporting for herself. A 38-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer -BioNTech, Lot# EL0140), intramuscular in left arm, on 08Jan2021 at 14:00, at single dose, for COVID-19 immunisation. Medical history included ongoing hypothyroidism (diagnosed about 25 years before) and COVID-19 from Oct2020 to an unknown date. Concomitant medications were not reported. The patient experienced hives on 10Jan2021 with outcome of not recovered; rash on her neck, largely on her chest across both breasts and some going down her belly, near her belly button and upper back on 10Jan2021 with outcome of not recovered. The events did nor require emergency room visit or physician office visit. The reporter considered the events as non serious, stated they were not interfering, not causing any issues. The reporter also stated that she was not convinced that they were due to the vaccine, since she thinks it is autoimmune (her body's immune response to the vaccine). She gets the same type of rash when she gets sick.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: hives; rash on her neck, largely on her chest across both breasts and some going down her belly, near her belly button and upper back; This is a spontaneous report from a contactable pharmacist reporting for herself. A 38-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer -BioNTech, Lot# EL0140), intramuscular in left arm, on 08Jan2021 at 14:00, at single dose, for COVID-19 immunisation. Medical history included ongoing hypothyroidism (diagnosed about 25 years before) and COVID-19 from Oct2020 to an unknown date. Concomitant medications were not reported. The patient experienced hives on 10Jan2021 with outcome of not recovered; rash on her neck, largely on her chest across both breasts and some going down her belly, near her belly button and upper back on 10Jan2021 with outcome of not recovered. The events did nor require emergency room visit or physician office visit. The reporter considered the events as non serious, stated they were not interfering, not causing any issues. The reporter also stated that she was not convinced that they were due to the vaccine, since she thinks it is autoimmune (her body's immune response to the vaccine). She gets the same type of rash when she gets sick.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Vomiting
Clinical narrative: fever; chills; body aches; Vomited; This is a spontaneous report from a contactable consumer (Parent). A 23-year-old female patient not pregnant received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 08Jan2021 08:00 AM as a single dose for COVID-19 immunization, lot number: EL1283. Medical history was reported as none. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 03:30 PM via an unspecified route of administration in the Left arm lot number: EK5730. It was reported that on 08Jan2021 at 04:00 PM, after second vaccine dose that was administered at 8:00 am, patient vomited at 4:00 pm. On 09Jan2021 at 3:30 am woke up with fever, chills and body aches. No treatment received for the events. Patient was not tested for Covid post vaccination. Patient recovered from all the reported events, at the time of the report.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site mass
Clinical narrative: I have a major side sore arm, soreness has gotten better, it has developed into a bump on the site of the injection; I have a major side sore arm, soreness has gotten better, it has developed into a bump on the site of the injection; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on an unspecified date at a single dose as a COVID-19 vaccine. The patient's medical history and concomitant medications were not reported. The patient stated that she had a major side sore arm, but the soreness has gotten better. It had developed into a bump on the site of the injection. She was not sure if it's swelling. Stated that it's still there. The patient was asking if this was normal and how long it will take. Outcome of the event pain in arm was recovering, while for the event vaccination site mass was not recovered.  Information about the batch/lot number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: a redness and swelling appeared around the injection spot; a redness and swelling appeared around the injection spot; itchy; This is a spontaneous report from a contactable healthcare professional (patient herself) and consumer. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 02Jan2021 10:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant and had not tested positive for COVID prior vaccination. On 11Jan2021 07:30AM, 9th day after the vaccination, a redness and swelling appeared around the injection spot, as a round region of  2.5'' in diameter. One spot inside this round region was very itchy. A much smaller region of redness was seen during the first two days but disappeared on the 3rd day and reappeared as described above. No treatment was received for the events and the outcome was not recovered.  Information about lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Headache, Memory impairment
Clinical narrative: couldn't remember passcode for the phone or her address; feeling heavy; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration first dose on 10Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that after receiving her Covid19 vaccine on Sunday 10Jan2021, reports feeling "heavy", chills, and a headache on Sunday 10Jan2021. On 11Jan2021 Monday afternoon she reports that she "couldn't remember the 4-digit passcode to my phone" or her address, but that her memory came back "in a second". The event couldn't remember passcode for the phone or her address was reported as recovered and unknown for the other events.   Information on the Lot/Batch number has been requested
