chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 9:40 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 9:40 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 29.33 for dose administered on 13-Feb-2021.  No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Pt complaint of marked pain left upper arm/shoulder area immediately after injection continued for 5 hours requiring TORADOL injection, arm sling. Arm exam by doctor unremarkable.
I noticed midday on Sunday 1/17 that i had a large red and raised mark on my arm around the injection site. It was slightly itchy. I took a Benadryl and drew a line around it to see if it got bigger. The Benadryl reduced the itch, redness and swelling. The next day the redness and swelling were still down but the area moved just slightly outside of the lines I drew. I took another Benadryl. NOt much change. Calling doctor today.
After 2nd vaccine on 2-1-21 Moderna 004M2OA I experienced  continuous tinnitus 24 hours after with fever chills etc.  I thought the tinnitus would resolve with time but it hasn?t.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 20-OCT-2015, the patient was vaccinated with improperly stored GARDASIL 9 (strength, dose and route of administration were not reported, lot # L007560, expiration date: 15-JUN-2017). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
I was 9 weeks pregnant when I had my first COVID vaccine on Aug 24.  My estimated due date was March 22, 2022. I started spotting 11 days after the vaccine, on Sep 4. The spotting gradually increased. Two days later to large blood clots and the blood loss was so much that I went to the ER. I miscarried  on Sep 6 at 11 weeks pregnant. A D&C procedure was performed to complete the tissue removal. A blood transfusion was thought to be necessary but I did not end up having one.
This spontaneous report as received from a male consumer of unknown age refers to himself. The consumer inquired about restarting his GARDASIL series after possibly receiving dose1, or 2 or both doses of GARDASIL (lot# and dosing regimen unspecified) that would have been given 10 years ago (approximately in 2003), no adverse event reported. Additional information has been requested.
8 days after vaccine I had a red raised spot on my arm at the site of the vaccine.  It was itchy and warm to the touch.  It was not painful and I did not have to take any medication.  It went away around 24 hours after I noticed it.
Initially, I had pain running down my right arm from the shoulder all the way down. My fever was 101.5. I really couldn't do anything just pure exhaustion,  body aches. I also felt light headed. I felt terrible for 3 days but better for 2 and then it came back including the pain in my arm. I just kept hoping that if I rest it would go away, I'm just so exhausted and malaise.  After 3 weeks I saw my neurologist Dr. on march 31. the 8th or 9th of April I had bloodwork order from my Internal medicine. The long term I have digestion, brain fog, fatigue, vaginitis
This spontaneous report as received from a pharmacy technician refers to 11 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or pertinent medical histories provided. On multiple unspecified dates, 11 unspecified patients were vaccinated with improperly stored doses of VARIVAX lot # N004628, expiration date 08-FEB-2017 (dose, concentration and route of administration were not reported). Concomitant therapies included properly stored sterile diluent. No adverse effects were reported. Digital data logger was involved. Doses of vaccines administered to 2 unspecified patients experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 1 hour and 15 to 46 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. Doses of vaccines administered to 7 unspecified patients experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 1 hour and 30 minutes and 15 to 46 degrees Fahrenheit for 2 hours and 30 minutes. There was previous temperature excursion of 6 to 14 degrees Fahrenheit for 1 hour and 15 to 46 degrees Fahrenheit for 1 hour. Doses of vaccines administered to 2 unspecified patients experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 1 hour and 40 minutes and 15 to 46 degrees Fahrenheit for 45 minutes. There was previous temperature excursion of 6 to 14 degrees Fahrenheit for 2 hours and 30 minutes and 15 to 46 degrees Fahrenheit for 3 hours and 30 minutes. The outcome of incorrect product storage was unknown.
This spontaneous report was received from a medical assistant r4egarding a 37 year old patient of  unknown gender. No concurrent condition and historical medication was reported. On 19-DEC-2014, the patient was vaccinated with RECOMBIVAX HB injection series, dose 1 and second dose was administered on 18-MAY-2015, outside of the quality complaint was involved. The outcome of event was unknown. Additional information has been requested.
flash cheeks, internal itching all over the body that lasted for 5 hours. participant's arm was bleeding for 6 hours from the vaccine site. 3 days later participant had severe abdominal pain which lasted for an hour. Rash all over neck, cheeks, inner thighs and hips for 7 days.
21JAN93 pt noticed lt middle finger swollen & very stiff & sore; came on suddenly palm lt hand tender to touch; also noticed a red spot w/white area outside fingers; feels may have been bitten?
Patient is 31 yo male s/p full Pfizer COVID vaccination: dose 1 on 1/25 and dose 2 on 2/15. Patient is an employee of this institution with new onset cough, headache, and congestion on 7/27. Patient reports possible COVID-19 exposure. Rapid test resulted positive on 7/27. Patient underwent casirivimab/imdevimab infusion on 7/28.
