chrisvoncsefalvay/vaers-outcomes huggingface dataset:
can't stop itching; is having an allergic reaction to it; has an allergy or something to whatever is in it; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (can't stop itching), HYPERSENSITIVITY (is having an allergic reaction to it) and ALLERGY TO VACCINE (has an allergy or something to whatever is in it) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (can't stop itching), HYPERSENSITIVITY (is having an allergic reaction to it) and ALLERGY TO VACCINE (has an allergy or something to whatever is in it). At the time of the report, PRURITUS (can't stop itching) had not resolved and HYPERSENSITIVITY (is having an allergic reaction to it) and ALLERGY TO VACCINE (has an allergy or something to whatever is in it) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
COVID-19 ALMOST A YEAR AFTER THE VACCINATION; This spontaneous report received from a patient via a company representative via social media concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient was previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 almost a year after the vaccination (Dose number in series 2).  It was reported that "I took them too. I know first hand that they don't keep you from getting COVID-19, and as far as I know they don't keep you from spreading it. I also know that I had COVID-19 before the vaccination and almost a year after the vaccination. No difference, exactly the same, so it didn't reduce the severity. Did they actually give me a vaccination or was it saline solution both times". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 almost a year after the vaccination was not reported. This report was non-serious. This report was associated with product quality complaint 90000263493. This case, from the same reporter is linked to 20221234743, 20221235149, 20221235383 and 20221234779.
Patient received a dose of vaccine that may be less than completely effective due to storage conditions.  No adverse events noted.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL0142), as dose 2, single (Lot number: EL9262) and as dose 3 (booster), single (Lot number: ER8729) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "Iodine allergy" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: Tested positive for COVID. Prescribed Paxlovid at ER; (Aug2022) Negative, notes: Tested negative 6 days later; (Aug2022) Positive, notes: Symptoms reoccurred on day 4 after last dose of Paxlovid. Retest is positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 15Aug2022 to 20Aug2022.  Clinical information: Tested positive for COVID. Prescribed Plaxlovid at ER. Tested negative 6 days later. Symptoms reoccurred on day 4 after last dose of plaxlovid. Retest is positive. Increasing of symptoms.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on possible temporal association the causal association  of suspect drug cannot be excluded for reported  events ,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
Chills, Fever, Body aches, fatigue on 3/11/21. Rash at injection site, upper torso, and throat and face.  took benedryl , rash was gone by 3/15/21 except for injection site.
I had my vaccine on 04/2021 and  mid May I started getting Bumps on my arms and all over my body, I was seen by by my Cosmetologist and a Vile was removed from one of the bumps to be sent to the Lab, I was prescribed a cream but is still scabs bad, the cream seems to dry it faster but it is a still an ongoing issue.
PATIENT WITH HISTORY OF SIEZURE DISORDER HAD A SEIZURE APPROXIMATELY 5-10 MINUTES AFTER RECEIVING HER BOOSTER OF MODERNA 0.25ML.  STATED HAD NOT HAD THIS HAPPEN WITH PREVIOUS TWO DOSES.
Patient presented to emergency department on 7/22/2021 with shortness of breath, cough, and fever. She was recently diagnosed with COVID-19 infection on 7/19/2021. She was admitted to hospital for further management. She was treated with remdesivir, dexamethasone, and supplemental oxygen. She was discharged home on 7/28/2021 with supplemental oxygen.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). The patient's past medical history included shingles. On 27th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, 3 days after receiving SHINGRIX, the patient experienced injection site pain and stomach pain. On an unknown date, the outcome of the injection site pain and stomach pain were recovered/resolved. It was unknown if the reporter considered the injection site pain and stomach pain to be related to SHINGRIX. Additional details were provided as follows: At 11:00, the patient received SHINGRIX on left arm. The patient reported pain presenting at the injection site and on an area of her stomach where she previously had shingles. This pain presented 3 days after the vaccination and resolved within 7 days.