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Hypersensitivity, Lymphadenopathy
Clinical narrative: itching; palpitations; back ache; had an allergic reaction; full blown hives; rash on her face, ears, legs and arms; fever; tired; sore throat; swollen lymph nodes; chills; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EJ1685, expiry: Mar2021) intramuscularly on 19Dec2020 at a single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. On 20Dec2020, the patient experienced fever, tired, sore throat, swollen lymph nodes and chills. On 08Jan2021, the patient experienced rash on her face, ears, legs and arms. On 09Jan2021, the patient had an allergic reaction and had full blown hives. It was also reported that the patient experienced itching and back ache on an unspecified date. The patient also experienced palpitation on an unspecified date and she went to the emergency room in which she was prescribed with lorazepam (ATIVAN). The patient was also treated with naproxen (ALEVE) for fever and back ache, steroid (unspecified) for allergic reaction and hives, TRIAMCINOLONE cream for the rash and HYDROXYZINE for the itching. Outcome of the events fever, tired, sore throat, swollen lymph nodes and chills recovered on 21Dec2020 while for the events full blown hives, itching, had an allergic reaction, rash on her face, ears, legs and arms, palpitations and back ache was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Palpitations, Pruritus, Pyrexia, Rash
Clinical narrative: itching; palpitations; back ache; had an allergic reaction; full blown hives; rash on her face, ears, legs and arms; fever; tired; sore throat; swollen lymph nodes; chills; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EJ1685, expiry: Mar2021) intramuscularly on 19Dec2020 at a single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. On 20Dec2020, the patient experienced fever, tired, sore throat, swollen lymph nodes and chills. On 08Jan2021, the patient experienced rash on her face, ears, legs and arms. On 09Jan2021, the patient had an allergic reaction and had full blown hives. It was also reported that the patient experienced itching and back ache on an unspecified date. The patient also experienced palpitation on an unspecified date and she went to the emergency room in which she was prescribed with lorazepam (ATIVAN). The patient was also treated with naproxen (ALEVE) for fever and back ache, steroid (unspecified) for allergic reaction and hives, TRIAMCINOLONE cream for the rash and HYDROXYZINE for the itching. Outcome of the events fever, tired, sore throat, swollen lymph nodes and chills recovered on 21Dec2020 while for the events full blown hives, itching, had an allergic reaction, rash on her face, ears, legs and arms, palpitations and back ache was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: itching; palpitations; back ache; had an allergic reaction; full blown hives; rash on her face, ears, legs and arms; fever; tired; sore throat; swollen lymph nodes; chills; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EJ1685, expiry: Mar2021) intramuscularly on 19Dec2020 at a single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. On 20Dec2020, the patient experienced fever, tired, sore throat, swollen lymph nodes and chills. On 08Jan2021, the patient experienced rash on her face, ears, legs and arms. On 09Jan2021, the patient had an allergic reaction and had full blown hives. It was also reported that the patient experienced itching and back ache on an unspecified date. The patient also experienced palpitation on an unspecified date and she went to the emergency room in which she was prescribed with lorazepam (ATIVAN). The patient was also treated with naproxen (ALEVE) for fever and back ache, steroid (unspecified) for allergic reaction and hives, TRIAMCINOLONE cream for the rash and HYDROXYZINE for the itching. Outcome of the events fever, tired, sore throat, swollen lymph nodes and chills recovered on 21Dec2020 while for the events full blown hives, itching, had an allergic reaction, rash on her face, ears, legs and arms, palpitations and back ache was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: fever; tiredness with pain in the body; tiredness with pain in the body; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of an unspecified age received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not reported) via an unspecified route of administration on 05Jan2021 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever, tiredness with pain in the body on an unspecified date in Jan2021. The events were not resolved.  Information on batch/lot number was requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness and tingling in hands and spread to calves and feet; numbness and tingling in hands and spread to calves and feet; This is a spontaneous report from a contactable Consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunisation. Medical history included nerve issues. The patient's concomitant medications were not reported.  On 12Jan2021, the patient received vaccine and developed numbness and tingling in hands and spread to calves and feet. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Off label use, Product use issue
