chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2016, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster.  Later in 2016, the patient was treated at a hospital for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving 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. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Active duty Marine, transferred to this hospital for care.  History is as reported by patient.  Starting 24 hours after vaccination, patient developed fever, naurea, vomiting, body aches, diarrhea, weakness, dyspnia, chest and abdominal pain.  Became dehydrated secondary to vomiting and diarrhea.  Treated with IV fluids, tylenol and phenergan.  Hospitalized x 2 days.
When the vaccine was administered some of the vaccine came out of the syringe and ran down the patient's arm.
Client noticed rash and swelling on face (only) on 11/11/2000 at 2AM. The flu vax was administered on 11/08/2000 at 10AM. Client called physician's office and was told the 'rash was caused by the flu shot and client should not receive flu shot next year.'
A non-serious spontaneous report of administration of H1N1 2009 MONOVALENT Vaccine Live, Intranasal to a six-month old was received from a nurse involving a six-month-old subsequent to administration of H1N1 2009 MONOVALENT Vaccine Live, Intranasal. The patient did not have any past medical history and was not taking any concomitant medications. On 30-Oct-2009, the patient received H1N1 2009 MONOVALENT Vaccine Live, Intranasal. 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 to be resolved. Additional information was received 01-Dec-2009 and incorporated into the narrative medical history and concomitant medication confirmed; no adverse event reported.
Sore arm by 3 pm 6 pm nauseous 8 pm chills and fever
I got both shots and still got it/suspected vaccination failure; I got both shots and still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got both shots and still got it/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got both shots and still got it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 16-Mar-2023 The case was received from the patient via interactive digital media. The patient got both shots and still got them. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
swollen and had red spots on the area from the  site only; swollen and had red spots on the area from the  injection site only; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE SWELLING (swollen and had red spots on the area from the site only) and VACCINATION SITE ERYTHEMA (swollen and had red spots on the area from the  injection site only) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swollen and had red spots on the area from the  site only) and VACCINATION SITE ERYTHEMA (swollen and had red spots on the area from the  injection site only). On 22-Mar-2021, VACCINATION SITE SWELLING (swollen and had red spots on the area from the  site only) and VACCINATION SITE ERYTHEMA (swollen and had red spots on the area from the  injection site only) had resolved.        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.   The patient was prescribed to take Benadryl even after her Adverse event has subsided as treatment.
Adult patient got a 0.5mL pediatric dose; Adult patient got a 0.5mL pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 47-year-old male patient who received HBV (Engerix B pediatric) (batch number 77X47, expiry date 22nd December 2023) for prophylaxis.   On 8th September 2022, the patient received the 1st dose of Engerix B pediatric .5 ml. On 8th September 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's comments: Nurse reported that a 47 year old male patient was administered a 0.5 mL pediatric dose of Engerix-B vaccine on 08th September 2022. This was the patient's 1st dose in the series. At the time of reporting, the patient had not been redosed. The reporter had consented to follow-up. Reporter did not want contact information stored in GlaxoSmithKline database, but agreed to follow-up by safety. Additional supportive information: The patient who had received pediatric dose of Engerix-B was 47 years old adult patient, which had led to underdose and adult use of a child product.
lightheaded/dizziness, nausea, blurred vision, EMT evaluated, pt. refused transport.
Fever, up to 101 degrees, still present, as of 3:35 on 10/09/2015; sore arm; very stiff and painful neck and shoulders, coughing, dry throat, nausea, very painful headache, loss of appetite, fatigue, dizzy, pain at injection site.
