chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Off label use
Clinical narrative: Fatigue; Chills; Off-label use; Booster dose; This is a spontaneous report from a non-contactable consumer. An elderly non-pregnant female patient of unknown age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Oct2021 as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 01Oct2021, the patient experienced fatigue and chills. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue and chills were resolved on an unknown date in Oct2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19 after receiving both doses of Pfizer vaccine; Tested positive for COVID-19 after receiving both doses of Pfizer vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 27-years-old female patient received the first and the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, (Batch/Lot Number of the first dose: EW0173; Batch/Lot Number of the second dose EW0153), both via an unspecified route of administration on unspecified dates as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID-19 on an unspecified date after receiving both doses of Pfizer vaccine. The patient underwent lab tests and procedures which included SARS-CoV-2 test positive on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Fatigue, Immunisation
Clinical narrative: Site is itchy; Became so very very tired; Had chills; Had an upset stomach; No appetite at all; Right arm was sore; Booster; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8020) via an unspecified route of administration in the right arm on 16Oct2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and Diabetes 2. The patient had no known allergies. Concomitant medications included unspecified regular medications from unknown dates for unknown indications and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received influenza vaccine (flu high dose) (MANUFACTURER UNKNOWN) via an unspecified route of administration in the left arm on 28Sep2021 for immunization within 4 weeks prior to the COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 17Mar2021 (at the age of 73-years-old) as a single dose and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. On 16Oct2021, on the day of vaccination, nothing happened to the patient. On 17Oct2021, the next day of vaccination, the patient became so very very tired, had chills, had an upset stomach, had no appetite at all and also the patient's right arm was sore. That was all on 17Oct2021 (Sunday). On 18Oct2021, the patient's arm was still slightly sore but the site was itchy with no redness or swelling and the patient was still tired. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events became so very very tired, had chills, had an upset stomach, no appetite at all, right arm was sore and site was itchy was resolving at the time of the report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus
Clinical narrative: Site is itchy; Became so very very tired; Had chills; Had an upset stomach; No appetite at all; Right arm was sore; Booster; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8020) via an unspecified route of administration in the right arm on 16Oct2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and Diabetes 2. The patient had no known allergies. Concomitant medications included unspecified regular medications from unknown dates for unknown indications and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received influenza vaccine (flu high dose) (MANUFACTURER UNKNOWN) via an unspecified route of administration in the left arm on 28Sep2021 for immunization within 4 weeks prior to the COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 17Mar2021 (at the age of 73-years-old) as a single dose and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. On 16Oct2021, on the day of vaccination, nothing happened to the patient. On 17Oct2021, the next day of vaccination, the patient became so very very tired, had chills, had an upset stomach, had no appetite at all and also the patient's right arm was sore. That was all on 17Oct2021 (Sunday). On 18Oct2021, the patient's arm was still slightly sore but the site was itchy with no redness or swelling and the patient was still tired. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events became so very very tired, had chills, had an upset stomach, no appetite at all, right arm was sore and site was itchy was resolving at the time of the report.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes; pain; This is a spontaneous report from a contactable Nurse.  A 46-Year-Old male Nurse reported for himself that received the third dose (booster dose) of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FF2090) in Arm  Right on 16Oct2021 around 16:30 (at the age of 46-year-old) at single dose for COVID-19 immunization. He states he received his initial two doses and then went for another booster shot. He received the first dose on 09Jan2021 (lot P12 EK9231 )  and the second dose on 30Jan2021 (P12 EN5318 ) Intramuscular injections. He mentioned he got a flu shot a week before the booster shot Intramuscular, left arm.  Patient history included Pre-diabetic. Concomitant drugs were none. On 17Oct2021, the lymph nodes on his arm where he got the shot in his right arm started swelling, he started to feel it in the morning. Then were real swollen.  He stated he considered this event to be medically significant because he has pain too, but it is not life threatening. Swollen lymph nodes was reported as worsened. The event did not require a visit to Emergency Room or to Physician Office. The reporting nurse considered the swollen lymph nodes was related to the vaccine because he wasn't experiencing it before the vaccine.; Sender's Comments: Based on the temporal association, a causal relationship between the events and BNT162b2 is possible.  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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pain, Swelling, Ultrasound scan
