chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EL9265), on 22Feb2021 as dose 2, single (Lot number: EN6198), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: EW0191), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CRESTOR, start date: 07Aug2018; DULOXETINE, start date: Feb2012; AMABELZ, start date: Feb2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Positive, notes: Recurrence of Covid positive test, 3 days after a negative test following Paxlovid treatment; Negative, notes: Recurrence of Covid positive test, 3 days after a negative test following Paxlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. clinical course : Anti viral product for COVID 19 Treatment, brand-Paxlovid, treatment start date-08May2022, treatment stop date-12May2022, indication-Treatment of COVID-19. Recurrence of Covid positive test, 3 days after a negative test following Paxlovid treatment. Symptoms are headache and fatique. This is a notification generated from the system. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lots FM0698, EW0191, EN6198 , EL9265 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and products  type. The final scope included the reported finished goods lots FM0698, EW0191, EN6198 , EL9265 , fill lot EP8738, and bulk formulation lot EP8619. fill lot EN5330, and the formulated drug product lot EN5319, fill lot EL9256, and the formulated drug product lot EL9247.  A complaint samples  was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are needed. No further information is expected.
Received Flumist on 10/15.  Began with low grade fever and runny nose on 10/16 so bad had to be kept home from school. Progressed to shortness of breath with wheezing and fevers reaching 103 with treatment of Tylenol and Motrin, saline spray on 10/17, same on 10/18, worse on 10/19 sought tx at urgent care, diagnosed with bronchospasm and viral infection requiring neb tx and Flonase and orders to be kept at home on bed rest for few days.
Dull, depressed feeling; Like tired; This is a spontaneous report from a non-contactable nurse. A 6-decade-old (Age: Fifties) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dull, depressed feeling and reporter asked if a dull, depressed feeling was reported as a side effect of the COVID-19 vaccine. On an unspecified date the patient was  tired after the first dose of the COVID-19 vaccine. She declined to be transferred to the hospital and expressed her refusal to have the AE reported. She explained she will wait to see after the second dose. The outcome for both the events was unknown.   No follow up attempts are possible. No further information is expected.
itching and pink rash in her skin under and around her breast, in the back of her neck, in her belly, in he arm and in her flank; itching and pink rash in her skin under and around her breast, in the back of her neck, in her belly, in he arm and in her flank; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date (Sunday) around 10:30 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date (the next day) the patient experienced itching and pink rash on her skin under and around her breast, on the back of her neck, on her belly, in the arm and on her flank. The rash was itching constantly and she scratched constantly. The outcomes of itching and pink rash were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
After my 3rd dose I started getting heart palpitations everyday. At first I thought it was my Adderall, it kept going though. I called my NP and she went through meds and blood work and EKG. Everything was normal. I mentioned my booster and my NP thought this could be a side effect. They went away after 3 months after the vaccination. I am resolved now.
At pt's 4mo check-up, mom reported that after pt's 2mo shots (at another pediatrician) she had a period of crying that lasted for 5 hours. She calmed down for a short moment but "would kick her legs and then begin crying again". Mom also reports the pt's injection site was slightly red and swollen??, but that it only lasted until the next day. Pt's temp was ~99.1F during this crying episode, per parents. No medical attention was sought by the parents and the symptoms resolved by the next day.
Cardiac arrest, patient died in ER. This visit was within 6 weeks of receiving the COVID vaccine.
Around 4:00-5:00 in the afternoon, the patient  developed a headache.  Then around 5:00-6:00 the same evening, the patient developed blisters in her mouth and her skin became itchy.  At about midnight, the patient woke up and her skin was red from head to toe like she had a sunburn.  The patient did not specifically seek treatment for adverse reaction.  She did see her physician on 8/3/22 for a regular appointment and all symptoms had resolved by this time.  Patient did state that she had recently recovered from Covid.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a male patient who receive BEXSERO. On 1st March 2017, the patient received the 2nd dose of BEXSERO. In March 2017, less than a week after receiving BEXSERO, the patient experienced injection site swelling, injection site redness, injection site rash, injection site induration and pain in arm. On an unknown date, the outcome of the injection site swelling, injection site redness, injection site rash, injection site induration and pain in arm were unknown. It was unknown if the reporter considered the injection site swelling, injection site redness, injection site rash, injection site induration and pain in arm to be related to BEXSERO. Additional details were provided as follows: This case was reported by the patient's mother. The age at vaccination was not reported. The patient's mother called to report a side effect with BEXSERO. The patient's arm was swollen, red, blotchy and hard a little bit and it hurts after receiving 2nd dose of BEXSERO.
