chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; Customer reporting administration of improperly stored PEDVAX HIB and ROTATEQ; This spontaneous report was received from an office manager, concerning an approximately 7 weeks old (also reported as 5 month old) male patient. Patient had glucose-6-phosphate dehydrogenase (G6PD) deficiency and family would like to establish case with a hematologist. He presented for a physical examination concerns/questions relating the penis (illness at vaccination). The patient's concomitant medications and drug allergies were not reported.  On 06-APR-2021 (also reported as 27-APR-2021), the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (first dose, orally at the dose of 2 milliliter (ml), lot number 1687012 has been verified to be a valid lot number, expiration date reported and validated as 08-JUL-2021; strength was not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (first dose, at the dose of 0.5ml, intramuscular, lot # T001206 has been verified to be a valid lot number with an expiration date reported and validated as 03-JUN-2022; strength was not provided) for prophylaxis (product storage error), however, the temperature was not reported.  It was stated that the patient did not received any treatment, it was confirmed that the operator was trained, and it was used according to the instruction leaflet. Previous temperature excursions were reported as yes, and digital data logger was involved. No adverse events were reported, nor product quality complain.   This is one of the several reports received from the same source.; Sender's Comments:  US-009507513-2106USA001370: US-009507513-2105USA001739: US-009507513-2106USA002133:
The vaccine was expired when given past the 30-day recommendation. There have been no s/s of an adverse event at this time
Patient received second dose on 5/9/2021 when they were supposed to receive second dose on 5/14/2021 (21 days after first dose)
I went for dental hygiene on Dec 2nd, 2021 and they saw oral lichen planus in my inner cheek. I never had this condition before and only just got diagnosed with it this year 2021. I didn't feel any pain so not sure when the lichen planus started. Now, very rarely,  I feel a little pain on the area.
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves adult patient (age and gender not reported) who was vaccinated with a 0.5 ml dose of MENACTRA via intramuscular route (Batch number, expiry date, dose in series and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included GARDASIL 9 for Immunisation on an unknown date. It was a case of actual medication error due to incorrect product storage (it was reported that moved their vaccines due to the hurricane and initially thought the temp excursion was to 0.2C but later discovered it was actually negative 0.3 degree Celsius). It was reported that no treatment as no symptoms reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. 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. Documents held by the sender: none.
Black & blue and sore around injection site. After about 10 hours from the time the shot was given I had tiredness, weakness, chills, muscle aches, and fever of 102.  No more serious symptoms lasted for about 10 hours.  After the fever went away, I was left with a splitting headache and some body aches and sweats.
Afternoon after receiving the vaccine she reported redness in the arm and viral like rash on sides of trunk, more on the left side then the right side.  Did not itch and NO swelling in the area or mouth or tongue.  The redness faded by 6/11/2023.
During the 1st 24 hours, this child had a fever of 100.8; she responded to Motrin. Then it seemed ok until the 2nd night, she had a spiked fever of 102.5. The 3rd day , the fever again 101 to 102.5. she was seeing the MD on the  3rd day. Now recovering.
Received 1st dose of Moderna vaccine on 12/29/20. Besides general left arm soreness for 2-3 days following vaccine, I had no other symptoms until Sunday January 3rd, at which time I began to notice increased fatigue, chills, and mild cough. Symptoms did not subside by Monday morning, January 4th, and I called in sick to work and requested that I receive a Covid 19 test from an urgent care. I tested positive for Covid 19 that day, and remained off work until 1/14/21. I experienced moderate chills, moderate increased skin sensitivity, and significant fatigue from 1/3/21 to 1/8/21, sleeping ~16-20 hours per day every day during that time. I began feeling better 1/9/21 and symptoms gradually improved until I was symptom-free on 1/12/21. I returned to work on 1/14/21, >10 days following initial symptoms.
Pt received 2 Pfizer COVID vaccine 1 week early vs waiting the  CDC recommendation of 3 weeks between doses
This spontaneous report was received from a healthcare worker (quality assurance coordinator) regarding a 38 year old female patient. The healthcare worker reported that her facility had administered 9 doses of RECOMBIVAX HB, lot # J001183. On 15-MAY-2013, the one of the patient's was vaccinated with dose 1 of RECOMBIVAX HB (lot # J001183, expiry: 08-SEP-2014). On 14-JUN-2013, the patient received her second dose of RECOMBIVAX HB (lot # J001183, expiry: 08-SEP-2014) one day early. No adverse effects reported. This is 1 of 6 reports received from the same reporter. Additional information has been requested.
Patient stated her forearm was numb. Injection site was her left deltoid. Patient stated only her forearm was numb. Pt was called next day. Mom stating pt was ok, and forearm no longer numb.
