chrisvoncsefalvay/vaers-outcomes huggingface dataset:
two positive Ag tests; two positive Ag tests; mild ST; sinus congestion; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 23 year-old male patient received bnt162b2 (BNT162B2), administration date 03Jan2022 (Batch/Lot number: unknown) at the age of 23 years as dose 3 (booster), single, administration date 01May2021 (Lot number: EW0172) as dose 2, single and administration date 10Apr2021 (Lot number: ER8734) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Mar2022, outcome "unknown" and all described as "two positive Ag tests"; OROPHARYNGEAL PAIN (non-serious) with onset 23Mar2022, outcome "unknown", described as "mild ST"; SINUS CONGESTION (non-serious) with onset 23Mar2022, outcome "unknown", described as "sinus congestion"; FATIGUE (non-serious) with onset 23Mar2022, outcome "unknown", described as "fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Mar2022) positive, notes: COVID test type post vaccination: Unknown; (23Mar2022) positive, notes: COVID test type post vaccination: Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, oropharyngeal pain, sinus congestion, fatigue.  Clinical course: It was reported that, on 23Mar2022, the patient had been tested two Ag tests for COVID-19 since the vaccination and both time tests were positive after partying on the week end.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.Based on the information provided there is a reasonable possibility of causal association between the events oropharyngeal pain, sinus congestion and fatigue with the suspect product bnt162b2.
Tingling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling). At the time of the report, PARAESTHESIA (Tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was reported.
sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An elderly male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm".  Additional Information: consumer reported for a male patient (father) that: reporter worked in medical information and a friend from (state name) texted reporter at 13:00 on 13Apr2021 to tell reporter that her Dad (elderly male) received dose 2 of the Pfizer-BioNTech covid-19 vaccine and had a sore arm for 24 hours. Reporter have no other details to provide.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had typical arm pain after an injection that was to be expected. I am now a month out from the second dose of the vaccine and I continue to have residual arm pain that is worse with movement. The pain is deep into the arm, almost like a bone pain. Rates 3/10 on pain scale. Noticeable decrease in strength in arm where vaccine was administered as well.  I chose the dominant arm, as I am aware that the more the movement of the muscle the less likely the vaccine would pool in the muscle. I am an RN, I received vaccines through out my life time and I have never had a similar outcome. I typically do quite well with vaccinations. I had no other symptoms or reactions to either doses. Arm pain was significant with the first dose and did resolve fully. The arm pain with the second dose was increased in severity and then did decrease however it has not resolved. Concerned due to length of time that has passed.
Painful stomach cramps, worse than period. First it just felt like mild, regular cramps.; Felt like severe gas; Woke "me" up in the middle of the night, could not sleep for the whole night due to the pain and COVID arm pain; COVID arm pain; Had slight nausea; Tried to make "myself" vomit; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Apr2021 at 13:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included anemic. The patient was mildly allergic to pineapples. 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 medication within 2 weeks of 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 in the left arm on 04Apr2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021, the patient experienced painful stomach cramps, worse than period. First it just felt like mild, regular cramps. But later on in the night the pain woke her up and it felt like severe gas. It woke her up in the middle of the night and she could not sleep for the whole night due to the pain and COVID arm pain. The patient had slight nausea as well, which was taken care of when she tried to make herself vomit. The events did not result in doctor or other healthcare professional office/clinic visit, and 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 painful stomach cramps, woke her up and it felt like severe gas, could not sleep for the whole night due to the pain and COVID arm pain and had slight nausea and vomit was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
4-5  Flat red macular lesions. Mom reports one was a clear vesicle. High fever 48 hours.