This case was reported by a other health professional via call center representative and described the occurrence of urticaria in a 14-year-old male patient who received FLUARIX QUADRIVALENT (batch number 37CC4, expiry date 30th June 2016). On 9the December 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 10th December 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced urticaria and injection site urticaria. On an unknown date, the outcome of the urticaria and injection site urticaria were not recovered/not resolved. The reporter considered the urticaria and injection site urticaria to be possible related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The reported injection site of FLUARIX QUADRIVALENT vaccine was left arm. The patient experienced severe urticaria on his trunk, back, torso and arm (injection site urticaria). The reported adverse events were worsened and unresolved throughout the day. The patient visited the reporting healthcare professional twice but no hospitalization was required.
6 mo. male with 2cm area of erythema around injection site that was warm and tender. The patient was afebrile in office after he had been given ADVIL and TYLENOL at home for fever of 102.8. He also had vomiting and diarrhea. Left TM was pink on exam.
ER to bring down temperature and blood pressure; ER to bring down temperature and blood pressure; Stomach cramps; nausea; sever body shakes( uncontrollable); This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 30Jan2021 08:00 at a single dose for covid-19 immunization. Medical history included A-fib. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included apixaban (ELIQUIS), metoprolol, rosuvastatin, furosemide sodium (LASIX) and spironolactone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took aspirin [acetylsalicylic acid] but had allergies. On 31Jan2021 02:00 AM, the patient experienced stomach cramps, nausea and severe body shakes (uncontrollable). They had to call 911 and the patient had to be taken to hospital. The adverse events stomach cramps, nausea and severe body shakes (uncontrollable) resulted in doctor or other healthcare professional office/clinic visit and emergency room (ER)/department or urgent care. The patient received treatment for the adverse events and the patient received treatment in the ER to bring down temperature and blood pressure. The reporter considered the events as non-serious. The patient has been tested for COVID-19 since the vaccination, nasal swab (sars-cov-2 test) with the result of negative on 31Jan2021. The outcome of the events stomach cramps, nausea and severe body shakes (uncontrollable) were recovering while the outcome of the other events was unknown.   The following information on the batch/lot number has been requested.
vaccine that had experienced a temperature excursion was given as 1st dose; poor quality product administered; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (vaccine that had experienced a temperature excursion was given as 1st dose) and POOR QUALITY PRODUCT ADMINISTERED (poor quality product administered) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (vaccine that had experienced a temperature excursion was given as 1st dose) and POOR QUALITY PRODUCT ADMINISTERED (poor quality product administered). At the time of the report, PRODUCT STORAGE ERROR (vaccine that had experienced a temperature excursion was given as 1st dose) and POOR QUALITY PRODUCT ADMINISTERED (poor quality product administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  The refrigerator was cooled a little bit more than normal. Six vials stored in the refrigerator were exposed to temperatures below 36°F. Minimum temperature was 34.7°F. There were 145 incidents in total and each one lasted less than 15 minutes: 142 times fridge temperatures were between 35°F and 36°F; while three times temperatures were under 35°F, reaching 34.7°F (minimum).  Five patients received doses from  four of the 6 vials.
Difficulty breathing - 1800 8/8/08; Dizziness - 1800 8/8/08; Went to ER, given Benadryl IM and observed approx 3 hours.
This spontaneous report as received from a certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On 13-APR-2015, 16-APR-2015, 17-APR-2015, 20-APR-2015, 05-MAY-2015, 06-MAY-2015, 21-MAY-2015, 16-JUN-2015, 17-JUN-2015, 19-JUN-2015, 24-JUN-2015, 08-JUL-2015, 13-JUL-2015 and 14-JUL-2015, the patient were vaccinated with doses of improperly stored oral, ROTATEQ (Lot # K010217, expiry date: 31-MAY-2016 (also reported as 03-MAY-2016)). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 13 years old, female patient with no pertinent medical history reported. On 31-JAN-2013 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 02-APR-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). This is one of the several reports from the same source. Additional information is not expected.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided.  Concomitant medication was not provided.
This spontaneous report has been received from a pharmacist and refers to a 53 year old female patient. There was no information about the patient's concurrent conditions or medical history provided. The patient's concomitant therapies included acetaminophen (+) oxycodone hydrochloride, meloxicam (manufacturer unknown) and zolpidem. The patient did not have any known drug reactions or allergies. On 07-APR-2017, the patient was vaccinated with ZOSTAVAX lot # M032141, expiration date 02-OCT-2017, subcutaneously (dose was not reported). On 07-APR-2017, the patient experienced "severe" local injection site reaction: redness (erythema) that measured 6 to 8 inches. No treatment was given for the adverse events. The patient sought medical attention by visited pharmacy. No product quality complaint was involved. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA004604:
COVID-19; Loss of smell; Loss of taste; This spontaneous case was reported by a dental hygienist and describes the occurrence of COVID-19 (COVID-19), ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced COVID-19 (COVID-19), ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste). The patient was treated with ASCORBIC ACID (VITAMIN C ACID) at a dose of unknown and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) at a dose of unknown. At the time of the report, COVID-19 (COVID-19), ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of tested positive for COVID-19  and mRNA-1273 use is assessed as unlikely.  The events of loss of smell and loss of taste are also consistent with symptoms of COVID-19. hence also assessed as unrelated to mRNA-1273 use
C/o arm + generally hot feeling well last night.  Erythema 50cm sized.  Afebrile.  Took BENADRYL + IBUPROFEN.