fever 103 8PM on 24AUG94, lasting about 16-20 hrs accompanied by fussiness, high pitched cry & vomiting of all breast feedings; gave APAP suppositories;
sore throat; Headache; fatigue; muscle aches; This is a spontaneous report from a contactable nurse. A 61-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# ELO142), via an unspecified route of administration on 09Jan2021 09:45 single dose for covid-19 immunisation. Vaccine location was right arm. No other vaccine was received in four weeks.  Medical history included seasonal allergy. Historical vaccine included BNT162B2 first dose at unknown date. Concomitant medication included ergocalciferol (VIT D) and multivitamin. The patient experienced sore throat on 10Jan2021 02:00, headache on 10Jan2021 02:00, fatigue on 10Jan2021 02:00, muscle aches on 10Jan2021 02:00. Patient was treated with ibuprofen and tylenol. The events outcome was recovered in Jan2021
Information has been received from a consumer concerning her 75 to 80 year old male friend who on an unspecified date, received a one time subcutaneous dose of 0.65ml ZOSTAVAX (OKA/Merck). The consumer stated that "even though he was vaccinated", within the last six months (approx.July 2007), the patient developed shingles. Current patient status was not reported. A product quality complaint was not reported. Follow up information provided no additional information. Additional information is not expected.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender with no pertinent medical history, drug reaction or allergies reported. On 28-JUL-2015, the patient was vaccinated with an expired dose of GARDASIL lot # H017698, expiration date: 02-JUL-2015, dose 1, 0.5 ml, intramuscular. Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On an unspecified dates, the patients were administered doses of (Oka-Merck) PROQUAD (lot # L008354, expiration date: 11-SEP-2016 and lot # L005293, expiration date: 17-AUG-2016) (dose and route of administration were not reported) which were exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of several reports from the same reporter. Additional information has been requested.
light headache; but I still see my pee is real yellow; saw some blood in my urine; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) first dose via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as single dose and second dose via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included yeast infection and ongoing glaucoma (in my right eye so need to put on glasses to see the names of the prescriptions - preexisting condition). Concomitant medication included fluconazole (tablet, strength: 15 mg) taken for yeast infection and cefdinir (capsule, strength:300 mg). The patient stated, "I wanted to get the vaccine. People tell me not to take the vaccine but I did what I felt I needed to do for me and I am happy about it. I have not had no side effects beside a light headache and I feel good on an unspecified date. On 01Feb2021, I went for my annual check up and they saw some blood in my urine so that's when they gave me the first antibiotic (name not provided) and I took all of them but I still see my pee is real yellow. I decided to call my doctor the other day after my second Pfizer vaccine dose on last Wednesday, 17Feb2021, and they called in these antibiotics that I just picked up: fluconazole and cefdinir (note: When looking up antibiotic names, she stated "I have glaucoma in my right eye so need to put on glasses to see the names of the prescriptions - preexisting condition). They think it's a yeast infection. I have called my doctor to see if it was ok to start taking these but decided to call you as well. I will wait for them to call me back. The patient underwent lab tests and procedures which included urine analysis: some blood in my urine on 01Feb2021.Therapeutic measures were taken as a result of but I still see my pee is real yellow and saw some blood in my urine. The outcome of the event "but I still see my pee is real yellow" was not recovered and other events was unknown.   Follow-up attempts completed. No further information expected; Information about lot/Batch number cannot be obtained.
Fever since immunizations - 6 days ago. Tympanic T max 101.6.
Pt. developed an exacerbation of ringworm rash that was present at time of vaccine.  Pt. developed samdpaper rash on abdomen, legs, and arms.  Duration of treatment was 3 weeks.
Late night sneezing and runny nose on August 30. Positive home antigen COVID test the next morning. My wife had a positive test and a visit to hospital two days earlier. I called my doctor on August 31 and she prescribed Paxlovid. I started taking it that day. Symptoms were a sore throat, fatigue and a 99.4 degree fever on 9/1. Started acetaminophen. No fever thereafter, but I did have nose bleeds for a few days. I tested negative on 9/6. Rebound begins on 9/10. Sneezing and runny nose on 9/10, positive test on 9/10. Some dizziness in the morning of 9/11 and a temp of 99. My notes don't say when I tested negative but I moved out of the guest room and back into our own bed on 9/15.
