chrisvoncsefalvay/vaers-outcomes huggingface dataset:
aching; runny nose; malaise; got tested positive for covid-19; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got tested positive for covid-19), DRUG INEFFECTIVE (Lack of drug effect), PAIN (aching), RHINORRHOEA (runny nose) and MALAISE (malaise) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20H and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021, the patient experienced COVID-19 (got tested positive for covid-19) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced PAIN (aching), RHINORRHOEA (runny nose) and MALAISE (malaise). At the time of the report, COVID-19 (got tested positive for covid-19), DRUG INEFFECTIVE (Lack of drug effect), PAIN (aching), RHINORRHOEA (runny nose) and MALAISE (malaise) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2021, SARS-CoV-2 test: positive (Positive) COVID-19 Virus test was positive.         The concomitant medications information was not reported. Treatment information was not provided.     Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up information included additional events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, based on the mechanism of action of mRNA-1273, causal association between the event of COVID-19 infection  and mRNA-1273 is assessed as not applicable.
Pt recvd 3 doses of Engerix-B on 6SEP89, 25SEP89, & 12MAR90; following these titer=17; p/1 yr titer was neg; Pt was given a 4th dose on 12APR91 & following 4th dose titer=155;
Fever 103, headache, lightheaded, weakness, difficulty standing.  Site of injection red, swollen and hot.
One day post vax, on 4/5/00, the pt experienced swelling, erythema and induration at the injection site which increased in size. At the time of the report, the pt had 11 mm induration 50 mm erythema and the site was firm and hot. An ER room or doctor visit was required. No treatment was given. The most recent information received on 4/7/00 reports the condition of the pt as ongoing.
ongoing fever of 101 F x 1 week, dry cough. Treated with children's MOTRIN.
Med Error: Patient received the 21st dose of a 20 limit Moderna Vial. Patient had left the post recovery area before the incident was caught and patient was not able to be notified.
Headache, Arthralgia, FATIGUE, PAIN/SWELLING INJ SITE
End up getting BioThrax (anthrax vaccine) but it was after the 28 days of the vial being opened; Spontaneous report received on 08FEB2022.  A healthcare professional reported that the patient (patient 2) (unknown age and gender) "end up getting BioThrax (anthrax vaccine) but it was after the 28 days of the vial being opened" (PT: Poor quality product administered). It was reported that over the weekend the patient got BioThrax vaccine (lot number unknown) after the 28 days of the vial being opened. Reportedly, the patient did not experience any side effects after taking the vaccine. Action taken with BioThrax with respect to the reported event was not applicable. Outcome of the reported event was unknown.  No additional information was reported.  Based on the information available in the document two individual case safety reports (patient 1) and (patient 2) were created and cross linked in the database.  Company comment: It was reported that a consumer was administered with BioThrax but it was after the 28 days of the vial being opened (poor quality product administered). BioThrax vial is to be used within 28 days after first opening. Considering the case information, the causality of poor quality product administered is assessed as not related with BioThrax due to the nature of the event.; Sender's Comments: It was reported that a consumer was administered with BioThrax but it was after the 28 days of the vial being opened (poor quality product administered). BioThrax vial is to be used within 28 days after first opening. Considering the case information, the causality of poor quality product administered is assessed as not related with BioThrax due to the nature of the event.
chest pain upon inspiration while sitting down; numbness and tingling to face; numbness and tingling to face; arms and left hand cramping/contracted; This is a spontaneous report from a contactable Nurse (patient). A non-pregnant 38-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 19Aug2021 15:00 (Batch/Lot Number: FC3180) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included seasonal allergies, covid-19 prior vaccination. Concomitant medication(s) included curcuma longa root (TURMERIC CURCUMIN). No other vaccine in four weeks. On 20Aug2021 14:00, approximately 24 hours after received the vaccine at about 2 pm, patient began to experience chest pain upon inspiration while sitting down (she works from home). Symptoms got worse and also felt numbness and tingling to face and arms and left hand cramping/contracted. Treatment Benadryl 50mg received for the events. The outcome of events was unknow. Nasal Swab Covid test BinaxNow conducted post vaccination was Negative on 11Aug2021. Case reported as serious due to medically significant.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events paraesthesia, chest pain, hypoaesthesia and muscle spasm and the suspect drug BNT162B2. 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.
