chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 17-DEC-2015, the patient was vaccinated with an improperly stored PEDVAXHIB Single Dose Vaccine, 10-pack, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and, the highest temperature of excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
Pt was a non-responder p/3 doses of Engerix-B;
Arm soreness is severe based on arm movement soreness is intermittent. Slight redness at the injection site which is discernible. No other symptoms reported at this time.
No adverse event; vaccines administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date).    This is case is for Patient 3 of 3 patients.  No concomitant medications were reported.   It was reported that as per the provider the vaccines were stored in a standard freezer (15°C to -25°C). Their temperatures were Max: -24C and Min: -23C. It was reported that Moderna Bivalent COVID-19 Vaccine with Lot number: 083B22A was received on 15-Nov-2022 with expiration date as 28-Feb-2023 but the date of administration was 05-Apr-2023 with doses of 3.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2023: Follow up received with no significant information
Initial symptoms started in less than 5 minutes were tingling in the lips and tongue.  Thickness feeling to the tongue.  Progressed to hoarseness to voice that worsened.  Received 50mg Benadryl chewable tablets. Symptoms continued to worsen.  Epi pen injection in left thigh.  5 minutes later still no improvement and another Epi pen injection in right thigh.  Monitored for 5 to 10 min and no improvement and was taken to the ER.  In the ED, received IV fluids, IV Benadryl, IV Decadron and IV Pepcid.  Monitored for 3 1/2 to 4 hour and discharged home with 3 days of Prednisone 60 mg and Benadryl po every 6 hours as long as allergic like symptoms persisted.  12/18 morning still with lip tingling and Asthma like symptoms.  Voice is still in and out of hoarseness
Pain radiating from lower back to backside of left leg (mostly thigh but also calf). Particularly when getting up after rest or sitting.; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number: EN6201; Expiration date was not reported), via an unspecified route of administration in the right arm on 11Feb2021 08:00 AM (at the age of 40-years-old) as dose 1, single for COVID-19 immunisation. Medical history included polycystic kidney disease from an unknown date and unknown if ongoing. The patient has no concomitant medications. No other vaccine was received by the patient in four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The patient has no known allergies. The patient experienced pain radiating from lower back to backside of left leg (mostly thigh but also calf), particularly when getting up after rest or sitting on 12Feb2021 08:00 AM. Treatment with ibuprofen and paracetamol was taken for the event. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Reports dizziness more than 24 hours after H1N1 vaccination, had syncopal episode 1.5 months earlier 24 hours after seasonal flu vaccination according to mother.
Weakness,  difficulty breathing. Lasted 3 days.  Deep cough and lethargic still. Over a week later.  Contact pc and advised if symptoms got worse to go to er. Not worse but won't go away
a 5 year old patient was given FluBlok by mistake, no AE; Initial information was received on 17-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional via phone   This case involves a five-years-old male patient who was vaccinated with a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (pre filled syringe, lot number QFAA2009 and expiration date was 03-Jun-2021) via an intramuscular route in the left deltoid on 16-Sep-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient was concomitantly vaccinated with a dose of  DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and POLIO VACCINE INACT (IPV) on for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration (latency was same day).  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
COVID-19 TEST POSITIVE; This spontaneous report received from a company representative concerned a female patient of an unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 11-JUL-2022. The patient's weight, height, and medical history were not reported. On an unspecified date in MAY-2021 or JUN-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s (dose number in series: 1). On an unspecified date in DEC-2021, the patient received booster dose of non-company suspect vaccine tozinameran (Pfizer covid-19 vaccine) (dose number in series: 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2022, the patient tested positive for covid-19 in a rapid test (dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report is associated with a product quality complaint: 90000241377. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.
received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 7-month-old female patient who received Hib (Hiberix) (batch number 937JX, expiry date 26th September 2021) for prophylaxis.   On 25th October 2021, the patient received Hiberix. On 25th October 2021, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received a dose of Hiberix, which was already expired on 26th September 2021. The reporter consented to follow up.
Infant had grand mal seizures on 4/12/2008 and 4/18/2008.
Injection site reaction: pain, swelling General: headache, muscle aches Worse reaction: swollen left underarm lymph nodes
Initial and follow up information has been received from a medical assistant concerning a patient of unknown age and gender. On 15-APR-2015 the patient was vaccinated with GARDASIL lot # K006960 (expiration date, route and site of administration were not reported) that was exposed to temperatures outside of the recommended range for 12 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information is not expected as all follow ups requested to complete the case were received.
