chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HANDS WERE FREEZING; SORE BODY; HEADACHE; FEVER; PAIN IN THE MUSCLES; This spontaneous report received from a patient concerned a 26 year old male. The patient's weight, height, and medical history were not reported. The patient was previously treated with quetiapine fumarate.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203AZ1(A/I), and expiry: 23-JUN-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAY-2021, the subject experienced hands were freezing. On 12-MAY-2021, the subject experienced sore body. On 12-MAY-2021, the subject experienced headache. On 12-MAY-2021, the subject experienced fever. On 12-MAY-2021, the subject experienced pain in the muscles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hands were freezing on 12-MAY-2021, and had not recovered from headache, fever, pain in the muscles, and sore body. This report was non-serious.
a four months old patient received an expired dose of Daptacel  vaccine, no adverse event; Initial information was received on 04-Jun-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a four month old patient (gender unspecified) who was administered an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE INACT (HAVRIX) and INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) for prophylactic vaccination on 09-Mar-2020.   On 09-Mar-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5367AA, expiry 30-Jan-2020) once via intramuscular route in left vastus lateralis for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  At the time of report, adverse event was not 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Pfizer COVID-19 vaccine (5-11yrs) manufacturer expiration date is 8/31/2022. However, vaccine expiration date after being transferred from freezer to refrigerator is 5/17/22. Vaccine was administered on 5/27/2022.
Med error by RN administering vaccine. Pfizer BioNTech Bivalent Booster given instead of Pfizer BioNTech dose #1
She noticed a cold sore that occurred the day after she received the 2nd dose of vaccine. Treated with Valtrex
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by state for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Diarrhea for 1 week, 3+ stools per day (normal 1 per day).
Red, raised rash for 2 days; seen in our office today(11/22/02) with vesicular, crusty rash, Dx: per physician as "varicella"
This spontaneous report as received from a Certified Medical Assistant refers to 4 patients of unknown age and gender. On an unknown date (reported as during the month of June and July) the patients were vaccinated with improperly stored GARDASIL (dose, route and lot number were not reported). Concomitant medications were not reported. No adverse effects reported. This case is linked to case 1407USA013966 via same reporter link. Additional information is not expected.
Feeling bad; Flushing; Headache; Nausea; Ill feeling; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Ill feeling), FEELING ABNORMAL (Feeling bad), FLUSHING (Flushing), HEADACHE (Headache) and NAUSEA (Nausea) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 05-Mar-2022, the patient experienced MALAISE (Ill feeling). On an unknown date, the patient experienced FEELING ABNORMAL (Feeling bad), FLUSHING (Flushing), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, MALAISE (Ill feeling) had not resolved and FEELING ABNORMAL (Feeling bad), FLUSHING (Flushing), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.            There was no reported medical history.   Concomitant drugs not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  The reporter's causality for the events of feeling ill and lack of effect was a reasonable possibility and for events feeling like crap, headache, nausea and feeling flush was not provided with humira (adalimumab).  No treatment medication were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Mom called and reported (R) arm red and irritated. Mom said you could not touch due to pain. Referred to PCP. PCP reported mild irritation.
Red/swelling of arm, underneath armpit to rt breast also rash. Rt arm sore hardly able to move arm for 2 days. She also felt "foggy" in the head. Treatment - alternating heat and ice taking BENADRYL - MOTRIN.
Started hurting when given and never stopped Moved arm around during the rest of the day About 7 hours later when she went to bed, the pain got much worse  #10 on pain scale - unable to move arm Stayed at a #10 for a few more hours About 4am it started easing up a little. Bearable by the next morning at 7am - was able to move it again It was pain free in about 24 hours, although it's still tender
Moderna COVID?19 Vaccine EUA  10 minutes after vaccine : injection site pain, feeling warming  of entire body. 1 hour after vaccine: fatigue, worsening injection site pain.  15 hours after vaccine: woken up to mild head ache, mild body ache, moderate chills, restlessness.  General malaise. Worse injection site pain
pt recvd flu vax & devel sore throat & 3 wks later had a bad cold which lingered;
body aches for 24 hrs; COVID19 Booster; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Dec2021 14:30 (Lot number: FH8027) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL 3247, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 11Mar2021, when the patient was 44 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP-6955, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 01Apr2021, when the patient was 44 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 14:30, outcome "unknown", described as "COVID19 Booster"; PAIN (non-serious) with onset 06Dec2021 20:00, outcome "recovered" (07Dec2021 20:00), described as "body aches for 24 hrs". Therapeutic measures were not taken as a result of pain. Additional Information: The patient had no list of any other medications received within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient was not diagnosed with COVID-19 prior to vaccination.  The patient had not been tested for COVID-19 since the vaccination.  The patient had no known allergies  No follow-up attempts are possible. No further information is expected.