Moderna 2/24/21, 3/31/21, 12/2/21. Positive on 9/9/22.
Blacked out/collapsed the morning after Pfizer shot. Pale and nauseous.
Chills, fever, body aches and exhaustion. Tylenol,fluids and rest. Subsided in about 16 hours.
Information has been received from a Nurse Practitioner (N.P.) concerning a 25 year old female patient who on 16-APR-2007 was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Strattera. On 16-APR-2007 the patient experienced dizziness and headache. The headache was resolved when patient awoke the next day. The patient's dizziness persisted. Unspecified medical attention was sought. The patient had not recovered. Additional information has been requested.
Initial report from a health care professional on 12 February 2010. A 40 year-old female patient was vaccinated with FLUZONE (Lot # U21210AA) on 15 September 2009. Four to five days post vaccination the patient developed swollen glands (location not specified), dizziness and cold symptoms. The patient went to the emergency room for these symptoms. The swollen glands and the cold symptoms resolved but the dizziness continues. The patient has been unable to work. It was reported that an MRI was performed and was negative (dates of procedure were not provided). It was reported that this event was previously filed with VAERS but no further information was provided. Follow-up information was received on 05 April 2010 from a healthcare professional. Upon receipt of this information, it was determined that the case meets seriousness criteria and it has been upgraded to serious. The FLUZONE vaccination was a left deltoid intramuscular injection and was given at 1300 on 15 September 2009. The patient had cold like symptoms at the time of the vaccination. The reporter stated that per the patient, the previously reported MRI was negative for a brain tumor. The dizziness haS not resolved. List of documents held by sender: none.
administered "10 cc"; A spontaneous report was received from a healthcare professional concerning a 63-year-old female patient who stated that after her injection she asked the nurse what dose she received and the nurse stated she administered "10 cc"/accidental overdose.   The patient's medical history included allergy to hydromorphone hydrochloride (has severe vomiting), diabetes and hypertension.    Products known to have been used by the patient included insulin detemir, insulin aspart, carvedilol, and losartan.   On 08 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  After the injection, the consumer asked the nurse what dose she received, and the consumer reported that the nurse stated she was administered "10 cc". The consumer stated she was going to call the vaccination site back to verify what dose she was given. She reported that she isn't experiencing any adverse events or side effects after the vaccination.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event was not reported.; Reporter's Comments: This case concerns a 68-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 039K20A), reporting accidental overdose without any associated adverse events.
This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of incorrect storage ZOSTAVAX lot # J000445, expiration date 11-APR-2014, dose and route unspecified. This is one of several reports received from same source. Additional information is not expected.
pt seen in office 28AUG92 for PE & recvd MMR revax; return visit 29AUG92 w/c/o hives 3 hrs p/recvd vax;
Chest pain that came and went Fever of 101.8 Chills Malaise Inflammation Body aches Nausea Trouble sleeping
I started my period two days after my second dose of the Pfizer vaccine.  This was way several weeks off-cycle for me and I am usually fairly regular.  I also had a very large flare up of genital herpes which I usually manage with Valcyclovir.  But, it came on so suddenly I didn't have the typical warning and I wasn't sure about taking the medication.
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 POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021 at 10:01 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Oct-2021 at 11:24 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (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 47.16  Concomitant products were not provided.  On 27-Oct-2021,, Excursion time was 09,AM temperature was 29 total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-Sep-2021 vial was moved to clinic on 27-Oct-2021.  2 vials were sent to clinic. Vaccine BUD date was 29-Oct-2021  On 27-Oct-2021,, Excursion time was 10,AM temperature was 32 total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021 vial was moved to clinic on 27-Oct-2021.  4 vials were sent to clinic. Vaccine BUD date was 04-Nov-2021    On 27-Oct-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM: 46, 3 PM: 46, 4 PM: 46 and 5 PM: 45.   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 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
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. No treatment medications were provided by reporter.
fatigue, chills, nausea, could not stand up, weakness, headache, intolerance to any smells long over 30 hours
Redness, swelling of left thigh, site of Dtap, IPV improving.
Redness and swelling with pain to touch a couple of inches below the injection site; Swelling below the injection site; Pain to the touch below the injection site; This case was reported by a consumer and described the occurrence of localized erythema in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced localized erythema, local swelling and pain localized. Shingrix was discontinued. On an unknown date, the outcome of the localized erythema, local swelling and pain localized were unknown.   It was unknown if the reporter considered the localized erythema, local swelling and pain localized to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The patient received shingrix shot and had a reaction a couple of days after. The patient had redness and swelling with pain to touch a couple of inches below the injection site. The reporter gave consent for follow up.
pt recvd vax; pt devel abscess of lt thigh; par took to er for tx; f/u care was recvd in ofc;
pt recvd MMR/HIB vax 7MAY91 & a few minutes following vax pt devel a rash, 8.6 cm in area; ice was applied to rxn site; tx w/DPH; pt recovered;
Adverse effect of other vaccines and biological substances, initial encounter on 2022-01-31.
