chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for COVID; This is a spontaneous report from a contactable consumer (patient's wife). A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 18Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter called on behalf of her husband who had tested positive for COVID after getting the first dose of PFIZER-BIONTECH COVID-19 VACCINE last 18Jan2021. Patient developed COVID symptoms 21Jan2021 and received the COVID result 22Jan2021. On 24Jan2021 he received BAM infusion to manage COVID infection. He was out of quarantine and scheduled to have his second shot 11Feb2021. Asking if he was safe to get the second dose. His doctor advised them that BAM infusion has 90-day half-life and cannot have the vaccine. She wanted to know that it was a severe allergic reaction that was why he got COVID, and if her husband's doctor would tell him not to take the second dose yet, could he take it more than 21 days. Outcome of the event was unknown. No PQC Present.  Information on about lot and batch number has been requested.
While being monitor in post-vaccine area she developed dizziness similar to when she has had hypoglycemia in the past. Reports she did not eat breakfast this morning. No hx of diabetes, not on diabetic medications. She is on some pain medications for a recent surgery. Otherwise denies rash, throat swelling, dyspnea, nausea/vomiting. EMS contacted and came to assess pt. Vitals assessed and were wnl. Blood sugar check was 68. She was given apple juice, starburst, graham crackers and felt better. Monitored for additional period of time and felt well enough to leave. EMS advised transfer to hospital for additional monitoring however she declined. No other specific symptoms of post-vaccine side-effects and I do suspect this was primarily due to low blood sugar in setting of not eating breakfast before receiving the vaccine.
Vial dropped from 4 ft to the floor and doses were administered; A spontaneous report was received from a consumer concerning a patient  (no gender or age information provided) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: vial dropped from 4 feet to the floor and doses were administered.  The patient's medical history was not provided. Concomitant product use was not reported.  On 10 Feb 2021, prior to the onset of the event, the patient was administered a dose (unknown if dose 1 or dose 2) of mRNA-1273 (Lot #: unknown, arm/location unknown) for prophylaxis of COVID-19 infection.  On 10 Feb 2021, at the facility where the reporter was volunteering, an unpunctured vial was dropped from approximately 4 feet to the floor but the vial did not break. The reporter argued with the doctor that the vial should not be used per his understanding that administration instructions say to "Swirl gently after thawing and between each withdrawal. Do not shake."  The reporter was concerned as the vial got shaken up instead of swirled when it was dropped from the 4 foot height.  The doctor still asked the nurse to use that vial.  No lot number or expiration date was available. There was no product available to retrieve as that vial was administered that day.  Action taken with mRNA-1273 in response to the event was unknown.  The event, vial dropped from 4 feet to the floor and doses were administered, was considered resolved.; Reporter's Comments: This report refers to a case of Product preparation issue for mRNA-1273 (lot # unknown) with no associated adverse events. The vial was dropped from 4 feet to the floor and doses were administered. Event occurred the same day as vaccine administration. Very limited information regarding this event has been provided at this time.  Further information has been requested.
Woke up 8 am 4/11 headache and body achs.  When I got moving my headach turned more migraine body achs were every joint/ muscle hurt, once I sat down after morning routines I found myself with the dead sweats. I was shivering and clammy sweating continuously. Symptoms subsided about 5pm
Patient with fever, malaise and rash immediately post immunization with rash down arm for 2 days. Seen by internal medicine with quarters for 24 hours. Felt better, till 8 days post immunization, when developed fever, chills, malaise and collapsed at dinner table. Wife reports patient unresponsive, with eyes rolled up for 1-2 minutes. Ambulance called, attendants report patient incoherent. On arrival, patient responsive to pain and loud stimuli, but confused. Patient assessed with labs, CT scan and LP, Transferred.
At about two weeks after the 1st shot, I began having an ear infection, a severe herpes simplex 1 outbreak, staph infections at multiple sites on my skin, acne, joint pain throughout multiple joints including ones I'd not had problems with before, IBS- which I'd never had before, and other minor signs of my immune system being rundown.  Normally if I am rundown in my life I might get ONE of the above sorts of conditions, NEVER all of them.  It has now been 23 days since the shot, and the different symptoms are continuing.  I will treat a skin condition with medication and it will flare up in a new spot.  I feel tired and rundown.  I feel concerned enough about the state of my body that I don't feel it's advisable to get the second shot while these issues are actively continuing.