Clinical narrative: had extensive swelling; pain; area and it showed edema and not clots from the vaccine; pain in the underarm, axillary area; felt swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient) .  An 55-year-old female nurse reported that received the third dose (booster dose) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number  FF8841), intramuscular into Deltoid Left, upper arm on 15Oct2021 at 4-5pm (at the age of 55-years-old) at single dose for COVID-19 immunization. The patient received the first dose on 25Feb2021 (lot number of EL9267) and the second dose on 16Mar2021 left arm (lot number EN6208). The patient met criteria laid out for immune booster, pre-existing conditions and age requirement. No other vaccines were given the same day and no problems with vaccines in past. The patient received a tetanus vaccine in Sep2021.  Concomitant drugs were unknown. medical history included 3 weeks before getting the vaccine had congestion and was given a steroid, 1 dose of Medro pack.  Stated she had been having that for the longest time, Went to get the booster and had no symptoms, no runny nose, congestion, nothing and so that's why she thought it was the safest to go ahead and do it.  The patient got the third dose immune booster vaccine, the Pfizer Covid vaccine, on 15Oct2021 The second day had pain in the underarm, axillary area and felt swollen lymph nodes. By the third day, she had extensive swelling and pain which resulted in her ER visit. They did an ultrasound of the area and it showed edema and not clots from the vaccine.  Stated she never had any problems with the first or second shots. Stated events started on the 16Oct2021 and she went to the ER on 17Oct2021. Everything was still the same and she still had the same swelling and pain. She stated it would be life threatening if the swelling and pain extended into her chest. The doctors cautioned her to pay attention to the swelling and if it extended to her chest. The events pain in the underarm, axillary area and felt swollen lymph nodes, extensive swelling and pain  were considered medically significant. The outcome of the events was not recovered.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of reported events 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site oedema
Clinical narrative: had extensive swelling; pain; area and it showed edema and not clots from the vaccine; pain in the underarm, axillary area; felt swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient) .  An 55-year-old female nurse reported that received the third dose (booster dose) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number  FF8841), intramuscular into Deltoid Left, upper arm on 15Oct2021 at 4-5pm (at the age of 55-years-old) at single dose for COVID-19 immunization. The patient received the first dose on 25Feb2021 (lot number of EL9267) and the second dose on 16Mar2021 left arm (lot number EN6208). The patient met criteria laid out for immune booster, pre-existing conditions and age requirement. No other vaccines were given the same day and no problems with vaccines in past. The patient received a tetanus vaccine in Sep2021.  Concomitant drugs were unknown. medical history included 3 weeks before getting the vaccine had congestion and was given a steroid, 1 dose of Medro pack.  Stated she had been having that for the longest time, Went to get the booster and had no symptoms, no runny nose, congestion, nothing and so that's why she thought it was the safest to go ahead and do it.  The patient got the third dose immune booster vaccine, the Pfizer Covid vaccine, on 15Oct2021 The second day had pain in the underarm, axillary area and felt swollen lymph nodes. By the third day, she had extensive swelling and pain which resulted in her ER visit. They did an ultrasound of the area and it showed edema and not clots from the vaccine.  Stated she never had any problems with the first or second shots. Stated events started on the 16Oct2021 and she went to the ER on 17Oct2021. Everything was still the same and she still had the same swelling and pain. She stated it would be life threatening if the swelling and pain extended into her chest. The doctors cautioned her to pay attention to the swelling and if it extended to her chest. The events pain in the underarm, axillary area and felt swollen lymph nodes, extensive swelling and pain  were considered medically significant. The outcome of the events was not recovered.