FEVER/CHILLS/SINUSITIS/JOINT PAIN/HEADACHE/NAUSEA/DIARRHEA/SWOLLEN GLANDS BEHIND HEAD SIDES OF OCCIPITAL AREA/AND UNDER NECK/MUSCLE WEAKNESS/ERYTHEMA/BRUISING/3/24/2016-DIPLOPIA REQUIRING ER VISIT WHICH INCLUDE MRI/MRA/EMG NOW SCHEDULED-04/25/2016/ STILL HAVING SYMPTOMS.
2/14/2023-Presents to ED, c/o headache, aneurysm repair previous week. Blurry and double visions. Aphasia. Afebrile BO 147/91. Covid + test. CXR- no pulm disease . 95%  on 4/L NC, desat to 83% on 6/L NC, intubated (40% mechanical ventilation). CT/CTA- no artery occlusion. Cerebral angio completed (robust flow to b/l PCA's). Remdesivir.  2/16/2023- Remained intubated, awake and following commands. Chest CT-small effusions and basal atelectasis. Cont on heparin gtt. Exubated. Hemo stable. WBC 11.9 afebrile but on decadron. Remdesivir d/c AST-73 ALT-91 Lipase- 466   Remains on ceftriaxone 2/18/2023- Remains on RA. Uprendng transaminase transaminitis AST 117 and ALT 124  Lipase now 857 CT abd-post/op chole clips in plac  show no complications of pancreatitis. GI consult_ increase in lipase r/t constipation and UTI. bowel regimen.  2/20/2023 WBC wnl. Downtreding LFT's AST 72 and ALT 116 2/23/2023- Remains on RA. Hemo stable. WBC-9.6  ALT-137 AST -74. Lactic acid negative. Hepatitis serologies negative . Afebrile. D/c to home follow for autoimmune hepatitis  outpatient basis.
FEVER; This spontaneous report received from a patient concerned a male of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously vaccinated with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date not reported) dose, 1 total administered on unspecified date for prophylactic vaccination. Following vaccination, no adverse events associated with covid-19 vaccine (dose number in series 1).  The patient received Covid-19 vaccine ad26.cov2.s (dose number series 2) (suspension for injection, route of admin not reported, batch number and expiry date not reported) dose, 1 total, administered on unspecified date in NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date in NOV-2021, the patient had fever (for an hour). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on an unspecified date NOV-2021. This report was non-serious.
Report 2001029746-1 describes an adult female of unspecified age who received hepatitis B vaccine recombinant and contracted hepatitis B. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not specified. The vaccinee's spouse is also infected with the hepatitis B virus. The spouse was allegedly tested after the vaccinee found that she had contracted hepatitis B; it is not known if the spouse contracted hepatitis B before or after the vaccinee allegedly did. The vaccinee's job responsibilities placed her in direct contact with bodily fluids from a patient with known hepatitis B infection. The vaccinee allegedly received injections of Engerix B on 8/31/98, 9/30/98, and 3/1/99. Lot numbers of vaccine administered were not reported. It was alleged that on or about 11/18/99, plaintiff.....received a letter from her employer stating that there may have been a problem with a particular batch of hepatitis B vaccinations from which she received on of her injections and that she should receive a lab test, known as a titer, to determine if she has a positive immunity to hepatitis B or if she needed a booster injection. The vaccinee received a booster injection of Engerix B on 12/3/99. The attorney stated as directed by the aforementioned letter, plaintiff.....was tested by her local physician on or about 1/7/00.....on 1/11/02, plaintiff.....learned that she had contracted the hepatitis B virus. It is not known if she had contracted hepatitis B before, during or after completing the Engerix B immunization series. Treatment and outcome of the hepatitis B infection were not reported. Hepatitis B is considered medically serious.
This spontaneous report was received from a pharmacist refers to patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapy included sterile diluent. On 31-DEC-2017, the patient was vaccinated with one dose of improperly stored ZOSTAVAX (units and frequency were unknown) (Lot # N020943 and expiration date 26-OCT-2018) for prophylaxis. Reporter informed that, there was temperature excursions for the ZOSTAVAX (Lot # N020943 and expiration date 26-OCT-2018) at a temperature of 6°F to 14°F and time frame 10 hours 45 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported.