Information was received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 09-JUN-2016 the patient was administered the 1st dose of GARDASIL (dose and route unknown). On 23-JUN-2016 the patient received the 2nd dose of GARDASIL (dose and route unknown) (inappropriate schedule of drug administration). On 20-JUL-2016 the patient was administered dose three of the series with GARDASIL 9 (interchange of vaccine products) (inappropriate schedule of drug administrations). This interval was shorter than recommended. No adverse effect was reported. Additional information has been requested.
Rash on the left side of the body that is buttock, stomach, foot and pain and itching; back left side its itching; Rash on the left side of the body that is buttock, stomach, foot and pain and itching; back left side its itching; Rash on the left side of the body that is buttock, stomach, foot and pain and itching; back left side its itching; down on the foot and knee, it is on the left leg near the foot that  inside portion right there around the heel, just above the heel and on the outside leg two spots little pink spots; This is a spontaneous report from a contactable consumer (patient). This Over 65 years old female patient received 2nd dose of BNT162B2 (COVID 19 vaccine) on 01Apr2021 at single dose on left arm for covid-19 immunization. Medial history was not reported. Concomitant Products included Ramipril Tablet, Amlodipine Tablet, ergocalciferol (VITAMIN D, Soft gel), multivitamin, calamine/phenol (CALAMINE LOTION PHENOLATED). Historical vaccine was 1st dose of BNT162B2 on 11Mar2021 at single dose for covid-19 immunization. Consumer stated had the Pfizer and the side effect is a rash on the left side of the body on the buttock, stomach, foot, pain and itching on left side of the back from 08Apr2021. Itching and rash and these effects were experienced after second shot. Consumer stated down on the foot and knee, it is on the left leg near the foot that inside portion right there around the heel, just above the heel and on the outside leg two spots little pink spots and then on the left rectum area, I mean buttock, I am trying to say left buttock quite a bit I mean and itching like I do not know what and then on the stomach and then on the back on the back left side its itching but I cannot really reach that. So, it is there in that area and I got the shot both of them on the left arm. Consumer stated, I mean it is still itching but I put some calamine lotion on it so I am trying to see if that is helping it to subside but it is still there. It might be helping some since I put that on as far as the itching is concerned. Calamine lotion (Treatment) could be helpful for itching so I am trying to see it is going to help it or not, I have to keep on rubbing that area. The rash is large on the buttock than any other parts of the body. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient complained of itching on arms, legs, back & ears - 10 minutes after receiving a flu shot.
Patient presented with expressive aphasia 2 days after infection and was found to have a L M2 occlusion requiring tPA and emergent mechanical thrombectomy
Narrative:  Per allergist: Given the delayed nature of the sensations and mild redness, this is not indicative of risk for an immediate type of reaction mediated by IgE antibodies towards vaccine components.
Within minutes of receiving the injection, patient developed erythematous macular rash over entire body. Did not appear to be urticaric. No swelling of face, tongue. No airway involvement. No GI distress. PO BENADRYL given- rash began to resolve within 15 minutes. Patient also received PEDIARIX, ACTHIB, PREVNAR 13 at the same time- had 2 prior doses of each of those without problem.
Child received immunization (Hep A #2) about 1015 and sent back to school. States he was fine during lunch. LAter in the afternoon, c/o headache and sore throat. Sent to school nurse. Had fever 102.5. Sent back to us. No signs of infection. Advised to treat with Acetiminophen/Ibuprofen and to call if any further symptoms or no improvement.
cough after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough after 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (cough after 1st dose). At the time of the report, COUGH (cough after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not reported.  Treatment medication not reported.
pt recv vax & the day p/vax was sore all over & had a flu-like synd;
Started having waves of intense chills and extreme fatigue early morning (2:00am) on Sat (4/03/21). This has continued until today (4/06/21). Had temp of 99.8 this morning.  Also, yesterday (4/05/21) started a possible herpes simplex 2 outbreak (or it?s an outbreak of lichen planus or lichen sclerosis).  Have been just trying to rest and drink fluids.