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of reported events 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID-19 infection with mild symptoms; tested positive for COVID-19 infection with mild symptoms; This is spontaneous report from an agency. The consumer reported same events for two patients. This is the report for her husband. A 43-year-old male patient received bnt162b2 (COMIRNATY, both Lot Number: EW0177) via an unspecified route of administration, on 04Jun2021 as DOSE 2, SINGLE and on 14May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer stated that her husband and herself received their second dose of the Pfizer COVID-19 vaccine last Jun2021. She states they both have tested positive for COVID-19 infection with mild symptoms on 13Oct2021. Caller is surprised that they have been infected so soon. She states that they have been very cautious and taking all the precautions and they don't understand how they caught it. The patient was diagnosed with Covid 19 virus on Wednesday (13Oct2021), he displayed symptoms first and within 48 hours she had symptoms. He was confirmed positive on 13Oct2021 (nasal swab), and he is also Pending PCR Test results.   Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101393306 same reporter/drug/event, different patients
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: despite the two doses of the COVID-19 vaccine, tested positive for COVID; despite the two doses of the COVID-19 vaccine, tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (COMIRNATY; lot number and expiration date were not reported) on an unspecified date, dose 1, single and on an unspecified date, dose 2, single; both via an unspecified route of administration for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, despite the two doses of the COVID-19 vaccine, the patient tested positive for COVID with the following symptoms of sore throat, congestion, chills, headache, tiredness, loss of sense of smell and taste. The patient underwent lab tests and procedures which included COVID test: positive on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 22-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 22, via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunisation. Medical history included COVID-19 (prior to vaccination, patient diagnosed with COVID-19). Concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunisation. On an unknown date, patient experienced pityriasis rosea outbreak all over body. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, patient has not tested for COVID-19. Therapeutic measures taken as a result of the  event included treatment with steroid cream (unspecified) and bacteria cream (unspecified). The outcome of pityriasis rosea outbreak all over body: not resolved (at the time of this report).  The lot number for BNT162B2 not provided and will be requested during follow-up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Immunisation, Off label use
Clinical narrative: previously had a root canal a year ago that had been healing perfectly. After getting the booster, started getting sore where the cyst was previously and within a week it has swollen and became very painful; Patient was received third/booster dose 3, BNT162b2; Patient received third/booster dose 3, BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received third dose (BOOSTER DOSE) BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 08Oct2021(at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome, hashimoto's disease, lupus erythematosus systemic, root canal infection and cyst. The patient had known allergies to spectra, cipro, codeine and macrobid. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine, liothyronine (NP THYROID), lisdexamfetamine mesilate (VYVANSE), vortioxetine hydrobromide (TRINTELLIX), losartan (MANUFACTURER UNKNOWN) and hydroxychloroquine sulfate (PLAQUENIL) all from unknown date for unspecified indication and unknown if ongoing. The patient previously received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 07Apr2021(at the age of 34-year-old) as a single dose for COVID-19 immunisation and also the patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the arm right on 15Mar2021(at the age of 34-year-old) as a single dose for COVID-19 immunisation. On 09Oct2021, the patient experienced previously had a root canal a year ago that had been healing perfectly. After getting the booster, it started getting sore where it had the cyst previously and within a week it has swollen and became very painful and hadn't been able to get in with the dentist or the doctor that performed the root canal, but had an appointment made and had no idea if this is related to the booster, but it didn't start until after, received it. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether the therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event (previously had a root canal a year ago that had been healing perfectly. After getting the booster, started getting sore where the cyst was previously and within a week it had swollen and became very painful) cyst was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Increasing warmth and itchiness s/p 24 hours.; Iincreasing warmth and itchiness s/p 24 hours.; red symmetrical raised area around injection site, warm to touch, extremely itchy. Noticed red, raised area s/p taking off bandage.; red symmetrical raised area around injection site, warm to touch, extremely itchy. Noticed red, raised area s/p taking off bandage.; red symmetrical raised area around injection site, warm to touch, extremely itchy. Noticed red, raised area s/p taking off bandage.; Booster; This is a spontaneous report from a contactable other health care professional, the patient. A 35-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the left arm on 15Oct2021 at 15:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, anxiety and attention deficit-hyperactivity disorder (ADHD). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid/ caffeine/salicylamide (EXCEDRIN); amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL); cetirizine hydrochloride (ZYRTEC); vitamin d nos (unspecified); escitalopram oxalate (LEXAPRO) and ethinylestradiol/ ferrous fumarate/ norethisterone acetate (LO LOESTRIN FE); all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9265) via an unspecified route of administration in the left arm on 28Jan2021 at 15:00 as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6200) via an unspecified route of administration in the left arm on 19Feb2021 at 09:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation and experienced no adverse reactions for both the doses (reported as no noticeable symptoms). On 15Oct2021 at 23:00, the patient experienced a red symmetrical raised area around the injection site, warm to touch, extremely itchy. Noticed red, raised area status post (s/p) taking off a bandage. On 16Oct2021, status post (s/p) 24 hours, the patient experienced increasing warmth and itchiness. It was reported that if the physician's office were open, she would contact them with respect to the intensity of itching and heat of the arm. It was unknown if therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events red symmetrical raised area around the injection site, warm to touch, extremely itchy, noticed red, raised area s/p taking off the bandage, increasing warmth and itchiness was not resolved at the time of this report.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Off label use
Clinical narrative: chills; felt feverish; whole body hurts; other vaccine same date product: Flu vaccine; other vaccine same date product: Flu vaccine; arm hurt from the covid shot; headache; nauseous; This is a spontaneous report from a contactable other hcp. A 29-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 16Oct2021 (at the age of 29-years-old) as dose 3 (booster), single for COVID-19 immunisation and received flu vaccine (INFLUENZA, formulation: not reported), via an unspecified route of administration from 16Oct2021 (Batch/Lot number was not reported) to 16Oct2021, at single for an unspecified indication. The patient's medical history included thyroid disorder, may have a gluten allergy. Patient was not pregnant at the time of vaccination. Patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on unspecified date as dose 2, single and first dose of 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 unspecified date as dose 1, single for COVID-19 immunisation. Patient had two other shots within the week, likely allergy medication. It was reported that patient received flu vaccine on same date (I believe in opposite arm) and had received a total of 4 shots that week with also blood drawn. Patient said their arm hurt from the covid shot more so than from the flu shot on an unspecified date on Oct2021. They said the flu vaccine was administered with more force (based on how the HCP(s) administered both). Unsure when this side effect started. On 17Oct2021, day after vaccine between 10:30 am and 12:00 pm started getting chills and felt feverish. Unsure how long this lasted. Took temperature but did not get follow-up on reading. Patient might had taken ibuprofen to mitigate, but unsure. Additionally, at one point during the day on 16Oct2021 (after vaccine) before noon, hit arm with the vein from which they drew blood and shouted, "My whole-body hurts". Patient complained that she had a headache that day and were nauseous the whole day on an unspecified date on Oct2021. Unsure the timeframe in which there was a headache issue was brought up between 7-8 pm, which implies headache during that approximate time at least. The patient underwent lab tests and procedures which included took temperature but did not get follow-up on reading on an unspecified date. Patient might take ibuprofen to mitigate fever and chill. Reporter assesses the case was non-serious. 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.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Product use issue, Pyrexia, Vaccination site pain
Clinical narrative: chills; felt feverish; whole body hurts; other vaccine same date product: Flu vaccine; other vaccine same date product: Flu vaccine; arm hurt from the covid shot; headache; nauseous; This is a spontaneous report from a contactable other hcp. A 29-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 16Oct2021 (at the age of 29-years-old) as dose 3 (booster), single for COVID-19 immunisation and received flu vaccine (INFLUENZA, formulation: not reported), via an unspecified route of administration from 16Oct2021 (Batch/Lot number was not reported) to 16Oct2021, at single for an unspecified indication. The patient's medical history included thyroid disorder, may have a gluten allergy. Patient was not pregnant at the time of vaccination. Patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on unspecified date as dose 2, single and first dose of 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 unspecified date as dose 1, single for COVID-19 immunisation. Patient had two other shots within the week, likely allergy medication. It was reported that patient received flu vaccine on same date (I believe in opposite arm) and had received a total of 4 shots that week with also blood drawn. Patient said their arm hurt from the covid shot more so than from the flu shot on an unspecified date on Oct2021. They said the flu vaccine was administered with more force (based on how the HCP(s) administered both). Unsure when this side effect started. On 17Oct2021, day after vaccine between 10:30 am and 12:00 pm started getting chills and felt feverish. Unsure how long this lasted. Took temperature but did not get follow-up on reading. Patient might had taken ibuprofen to mitigate, but unsure. Additionally, at one point during the day on 16Oct2021 (after vaccine) before noon, hit arm with the vein from which they drew blood and shouted, "My whole-body hurts". Patient complained that she had a headache that day and were nauseous the whole day on an unspecified date on Oct2021. Unsure the timeframe in which there was a headache issue was brought up between 7-8 pm, which implies headache during that approximate time at least. The patient underwent lab tests and procedures which included took temperature but did not get follow-up on reading on an unspecified date. Patient might take ibuprofen to mitigate fever and chill. Reporter assesses the case was non-serious. 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.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash, Rash erythematous, Rash pruritic, SARS-CoV-2 test
Clinical narrative: Painful rash on ''my'' inner right thigh. It is red, itchy and burning to touch; Painful rash on ''my'' inner right thigh. It is red, itchy and burning to touch; Painful rash on ''my'' inner right thigh. It is red, itchy and burning to touch; Painful rash on ''my'' inner right thigh. It is red, itchy and burning to touch; Starts to peel like sunburnt skin and then is fine for a couple weeks before repeating the cycle.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 19May2021 at 14:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 28Apr2021 at 14:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 20May2021 at 18:00, the day after received the second dose, the patient developed a painful rash on her inner right thigh. It was red, itchy and burning to touch. On an unknown date in May2021, after a day or so it started to peel like sunburnt skin and then was fine for a couple weeks before repeating the cycle. On 04Oct2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was negative. On 06Oct2021, the patient underwent SARS-CoV-2 test via spit tub and the result was negative. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had been tested for COVID-19.  The clinical outcome of the events painful rash on inner right thigh, it was red, itchy, burning to touch and started to peel like sunburnt skin were not resolved at the time of this report.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: Painful rash on ''my'' inner right thigh. It is red, itchy and burning to touch; Painful rash on ''my'' inner right thigh. It is red, itchy and burning to touch; Painful rash on ''my'' inner right thigh. It is red, itchy and burning to touch; Painful rash on ''my'' inner right thigh. It is red, itchy and burning to touch; Starts to peel like sunburnt skin and then is fine for a couple weeks before repeating the cycle.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 19May2021 at 14:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 28Apr2021 at 14:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 20May2021 at 18:00, the day after received the second dose, the patient developed a painful rash on her inner right thigh. It was red, itchy and burning to touch. On an unknown date in May2021, after a day or so it started to peel like sunburnt skin and then was fine for a couple weeks before repeating the cycle. On 04Oct2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was negative. On 06Oct2021, the patient underwent SARS-CoV-2 test via spit tub and the result was negative. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had been tested for COVID-19.  The clinical outcome of the events painful rash on inner right thigh, it was red, itchy, burning to touch and started to peel like sunburnt skin were not resolved at the time of this report.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: Extreme hot flashes; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL5302) via an unspecified route of administration on an unknown date in Jan2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration on an unknown date in Dec2020 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Jan2021, with the second dose, the patient experienced extreme hot flashes. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hot flashes was not resolved at the time of this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Immunisation, Swelling