Rt arm became red, hard hot and really sore-The redness soreness The size of a salad plate - Also felt nauseous for two days, took about six days to recede completely.
Patient daughter reported that the patient broke out in a body rash a day or so after she received her second dose of Pfizer COVID-19 vaccine.
Pt medicated with TYLENOL in office with successful fever reduction. Rapid flu test negative.  Rapid onset of fever the evening after vaccination for influenza. T max 103.3 po.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SWOLLEN LEFT LEG AND SWOLLEN LEFT ARM; FATIGUE; This spontaneous report received from a patient concerned a 64 year old male of other race, and unknown ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 08-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the patient experienced fatigue, swollen left arm and swollen left leg, which lasted for a week. On 17-AUG-2021, the patient underwent ABIGGIGM (SARS-COV-2 IGM ANTIBODY TEST), IGG (SARS-COV-2 IGG ANTIBODY TEST) and IA test (immunoglobulin a), and the IA test was negative (confirmed immunological vaccine failure). On 18-AUG-2021, the results were given and those were negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen left leg and swollen left arm, and fatigue on 15-MAR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with Product Complaint Number: 90000190130; Sender's Comments: V0: 20210837674-Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive 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: SPECIAL SITUATIONS
This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. On 13-SEP-2018, the patient might have received an improperly stored dose of VARIVAX (lot # N029628, expired date 23-NOV-2019) subcutaneously for prophylaxis. The temperature excursion in the range of 6 Fahrenheit (F) to 14 F for 21 minutes and in range of 15 F to 46 F for 3 hours and 25 minutes. There was previous temperature excursion of total time in the range of 6 F to 14 F for 34 hours and 57 minutes and in the range 15 F to 46 F for 36 hours and 32 minutes. Data logger involved. No adverse effect was reported. It was unknown if sterile diluent was improperly stored.
pt presents w/ swelling bil eyes, no swelling noted to face, no other s/s, pt in no distress, eye swelling subsided w/in 30 mins. A&Ox4. mother with son, released home & encouraged to continue to monitor and report additional or adverse reactions to physician or to call 911 if difficulty breathing, pt will take benadryl po at home. mother states that this happened with 1st dose.
During mass flu clinic, child was given LAIV FLUMIST instead of inactivated influenza injection as requested by mom. Child developed nasal ulcers with nose bleeds requiring MD visit, antibiotics for 2 weeks.
This spontaneous report was received from a medical assistant who reported that on an unknown date, improperly stored doses of ROTATEQ, (lot # M041768, expiry date 25-JUN-2018) had been administered to unspecified patients (incorrect product storage). The numbers of doses were unspecified. There was a previous temperature excursion for the vaccines of 47°F to 77°F for 45 minutes. Then, the vaccines had other temperature excursions of 47°F to 77°F for 4 hours. No data logger involved. No adverse effects were reported. This is one of three reports from the same reporter source, (linked to MARRS # 1706USA009318 and 1706USA009319). Additional information has been requested. Lot # M041768 is valid lot # for ROTATEQ.; Sender's Comments: US-009507513-1706USA009318: US-009507513-1706USA009319:
Patient given undiluted (PEDS) vaccine, .2 ml w/o dilution.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 14-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 25-OCT-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Right deltoid sore from vaccine for 5 days, then developed bulla, vesicles, induration "pain". Over next week skin surface improved, bulla scabbed over, hyperpigmented area where vesicles were (circular around IM site), some edema bicep and regional pain.
sweating at night; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating at night), CHILLS (chills) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history). Concomitant products included LOSARTAN for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced HYPERHIDROSIS (sweating at night), CHILLS (chills) and HEADACHE (headache). At the time of the report, HYPERHIDROSIS (sweating at night) and CHILLS (chills) had not resolved and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included fluticasone.
Initial redness and swelling at injection site, transitioned into 1.3cm subq hematoma
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in September 2016, the patient started her series of GARDASIL. On an unknown date in June 2017 (reported as now), the patient would like a second dose of GARDASIL 9 (lot # M014929, expiration date: 22-MAY-2017) for prophylaxis. It was unspecified if the patient was in the office. There was no adverse effects reported. Additional information has been requested.
Post vax 24 hrs, pt ld was red & swollen. Mom applied warm compress, swelling decreased. 48 hrs later, swelling increased to elbow w/redness to elbow. Took pt to Dr/tx w/antibiotics, redness and swelling decreased.
First Pfizer dose was 08/06/2021 of which was the last day of patients menstruation cycle. Second dose of Pfizer given 08/29/2021. Patient has not had a period since her last cycle 08/01/21-08/06/21
MMR vaccine powder lot #L032181 exp 8/25/17 was mixed with Menveo liquid conjugate lot #X15019 exp 10/2017.
