chrisvoncsefalvay/vaers-outcomes huggingface dataset:
it itches; big red spot at the injection site; sore arm/arm is sore again; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/arm is sore again), VACCINATION SITE PRURITUS (it itches) and VACCINATION SITE ERYTHEMA (big red spot at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for Hypertension.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm/arm is sore again). On 07-May-2021, the patient experienced VACCINATION SITE PRURITUS (it itches) and VACCINATION SITE ERYTHEMA (big red spot at the injection site). On 27-Apr-2021, PAIN IN EXTREMITY (sore arm/arm is sore again) had not resolved. At the time of the report, VACCINATION SITE PRURITUS (it itches) and VACCINATION SITE ERYTHEMA (big red spot at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
This spontaneous report has been received from a physician and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL, injection, (dose, route of administration, lot #, expiration date were not reported and dose in series was unknown). Concomitant medications were not reported. The mother of the patient stated that on an unknown date (reported as "within the last couple of months"), her child developed Wernicke-Korsakoff syndrome post vaccination with GARDASIL. The child was vaccinated by another health care provider and was treated for the adverse event (AE) with vitamin B12 injections. The physician did not have any more information. The outcome of the adverse event was reported as recovered. The relatedness between the adverse event and GARDASIL was not reported. Additional information is not expected, because the physician did not want to be contacted.
This is a spontaneous report from a contactable consumer (who reported for the mother) via Pfizer sponsored program. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (unknown manufacturer) on an unspecified date at single dose for pneumococcal immunisation. The patient medical history and concomitant medications were not reported. The patient died of pneumonia on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Pfizer is the Marketing Authorization holder of pneumococcal 13-val conj vaccine (dipht crm197 protein) in reporter's country. This may be a duplicate report in situations where another Marketing Authorization holder of pneumococcal 13-val conj vaccine (dipht crm197 protein) has submitted the same report to the regulatory authorities. No follow-up attempts are possible, information about batch number cannot be obtained. Reported Cause(s) of Death: died of pneumonia; died of pneumonia.
This spontaneous report was received from an office manager, referring to multiple unspecified patients of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, patients were administered doses of improperly stored GARDASIL 9 (lot # L026602, expiration date 19-OCT-2017). It was reported that the vaccine was exposed for 22 hours at 30.9 F degrees. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; No adverse event; They inadvertently administered dose of the Moderna Monovalent primary series to patient after date of expiry of 13-Feb-2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They inadvertently administered dose of the Moderna Monovalent primary series to patient after date of expiry of 13-Feb-2023), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (They inadvertently administered dose of the Moderna Monovalent primary series to patient after date of expiry of 13-Feb-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They inadvertently administered dose of the Moderna Monovalent primary series to patient after date of expiry of 13-Feb-2023), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (They inadvertently administered dose of the Moderna Monovalent primary series to patient after date of expiry of 13-Feb-2023) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry).    No allergy, concomitant diseases and risk factor were reported. No known Allergies were reported.  No concomitant medication was reported. Date the vial was initially stored in the refrigerator on 20-Jan-2023. The vial did not undergo any temperature excursions. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712280 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712280:Patient 1
Heart rate at 107; Stomach issue; Nausea; Chills; Passed out; Dizzy; Temperature; Hands were shaking; Sweating profusely; A spontaneous report was received from a consumer who is a 73 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, dizzy(dizziness), temperature(temperature abnormal), hands were shaking(tremors), passed out(loss of consciousness), sweating profusely(hyperhidrosis), nausea, heart rate at 107(heart rate increased) and stomach discomfort(abdominal discomfort).  The patient's medical history, as provided by the reporter included breast cancer.  No concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 22 Jan 2021, the patient experienced chills, dizzy, temperature, hands were shaking, passed out and sweating profusely. The treatment for the events included paracetamol.  On an unknown date, the patient experienced, nausea, heart rate at 107 heartbeats per minute and stomach discomfort.   The treatment for the events included paracetamol.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, chills, dizzy, temperature, hands were shaking, passed out, sweating profusely, nausea, heart rate at 107 and stomach discomfort was unknown.; Reporter's Comments: This case concerns a 73-year-old female patient, who experienced serious event of loss of consciousness and non-serious events of chills, dizziness, temperature abnormal, tremors, hyperhidrosis, nausea, heart rate increased, and abdominal discomfort. The reported events occurred on the same day after first dose of mRNA-1273, (lot # 029L20A) with the exception of nausea, heart rate increased, and abdominal discomfort which occurred at unknown date. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient received the following vaccines today, Meningococcal, Varicella, Influenza, and GARDASIL 9. After the last injection, GARDASIL 9, patient stated "Ouch, that one hurt," and then fell backwards onto the table. Patient started to have movements, and head shaking, along with moaning. Provider notified, vitals taken, EMS notified at 12:25PM. Patient was monitored until EMS arrived at 12:29PM. Patient was then transported to MC via 911.
