chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed generalized pain in finger; developed generalized pain in finger, wrist and elbow joints bilaterally; This is a spontaneous report from a contactable health professional (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included hypothyroidism and allergies: PCN. Concomitant medication (other medication in two weeks) included levothyroxine sodium (SYNTHROID). Patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in the right arm on 28Dec2020 (Batch/Lot number: EL1284) for COVID-19 immunization and experienced right elbow pain with movement 24 hours after injection followed by hand and wrist joint pain. The patient developed generalized pain in finger, wrist, and elbow joints bilaterally on an unspecified date, within one week after the second shot. This was followed by generalized joint pain that has been slowly getting worse since. Outcome of the events was not recovered. No treatment was received. Events were reported as serious with seriousness criteria: disabling/incapacitating. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination.   The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events (Pain in fingers, Arthralgia) and the BNT162B2 cannot be excluded. The case will be reassessed once new information is available. "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."
Fingers and hands turned blue in certain areas; Head, neck, and shoulders extremely sore and achy; Head, neck, and shoulders extremely sore and achy; Head, neck, and shoulders extremely sore and achy; Extremely tired; Pain/burning about an inch under the shot site down to elbow for a few hours after receiving vaccine; This is a spontaneous report from a contactable Other HCP (patient).  A 29-year-old female patient (not pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), intramuscular in arm left on 21Dec2020 14:30 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included hydromyelia. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported.  The patient previously took pregabalin and experienced 'Known allergies: Pregabalin'.  Pain/burning about an inch under the shot site down to elbow for a few hours after receiving vaccine on 21Dec2020 16:30. Day 1 (22Dec2020)- Extremely tired. Day 2 (23Dec2020)- head, neck, and shoulders extremely sore and achy. Day 3 (24Dec2020)- fingers and hands turned blue in certain areas. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Case was non-serious.The outcome of the events was recovering.
nausea; chills; in the morning sweating; in the morning some frequent belching; in the morning stomach ache; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (in the morning sweating), ERUCTATION (in the morning some frequent belching), ABDOMINAL PAIN UPPER (in the morning stomach ache), NAUSEA (nausea) and CHILLS (chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026AZ1A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included H.pylori gastrointestinal disease (7 years ago).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced HYPERHIDROSIS (in the morning sweating), ERUCTATION (in the morning some frequent belching) and CHILLS (chills). 04-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (in the morning stomach ache). On an unknown date, the patient experienced NAUSEA (nausea). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (in the morning sweating), ERUCTATION (in the morning some frequent belching), ABDOMINAL PAIN UPPER (in the morning stomach ache) and NAUSEA (nausea) had resolved and CHILLS (chills) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Additional treatment included ginger ale.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received on 17-MAY-2021 contains significant information - events resolved
patient had a shingles episode last year/suspected vaccination failure; patient had a shingles episode last year; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: patient had a shingles episode last year/suspected vaccination failure) (serious criteria medically significant) and shingles (Verbatim: patient had a shingles episode last year). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: Receipt date: 17-AUG-2023 A pharmacist reported that information about a patient who received the 2 doses of Shingrix back in 2020.  The pharmacist mentioned that the patient had a shingles episode last year and asked if it was recommended to repeat the series.  The reporter did not provide any information about the 2 Shingrix doses. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Permission to follow up was not requested.
Child was at school and teacher noticed some swelling around his injection site. Child then was taking to Urgent care by parents. Their they gave him benadryl. From the time the patient left the hospital the symptoms had worsen. Patient right leg from injection site down to his lower leg about an inch or two past his patella was swollen and warm to touch.
Chest pain w/in 1 hr after vaccinated - Cardiac Cath -neg - Symptoms subsided hours later.
3/18/10 resident given MENACTRA vaccine left arm. Within 5 - 10 minutes later reported hives right cheek - 2 hives noticed (R) cheek. No difficulty breathing or other symptoms mentioned. BENADRYL given - symptoms resolved.
Next morning after shower notice tennis ball size lump that is water filled and a little painful on L lymph node on axillary and neck.  Applied head to the area for 2 days with decrease in size and pain.
Hives under and around both arms. Some hives on insides of legs. Very itchy.
Info has been received from a registered nurse concerning a pt who was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #641532/1353L). Concomitant therapy included "some type of allergy medicine" including loratadine (CLARITIN), cetirizine hydrochloride (ZYRTEC) or fluticasone propionate (FLONASE). Subsequently the pt developed 2 warm red spots on the arm (not at the injection site). Unspecified medical attention was sought. Additional info has been requested.
Left arm pain at time of injection 6 weeks later still sore the whole arm and behind left shoulder blade and left color bone .weakness in arm and pain.
Intense dizzyness, Vertigo, Nausea about 36 hrs after first dose, subsided after about a day. Same symptoms occurred about 108 hours after second dose, still waiting for them to subside.