1st 8/24/21 vaccine- Side effects started 8/25/21: SOB, upper arm soreness, fatigue & lasted 2 days. SOB lasted about 6 days. 2nd 9/14/21 vaccine- Side effects started 9/15/21: Fever 99-100.4°F, fatigue, SOB, body aches, upper arm soreness much more severe than 1st vaccine, SOB, O2 staying in 93-98% average of 95%. All subsided within 48-72hrs, SOB lasting weeks.
I first noticed an increase in mucus in my lungs, causing me to cough up phlegm.   The vision issues have increased the MS Optic Nuritis problems, loosing vision in right eye!  But its the headaches I can't stand.  They come and go, and sometimes its sooo bad that I can't move my head and body.  Sitting in the dark helps.  Thus having MS and lowered immune system has the headaches causing me to be immobile during episodes, sometimes lasting only an hour, sometimes all day!   And chills, but not as bad as the headaches.  I don't want to lose my vision again due to having to do these vaccines every year with these side affects.
7 days after 2nd shot began to develop 3 swollen lymph nodes under left arm.  This is same arm as injection.  Swelling was red and painful.  (I also became very sick after 2nd injection and was in bed for 2 days... had sweats, nausea, chills and brain was foggy.)
Case number PH#H2015US011126, is an initial spontaneous report from a physician received on 04 JUN 2015., This report refers to a 10 months old female patient. Medical history and concomitant medications were not reported. Her vaccination history included administration of first dose of RABAVERT (batch number: 559011A, expiry date: 28 APR 2018) on 26 MAY 2015 and experienced loose stool (see case: PHEH2015US010822). She was vaccinated with second dose of RABAVERT (batch number: 546011A, expiry date: 30 MAY 2018) on 03 JUN 2015. On the same day, six hours after vaccination, the patient experienced fever of 100.4 degrees F. At 02:50 PM, fever was 103.7 degrees F (maximum temperature reading noted as per physician). On the same day, the patient was treated with Tylenol. On 04 JUN 2015, the patient's temperature was trending down; 102.5 degrees F at 05:30 AM and 100.2 degrees F at 10 AM. On the same day, the patient was treated Tylenol and Motrin. Final outcome of the event was unknown. Seriousness and causality of the event was not reported.
Left arm sore immediately following vaccine. Continued soreness over next few weeks.  During routine annual mammogram/sonogram, radiologist noted an enlarged lymph node in left armpit attributed to the vaccine.  Follow-up sonogram is scheduled for Jan. 2020.  Arm pain continued with pain radiating from left shoulder to left hand.  Followup with primary physician and 5 day course of steriods prescribed and started 10/30/2019.  I have not completed the course of steriods yet.
Headache, Myalgia, Arthralgia, FEVER, CHILLS, SORE ARM Narrative:  Other Relevant History:
flare up of Neuropathy disease; flare up of RA and Neuropathy disease/pain in  left knee/neck pains; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (flare up of Neuropathy disease) and RHEUMATOID ARTHRITIS (flare up of RA and Neuropathy disease/pain in  left knee/neck pains) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis rheumatoid and Neuropathy (Neuropathy diisease).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (flare up of Neuropathy disease) (seriousness criterion medically significant) and RHEUMATOID ARTHRITIS (flare up of RA and Neuropathy disease/pain in  left knee/neck pains) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (flare up of Neuropathy disease) and RHEUMATOID ARTHRITIS (flare up of RA and Neuropathy disease/pain in  left knee/neck pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter. No treatment information was provided by the reporter.  Company Comment: Alternative explanation is that the serious unexpected events Rheumatoid arthritis and Peripheral neuropathy were possibly consistent with the flare up of pre-existing conditions.; Sender's Comments: Alternative explanation is that the serious unexpected events Rheumatoid arthritis and Peripheral neuropathy were possibly consistent with the flare up of pre-existing conditions.
Pfizer-BioNTech COVID-19 Vaccine EUA About a minute after the shot I experienced dizziness, weakness and a bad headache. I also become very nauseous, had injection site numbness, a tingling feeling in my fingertips, lower back pain/joint pain and felt sick the rest of the day.
several hrs p/vax pt devel hives w/itching on the face & torso; there was no SOB nor shock sx; pt cont to exp same sx w/gradual diminuition over 3-5 days;
Patient received DTaP and IPV in right deltoid on 8/23/04. On 8/24/04 erythema and swelling developed. Worsened 8/25/04 to include induration, axillary node enlargement. Seen in clinic, placed on Keflex po.