broke out w/herpes w/in hr p/vax;flu shot-leg vesicles on lt side of face involving trigeminal nerve covering entire side lt of face & ear;severe pain in entire area of face & neck;(inj given lt arm)-signs of inflammation;tx w/med;high temp
Sore throat, body aches, lumps of phlegm, fatigue, stuffed nose.
couldn't think and progress my speech and thoughts; had a few seizures; couldn't think and progress my speech and thoughts; couldn't think and progress my speech and thoughts; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Dec2021 14:45 (Lot number: FL3197) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: MENTAL IMPAIRMENT (non-serious), SPEECH DISORDER (non-serious), THINKING ABNORMAL (non-serious) all with onset 22Dec2021 07:00, outcome "recovered with sequelae" and all described as "couldn't think and progress my speech and thoughts"; SEIZURE (non-serious) with onset 22Dec2021 07:00, outcome "recovered with sequelae", described as "had a few seizures". Therapeutic measures were not taken as a result of mental impairment, seizure, speech disorder, thinking abnormal. The patient had no covid prior vaccination, covid tested post vaccination and known allergies.
Neuropathy; Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In or around October 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for routine health maintenance and for its intended purpose: the prevention of singles (herpes zoster). Shortly, on an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt. suferred singles and neuropathy(neuropathy peripheral ). As a direct and proximate result of use of defective zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations, not present prior to vaccination. The pt. also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Further, as a tragic consequence the pt. suffered severe and permanent personal injuries, as well as significant conscious pain and suffering, mental aguish, loss of enjoyment of life, physical impairment and injury.  The outcome of singles and neuropathy peripheral  was not recovered.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the events to be disabling.  Upon internal review, the event neuropathy peripheral was considered to be medically significant.
3/25/21:  work up before 6 a.m. with extreme muscle pain that moved throughout the body.  Spasm.  Could not go back to sleep?  Unable to get out of bed much at all.  No appetite.  Stayed that way all day and night; 3/26/21:  body pain now localized to hips and low back.  Extremely fatigued and nauseated,  nauseated is without warning and need to stay upright to not vomit slightly with food or drink, feel extremely hot.  Feel foggy headed.  Later in evening, injected arm swelling and redness got severe and developed raised rash across front and back of upper torso and shoulders to opposite arm.  The rash was extremely heat intolerant.  3/27/21:  hip pain subsided, but still nauseated and rash is worse as it a swelling in injected arm.  Finally took 25 mg. of benadryl and rested more.  Still very tire d and no appetite or thirst at all.  Nausea better.  By 5:00 p.m. rash is improved and swelling lessening.  Arm still bright red and swollen in patchy areas.  The injected arm feels lumpy.  Still belching and nausea.  3/28/21:  feeling better overall, but still fatigued.  3/29/21:  Returned to work (WFH), but still no appetite or thirst at all.   4/1/21:  symptoms have finally subsided except for complete lack of hunger or thirst.