Patient had her vaccine on 12/31/2020 and then on 1/7/2021 she developed rash to arm with injection; deltoid with full arm circumference up to neck; warm to touch; fever for 24 hours, pain to site; prescribed antibiotics for possible cellulitis by ED physician.
possible shingles rash; unusual pain on right side of her neck; pain extended to her head and skull; Eczema rash; right side of her skull the rash is not fluid-filled, it is raised and hardened; Localized swelling at the injection site; Flu-like symptoms; Feeling warm or feeling febrile; Generalized aching/ rash hurts; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eczema (had been flaring up for a couple of months.).   On 21st November 2019, the patient received the 1st dose of Shingrix. On 21st November 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, flu-like symptoms, feeling of warmth and generalized aching. On 24th November 2019, the patient experienced shingles, neck pain, headache, eczematous rash and rash. The patient was treated with ibuprofen (Advil). On 23rd November 2019, the outcome of the injection site swelling, flu-like symptoms, feeling of warmth and generalized aching were recovered/resolved. On an unknown date, the outcome of the shingles, neck pain, headache, eczematous rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles, injection site swelling, flu-like symptoms, feeling of warmth, generalized aching, neck pain, headache, eczematous rash and rash to be related to Shingrix.   Additional case details were reported as follows: The patient was a retired nurse and she reported the case for herself. In the evening of vaccination, the patient noticed localized swelling at the injection site. She also reported flu-like symptoms and described as having generalized aching and felt warm or febrile although she did not check her temperature.  The patient took Advil and swelling and flu-like symptoms approximately lated for 48 hours or 1 to 2 days.  On Sunday, 3 days after Shingrix vaccination, the patient felt an unusual pain on right side of her neck that extended to her head and skull. She was unsure if it was an eczema rash or possible shingles rash. She further stated that, on the right side of her skull the rash was not fluid-filled, it was raised and hardened but it did not itch like regular eczema, rather the rash hurt.
While driving home noticed arm was uncomfortable from injection. Once home, roughly an hour after injection. She became sweaty, nauseous, fatigued. She did not feel well all night, had hard time sleeping because of this. She did make sure to eat that evening. The next morning while in the shower, she noticed her heart racing, started seeing stars and started to have chest pain. She was planning on going to the ER, but her husband talked her out of it. Her symptoms resolved after about 36 hours.
Patient came in for second covid vaccine. The medical assistant entered room to give vaccine. Medical assistant ready to give, Stated''the patient moved prior to administration". The vaccine was accidently given in the patients tendon above bicep.
Case previously recorded as MA2009-6468. Initial case report received via Med Com from a health care professional on 30 NOV 2009: A 1-year-old female patient was vaccinated with 0.5 ml of S-OIV FLUVIRIN (batch no. 10007396P) on 30 NOV 2009. No adverse event was reported. MedCom ref. no.: NA09-008919.
Full body skin rash, dermatitis with blisters and itch.  Swollen fingers from the reaction also.
suspected vaccination failure; I got the shots, so had them very light; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, 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 Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the shingles shots, so had shingles very light. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Localized - 6 cm x 3 cm erythema, edema, pain, @ (L)eft deltoid injection site.