Pfizer-BioNTech COVID- 19 Vaccine EUA: No vaccine injected due to left deltoid scar tissue. The dose was re-administered.
Developed right scapula area pin 2 weeks after first dose. Became severe the day after the 2nd dose. Then noted right axilla numbness on 1/18/76.
No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/expiration date 13Jul2022 Date(s) of administration of vaccine was 30SEP2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/expiration date 13Jul2022 Date(s) of administration of vaccine was 30SEP2022) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/expiration date 13Jul2022 Date(s) of administration of vaccine was 30SEP2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/expiration date 13Jul2022 Date(s) of administration of vaccine was 30SEP2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/expiration date 13Jul2022 Date(s) of administration of vaccine was 30SEP2022).    No concomitant medication were reported. Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines with Lot number 004M21A and expiration date 13-Jul-2022. Dates of administration of vaccine were 26-Jul-2022 (40 doses), 04-Aug-2022 (1 dose), 19-Aug-2022 (1 dose), 30-Sep-2022 (1 dose). No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:(Master case)
2 hours after administration, patient began to have severe pain, chills, fever, sweats, and difficulty sleeping. symptoms lasted for roughly 24 hours. at the current time, patient's only complaint is large swollen red area at the injection site and itching. to help sleep the first night, patient took a hydrocodone pill he had from a recent surgery. I recommended he use benadryl before bed, and zyrtec during the day to help with the current itching.
administered intramuscular instead of subcutaneous; no adverse effect; This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-MAY-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # R031628, expiry date 01-NOV-2020) intramuscularly instead of subcutaneous for prophylaxis. No adverse effects were reported. No product quality compliant was filed.
Patient was administer a Moderna covid vaccine with expiry date10/15/2021.  Patient tolerated the injection well and was observed for 15min after injection.  No complications or adverse events were noted.
Received Hep A/B on June 13 with no issues then Aug 14 woke up with the area she received the vaccine with her muscle sunken in and atrophied. There were no other injuries vaccine the only thing that occurred for that to happen to arm.
No additional AE reported; PROQUAD had a temperature excursion and was administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 28-AUG-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (dosage regimen was not reported), lot # T036735 (rHA) and expiration date 28-APR-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -11.0 degree celsius (°C) for 2 hours and 5 minutes, and -7.5 °C for 71 hours on an unknown date; no previous temperature excursions were reported.  No adverse symptoms were reported
Narrative: An 80yo male with PMH of DM, HTN, Coronary arteriosclerosis, Hyperlipidemia, DVT of lower extremities, Impaired Cognition, PVD and CKD Received Pfizer's Covid -19 vaccine per policy and protocol without complication Frist dose on 04/05/2021 and second dose on 04/26/2021 Per reporting Physician's on April 16, 2021, the patient's wife called on 04/15/2021 and reported he had a new urinary incontinence x 4 days after first dose of Covid-19 vaccine
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) and in Sep2021 as dose number unknown (booster), 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 "my brother got sick first, he got sick first and then I got sick couple days after tested positive/We didn't get sick for two years, now get covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: We didn't get sick for two years, now get covid. Clinical course: It was reported that reporter's brother also had all the vaccine and booster shot we all had Pfizer and Pfizer booster and took booster in September it been about 5 months or 4 month, we had our vaccine last year. It was also reported that reporter's brother also had all the vaccine and booster shot we all have Pfizer and Pfizer booster. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : PFIZER INC-202201020871 same reporter/drug/event, different patient;
Pt had gradual increase of redness and swelling starting evening of immunization. The next day had fever and upper arm beet red and very swollen. Ice for swelling and tylenol for fever for 2 days. Today (1/28/02), itchy but decreased redness and swelling.
Mild pain began the next morning. By that afternoon, the site was red and sore. Redness continues today - 3 days post injection.
Pt had fever to 104 4 days after vaccine administration and onset of status epilepticus requiring intubation for one day.
On 08/09/2000 the patient experienced mild case of chicken pox. The patient sought unspecified medical attention. Follow up information from the RN indicated that on 08/09/2000, the patient's mom called the physician's office and reported "red bumps". The patient was seen by the physician and was questioning insect bites. It was reported that on 08/10/2000, the patient's father reported an increase in the number of bumps and he thinks that it is chickenpox. The father declined to have the patient come to the physician's office for a visit. The nurse reported that the patient subsequently recovered on an unspecified date. No further information is expected.