left side of face at area of eyebrow swollen and sore 3/27.....then......3/28 swollen red areas covering forehead and sore.......made appt with pcp 3/29/2021
hot flashes; pain in rotator cuff and back; spot on arm sore about the size of a nickel where they gave the shot; sore throat; This is a spontaneous report from a contactable consumer or other non-healthcare professional. An 81-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot Number: EN9809) (at the age of 81-years-old) as DOSE 2, SINGLE for covid-19 immunization.  Medical history included none. There were no concomitant medications reported. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 1 via an unspecified route of administration on 22Jan2021 (Batch/Lot Number: EN5318) for covid-19 immunization ns experienced sore throat. On 21Feb2021, the patient experienced sore throat. On an unspecified date, the patient experienced hot flashes, pain in rotator cuff and back, spot on arm sore about the size of a nickel where they gave the shot. It was reported that she received her first covid vaccine dose on 22Jan2021 and 10 days later on 02Feb2021 got a sore throat that lasted about 8 days before going away, had to take a Z-pack, which was not normal for her. She reported that she received her second vaccine dose on 12Feb2021 and again 10 days later on 21Feb2021 she experienced another sore throat. Stated that she got up Sunday morning, 21Feb2021, with a sore throat again, states it is worse today that it was when she woke up yesterday. She also endorses some hot flashes. It was also reported that she has a tear in her rotator cuff, started hurting her last week, got a corticosteroid injection in that area about 6 weeks ago prior to vaccine, states now arm is hurting and back is hurting and is unsure if it is related to the vaccine. States she did have little spot about the size of a nickel after the vaccine where they gave the shot that was a little sore, whole arm was fine. Wanted to know if this could be a delayed reaction to the vaccine. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Passed away in the sleep; This is a spontaneous report received from a non-contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration in the right arm on 02Oct2021 05:00PM (at the age of 66-years-old) as dose 3 (booster), single for COVID-19 immunisation at a pharmacy or drug store. The patient's medical history included diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication included insulin taken for an unspecified indication, start and stop dates were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unspecified date in Feb2021 (at the age of 66-years-old; Batch/lot number and expiration date were not reported) as dose 2, single and on an unspecified date in Jan2021 (at the age of 66-years-old; Batch/lot number and expiration date were not reported) as dose 1, single, both via an unspecified route of administration in the right arm and for COVID-19 immunisation. No other vaccine in was administered in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient has no known allergies. On 07Oct2021 09:00AM, 4 days later after the booster shot, the patient passed away in the sleep. It was unknown if treatment was received for the event. The outcome of the event was fatal. The patient died on 07Oct2021.  An autopsy was not performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Passed away in the sleep
Redness and visible bump at injection site, rash on left arm at the inner elbow on the right side of his neck. Sore throat.
Patient presented to vaccination clinic on 7-26-04 with concerns re:  possible satellite lesions near smallpox vaccination site.  Vaccination site assessed by an RN.  RN documented 1 (one) small (approximately 3mm) red spot with 2 very small raised white areas.  Additional small red, flat (approximately 3mm) area approximately 3cm from primary vaccination site.  Patient also had 4-5 inch "hive-like" reddened lesions on outer aspect of arm.  These additional lesions appeared 1 day post vaccination (July 24, 2004) per patient additional lesions were not assessed to be related to primary vaccination site.  Patient was instructed to call vaccination clinic if any of described lesions became pustular.  Patient returned to vaccination clinic on 7-30-04 for vaccination site reading.  Patient with major take.  No other problems noted.  Lesions assessed on 7/26/04 not visible on July 30th8-6-04:  Form forwarded to doctor for additional notes regarding patient's hospitalization related to onset of serum sickness.  Day 7 after vaccination:  Patient observed joint aching (wrists, knees, and other joints); hive-like rash on palms of hands, ventral aspect of fingers, and later on legs; fever to 104 degrees, general malaise, conjunctivitis.  Also sterile pyuria, 1+ proteinuria, elevated LFTs.  Admitted for 48 hours on 08/09/2004. Diagnosis:  serum sickness secondary to smallpox vaccination.  Nurse follow up on 08/19/04 states: "Complete."
Pt developed high fever, refusal to walk and lower extremity dystonia which lasted a few hours, 2 days following admin of injectible flu vaccine.
This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a female patient who received TWINRIX adult (batch number 3C422, expiry date 27th April 2021) for prophylaxis. On 11th January 2019, the patient received TWINRIX adult. In January 2019, 2 days after receiving TWINRIX adult, the patient experienced pain in arm and injection site lump. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the injection site lump was not recovered/not resolved. It was unknown if the reporter considered the pain in arm and injection site lump to be related to TWINRIX adult. Additional details were provided as follows: The patient experienced sore arm and a lump under the skin at the injection site, 2 to 3 days after vaccination. The lump took a while to decrease in size. At the time of reporting, she reported a nodule under the skin at the injection site which was size of a pea. The patient stated that, it was not painful or sore. The patient gave consent to follow up.
Pfizer Gray cap administered past the BUD of 04/20/2022. Pfizer contacted and extended BUD to 04/22/2022. Revaccination recommended.