Joint pains -fingers, toes, left elbow, knees; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0186) via an unspecified route of administration in the left arm on 14May2021 as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0171) via an unspecified route of administration in the left arm on 23Apr2021 as a single dose for COVID-19 immunisation. On 18May2021 the patient experienced joint pains -fingers, toes, left elbow and knees. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event joint pains -fingers, toes, left elbow and knees was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
no adverse reaction was noted; patient was given expired PNEUMOVAX 23; underwent a previous temperature excursion; This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On 09-MAR-2021 the patient was vaccinated with an expired vaccine of  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), prefilled syringe, dose:0 .5 milliliter,  lot # S013490,expiration date: 06-MAR-2021, for prophylaxis (dose number and anatomical location was not reported).  It was stated that the vaccine had also underwent a previous temperature excursion. She reported that the patient was monitored for 15 minutes and no adverse reaction was noted and no reports of an adverse reaction have been reported since administration. No product quality complaint. No additional information. No additional adverse events. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: S013490; expirationdate: 06-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
nausea, vomiting, headache, myalgia x 48 hours.  Works at medical facility-vaccine administered by medical facility.
The next day around 2PM I felt lightheaded and overheated and I felt like I was going to pass out. Around 3PM I started with real bad chills. I was in front of the fireplace and could not get warm. Temp was 100.8F. I think I took a Tylenol. Struggled staying warm at night. Fatigue settled in and started with dry cough and it continued on Saturday. Sunday I just felt fatigue. Monday I felt a little better and Tuesday I had facial numbness so I was sent to the ER. 2-3 years ago I had bells palsy. At the ER they did a cat scan to rule out stroke and no problems there. I have been fine ever since. My arm was sore throughout everything. I had COVID in March/April. It was not confirmed with PCR but with antibody tests in May/June.  The 2 things that concerned me was the cough and the facial numbness. I had a COVID test and was negative.
Intense chills, racing heart for 8 to 10 hours, nausea, headache, fatigue, general malaise (urinated on the bathroom floor).
Body aches started next morning, fever started about 24 hours after injection.  Both began to subside before bedtime the day after the injection and were completely gone the next morning.
Patient became diaphoretic and experienced dizziness post covid vaccine Pfizer bivalent booster. Attending nurse called team alert and emergency response team quickly arrive. Charge nurse took and attending nurse obtained vitals on 1020 with bp (n/a) p 94 rr 22 with 97% o2. 1025 BP 106/69 P 78 RR 18 AITH 99% O2, 1038 BP 116/69 P 79 O2 98%. Patient was laid Trendelenburg and monitored for 30 minutes. Patients vitals stabilized.
sweating; Body temperature goes from very cold to very hot; Chills; Headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), BODY TEMPERATURE FLUCTUATION (Body temperature goes from very cold to very hot), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body ache) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HYPERHIDROSIS (sweating), BODY TEMPERATURE FLUCTUATION (Body temperature goes from very cold to very hot), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body ache). At the time of the report, HYPERHIDROSIS (sweating), BODY TEMPERATURE FLUCTUATION (Body temperature goes from very cold to very hot), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.