Administered a 2nd booster dose of the Moderna Covid-19 Vaccine from a vial that was 25 hours and 45 minutes post puncture and after 25 hours 45 minutes of room temperature storage.; Administered a 2nd booster dose of the Moderna Covid-19 Vaccine from a vial that was 25 hours and 45 minutes post puncture and after 25 hours 45 minutes of room temperature storage.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a 2nd booster dose of the Moderna Covid-19 Vaccine from a vial that was 25 hours and 45 minutes post puncture and after 25 hours 45 minutes of room temperature storage.) and PRODUCT STORAGE ERROR (Administered a 2nd booster dose of the Moderna Covid-19 Vaccine from a vial that was 25 hours and 45 minutes post puncture and after 25 hours 45 minutes of room temperature storage.) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2022 at 12:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2022 at 12:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a 2nd booster dose of the Moderna Covid-19 Vaccine from a vial that was 25 hours and 45 minutes post puncture and after 25 hours 45 minutes of room temperature storage.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered a 2nd booster dose of the Moderna Covid-19 Vaccine from a vial that was 25 hours and 45 minutes post puncture and after 25 hours 45 minutes of room temperature storage.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a 2nd booster dose of the Moderna Covid-19 Vaccine from a vial that was 25 hours and 45 minutes post puncture and after 25 hours 45 minutes of room temperature storage.) and PRODUCT STORAGE ERROR (Administered a 2nd booster dose of the Moderna Covid-19 Vaccine from a vial that was 25 hours and 45 minutes post puncture and after 25 hours 45 minutes of room temperature storage.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Date the vial was initially stored in the refrigerator 24-Apr-2022.  The vial was first punctured on 25-Apr-2022 at 10:15 am, left out at room temperature all day and overnight and then administered a 2nd booster dose of the Moderna Covid-19 Vaccine from a vial that was 25 hours and 45 minutes post puncture and after 25 hours 45 minutes of room temperature storage. Vial did not undergo any temperature excursions.  Treatment information was not provided by the reporter.
Administered incorrect quantity of vaccine (only 0.3 mL). Called Pfizer to advise. Suggest to administer full amount of vaccine in opposite arm.
This spontaneous report was received from a physician referring to an 8 and a half weeks male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 20-NOV-2018, the patient was vaccinated with a dose of ROTATEQ per oral, lot # R002515 with expiration date 13-SEP-2019, for prophylaxis (strength was not provided).  On 05-DEC- 2018, the patient experienced three episodes of vomiting and diarrhea, was taken to the emergency room and received a dose of acetaminophen (TYLENOL). On 05-DEC-2018, a stool culture for rotavirus was performed an it was positive (rotavirus test positive). On the same date, the patient was sent home from the emergency room. On an unspecified date in December 2018, the patient went to the physician's office and he was fine (recovered). The causality assessment between the events and ROTATEQ was not provided.
Doses 7 months apart; Sore arm; Fever  of 100.8 F; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Doses 7 months apart), VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever  of 100.8 F) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever  of 100.8 F). On 25-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Doses 7 months apart). On 09-Jan-2021, VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever  of 100.8 F) had resolved. On 25-Aug-2021, PRODUCT DOSE OMISSION ISSUE (Doses 7 months apart) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature: 100.8 (High) 100.8F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  It was reported that the patient had an appointment to take his second dose on 25-Aug-2021.  Treatment information was not provided.