Severe New onset of Rheumatoid arthritis flare up in left hand and wrist- On going
Presented with SOB; Covid + and CHF exacerbation; Tx with Vit D3, antibiotics, lasix, lovenox, Remained on room air during stay
Chills, high fever of 101, muscle aches, fatigue, slight headache. Lasted for over 24 hours. Last symptoms of muscle aches stopped after 5pm the following day.
Dehydrated; Weakness; Chills; Nausea; Fever (97.4); This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (Dehydrated), ASTHENIA (Weakness), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever (97.4)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEHYDRATION (Dehydrated), ASTHENIA (Weakness), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever (97.4)). At the time of the report, DEHYDRATION (Dehydrated), ASTHENIA (Weakness), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever (97.4)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided
sz, stridor, difficulty breathing w/upper airway edema, temp up to 102.6;19SEP98 adm, intubated;negative CT of head & MRI of brain;
MUSCLE  LOSS; LOSS OF SENSATION ON THE SIDE; IT HURTS TO TRY TO MAKE THE ARM MOVE; VACCINATION SITE PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: UNKNOWN) dose was not reported, administered on 31-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On JAN-2022, the patient experienced muscle loss. On JAN-2022, the patient experienced loss of sensation on the side. On JAN-2022, the patient experienced it hurts to try to make the arm move. On JAN-2022, the patient experienced vaccination site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle loss, loss of sensation on the side, it hurts to try to make the arm move, and vaccination site pain. This report was non-serious. This report was associated with product quality complaint:90000212229
Upset stomach/ Cannot hold down liquids or any food; Fever; Shivering; she is in bed for 48-72 hours; This non-serious case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 77J90, expiry date 15-OCT-2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 3R4ST, expiry date 17-SEP-2022) for prophylaxis and ELASOMERAN (MODERNA COVID VACCINE) for prophylaxis.   On 03-MAY-2021, the patient received the 2nd dose of Shingrix (intramuscular). On 18-FEB-2021, the patient received the 1st dose of Shingrix (intramuscular). On 15-JUN-2021, the patient received MODERNA COVID VACCINE. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced upset stomach (Verbatim: Upset stomach/ Cannot hold down liquids or any food), fever (Verbatim: Fever), shivering (Verbatim: Shivering) and bedridden (Verbatim: she is in bed for 48-72 hours). The outcome of the upset stomach, fever and shivering were not resolved and the outcome of the bedridden was resolved.   It was unknown if the reporter considered the upset stomach, fever, shivering and bedridden to be related to Shingrix and Shingrix.     It was unknown if the company considered the upset stomach, fever, shivering and bedridden to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 10-Jul-2023 The patient had her 1st and 2nd dose of Shingrix and ever since then, she had been having shivering, fever, upset stomach that was so bad she was in bed for 48 to 72 hours, and she could not hold down liquids or any foods. The patient was not able to provide when these adverse events started after receiving the Shingrix vaccines but reported that she used to have these side effects every 4 to 6 months, and now in recent time she was having these side effects every month. The patient also reported that she received her Moderna Covid vaccines on 15-JUN-2021. The pharmacist would call back if she could obtain other information. Neither the patient nor the pharmacy had the location of the administration available for either dose of Shingrix. It was unknown if the reporter considered the upset stomach, fever, shivering and bedridden to be related to Moderna Covid vaccines. The reporter consented to follow up with the pharmacy via pharmacist.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not provided. The patient's concurrent conditions included immunosuppression, because he was taking adalimumab (HUMIRA). On 10-AUG-2017, the patient was immunosuppressed and was administered 1 dose of ZOSTAVAX 19400 plaque-forming units (PFU) vial, lot # M042851 with expiration date on 18-JAN-2018, subcutaneously (dose was not reported), for prophylaxis. Concomitant therapies included sterile diluent. No adverse effects were reported.
RN administered the wrong Tetanus for a puncture wound for a patient presenting to the clinic.
Information has been received from a physician concerning a 4 year old female pt who on 3/19/1999, was vaccinated with a second dose of MMR virus vaccine. Subsequently, the pt developed a red and raised white area at injection site and the pt "lost 2 drops of blood." Additional information has been requested.