Some of the vaccine rolling down patient's arm; Some of the vaccine rolling down patient's arm; Some of the vaccine rolling down patient's arm; This case was reported by a consumer via call center representative and described the occurrence of accidental underdose in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 7th April 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the patient experienced inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.  Additional details were provided as follows: The patient reported that some of the vaccine was rolling down her arm, which lead to accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. The reporter consented to follow up.
Cardiac dysrhythmias; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Nurse). Other Case identifier(s): 2022US002147 (Health).  A 64-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Itching" (ongoing); "Skin lesions" (ongoing); "Redness" (ongoing); "Chest mass NOS" (unspecified if ongoing); "Mass excision" (unspecified if ongoing); "Surgical scar" (ongoing); "Sulfonamide allergy" (unspecified if ongoing); "Skin irritation" (unspecified if ongoing); "Sores" (unspecified if ongoing); "Blisters" (unspecified if ongoing). Concomitant medication(s) included: OXCARBAMAZEPINE; PYRIDOXINE HCL; VITAMIN C [ASCORBIC ACID]; PROLIA; CANNABIDIOL; TERIPARATIDE; METOPROLOL SUCCINATE; CALCIUM. Past drug history included: Fosamax, reaction(s): "Allergy:Fosamax"; Dilantin, reaction(s): "Allergy:Dilantin"; Lamictal, reaction(s): "Allergy: Lamictal"; Keppra, reaction(s): "Allergy: Keppra"; Aspirin, reaction(s): "Allergy: Aspirin"; Thimerosal, reaction(s): "Allergy:Thimerosal"; Topamax, reaction(s): "Allergy: Topamax"; Bactrim, reaction(s): "Allergy: Bactrim"; Sulfadiazine, reaction(s): "Allergy: Sulfadiazine". The following information was reported: ARRHYTHMIA (medically significant), outcome "not recovered", described as "Cardiac dysrhythmias". The patient underwent the following laboratory tests and procedures: Electrocardiogram ambulatory: (04Jun2021) Result not provided; (05Jun2021) Result not provided; (06Jun2021) Result not provided; (07Jun2021) Result not provided; (08Jun2021) Result not provided; (09Jun2021) Result not provided; (10Jun2021) Result not provided; (11Jun2021) Result not provided; Pain assessment: (unspecified date) Pain is a 10 N/A.  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) : US-PFIZER INC-202201026333 same reporter/patient/drug/event, different dose;US-PFIZER INC-202201026333 same reporter/patient/drug/event, different dose;
Narrative:  COVID infection following COVID vaccine series 01/16, Pfizer,  dose #1 02/06, Pfizer, dose #2 08/30, Pfizer, dose #3 08/30 pt cc: cough, fatigue, fever, headache, rhinorrhea exposure: unknown 0/30 COVID swab, result:  detected 09/27 COVID swab, result: detected
Vaccine that pt received had been stored at refrigeration temp for 72 days.  This is longer than the 70 days that is recommended. I called Pfizer's customer service line, and was told that the vaccine is stable at refrigeration temp for 72 days. Repeating dose was not recommended.
Bout of gastritis; Sick to my stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick to my stomach) and GASTRITIS (Bout of gastritis) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Gastritis.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Sick to my stomach). On an unknown date, the patient experienced GASTRITIS (Bout of gastritis). At the time of the report, ABDOMINAL DISCOMFORT (Sick to my stomach) and GASTRITIS (Bout of gastritis) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: new event has been updated.; Sender's Comments: 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. However, the medical history of gastritis could be a contributory factor.
Reactions: Hives Severity: High  From Office Visit Note: --had moderna sars-2 vaccine #1 today--delayed urticarial reaction, onset after leaving facility; Limited to face--small swellings with mild to moderate itch; Denies tongue or throat sx, wheezing, or other allergy hx;
Seizure episodes lasted 12 minutes about 10 minutes after giving Tdap, IPV, MMR. Given diazepam 10 mg,  Transferred by EMS to MCG.
Large swelling and Rash patch on right arm. Sore arm. Weakness and dizziness.
severe sympton of whole body itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (severe sympton of whole body itching) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Depression. Concomitant products included VALPROATE SODIUM (ENCORATE) and MIRTAZAPINE for Depression.    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 PRURITUS (severe sympton of whole body itching). At the time of the report, PRURITUS (severe sympton of whole body itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment reported.
In january i got a severe upper respiratory infection, ear infection and cough. Girl who called said to report it.
"covid arm" rash right below injection site, did not appear until over a week after injection.
Overall body aches, tired (whooped! - in patient's term) sore, felt like someone beat him up (in his words) slept, mid-afternoon for hours.
Pfizer vaccine was expired (6/29/2022) patient had no adverse reactions after 35 minutes. Patient was informed. Pfizer and CDC were made aware.