Sore arm, within 2 hours, fatigue within 6. Severe stomach cramps, vomiting, diarrhea, nausea,  headache onset at 35 hours. Fever of 100.2 and achy at 50 hours.
no other AE ocurred; VARIVAX was administered to a patient after improper storage/temperature excursion; This spontaneous report was received from a customer who was a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, or allergies were not reported.  On 06-JAN-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection dose 1, (strength, dose, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number T017686, expiration date: 21-MAY-2022) as prophylaxis. The vaccine administered experienced a temperature excursion of minus 12.5 degrees Celsius (C) for 11 hours and 10 minutes (product storage error), as recorded by a data logger. No other adverse effect (AE) occurred. Previous temperature excursion of minus 14 degree Celsius to minus 10 degree Celsius (minus 12 degree Celsius) for 2 hours and 30 minutes was reported.   .
pt recv vax 23JAN96 & 6FEB96 pt devel itchy, spots on face & back along w/chills;presented to clinic tx w/DPH;
Itchy arm. Location got hard and bigger, golf ball size.  Warm to touch.
light headiness, rapid pulse, cold hands, anxious: assessed, vital signs taken, water given: symptoms improved, pt went home
i started having joint pain in my left hip that may or may not be related to the vaccine since it came on 5 days later. I am also currently having stomach pains--mild..like cramping and gas off and on but regular bowel movements. I do feel as though I am having some sort of virus going through my stomach as it moves from the upper stomach to the lower right and back up again and no fever.
Patient was perfectly fine, was evaluated by the physician as a 6-year old checkup.  The vaccination was administered at approx 11:30 and by 12:30, she was becoming very hoarse.  By the time she returned home from school, she was very tired and was running a slight fever.  By bedtime her fever was 100.6.  She was awake every 1-1/2 hours or so all night long.  usually just to get a drink and then fell back to sleep.  I called the doctor the next morning and they had me bring her back in.  Her temp was 103.  They did a throat culture and after examining her, the doctor said she had croup.  He gave her a liquid steroid and told me to use a vaporizor for the next few nights.  Tylenol helped bring the fever down and she hasn't coughed at all.  She is still very hoarse and complains a little about a dry throat.  Therefore, I don't feel she has croup.  I think she is having a reaction to the vaccination.
Information has been received from a medical assistant concerning a 5 year old male who on 15-APR-2009 was vaccinated subcutaneously with a 0.5mL dose of VARIVAX (Merck) (LOT# 662577/0047Y). On an unspecified date after vaccination the patient experienced injection site redness and swelling. It also reported that unspecified medical attention was sought and the patient was recovered. A lot check has been initiated. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. (Complaint ID # 154674). This is one of several reports received from the same source. No further information is available.
This spontaneous report was received from a 63 years old female consumer regarding herself. No concomitant medications were reported. The patient reported that on 04-OCT-2012, after she was vaccinated with a dose of ZOSTAVAX (lot# and route not reported, product circular # 9989115) she had a large bruise and bleeding at the injection site and muscle soreness. She was worried that the needle hit her muscle since she was experiencing so much soreness and bleeding. At the time of this report the patient still has soreness and bruising at the injection site was worried that she did not get the protective dose of ZOSTAVAX. She thinks it was delivered into the muscle. She asked about titers and was told her that the prescribing information did not contain that data. She also gave the name of her healthcare professional (HCP) but did not want him to be contacted. No medical attention was sought. No treatment information was reported. Additional information has been requested.
Patient sat for 15 mins. While her and her mom were checking out at the register, she got really dizzy. We brought her a chair and she sat down and had cold chills and began sweating. After another 10-15 mins she began to feel a little better but still felt weak.
Pt describes pain and soreness to her left arm post vaccination. While she expected this as she has received vaccinations in the past, the pain and soreness has continued and increased to today (12/15/2016). Per pt she is taking anti-inflammatory's and is having difficulties lifting her arm above 90 degrees.
Case number PHEH2015US020568, is an initial spontaneous report received from a pharmacist on 13 Oct 2015. This report refers to female patient of unknown age. Medical history and concomitant medication were not reported. It was reported that the patient was vaccinated with FLUVIRIN (batch number: not reported) subcutaneously on an unknown date. No adverse event was reported following this maladministration.
Initially sore arm at injection site. Approx 24 hrs later arm still sore but also red, swollen and warm to touch in 1 and 1/2? diameter circle around injection site. still warm red swollen 3.5 days after injection.