Involuntary movements of jaw, face and eyes. Variable pupil size. Frequently rolls eyes and moves head and/or body.
This spontaneous report was received from a pharmacist and refers to a 49 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 07-OCT-2017, the patient was inadvertently administered an expired dose of ZOSTAVAX lot # M032141, expiration date on 02-OCT-2017, subcutaneously for prophylaxis. No adverse effects were reported in the patient.
This spontaneous report as received from a nurse refers to a 13 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 01-MAY-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 3, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
A spontaneous report has been received from a Pharmacist concerning an adult, female patient of unknown ethnicity. The relevant history and concomitant disease of the patient were not reported. The concomitant medications of the patient were not provided. Pharmacist reported that the patient stated she had a sinus infection and burning in her nose after receiving last years  FLUMIST Quadrivalent started on an unknown date. Action taken was not applicable for FLUMIST and the outcomes of the events were unknown. The vents, sinus infection and burning in her nose after last years FLUMIST considered to be non serious by the reporter.
2/16-Left thigh-round, elevated erythema with definedborder, Macular pastule lesions injection site within border of round erythema  No treatment.  2/18 After injection, itchy at site. Few papules appeared them become increasingly worse. No treatment
On 12/1/00; well child check; OM noted and began Amoxil, no fever, so MMR II and Varivax given. On 12/8/00; rash noted. On 12/9/00; had fever and was fussy per mom's report. On 12/10/00, seen for rash, still with OM so Keflex began but rash was down from 12/8/00 and no fever. On 12/11/00; rash more erythematous with increased induration over arms. Antibiotics changed to Zyrtec (Keflex discontinued). No fever. Still with rash, Follow-up on 12/21/00, to assess.
Pt vaccinated with DTP/OPV/PPD developed cellulitis of the arm below the injection site 6 days post injection.
doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Rash on the insides of both elbows.  It appears to get darker toward the end of the night.  Rash appears light pink/red with smaller red dots around the edge.   Rash started about a week after 1st dose and never fully went away. Rash became darker two days after the 2nd dose.
HCP reports a patient who has previously completed the GARDASIL QUADRIVALENT series had a positive pap smear in 04/2023 for HPV 18 OR 45.  Physician is unsure which one the patient is testing positive for and no further details provided.  No other AE; This spontaneous report was received from a physician referring to a female patient of unknown age. The patient's értinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On an unknown date, the patient completed quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) series, for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis.         On an unspecified date in April 2023, the patient had a positive smear for HPV 18 or 45 (smear cervix abnormal). The physician was unsure which one the patient was testing positive for and no further details provided. No other adverse event (AE) was reported. At the time of reporting, the outcome of the event was unknown.  The causality assessment between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) was not provided.
On 20Mar2021 he had dots form on his body so he went to Urgent Care and he was diagnosed with Shingle; This is a spontaneous report from a contactable reporter (patient). A 68-years-old male patient received bnt162b2 first dose of (Formulation: solution for injection) via an unspecified route of administration on 03Mar2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 20Mar2021, the patient had dots form on his body so he went to urgent care and he was diagnosed with shingle, patient was told by doctor that not to receive the second dose and to wait for the shingles to clear up. The patient said that, the shingles were gone. The patient was scheduled to receive the second dose on 23Mar2021. The events were considered as non serious. The outcome of the event dots form on his body so he went to urgent care and he was diagnosed with shingle was recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Pt described a localized reaction that included a large swollen, red, itchy and pain area around the site of injection that measures approximately 3 to 4 inches lateral for 7 days post vaccination.
3/14/03 c/o n&v, flu-like illness. Out of work 3/17/03, work half a day on 18th, out on 19th, worked half day on 20th and out since then. 3/19/03 had elevated liver enzymes, elevated monocytes and AlT tests. 3/24/03 SGPT enzymes elevated above the 3/19/03 levels. C-reactive protein also elevated. 3/22 & 23/03 had problems with left leg. 3/24/03 diagnosed with superficial phlebitis of upper and lower left leg. 3/25/03 CT scans done of head and abdomen due to continued headaches and elevated liver enzymes. No abnormalities on the scan. No history of heart disease. Lab tests for Hep B&C were negative. Had Hep B and Hep A vaccines previously. Lab tests for Epstein Barr and some other tests not back yet.Has referral to a gastroenterologists on 4/7/03 due to continued fever,nausea and weight loss. No treatment other than for the fever and nausea.
On March 18, 2021, I received my second dose of the Covid vaccine. I had no immediate adverse effects, but beginning on or around April 25, 2021, I lost most of my hearing in my left ear with some tinnitus associated with it. I checked out the internet for possible side effects and saw hearing loss as a possible, unverified side effect. It has been 4-5 weeks since my hearing loss and it hasn't returned. I don't know what to do about it except to tell you and hope that I'm not going to be deaf as a result of taking the Covid vaccine for the rest of my life. Thank you.
