chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARADSIL (Lot #, dose and route were not reported). No symptoms were reported. This is one of the several cases from same reporter. Additional information has been requested.
The patient presents for "body is burning", eyes burning, burning urination, muscle aches, sinus drainage. Describes back pain as 10/10.
Information has been received from a hospital pharmacist concerning an adult hospital employee who on 9/17/01 was vaccinated with the 1st dose of Hep-B vaccine recombinant (yeast). On 10/2/01, the pt presented to the hospital with an itchy rash on the arms and trunk of the body. The pt was dx'd with pityriasis rosea. In follow up reported that it had been determined by an emergency room physician and an Infection Control Nurse that the pityrissis rosea was not associated with hepatitis  B vaccine recombinant but were associated with a detergent or soap that the patient had used. Further, the patient had made a full recovery and continued with the Hepatitis B vaccine recombiant series. Upon internal review, the pityriasis rosea was considered an other important medical event. Additional information is not expected.
Patient had a seizure that lasted a little over 3 minutes. Exactly one week following that seizure, she had another one on 06/06/2015 she had another one also at 9:00 AM.
lt arm red-warm to touch approx 3 cm size; taken to MD 24APR92 was put on Augmentin; mom called back Monday morning states got redder went to MD pt hospitalized put on IV ATB; d/c 27APR92;
Pt described redness, itching, warmth peaking on 2/13/21 with fairly intense itching. Symptoms improved with a cold compress. Pt felt that the reaction may have had an impact on her mood or mental health. She felt fatigued in the week before the reaction and "cried all day" on 2/13/20 when the reaction was strongest. She acknowledged other factors in her life that might also impact her mood and did not feel certain it was related to the vaccine. Physical symptoms have improved but the redness is still visible.
My whole family got very very sick last night w Covid shot I can?t get out of bed sever sore arm massive headache flu symptoms shaking chills all night.  This is awful. New moderna shot!
Patient presents as a transfer from outside facility (note, i do not have information regarding outside facility information or providers caring for the patient) forpersistent acute hypoxic respiratory failure requiring HFNC and pneumothorax with persistent air leak. He was admitted to OSH on 12/05 for acute on chronic hypoxic respiratory failure d/t COVID-19. Patient was vaccinated and first positive test was on 11/30.  At OSH, patient received tocilizumab, remdesivir, and dexamethasone and required high flow nasal cannula.  On 12/14, patient had left small pneumothorax which progressed to a left tension pneumothorax requiring chest tube on 12/20.  Patient is transferred due to a persistent air leak and inability to further wean O2.    Has had increasing respiratory distress, compounded by anxiety, and has been receiving opiates and benzos for symptomatic relief.  Unfortunately was deemed too sick for consideration of lung transplant on 12/29. Multiple extensive discussions with patient and family and despite our belief that he is exceedingly unlikely to extubate, the decision has been made that he would like to be intubated.  After intubation pt had significantly worsening shock, requiring levo up to 0.8, vaso and neo sticks. It was discussed with the family that pt was worsen with maximal support. It was first decided to make him no escalation of care and then family decided to terminally extubate soon after that. Pt past comfortably and surrounded by family at 2126 on 12/29.
1545 vaccines emesis about 10 minutes after vaccines, developed facial and arm rash 20 minutes after vaccines, Pt sleepy. BENADRYL 15 mg IM administered at 1609. EPI Jr administered at 1625. Transferred to ER via ambulance 1630. Repeat EPI ER, admitted for observation and further treatment.  6/1/09 Hospital records received DOS 4/16/09 to 5/6/09. FINAL DIAGNOSIS: Anaphylaxis, asthma. Shortly after vaccination presented with cough, wheezing, emesis, and an erythematous macular rash over face, arms and legs. Considered by MD to have allergies to: streptomycin, neomycin, polymyxin B, vaccine and toxoid combination preparations, gelatin. 6/25/09 ICD9-999.4-Anaphylactic shock due to serum.  999.5 Other serum reaction NEC.
she needs this Paxlovid to deal with the COVID that she has; she needs this Paxlovid to deal with the COVID that she has; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she needs this Paxlovid to deal with the COVID that she has". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She wants to take this medication because she does not respond to the Pfizer COVID Vaccine. Caller states that she wants to take it because she doesn't respond to the COVID Vaccines, so she has no protection from COVID, so she needs this Paxlovid to deal with the COVID that she has.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
SHINGRIX mixed with COVID vaccine, discarded the mixture; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product preparation error in a 84-year-old male patient who received Herpes zoster (Shingrix) (batch number 5A9GE, expiry date 3rd June 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product preparation error. On an unknown date, the outcome of the intercepted product preparation error was unknown.       Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comments: The pharmacist reported that SHINGRIX vaccine was being reconstituted and instead of adjuvant , they mixed the COVID vaccine in with the antigen. The reporter quickly realizing the error, they discarded the mixture. The reporter was asking for a replacement of the adjuvant. The vaccine was not administered to the patient. Additional Supportive Information: The SHINGRIX vaccine was reconstituted with COVID vaccine and patient did not received vaccine which led to intercepted product preparation error.