Pt, indicated itchy rash at site 24 hours after shot rash was approximately size of silver dollar. She iced the site Sat and Sunday but it still was sore. She made appt but had to cancel appt due to dizziness.
No additional AE reported; she accidentally admnistered PNEUMOVAX 23  to a 6 months old instead of PREVNAR 13; she accidentally admnistered PNEUMOVAX 23  to a 6 months old instead of PREVNAR 13; This spontaneous report was received from a nurse and refers to a 6 month old male patient. The patient's current conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  The nurse reported that on 28-OCT-2021, she accidently administered pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot number U010533 with expiration date 29-OCT-2022 (dosage, route of administration and anatomical location were not reported) for prophylaxis, to the patient instead of the third dose of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (Wrong product administered and product use issue). No additional adverse event (AE) reported.
He received both Moderna Covid-19 shots in January & February of 2021 and he got the Johnson & Johnson shot today; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (He received both Moderna Covid-19 shots in January & February of 2021 and he got the Johnson & Johnson shot today) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product JNJ 78436735 for COVID-19 vaccination.    Concurrent medical conditions included Lung disease and Immunocompromised.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of JNJ 78436735 (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (He received both Moderna Covid-19 shots in January & February of 2021 and he got the Johnson & Johnson shot today). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (He received both Moderna Covid-19 shots in January & February of 2021 and he got the Johnson & Johnson shot today) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Pt recvd 2-1cc injects of Recombivax 5DEC90 & 7JAN91; 6JUN91 recvd Engerix-B; pt "did not develop immunity";
This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a 2-year-male patient who received DTaP vaccine. Co-suspect products included DTaP vaccine and DTaP vaccine. On an unknown date, the patient received the 1st dose of DTaP vaccine, the 2nd dose of DTaP vaccine and the 3rd dose of DTaP vaccine. On 30th January 2017, 1 year and 322 days after receiving DTaP vaccine, 1 year and 261 days after receiving DTaP vaccine and 1 year and 200 days after receiving DTaP vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to DTaP vaccine, DTaP vaccine and DTaP vaccine. Additional details were provided as follows: The mother of the patient stated that, the patient received DTaP vaccine at 2, 4 and 6 months of age. On 30th January 2017, the patient underwent a serology test which revealed zero antibody titers. This led to a patient to be a therapy non responder. The reporter did not want to fill out the report while on the phone.
feeling hot/cold, weakness Narrative:  Pt reported feeling hot/cold & weakness post 2nd covid vaccine dose on same day as injections. Pt treated with tylenol. Symptoms resolved.  Other Relevant History:
Had area of blanchable erythema across left thigh spreading laterally to medially.  Not tender no induration.  Treated with antibiotics in ED- discontinued by me & is recovering.
Patient immediately fell ill after injection. She was dizzy, nauseated, and weak.  Patient asked to lie on the floor.  She was breathing rapidly and looked pale.  She rested on the floor for several minutes but began to feel better once her partner entered the room with her.  He  provided comfort and stated that she normally has someone with her when she gets vaccinated because she has fainted in the past.  He said this was the first vaccine that she has had without him.  We offered ambulance service which she initially accepted but later declined once her partner entered the room and she began to feel better.
The following day after receiving the vaccine the patient started having episodes of shivering and nausea. Patient reported going to doctor and was prescribed ondansetron.
Patient reported vomiting and no other symptoms. Per patient, there were no visible injection site reactions.