Admitted to hospital for pre-diagnosed cellulitis in her right foot; Felt soreness; A spontaneous report was received from a consumer concerning a 71-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced, Admitted to hospital for pre-diagnosed cellulitis in her right foot (Cellulitis), Second dose of vaccine scheduled 53 days after the first dose of vaccine (Inappropriate schedule of product administration ), and Felt soreness (Pain).  The patient's medical history included pre-diagnosed Cellulitis in her right foot. Concomitant product use was not provided by the reporter.  On 22 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 042L20A) intramuscularly for prophylaxis of COVID-19 infection.   The same day, patient felt soreness. On 24 Jan 2021, the soreness went away. On 07 Feb 2021, the patient was admitted to hospital for her pre-diagnosed Cellulitis in right foot. On 14 Feb 2021, the patient was discharged from the hospital. Due to hospitalization, the patient's second dose of vaccine was pushed to 17 Mar 2021 (53 days from first dose of vaccine).  No treatment information was provided.  The second dose of mRNA-1273 was delayed in response to the events.   The event, Admitted to hospital for pre-diagnosed cellulitis in her right foot was resolved on 14 Feb 2021.  The event, Felt soreness, was resolved on 24 Jan 2021.  The outcome of event, Second dose of vaccine scheduled 53 days after the first dose of vaccine was considered as ongoing.; Reporter'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.
Received the vaccinations at 16 month appointment. Was on target for all well check areas. By 18 month appointment-speech had become less and now to the point of nonverbal at 23 months. Sleep patterns are terrible. Constipation frequently. Eating habits changed. Eye gaze. High and lows of emotions. Slow reaction to pain situations. Non affectionate. Doesn't respond to verbal cues at all. Does not interact with other kids his age.   5 days after vaccines on 08/04/2020 he was taken to Urgent Care for high fever, no eating, no wet diapers and being lethargic. On 08/26/2020 was taken back to pediatrician for fever, no eating, no sleeping. Was told it would pass.  On 08/28/2020 was taken to pediatrician for for same issues. Did a full blood screening, 2 catheters attempts, still high fever, lethargic, not eating.  Fever finally subsided on 09/01/2020. Pt. still received the polio vaccine and hep b vaccine on 09/04/2020.  Pt. still received the hep a vaccine on 10/13/2020.
Large red, swollen, hard lump that is sore and warm to the touch, starting appx. 2" below the injection site and getting larger daily.    Somewhat itchy.  I had this same reaction to my second Covid injection (2/26/21  Moderna Lot #014M2017).  In that instance, the rash spread to the entire upper half of my left arm and lasted almost 3 weeks.  Interestingly, I had no redness or reaction to the first shot (in my right arm)  but did have the rash and swelling after the second shot and the booster (both given in my left arm).  I was a little achy and tired after all 3 injections, but no other adverse reactions.
Acute pneumococcal meningitis; onset 11/23/04. Hospitalized 2 weeks; full recovery. Information from discharge summary states hyponatrenmia, fever, diarrhea, nuchal rigidity. Information from medicl records states increased cough, congestion, runny nose, decreased orl intake, agitation, withdrawn and otitis media.
Left lateral thigh with leg blanched area and small 1 cm area ecchymosis. Tx: Cool compresses and Motrin.
Moderna COVID-19 EUA  Fever of 102°, soreness, fatigue
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-OCT_2015 14:49, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 12.0 and 0.5 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Cough, treatment: prednisolone Fatigue Fever, treatment: acetaminophen Loss of appetite
Papule rash pruritic scattered on abdomen, face, hands/arms, legs/feet. Given PRN Benadryl and hydrocortisone cream 2.5% for itching.