queasy; tired; This case was reported by a consumer via call center representative and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd March 2020, the patient received Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced nausea and tiredness. On an unknown date, the outcome of the nausea and tiredness were unknown.   It was unknown if the reporter considered the nausea and tiredness to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced nausea and tiredness after vaccination. The patient asked how long the side effects last.
A non-serious, spontaneous report of administration of expired product was received from a health professional concerning a two-year-old female patient. Neither medical history nor concomitant medications were reported. The product expired on 22-Nov-2010. On 10-Dec-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 24-Mar-2011 and incorporated into the narrative: no late occurring adverse event was reported.
Patient returned to clinic following vaccination of smallpox. Diagnosed as secondary bacterial cellulitis with generalized pustular rash; unresponsive to Keflex. Sent to ER; placed inpatient with IV antibiotics.
Systemic: Stroke-Medium, Additional Details: Caregiver mentioned patient received vaccine on 6/4/21, and was admitted to hospital for a stroke on 6/8/21.  Please note this was 4 days after the vaccination, unsure if this is related to vaccine or other health factor.  However, have still reported per protocol.
1 week after injection, developed pain and 1.5 inch diameter pink, non-raised rash. Rash started to fade and symptoms fully resolved by 5-3-16.
vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VOMITING (vomiting). At the time of the report, VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No  treatment medication was reported.
Employee started had Headache but on 1/23/2021 started having Nausea and dizziness that has lasted a week.  a lot about 4 days post developed a rash, itch and swelling at injection site.
Patient was given a 2nd Zostavax vaccine. The first was administered at age 73 on 2/8/2010.
Mother reports child developed a rash that appeared like mosquito bites to face, arms, chest, and back, on 6-26-14. Around 7:00pm rash was very itchy. On 6-27-14 child was seen again at the office and rash greatly improved. Medication given was BENADRYL and started with prednisolone.
Had received both / in 2018. Came in and got another / He forgot. I gave him a dose today; This case was reported by a other health professional via interactive digital media and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had both doses in 2018).   On 30th May 2021, the patient received Shingrix. On 30th May 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination not reported. The patient had never received any dose . The patient forgot and so reporter gave him a dose on 30th May 2021, which led to extra dose administered.
This was a booster. I?d had Pfizer before so decided to try Moderna. The effects were typical body aches, etc, but the axillary lymph nodes have been noticeably swollen and very painful for days. This has not subsided, but seems to get worse.
Local tenderness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Local tenderness at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, LEVOTHYROXINE and METFORMIN for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Local tenderness at the injection site). At the time of the report, VACCINATION SITE PAIN (Local tenderness at the injection site) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient has an unspecified underlying condition.  Treatment information was not provided.
Pt. reported feeling dizzy for 3-4 days after the immunization and having headache. Pt. stated she normally has vertigo but this dizziness was different from her usual symptoms and she also had headache. Pt. fully recovered as of today (6 days post immunization).
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021 at 2:43 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:43 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 36.73.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 09 AM temperature was 32, total doses given for the day was not provided, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 31-Mar-2021. 14 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 32, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 AM: 43, 1PM: 44, 2 PM: 46, 3 PM: 46, 4 PM: 44 and 5 PM: 44.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34- or 35-degree F.  Treatment medications were not reported.
Swelling in the left arm of about 2 cm. Same arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling in the left arm of about 2 cm. Same arm of the injection) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (Swelling in the left arm of about 2 cm. Same arm of the injection). At the time of the report, VACCINATION SITE SWELLING (Swelling in the left arm of about 2 cm. Same arm of the injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no allergy or diseases. No concomitant product was reported. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was reported.