headache; fever; This is a spontaneous report from a contactable consumer (patient) from Pfizer. A 45-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: ER8736, Expiration date: Unknown), via an unspecified route in the Arm right on 18May2021 as 2nd dose, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included ongoing acetylsalicylic acid (ASPIRIN (E.C.)) at unknown dose daily for having some troubles with his heart (Has been taking this medication for about one month) and clonazepam (KLONOPIN), 7.5mg daily dose for mental care (Has been taking this medication for about one month). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: ER8736, Expiration date: Unknown) via an unspecified route in the Arm right on 21Apr2021 as, single for COVID-19 immunisation. On 01Jun2021, the patient experienced headache and fever. The patient confirmed he was calling in regard to Pfizer covid-19 vaccine. The patient received his second dose of the vaccine on 18May2021. However, last night he experienced a lot of headaches and fever. The patient asked that if it was normal that he received second dose of Pfizer Covid Vaccine 2 weeks ago and he started having a headache and a fever. The patient reported his headache has completely went away, but stated it was kind of hard yesterday. He clarified the headache hit him hard. The patient confirmed the fever also started last night, and it also went away. The patient clarified the headache and fever began last night around 18:00 or 19:00, stated he checked temperature at 22:00 last night and it was 38 degrees Celsius and he took the temperature with the one they point at the head with the light. Stated he was unsure of the time the symptoms went way, just when he woke up. He did not do anything for the headache or fever. He just wanted to know if this was normal. Outcome of the events was reported as resolved on an unspecified date in Jun2021.  Information on Lot/Batch number was available. Additional information has been requested.
Dose administered after 30-day Use By Date; the vial was initially stored in the refrigerator  26May2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator  26May2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator  26May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator  26May2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.  On 26 May 2022, the vial was initially stored in the refrigerator. Between 26 Jun 2022 to 04 Jul 2022 vaccines were administered. to 7 patients.
Received 3rd Covid Pfizer booster shot 9/3/21. Woke up 9/4 with bad chills and a fever of 103.6. Disoriented as to date and time. Spouse called EMTs who checked vital signs and advised she give patient Tylenol and he should be fine. She did as instructed and fever came down as expected. approximately 4 weeks later patient once again developed a fever of 103with chills and disorientation. Again successfully treated with Tylenol. Of not, patient recalls he had his flu shot 9/24/21. Not given at our facility and I have no further information on it.
Nausea, vomiting, chest pain, slight swelling noted, no redness.
Pt c/o nausea, soreness in arm, chills for brief time after receiving 2013 flu vaccine.
Large area on Rt. arm became swollen/red and itchy. Pt. saw nurse at nursing home and took BENADRYL. Patient told us about this on 2/15.
Had pain at injection site of left arm which resolved; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient had pain at injection site of left arm after vaccination. For tolerance with 2nd dose refer case US2021AMR112032. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR112032:Same reporter, Same patient. 2nd dose.
Daily persistent headaches, ear pain, hyperacusis, feeling like my head is under water, brain fog, lethargy, balance issues:  I had the J&J on April 12th. On the 20th I was awakened by fluid in my ears. I had a spot of blood from my left ear, and fluid from both. Then more ear fluid and head pressure and headache and head-cold symptoms developed over the next few days along with brain fog. By that weekend, I had a slight fever, symptoms worsened, and I was also sneezing and had a very runny nose. Took a rapid test and antibody test that Sunday, the 25th. Both Negative. On the 26th, I tested negative with a PCR test. Preplanned by my rheumatologist, I also had multiple labs drawn. Normal, except my Sed Rate had doubled from what it was on 3/23, and my Fibrinogen was high at 512. Phos, Mg, CMP, CBC, D-Dimer, were WNL. My daughter tested negative for Covid but positive for strep on 4/26, so my dr put me on Azithromycin for 5 days. He saw me the next day after confirming a negative PCR, on 4/27 to confirm that my ears were red, but my eardrums looked okay, and my throat was slightly red. On 5/4, I saw my PCP again and symptoms were unchanged. He put me on Neomycin/Polymyxin w/ HC Otic drops for a week, then steroids for a week after that when he saw me again on 5/14.  At this point, occasional dizziness/light-headedness was increasing, added to the other symptoms. I tried 3 different antihistamines though I have no environmental allergies but that didn?t help either. I started the methylprednisolone 4mg pack on 5/17 after I had the CT scan that he ordered. That was normal. When I close my eyes, my balance is off.  I used to have no problem with that, and would often walk to the bathroom in the middle of the night with the lights off and eyes closed. So I saw an ENT on 5/26, and my ears looked okay. Hearing and fluid tests were good too. Though the audiologist had to turn the left side volume down because it was too loud. I have developed hyperacusis, left ear. I had an MRI scan on 6/10, with a 1.5T machine, and that looks normal too. Now I will be seeing an Acupuncturist starting 6/14, and a Neurologist before the end of June as recommended by my ENT for suspected vestibular migraines.