Pulmonary fibrosis; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration, administered in right arm on 18Apr2021 12:30 (age at vaccination was 58 years) (Batch/Lot Number: EW0161) as dose 1, single for covid-19 immunization. Medical history included cardiac failure congestive from an unknown date. Concomitant medication included valsartan (VALSARTAN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had tested negative for COVID-19 since the vaccination. On 21Apr2021, at 12:00am after receiving the vaccine the patient experienced pulmonary fibrosis resulted in emergency room visit, Disability or permanent damage. The patient stayed 7 days in the hospital. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 30Apr2021 Post vaccination. The patient received treatment for the events. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected
This spontaneous report as received from a office manager via field representative refers to a 11 years old female patient. In August 2012 the patient was vaccinated with first dose of GARDASIL for prevention of HPV. The patient received the GARDASIL vaccines on the following dates in August 2013 (second dose) and October 2013 (third dose) (exact dates unspecified); instead of at 0,2 months, 6 months as indicated in the prescribing information for GARDASIL. Patient did not seek medical attention. Additional information has been requested.
Within 12 hours - chills and headache Within 12-36 hours - chills, headache, fatigue After 36 -48hours - headache, fatigue 36-72 hours - headache After 1 week - chest pain on left side of  chest; off and on and varies spordically; chest pain continued for 4 weeks after initial symptoms with decreasing episodes over time
Injection site reaction with 1 cm nodule with 20 cm surrounding induration and redness, duration 14+ days. Topical triamcinolone cream.
3-31-09 Mom reports that client "walks strange, bobs head, hands shake, and coordination is off" after series of hepatitis b vaccines in 2001-2002.
Right after my second dose of the Pfizer Covid vaccine I had three (currently having my third so it could go on to have more) flare us of my oral herpes. I typically have 1-2 a year. This was 3 in a week. I am not experiencing increased stress.
Redness and itching at injection site. Patient instructed to use cold compress, take Tylenol if needed, take Benadryl 1 to 2 capsules every 4 to 6 hours. Call doctor in morning if not better.
Initial report received from a healthcare professional on 08 Feb 2010: This patient with unknown medical history was vaccinated with S-OIV FLUVIRIN (batch no. 104043P1), IM, on 19 Jan 2010. This patient experienced soreness in the arm and when he moved it was still sore on 19 Jan 2010. Outcome of event was not reported. Following an internal review on 13 Apr 2010 of the information received on 08 Feb 2010, it was noted that the vaccine S-OIV FLUVIRIN was incorrectly coded as seasonal influenza vaccine. Therefore, it was correctly recoded to S-OIV FLUVIRIN.
COVID-19; COVID-19; Country: Language:  Reporting type: AE Report about covid treatment: Yes  Reporter type: Patient Age group: Elderly (65+ Years) Current age: 65 Current age unit: Years Gender: Female Is pregnant: Not Pregnant Patient occupation: Nurse  If vaccine received: Yes Other medication in 2weeks: No Anti viral details: Product=COVID 19 Treatment Brand=paxlovid Treatment start date=31Jul2023 Treatment stop date=04Aug2023 Indication=Treatment of COVID-19  Covid vaccine details: Vaccine brand=Pfizer/BioNTech Vaccine brand unknown=False Vaccine administration date=04May2023 Vaccine lot number=GH9702 Vaccine lot unknown=False Vaccine dose number=6 Vaccine dose number unknown=False  Adverse event: symptoms started 3 days after finishing Paxlovid. Have nasal congestion and sneezing, head fog and mild headache. Adverse event country:  Adverse event start date: 07Aug2023 Ae resulted in: None of the above If patient recovered: Not recovered  Known allergies: penicillin Other medical history: Migraines; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Eosinophilic oesophagitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
lost consciousness; Standing and suddenly felt hot; lightheaded/dizzy; This is a spontaneous report from a contactable consumer (patient). A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 30Mar2021 at 07:00 as a single dose for COVID-19 vaccination. The patient's medical history included anxiety, Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient had taken other medication in two weeks are Prozac, Taytulla. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 18:00 patient experienced standing and suddenly felt hot, lightheaded, dizzy and lost consciousness. The patient did not receive any treatment for the events. The outcome of the events was recovering.  Follow up information has been requested.