This is an spontaneous report from a contactable physician communicated to a Pfizer sales representative. A 3-year-old child (gender unknown) received a dose of PREVNAR 13 (Lot E 87534) on an unspecified date. Relevant medical history included viral URI immediately prior to onset pneumonia. Concomitant vaccines included Influenza virus vaccine and Hep A. Past product history included dose one of PREVNAR on 14Jan2009, 2nd dose on 17Mar2009, 3rd dose on 12May2009 and 4th dose on 03Dec2009; the 1st dose of DTaP on 14Jan2009, 2nd dose on 15Apr2009, 3rd dose on 12May2009, 4th dose on 16Feb2010; the 1st dose of Hib on 14Jan2009, 2nd dose on 17Mar2009 and 3rd dose on 03Dec2009; 1st dose of IPV on 13Aug2009, 2nd dose on 16Feb2010, and 3rd dose on 26Jun2010; the 1st dose of Hep B on 14Jan2009, 2nd dose on15Apr2009 and 3rd dose on 13Aug2009; the 1st dose of MMR on 23Apr2010; the first dose of VARIVAX on 23Apr2010; the first dose of ROTAVIRUS VACCINE on 14Jan2009, 2nd dose on 12May2009 and 3rd dose on 11Jun2009. On 09Feb2011, following administration of the vaccination, the patient was hospitalized after having been diagnosed with pneumonia and pneumothorax. The patient underwent lab tests and procedures which included blood immunoglobulin A: 113 mg/dl on 14Feb2011, blood immunoglobulin E: 24h mg/dl on 14Feb2011, blood immunoglobulin G: 946 mg/dl on 14Feb2011, blood immunoglobulin M: 123 mg/dl on 14Feb2011. Culture Blood (09Feb2011): Strep. Pneumo Serotype: 19A MRSA Screen culture (10Feb2011): No MRSA Detected. Culture Blood: (10Feb2011): no Growth. C difficile Toxin (13Feb2011): Negative for Clostridium Toxin. HIBE (15Feb2011): 7.1 ug/ml NBT:(15Feb2011): 65 L % Sweat volume 70 UL: (16Feb2011): sweat CL(MMOL/L) 47 f (Intermediate (30-59mmol/L) CRP: (10Feb11): 30.7 Hf CRP (12Feb2011): 21.5 Hf CRP (13Feb2011): 17.8 Hf CRP (14Feb2011): 29.0 Hf CRP (15Feb2011): 22.0 Hf CRP (18Feb2011): 15 Hf CRP (21Feb2011): 7.0 Hf CRP (24Feb2011): 4.4 Hf CRP (28Feb2011): 1.9 Hf Complete TOT (14Feb2011): 250 Hf Vancomycin (12Feb2011): 8 f (mcg/ml). The outcome of the event at the time of the report was recovered. Follow-up (22Dec2011): New information reported by contactable physician provided medical history, past product history, concomitant medications, clinical course, lab data, and event outcome.
(L) Deltoid Cellulitis after MENACTRA vaccine administration (at injection site).
pt recvd vax & exp dull, achy flank pain especially on inspiration; sx are slowly subsiding but as yet have not completely resolved;
miss 2nd dose by over a year; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter asked what if longer than 6 months for 2nd dose had been passed, would series repeated, if you miss 2nd dose by over a year what is procedure. The reporter disconnected the chat before confirming if there was patient involvement. The call center representative was unable to obtain follow up permission due to the HCP's abrupt disconnection. GSK note- it was unknown if patient was involved or not, so by considering worst case approach the case kept valid.
Right thigh swollen, feels warm, red and irritated. Applying Benadryl ointment.
I definitely had a soreness at the injection site, more than I have had with any other shot. It definitely subsided after a couple of days. Also had joint pain in my hands, elbows, and knees, and particularly in my left knee where I have arthritis, also decreased in intensity within a few days of the shot.   About a week after the shot, my arm began to itch at the injection site, and swelling and a half-dollar sized red patch appeared, and the skin was hot to the touch. Today (2 days later), the red patch is roughly the size of a small envelope. The skin is still warm or hot to the touch and the swelling may have subsided slightly. I am not taking any antihistamines or using any topicals- just working on not scratching the area. I have read some info on the internet referring to this as "COVID Arm". It is manageable, and I am NOT deterred from getting my second shot in April.