I got Covid arm; large circular rash around the injection site; lack of drug effect; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 07-May-2021. The most recent information was received on 07-May-2021 and was forwarded to Moderna on an unknown date.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got Covid arm), VACCINATION SITE RASH (large circular rash around the injection site) and DRUG INEFFECTIVE (lack of drug effect) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rash (Read Rash).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced COVID-19 (I got Covid arm), VACCINATION SITE RASH (large circular rash around the injection site) and DRUG INEFFECTIVE (lack of drug effect). The patient was treated with CLOBETASOL PROPIONATE ongoing since an unknown date for Steroid therapy, at an unspecified dose and frequency and DOXYCYCLINE ongoing since an unknown date at an unspecified dose and frequency. On 04-Mar-2021, DRUG INEFFECTIVE (lack of drug effect) outcome was unknown. At the time of the report, COVID-19 (I got Covid arm) and VACCINATION SITE RASH (large circular rash around the injection site) outcome was unknown.            Treatment medication was not provided.No concomitant medication was reported.  Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19  and mRNA-1273 use is assessed as unlikely related.  Based on the current available information and temporal association between the use of the product and the start date of the events of vaccination site rash and drug ineffective,  a causal relationship cannot be excluded   This case was linked to MOD-2021-114583 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Upon internal review on 16 Jul 2021, an event (lack of efficacy) was added at Moderna's request. On 07-Jun-2021: No specific follow-up information recorded.; Sender's Comments: Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19  and mRNA-1273 use is assessed as unlikely related. Based on the current available information and temporal association between the use of the product and the start date of the events of vaccination site rash and drug ineffective,  a causal relationship cannot be excluded
pt exp SOB, stomach pain & was very tired; also states was semi conscious, pt seen by MD & hospitalized for 1 1/2 wks; MD felt illness was due to the vax pt recvd;
This case was reported by a pharmacist via call center representative and described the occurrence of skin infection in a 35-year-old female patient who received FLUARIX QUADRIVALENT (batch number AL545, expiry date 30th June 2019) for prophylaxis. On 3rd November 2018, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 3rd November 2018, unknown after receiving FLUARIX QUADRIVALENT, the patient experienced accidental underdose. In November 2018, the patient experienced skin infection. The patient was treated with antibiotics nos. On an unknown date, the outcome of the skin infection and accidental underdose were unknown. It was unknown if the reporter considered the skin infection to be related to FLUARIX QUADRIVALENT. Additional information received as follows: The patient developed localized skin infection at the site of injection. On 5th November 2018, the patient came in with an antibiotic prescription. During the administration of the vaccine some of the vaccine had come out during administration and did not receive the entire dose, which led to accidental underdose. The patient's physician suggested that she should get the vaccine again. The pharmacist concern was whether the patient should be revaccinated or not. Emergency room visit was required. No further details were provided. Transferred call to medication information for further details.
Fatigue; bad headache (migraine type); nausea; vomiting; mild soreness at injection site; This is a spontaneous report from a contactable health care professional, the patient. A 55-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: NDC number: NDC:59267-1000-01(as reported)), via an unspecified route of administration in the left arm on 19Mar2021 at 16:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines and seasonal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not allergic to medication, food and other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications within two weeks of vaccination included Vitamin D and C. The patient experienced fatigue, bad headache (migraine type), nausea, vomiting and mild soreness at injection site on 20Mar2021 at 05:00. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care The patient did not receive treatment for reported events. The clinical outcome of fatigue, bad headache (migraine type), nausea, vomiting and mild soreness at injection site was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
Some of the vaccine came shooting out of the injection site; During administration and some of the vaccine came shooting out of the injection site; During administration and some of the vaccine came shooting out of the injection site; Some of the vaccine came shooting out of the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site leaking in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number F9TG5, expiry date 18th September 2023) for prophylaxis.   On 9th September 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 9th September 2022, immediately after receiving Shingrix, the patient experienced injection site leaking, incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the injection site leaking, incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the injection site leaking to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-SEP-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the reporter administered a Shingrix vaccine to a patient on the day of reporting. The reporter stated that the needle was retractable and refracted during administration and some of the vaccine came shooting out of the injection site when the needle was removed from arm. The reporter did not consent to follow up. Additional supportive information: The reporter stated that the needle was retractable and retracted during administration and some of the vaccine came shooting out of the injection site when needle removed from arm so complete dose not received, which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact.
Immediate brief episode of syncope without hitting head or injury. Full recovery after 30 minutes of observation
5/15/06 Mother reports child fine at time of vaccination. Started running temp of 103.2 on 5/16/06 at 3:30 vomited started 5/16/06 at 2:15pm. Saw PMD was told reaction to vaccination and not to take a shot ever again.
Got flu shot same day; Got flu shot same day; Sore arm; Felt tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (bivalent), single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Tdap (DOSE NUMBER UNKNOWN, SINGLE), for Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "Got flu shot same day"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "Felt tired".  Additional information: The patient reported that the event took place after use of product. Sore arm and felt tired after shot. Got flu shot the same day. Slept off any other side effects. Sore arm feels a little more painful than the flu shot in the other arm but more like a tdap feeling shot. Nothing strange.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case previously recorded as MA2009-4583. Initial case report received from a physician on 17 NOV 2009. A 3-year-old or younger patient was vaccinated with FLUVIRIN 2009/2010 i.m. on 13 NOV 2009. No adverse events was reported. Reference no: NA09-008308.