Red raised on IM location warm to touch. (+) size. MOP stated PT gets this with bug bites. MOP state she gave BENADRYL started the 10 Mar 10 with increase in redness.
IMMUNOCOMPROMISED; NO COVID ANTIBODY RESPONSE FOLLOWING VACCINATION; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a consumer concerned a 61 year old male of an unspecified race and ethnicity. Initial information was processed along with additional information received on 20-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: mantle cell lymphoma, and other pre-existing medical conditions included: No other concomitant drugs taken apart from ibrutinib. The patient previously received two doses of Moderna covid-19 vaccine (Elasomeran) (dose number in series 1) (form of admin unknown, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 01-MAR-2021, and on 30-MAR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with two doses of Moderna covid-19 vaccine (Elasomeran) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, 1 total, administered on 01-JUN-2021 for prophylactic vaccination which was off label use, and inappropriate schedule of vaccine administered. Age at time of vaccination 61 years old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ibrutinib for mantle cell lymphoma.  On an unspecified date, the patient was immunocompromised, had no covid antibody response following vaccination (low IgA, low IgE, low IgG, and low IgM) (dose number in series 2). Laboratory data (dates unspecified) included: IgA (NR: not provided) IgA decreased, IgE (NR: not provided) IgE decreased, IgG (NR: not provided) IgG decreased, and IgM (NR: not provided) IgM decreased (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from immunocompromised, no covid antibody response following vaccination, and the outcome of off label use and inappropriate schedule of vaccine administered was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000232180. This case, involving the same patient is linked to 20220529781.; Sender's Comments: V0: 20220541341-COVID-19 VACCINE AD26.COV2.S-Immunocompromised. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE. Therefore, this event(s) is considered not related.
Left arm went numb later turned pink/red.  Arm and head pain. Shortness of breath comes and goes since the day. I have constant pressure on my heart chest area. I get dizzy spells. I have a constant shaky feeling.  I had 2 trips to the ER.
Suspected UTI started roughly a month and a half after receiving the vaccine: burning sensation while urination, deep back pain, pain while urinating. By September 11, it had gone to the kidneys. I?ve only had one other UTI and that was in 2015.
Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. There was no information about concurrent condition, concomitant medication and medical history. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, dose and unit unknown). The next day after receiving the vaccination, patient complained of "a swollen arm that was warm to touch and that could not be moved without pain." At unspecified time after vaccination, the patient went to primary physician. The patient was prescribed ibuprofen and "three days later was cleared up." The causality between the event and PNEUMVOAX 23 was unknown. Additional information has been requested.
Itchy hives on legs, abdomen and arms.  Onset in the middle of the night that spread from legs upward and progressively got worse until morning when patient sought medical treatment.
Sore throat, nasal congestion, chest congestion, serious asthma/shortness of breath not managed by an inhaler.
Received Influenza and PPV23 vaccines on 08-31-2009. Began to have swelling and redness at injection site of PPV23 vaccine initially and then redness extended to below elbow and around entire arm. Has been putting cold compresses without releif. Arm is red, warm to touch and swollen extending below elbow .
Ileostomy stenosis. She was taken to the OR on 1/28/2022 for ileostomy revision. She tolerated the procedure well. There were no immediate complications. She was tolerating diet and having good bowel function. Stable to discharge on 1/30/2022. ED visit to hospital admission within 6 weeks of receiving the COVID-19 vaccine.
Became diaphoretic, pale and experience syncopal episode. Blood Pressure 100/60 pulse 50-60. Was laid flat and feet elevated and client became stable
Heart Attack -  2 day stay in the hospital. -  Stent placement in my heart. -  Now I'm on life long medication...