Head & neck all red, itchy; Head & neck all red, itchy; I'm scratching; my left ear was itching super bad; I almost felt like I was sun burned from my neck and head up, my thighs, my abdomen it was like super itchy; she received both her first and second dose; she received both her first and second dose; This is a spontaneous report from a contactable consumer.   This 61-year-old (non-pregnant) female consumer (patient) reported that she received both her first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) intramuscularly into the right arm on 09Mar2021 15:00 (at the age of 61-year-old) as single dose for COVID-19 immunisation. The patient medical history included hypertension, cancer and overweight. Concomitant medications included Xanax, Synthroid and Estratest (Female hormone). Blood Pressure medication, that was the only prescription she took. On 09Mar2021, she reported that she got her Covid shot about 3O Clock that day and about 8:30 that evening, she kind of itching some and scratching so she was going to bath and her left ear was itching super bad. She was itching and all red and had welch. So, she called her sister who was in the medical field too and that time what was going on and she took a couple of Benadryl and had some and then took a 10 mg of Prednisone and it calmed down but she almost felt like she was sun burned from her neck and head up, her thighs, her abdomen and it was like super itchy. She could not believe how red she was, looked like she have been in the sun. That was it. No investigation assessment done. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. She was treated with Benadry and prednisone. Prior to vaccination, she was not diagnosed with COVID-19 nor had been tested since the vaccination. She has allergies to medications, food or other products. She was a cancer survivor and considered herself a little over-weight, was not obese. Outcome for events was itching and all red was recovering and unknown for rest of the events.  Follow-up(10Mar2021): This is a Follow-up spontaneous report from a contactable consumer. This 61-year-old female consumer (patient) reported which included   Information related lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, A possible causal relationship between reported events and suspect drug BNT162B2 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.
Approximately 5 minutes following the second COVID vaccination she started to report itching at the injection site that migrated to the right chest area. PO Benadryl was given and she was observed for 30 minutes. All complaints resolved prior to leaving the vaccination area.
cold chills; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (cold chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced CHILLS (cold chills). At the time of the report, CHILLS (cold chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment drug were not reported.
Acute on chronic respiratory failure with hypoxemia; Acute urinary retention; Arterial leg ulcer; Cardiac rhythm disorder or disturbance or change; Chest discomfort; Chest pain; SOB (shortness of breath)
Initially, left arm warm, red, small white circle at injection site.  On March 18, 2020, noticed severe pain in lower head, neck and shoulders. Shivers, night sweats, awakened by neck pain, Temperature ranged anywhere from 100 to 102. While pain and other symptoms appear to be diminishing, they still exist to date (March 24, 2020).  Arm has slight discoloration in inoculation area but no longer is red.  Appetite is diminished.
3/19/2021  Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms: patient reported feeling of Swelling of right eye ear.   Assessment : Time of assessment . Actions taken: Vitals signs taken @ 1120 BP 180/84, P-73, O2-99%, held in observation for another 15 mins, husband with her, she reports decrease in symptoms, she also she reports that she took homeopathic drops labeled, vaccine related symptom, she also reported experiencing " white coat syndrome', she reports that she takes nothing for BP.     There were no vitals filed for this visit.   Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30  minutes. Discharged home.with husband
This spontaneous report as received from the patient's mother refers to a 6 year old female patient. The patient's medical history and drug reactions or allergies were not reported. On 02-AUG-2016, the patient was taken to the physician for vaccination with VAQTA, but was given GARDASIL instead (dose, route, lot # and expiry date were not reported) by the nurse practitioner. Concomitant medications were not reported. On 02-AUG-2016, the patient experienced injection site redness and pain. The patient did not have any other reactions, but the reporter felt that it was too coon to say whether any other affects would appear. The patient did not seek medical attention. No treatment was provided. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Blood under skin at shot area - continued for 8 weeks - shot area started to fade but continued to bleed until the blood completely covered arm - from shot area to my elbow. At 8 weeks it stopped bleeding.
vaccine may have been administered subcutaneously instead of intramuscularly; swelling in arm; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A 53 year-old female patient received bnt162b2 (BNT162B2), subcutaneous, administration date 30Mar2021 (Lot number: ER8733, Expiration Date: Jul2021) at the age of 53 years as dose 1, 0.3 ml,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "vaccine may have been administered subcutaneously instead of intramuscularly"; PERIPHERAL SWELLING (non-serious) with onset 31Mar2021, outcome "unknown", described as "swelling in arm".  No follow-up attempts are possible. No further information is expected.