Felt lightheaded and had tunnel vision that lasted for 2 minutes. Assisted by staff down to ground. Vitals stable. Pt had not eaten any thing before. Back to baseline almost immediately . Pt fiancé picking up patient
Information has been received from a consumer concerning her son who on an unspecified date was vaccinated with MMR II. The consumer reported that "My son's life horribly changed the day he received the MMR combo shot". It was unknown if the patient sought medical attention. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with PNEUMOVAX23. No dosage information, route of administration or lot number was reported. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced pneumococcal meningitis (considered as medically significant per manufacturer). It is unknown if the patient received any treatment for the adverse event. The outcome of pneumococcal meningitis is unknown. The reporter did not provide a causality statement. It was added that the reporter was not sure if the patient received PNEUMOVAX23 in the past. No further information was provided. Additional information has been requested.
dizziness, feverish, faint, nausea, tired started 1/2hr p/vax;lasted 5 1/2hr;felt drained
Patient had arm stiffness that lasted two weeks. She is having a hard time sleeping due to the pain. And she does not have full movement of left arm.
Itches; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itches) and RASH (Rash) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PRURITUS (Itches) and RASH (Rash). At the time of the report, PRURITUS (Itches) and RASH (Rash) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not  reported by the reporter. Treatment details was not reported by the reporter.
4hrs after receiving the vaccine. Right arm was swelling, red rash/flushing skin present on arm, neck, abd, and chest. Delayed cap refill on right hand with cold extremities, pallor and purple dusky discoloration.  Treatment was 50mg prednisone PO, Benadryl 50mg PO around 1630 At 1700 checked in as a patient to ED and clocked out as staff. Severe chills and muscle ache present no fever.  Received 1L NS, IV Pepcid, IV Benadryl 50mg. Unsure of time d/t feeling fatigued Observed in ED till 1920, chills and redness resolved. Left with only localized swelling and slight redness to site.  Was instructed to take several more days of prednisone.
Patient developed itchy rash on lower abdomen that began with red bumps and developed into bleeding blisters. Patient self-treated at home with hydrocortisone cream without improvement. Patient then went to urgent care and received steroid cream. Patient reports rash is improving but not completely resolved.
BlurredVision, Dizziness, Palpitations, Tachycardia, "throat tightening" Narrative: Patient with tachycardia, dizziness, blurred vision and throat tightening. Evaluated in ED. Benadryl IV
She has a small reaction after the first shot.  After the 2nd shot, she had the following reaction:  Injection site swelled up the size of a baseball and was very sore and hot to the touch,  broke out in a rash around her lips and in her mouth, lips started to swell and felt like they were "vibrating".  Has lost her appetite and lost taste for about a week following the injection.
Patient was given the COVID19 Pfizer vaccine. The patient felt very dizzy 5 minutes after so we had him lay on the floor. Seconds later the patient passed out. His eyes were rolling and hands clenching as if he was having a seizure. About less than a minute later the patient became responsive again. Patient has no history of seizures. Emergency services was called and the patient was evaluated.
Information has been received from a nurse practitioner concerning a 24 year old female, who on 15-MAY-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (lot# 657617/0384U). Concomitant therapy included CLARITIN as needed. On 16-MAY-2007 the patient developed an itchy, red, raised blisters. The patient stated that one of the blisters appeared on her back. At that time the patient did not think that it was related to the vaccination, so she did not call the office to report this. On 14-JUL-2007 the patient was vaccinated intramuscularly in the left arm with a second dose of Gardasil (Lot# 657617/0384U). On 15-JUL-2007 the patient developed the same type of blisters. The blisters were located on the left axilla, left forearm, right shoulder, and back. The patient was being treated with BENADRYL. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007. Additional information is not expected.
This 60 year old  black male received the Covid shot on  4/15/21  and went to the ED on  4/23/21  with the following diagnoses listed below and died on 4/27/21. K92.2 - Gastrointestinal hemorrhage, unspecified
Numbness and tingling in the left side of the face; Numbness and tingling in the left side of the face; This is a spontaneous report from a contactable physician (patient). A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), intramuscularly, administered in Left arm on 14Feb2021 11:00 at the age of 37-years-old as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient had no known allergies. Other medical history was reported as none. There were no concomitant medications. The patient previously took first dose of historical vaccine, bnt162b2 (Product- covid-19, Lot unknown- unknown) on an unspecified date as single dose for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. The patient did not receive other medications in two weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. The patient experienced numbness and tingling in the left side of the face on an unspecified date in Feb2021. The patient did not receive treatment for adverse events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The outcome of events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.