pt exp felt hot but temp not measured;local rxn;adenopathy: local inj site area;pain in joints;convuls;
Received the flu shot in L upper arm, too high up the arm in posterior shoulder near shoulder joint. I gradually developed worsening severe L shoulder pain over the next several weeks, saw an orthopedist, received an injection into the posterior deltoid area without any relief. Had MRI on 11/25/13 showing tendinopathy of supraspinatus tendon with bursal surface fraying and small amount of fluid in the subacromial sub deltoid bursa. Continued to have continued pain and then developed decreased ROM and a frozen shoulder, and continuing PT since 12/02/13.
Inconsolable irritability; severely diminished appetite/inability to nurse (newborn had nursed every hour prior to vaccines, didn't nurse for 6 hours post-vaccine) and didn't return to normal appetite for 4 weeks; hypertonic/inability/reluctance to bend hips/knees/bring feet up in air for 2 weeks; temperature instability - low @ 97.0 up to 102.0 and back and forth for 5 days; developed upper respiratory symptoms (hoarseness, stuffiness); red swelling at site of injections.
Body chills,arm pain,headache,nausea, vomiting and 100.1 fever a day after vaccine
shingles, had shot, still got them./suspected vaccination failure; debilitating; itching; burning; shingles; This case was reported by a consumer via interactive digital media 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), shingles, weakness, pruritus and burning sensation. On an unknown date, the outcome of the vaccination failure, weakness, pruritus and burning sensation were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, weakness, pruritus and burning sensation to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had been fighting the shingles for 2 months.  It was very debilitating because of itching and burning and nothing helped.  The reporter said if you had not had the shot and bonus shot get it, the patient had the shot and still got them. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
canker sores, many on bottom lip and a large one between by lower check and gum.
Family history of clogged heart arteries;  since vaccine tightening and soreness in  the chest with shortness of breath.    Symptoms have not subsided.  2nd dose scheduled for 7/8/21.  I've some apprehension and concerns about taking 2nd dose; I will follow keep the scheduled appointment and discuss with medical staff administering 2nd dose and decide if it is safe to take 2nd dose.
Migraine headache, Heart palpitations, Site redness and edematous with pruritus lasting longer than a week and size of a silver dollar
UrticariaPruritus, NauseaVomiting, Fatigue Narrative:
After I contracted the COVID-19 virus I was given PAXLOVID and then I seemed to be over Covid but I had a runny nose continually and I have still have a runny nose, my doctor told me to take an expectorant, guaifenesin. I have a cough that may subside for a few days but has not gone away since contracting the virus.
Information has been received from a medical assistant referring to a patient of unknown age and unknown gender. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided. On 12-SEP-2018, the patient was vaccinated with one dose of PNEUMOVAX 23 (intramuscular, lot # M032635, expiration date 05-MAY-2018; strength was not reported) for prophylaxis. No adverse effects reported.
Arm bruised bad right away. Noticed shortness of breath or labored breathing. Horrible flashes of hot then cold chills sweats really bad dripping. Muscles keep tightening. Weak very tired , no appetite for food or drinks. Headache body aches. Continues same symptoms then Saturday I started with crones pain abdominal cramps and diarrhea which has now  been when I eat anything .
Thigh swollen, red, hot to touch and has grown beyond outline. Treated with Augmentin ES600/Zyrtec 1/2 tsp. On 4/3/02, still with red welts all over body. To see on 4/2/02 to check again.
This patient who was hospitalized for endometrial cancer was administered a pneumococcal vaccine on 08/29/2005. On 08/30/2005 she noticed increased pain and swelling at the pneumococcal injection site. The inflamed area around the injection site was 2 inches. The affected area was warm to the touch and was treated with ice packs. The patient was prescribed Benadryl orally 25-50 mg as needed.
No Adverse event, patient was given 2 doses of Pfizer vaccine during same visit encounter. Patient monitored for adverse reaction, patient did not have any issues while in observation. Patient was scheduled with telephone visit with PA to discuss any issues or conerns.