Case number PHEH2013US001616, is an initial spontaneous report received from a nurse on 15 Jan 2013, and with a follow up report received on 05 Feb 2013. This report refers to a 26 year old female patient. The patient received MENVEO (batch number: A12024) at a dose of 0.5 ml subcutaneous route on 11 Jan 2013 at 10:30. After vaccination, the patient developed a site reaction, which appeared similar to any site reaction from a vaccine with erythema and slight induration on 11 Jan 2013. As per nurse, the patient had no constitutional symptoms. The outcome of the events was recovered as on 18 Jan 2013. Seriousness and causality of the event were not reported. Follow up report received on 05 Feb 2013. Patient demographics, vaccination details, onset and outcome of the event updated.
sore arm from which she could not raise arm; Dehydration; This is a spontaneous report from a contactable consumer. A 21-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in the right arm, on 22Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant. The patient had no other vaccine administered in four weeks. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 22Jan2021, the patient experienced sore arm from which she could not raise arm above shoulder and dehydration. The events were not treated. Outcome of the events was recovered on unspecified date in Jan2021.   Information on the lot/batch number has been requested.
Case number PHEH2014US006165, is an initial spontaneous report from a nurse received on 26 Mar 2014 with a follow-up received on 15 Apr 2014. This report refers to a 45-year-old female patient. She had her spleen removed and was advised to get a meningococcal vaccination by her doctor. Her concomitant medications included Amlodipine 5mg for hypertension and Citalopram 20 mg for depression. She was vaccinated with expired MENVEO (batch number: M12009) intramuscularly in to the right arm deltoid at a dose of 0.5ml on 26 Mar 2014 at 2:30pm. This was the initial application of MENVEO. No adverse event was reported following the maladministration. Follow-up received from the nurse on 15 Apr 2014: Updated medical history, concomitant medications and dosage, site and time of vaccination with MENVEO.
01/18/22 presents to ED as transfer from a HCF for "Extremity Weakness, LKW 2145; +slurred speech, facial droop, L sided immobility". No significant PMH.
Approx 24 hrs post/vax, pt was taking his bottle & started shaking legs & arms for approx 5 sec. then continued taking his bottle & went to sleep. No fever this day but day after shots, had fever of 99.5-100 & was cranky previous day.
This spontaneous report as received from a other health professional refers to a 18 year old female patient with none pertinent medical history or drug reaction allergies. It was reported that today, on 26-JUN-2013 (also reported as 21-JUN-2013), the patient was vaccinated with the first dose of GARDASIL (Lot # J003737, expiration date 07-NOV-2015) (0.5 ml, intramuscular route). Concomitant therapies applied on the same date included MENACTRA and HAVRIX (it was also reported that there were none concomitant medications). On 26-JUN-2013, 5 minutes after receiving GARDASIL, the patient walked into the waiting room, fell and hit her head. The patient was taken in ambulance to the emergency department and was administered oxygen (medically significant) in the ambulance. The patient was not admitted to the hospital and no injuries were determined. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Pain and redness at injection site. Redness warmth and induration around the arm/deltoid area. Patient "feels fine" but the arm just hurts.
Patient began having tingling in both feet as the first sign. Over the course of a week, the tingling began to creep up his lower extremities and caused numbness from the waist down. Patient does not report bowel functions being affected. Patient was treated with high dose IV methylprednisolone. Followed up with Neuroimmunology and received an MS diagnosis.
NO ADVERSE EVENTS, OTHER THAN THIS WAS AN EXTRA DOSE. PATIENT LIED ABOUT GETTING FIRST JOHNSON AND JOHNSON, SO SHE SHOULD HAVE ONLY GOT 1 PFIZER SHOT. BUT SHE GOT AN EXTRA PFIZER BECAUSE WE WERENT AWARE OF HER GETTING AN INITIAL J&J.
Dizzy; She was scheduled to receive the second dose on 08APR2021 but MD told her to wait until she feels better; Severe Side Effects; Diarrhea; Urge to go to the bathroom 6-7 times a day but nothing (#2) came out; Nausea; Vomiting; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Urge to go to the bathroom 6-7 times a day but nothing (#2) came out), PRODUCT DOSE OMISSION ISSUE (She was scheduled to receive the second dose on 08APR2021 but MD told her to wait until she feels better), ADVERSE REACTION (Severe Side Effects), DIARRHOEA (Diarrhea) and DIZZINESS (Dizzy) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced POLLAKIURIA (Urge to go to the bathroom 6-7 times a day but nothing (#2) came out), ADVERSE REACTION (Severe Side Effects), DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills) and FATIGUE (Fatigue). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She was scheduled to receive the second dose on 08APR2021 but MD told her to wait until she feels better) and DIZZINESS (Dizzy). On 19-Mar-2021, POLLAKIURIA (Urge to go to the bathroom 6-7 times a day but nothing (#2) came out), ADVERSE REACTION (Severe Side Effects), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (She was scheduled to receive the second dose on 08APR2021 but MD told her to wait until she feels better), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.