REALLY SICK; IN BED FOR 7 DAYS; DIZZINESS; NO APPETITE; JOINT PAIN; NAUSEA; This spontaneous report received from a patient via social media  via company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The batch number was not reported. The company is unable to perform follow-up to request batch or lot number.  No concomitant medications were reported. The patient received non-company suspect booster vaccine BNT 162 (form of admin, route of admin, and batch number were not reported), dose and start therapy date were not reported for prophylactic vaccination (Dose number in series 2).   On an unspecified date, following BNT 162 (Pfizer) vaccination, the patient got really sick. From the next day the patient was in bed for 7 days with joint pain, nausea, dizziness and no appetite (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s and BNT 162 (Pfizer) was not applicable. The outcome of the events in bed for 7 days (captured as recovered), really sick, joint pain, nausea, dizziness, and no appetite was unknown. This report was non-serious. This case, from the same reporter is linked to 20211229714.
Flu shot - got shot - 3 days could not walk went to hospital it turned into Guillain Barr Syndrome. Could not walk for 3 months. Still don't walk too good. In hospital 15 days could not walk or move.
Red, swollen at injection site, rash, hard at injection site. Taken to urgent care- prescribed steroid- Prednisone 3ml for 5 days 2x a day.
Patient and dad came to the pharmacy asking for travel vaccines, and they decided to get 4 vacines each. On questionnaire they answered no to all questions and they weren't afraid or nervous at the time of administration. After patient got the vaccines when he went outside he started feeling dizzy, pale, and almost passed out. I went outside with one of my techs, we gave him alcohol pad to smell, lie down him on his back on one of our benches, and raised his legs. We also put an ice pack on his neck, and recommended him to stay down for about 15-30 min. We also offered him to call EMS.After 10 minutes he tried to sit and he was still feeling dizzy, and nauseated  and throwed up a little bit. We checked his blood pressure, was 100/58,pulse was 68.We recommended him to remain lie down on the bench for another 15-20 min. After 20 min more we checked his blood pressure again, it was still low 98/45,pulse was over 100,but he said he want to go outside, and that that has happened to him on the past but when seen blood. Dad was close to him all times. Then, dad decided to take him to the car, when he came back we asked him and the patient was feeling better.
The patient reports receiving her 1st Pfizer COVID-19 vaccine dose on 02/10/2021. She denies any significant issues after that dose. She received her 2nd dose yesterday around 8:45 a.m. By 4:30 p.m. she had developed an acute lymphadenitis in her right axilla with a 4 cm tender node.
Several belly aches, Back/neck pain, fatigue, and low grade fever (max 100.2) for 2-3 days.
NO ADVERSE EVENT.  Reporting only clinical deviation from current COVID-19 vaccine schedule.  Booster #1 given too early at 10 days prior to 5-month mark from Primary Dose #2.  Patient felt OK after observation period and stated she felt OK on follow-up next day.
When I got J and J, it was 30 hours of yuck, Moderna booster a year ago was 56 hours of yuck; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (When I got J and J, it was 30 hours of yuck, Moderna booster a year ago was 56 hours of yuck) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis.    Previously administered products included for Product used for unknown indication: Shingles vaccine (Patient had received both shingles vaccine doses and had side effect for 2.5 days each.) and Shingles vaccine (Patient had received both shingles vaccine doses and had side effect for 2.5 days each.). Past adverse reactions to the above products included Adverse event with Shingles vaccine and Shingles vaccine. Concomitant products included INFLUENZA VACCINE for an unknown indication.   In 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (When I got J and J, it was 30 hours of yuck, Moderna booster a year ago was 56 hours of yuck). At the time of the report, IMMUNISATION REACTION (When I got J and J, it was 30 hours of yuck, Moderna booster a year ago was 56 hours of yuck) had resolved. Not Provided          It was reported that the only vaccine from which patient didn't got any side effects was the annual Flu vaccine. Patient had experienced general side effects after Janssen and Moderna vaccinations.   The causality of the events wrt to Janssen vaccine was related as possible.   Treatment drug information was unknown.