Clinical narrative: I felt nauseated; I experienced a severe headache the following day.; 1 dose start date 18Dec2020; 2 dose start date 07Jan2021; 1 dose start date 18Dec2020; 2 dose start date 07Jan2021; This is a spontaneous report from a contactable other health professional (patient). A 47-year-old female patient (pregnant: No) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number/expiration date unknown) via intramuscular on 07Jan2021 02:45 PM (vaccine location: Right arm) at a single dose for COVID-19 immunization. Previous vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number/expiration date unknown) via intramuscular on 18Dec2020 02:30 PM (vaccine location: Right arm) at a single dose for COVID-19 immunization. Medical history were not reported. The concomitant included Multi-vitamin, 2 naproxen sodium (ALEVE) the day of the 2nd dose of the vaccine (07Jan2021). No other vaccine in four weeks. Patient experienced a severe headache the following day (08Jan2021). On Saturday, 09Jan2021 patient felt nauseated. No treatment given for severe headache and nauseated. The outcome of the events, severe headache and nauseated was recovered in Jan2021.   Information on lot/batch number has been requested.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: he keeps throwing up and it's just mucus; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient's daughter) reported for her father that an 87-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 10Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient's daughter said her father has been vaccinated today 10Jan2021 for the 1st dose, and he kept throwing up and it's just mucus since an unspecified date in Jan2020. Outcome of the event was unknown.   Information on Lot/Batch has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Insomnia, Pain
Clinical narrative: had a temperature of 102 broke a fever; couldn't get out of bed/weak; chills; bad body ache; couldn't sleep the whole night; This is a spontaneous report from a contactable other HCP repot for self. A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 15:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the first dose of BNT162B2 at 35-year-old on 15Dec2020 and experienced sore arms, no other symptoms. After the 2nd dose patient was ok until got home around 9pm roughly 6 hours later, patient had chills and bad body ache. She couldn't sleep the whole night. In the morning (on 09Jan2021) she had a temperature of 102 broke a fever, couldn't get out of bed until the morning 24 hours later, she was really weak. Patient don't have any comorbidities, she was generally a healthy 35 year old person, no other health issues. Now patient feel like back to normal. The outcome of events was recovered.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: had a temperature of 102 broke a fever; couldn't get out of bed/weak; chills; bad body ache; couldn't sleep the whole night; This is a spontaneous report from a contactable other HCP repot for self. A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 15:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the first dose of BNT162B2 at 35-year-old on 15Dec2020 and experienced sore arms, no other symptoms. After the 2nd dose patient was ok until got home around 9pm roughly 6 hours later, patient had chills and bad body ache. She couldn't sleep the whole night. In the morning (on 09Jan2021) she had a temperature of 102 broke a fever, couldn't get out of bed until the morning 24 hours later, she was really weak. Patient don't have any comorbidities, she was generally a healthy 35 year old person, no other health issues. Now patient feel like back to normal. The outcome of events was recovered.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: injection site pain; feeling feverish; This is a spontaneous report from a contactable nurse reported for herself. This 51-year-old female patient (No pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration in right arm on 07Jan2021 at single dose for COVID-19 immunization. Medical history included childhood asthma, Type 2 diabetes mellitus (NIDDM), Latex allergies. Concomitant medication included Metformin, Glyburide, Lisinopril, empagliflozin (JARDIANCE), sitagliptin (JANUVIA), Atorvastatin, salbutamol (PROVENTIL), fluticasone propionate, salmeterol xinafoate (ADVAIR), paracetamol (TYLENOL), colecalciferol (D3), Diosmin, Niacin, fluticasone propionate (FLONASE), ascorbic acid (VIT C), MVI. Patient received first dose of BNT162B2 intramuscular in left arm on 17Dec2020 02:45 PM and experienced injection site pain, increased soreness in 24 hrs, Bleeding at left arm injection site, Flu like symptoms at the 12th hour of vaccination, feeling unwell, fatigue, mild headache. After the second dose on 07Jan2021, the patient experienced injection site pain and feeling feverish the first hour. The outcome of events was unknown. No COVID prior vaccination, no COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Discomfort, Malaise, Movement disorder, Myalgia
Clinical narrative: Nausea; Muscle aches; General unwell; Anxiety; Body feels heavy and hard to move; Body feels heavy and hard to move; Arm where injected is very uncomfortable; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 12Jan2021 at a single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Zk5730), via an unspecified route of administration on 22Dec2020 at a single dose on left arm for COVID-19 immunization (at 29 years old). The patient experienced nausea, Muscle aches, General unwell, Anxiety, Body feels heavy and hard to move around, Arm where injected is very uncomfortable on 13Jan2021 01:30 AM. The outcome of the events was recovering. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.