This spontaneous report was received from an other referring to a 12 month old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 13-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX injection (strength, dose, frequency and route were not reported) (lot # N020013 and expiry date: 17-JUL-2019) for prophylaxis. The administered dose of VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiry date were not reported). The vaccine was stored in between -14 degrees Celsius (C) to -10 C (-14.37 C) for 15 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA008334.
rash, hives devel during the noc; called clinic 22OCT93; pt instructed to call MD immed; seen by MD 22OCT93;
waxing and waning redness and intense itching of both palms; waxing and waning redness and intense itching of both palms; This is a spontaneous report from a  non-contactable consumer. A 63-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number EH9899), via an unspecified route of administration in left arm on 15Dec2020 17:30 at a single dose for immunization, administered in the hospital. Medical history included seasonal allergies (dust, mold, juniper pollen), allergies to erythromycin, coconut, blueberries, banana, cocoamidopropyl betaine in anything (shampoo, toothpaste, soap). The patient was not diagnosed of COVID 19 prior to vaccination. Concomitant medication included multivitamins, ergocalciferol (VIT D), ascorbic acid (VIT C), and zn [zinc] (ZN [ZINC]). On  16Dec2020 11:30, about 18 hours after injection, developed waxing and waning redness and intense itching of both palms. This lasted for about 6 hours. The patient reported that she never had this before following a vaccine. Never had this before related to any food or seasonal allergy reaction. The patient was concerned about getting the second injection of the series. The patient's BMI was 30. The patient was not tested for covid 19 after the vaccination. The outcome of the events was recovered on 16Dec2020. The events was considered non-serious. There was no treatment for the reported events.  No follow-up attempts are possible. No further information is expected.
She had a hard and painful lump at injection site. Skin became bright red to the back of the arm, about the length of a dollar bill. Denied any other symptoms. She applied heat packs to the back of the arm. The symptoms started resolving on 12/26/16. She still has some itching to site but redness is resolving. She did not take any medications OTC to help with pain or redness.
Had headache night of 04/13/2011 which resolved. Noticed on day of 04/14/2011 to have full body rash. No difficulty with breathing, fever, or neuro symptoms. Gave Benadryl and discussed reasons to go to ER.
This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch/lot number: unknown, expiry: unknown) dose: not reported, on Mar 2021, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient developed cramps in both legs and the calf area. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome: not reported.
Sore arm, fatigue, aches and chills lasted 24 hours after injection  One week later on 1/14/21 a cluster of hives developed at the injection site. Hives gradually faded that evening and redness at site faded over the course of next several days.
Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. During June 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Patient received incorrect dose of Moderna 0.5mL instead of 0.25mL
Sore arm injection site, extreme fatigue still ongoing, severe nausea, rash on left side of ribs approx palm size, chills, sleeping excessively with bouts of sweating and chills alternately.
Body rash and welts. Primarily upper body but some on arms and legs.\ Intense itching. 4 visits to urgent care.  Triam 0.1% cream daily for 2 weeks.No relief. Then Prednisone 5mg dose pak for 5 days with some relief but symptom returned. then another stronger and longer duration Prednisone therapy.  Again some relief but itching and rash returned.  This took place Feb, March and first week of April (presently) Currently no diagnosis.
Pt was given Boostrix instead of Kinrix; 5 year old pt was given Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 5-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5F945, expiry date unknown) for prophylaxis.   On 1st November 2021, the patient received Boostrix (intramuscular). On 1st November 2021, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The reporter was physician Assistant. The reporter stated that, the 5 year old patient was administered the Boostrix vaccine instead of the Kinrix vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
GARDASIL given 10/28/08 in (L) arm. Gradual onset of numbness, tingling and pain in (L) arm beginning on the morning of 10/30/08.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.
Patient recv'd H1N1 shot on 01/04/10 at pharmacy, approx at 5 PM that same day pt. began to feel very tired, no pain. On 1/5/10 at approx. 1:00 AM pt started to experience pain and fever, nausea, no vomiting. Pt experienced a feeling of acid reflux, no swelling or redness at injection site, did not sleep all night on 1/5/10. At 7 AM on 1/6/10, pt passed out,about 10-15 min, pt. was then given toast and hot tea by his wife. Approx. 2 hours after eating toast and hot tea, pt had severe nausea and started to vomit and have diarrhea at the same time. At 10:00 AM the patient felt so much better. As of today, pt feels 75%-80% better.
Chills High fever Muscle aches Joint pain Nausea Arm pain (could not apply pressure, such as lay on that side)  Began 6 hours after shot, and lasted for 36 hours. Very intense, unable to get out of bed.
This case was reported by a consumer via call center representative and described the occurrence of sickness in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were reported as follows: This case was reported for reporter's son. The age at vaccination was not reported. The reporter indicated that the adverse events experienced by her son and coworkers were reported to the health department where they received the vaccination. The reporter would not provide additional information. This case was 1 of the 3 linked cases.