Clinical narrative: Swelling; Redness; Severe dizziness 2 days after, slight dizziness 3rd day; Administration date 15Oct2021, dose number=3; This is a spontaneous report from a contactable nurse, the patient. A 65-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the right arm on 15Oct2021 at 14:45 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231) via an unspecified route of administration in the right arm on 30Dec2020 (at the age of 64-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the left arm on 22Jan2021 at 08:45 (at the age of 64-years-old) both as a single dose for COVID-19 immunisation. On 15Oct2021 at 14:45, the patient had "administration date 15Oct2021, dose number=3". On 16Oct2021, the patient experienced swelling, redness and severe dizziness 2 days after, slight dizziness 3rd day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events swelling, redness and severe dizziness 2 days after, slight dizziness 3rd day. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling, redness and dizziness was not resolved. The clinical outcome of the event "administration date 15Oct2021, dose number=3" was unknown at the time of this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Gait disturbance, Headache, Motor dysfunction, Pain
Clinical narrative: Extreme pain and swelling on right arm; Extreme pain and swelling on right arm; Unable to function; Itchy welts appeared on right arm; Extreme headache; I was not able to move with out have extreme pain; Electric shock to the base of my neck halfway down my spine/shock feeling; I had to make gradual moves and not stand or walk; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301538a) via an unspecified route of administration in the right arm on an unknown date in Oct2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient medical history reported as not applicable. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 16Oct2021 at 16:00, the patient experienced extreme pain and swelling on right arm, unable to function, itchy welts appeared on right arm, extreme headache that had an electric shock to the base of her neck halfway down her spine, she was not able to move without had extreme pain and the shock feeling, she had to made gradual moves and not stand or walk. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme pain and swelling on right arm, unable to function, itchy welts appeared on right arm, extreme headache, she was not able to move without had extreme pain, electric shock to the base of her neck halfway down her spine/shock feeling and she had to made gradual moves and not stand or walk was unknown at the time of this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: Extreme pain and swelling on right arm; Extreme pain and swelling on right arm; Unable to function; Itchy welts appeared on right arm; Extreme headache; I was not able to move with out have extreme pain; Electric shock to the base of my neck halfway down my spine/shock feeling; I had to make gradual moves and not stand or walk; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301538a) via an unspecified route of administration in the right arm on an unknown date in Oct2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient medical history reported as not applicable. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 16Oct2021 at 16:00, the patient experienced extreme pain and swelling on right arm, unable to function, itchy welts appeared on right arm, extreme headache that had an electric shock to the base of her neck halfway down her spine, she was not able to move without had extreme pain and the shock feeling, she had to made gradual moves and not stand or walk. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme pain and swelling on right arm, unable to function, itchy welts appeared on right arm, extreme headache, she was not able to move without had extreme pain, electric shock to the base of her neck halfway down her spine/shock feeling and she had to made gradual moves and not stand or walk was unknown at the time of this report.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. A 44-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 16Oct2021 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was not reported if the patient received any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 16Oct2021, the patient experienced left arm pain, tired, run down, achy and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events left arm pain, tired, run down, achy and chills was resolving at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Dizziness, Fatigue
Clinical narrative: Headaches; Dizziness; Fatigue; Sweating; Chills; Joint pain; Body aches; Sore throat; Coughing; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the right arm on 06Oct2021 at 09:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic and osteoarthritis, spondylosis, migraines. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included trazodone hydrochloride (DEPRAX) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA8780) via an unspecified route of administration in the right arm on 15Sep2021 at 09:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient previously also received pneumococcal 13 valent vaccine (PVC-13 PNEUMONIA VACCINE) for unknown indication from an unknown date and experienced allergy to vaccine and triamcinolone acetonide (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and experienced drug allergy. On 06Oct2021 at 23:00, the patient experienced chills, joint pain, body aches, sore throat and coughing. On 07Oct2021 at 22:00, the patient experienced sweating. On 08Oct2021 at 21:00, the patient experienced headaches, dizziness and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events chills, joint pain, body aches, sore throat and coughing was resolved on 07Oct2021 at 19:00, sweating was resolved on 08Oct2021 at 21:00 while headaches, dizziness and fatigue was resolved on 15Oct2021 at 08:00.