chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (refer case US2018147888). On 7th August 2018, the patient received the 2nd dose of SHINGRIX. On 7th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, general body pain, chills, injection site warmth and joint pain. On an unknown date, the outcome of the injection site pain, injection site swelling, general body pain, chills, injection site warmth and joint pain were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, general body pain, chills, injection site warmth and joint pain to be related to SHINGRIX. Additional details were provided as follows: The patient received her 2nd SHINGRIX dose on 7th August 2018 at the doctor's office and the patient experienced a pain as the needle was injected. The patient experienced a sore arm which was hot to the touch and the injection site appeared swollen. The patient also experienced an achy feeling all over with joint pain. The patient reported being chilled, and needed a hot water bottle and wrapped in blankets to alleviate, the patient also reported shaking from being so chilled. The events began to improve a few days later, and at day 5 post injection events had resolved. This case has been linked with case US2018147888 reported by the same reporter for the same patient.
Day after shot - period started early very heavy. Two days after shot experiencing brain fog, very dizzy feeling like I may pass out.
This patient was given an 12yr and older dose of Pfizer instead of the dose for 5-11yr olds. Patient had no reaction, illness or any effect. with the mandatory 15 min waiting period. It was not realized until after the patient had left the building  that she had been given the incorrect dose/vaccine.  Parents were contacted by a physician and was informed and counseled. Patient had no late reactions, illness's or effects and no further action was taken.
Moments after flu shot, while observing my younger child receive his shot, I turned to notice my daughter unconscious on the floor of the cafeteria where the shot was administered.  Blood was pooling around her face.  Her eyes were rolled back in her head.  She was unconscious and unresponsive.  Her jaw was clamped shut.  Her back was arched with her chest forward.  Her entire body was stiff.  She was white.  She was not breathing.  911 was called.  She was unresponsive for nearly 30 seconds from when it was noticed she was on the ground.  She jumped to her feet.  She didn't know who or where she was.  She was solid white and her pupils hadn't returned.  We then realized that significant damage had been done to her teeth.  The 2 front adult teeth were broken off.  We were not able to find them.  She was transported to Hospital of via paramedic level ambulance.
11x18 cm area of well demarcated erythema over R deltoid area.  Warm to touch.  Small papules on the surface- Treated with KEFLEX.
COVID-19 Breakthrough Case leading to prolonged hospitalization  Fully Vaccinated Moderna: 4/2/21 & 4/23/21  The case originally began with COVID-19 symptoms on 10/26/21. Case symptoms: nasal congestion, difficulty breathing, and confusion in mental status. Case's wife informed LHD that the case was admitted to Medical Center, 10/28/2021 due to nasal congestion, difficulty breathing, and confusion in mental status. He is being treated for fluids in his lungs from COVID-19.  The patient developed pneumonia.   Information from staff @ Health Department (11/12/21 at 12:36pm): Spoke to patient. Patient was admitted for rib pain and shortness of breathe. Patient was diagnosed with pneumonia. Chest xray showed acute right upper lobe aspiration. Patient has yet to be discharged as of 11/12.  Information from staff @ Hospital  (11/15/21 at 9:15am): The case was later transferred to Medical Center on 11/12. PCR positive on admission 11/12. Admitted to Medical Center 10/29 for COVID pneumonia. At discharge, patient fell, injuring spine and transferred to MC.  Did the patient have ARDS? No Did the patient have an abnormal chest x-ray? Yes Did the patient have an abnormal EKG? N Did the patient receive ECMO? N ICU? N Mechanical ventilation (MV)/Intubation? N
Information has been received from a physician concerning a female between 15 and 16 years old who was vaccinated with a 0.5 ml dose of HPV vaccine (yeast). After receiving the vaccine, the patient fainted. Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown. No product quality complaint was involved.  Additional information has been requested.
NEVER BEEN THE SAME; This spontaneous report received from a patient via a company representative from social media concerned a male of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced never been the same. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of never been the same was not reported. This report was non-serious.
Fever up to 102 degree F on 10/15/18 about 2100. Had fever, headache, body aches, and nausea until 10/17/18. Continued until MD gave me Prednisone 20mg. Systemic reaction then stopped, but arm continued to be red and itchy. (L) arm injection site became hard, red, and hot to touch. Site was about the size of a softball at the time, from Monday until Wednesday night.
feet and lower leg became very red and very itchy in the night. by morning only toes blotchy red and itch gone.
I got up on 01/16/2022, I did not remember anything. Everything was a blur. I went to ask wife questions and was evaluated by son who a physician is. I was told to go to hospital and was evaluated by ER doctor. Did a CT scan and an MRI. Was kept overnight and diagnosed with having a stroke.
This case was reported by a other health professional via call center representative and described the occurrence of swelling of fingers in a 84-year-old female patient who received SHINGRIX for prophylaxis. On 10th December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, 5 days after receiving SHINGRIX, the patient experienced swelling of fingers, numbness in fingers and grip strength decreased. On an unknown date, the patient experienced serum total protein increased. The patient was treated with Steroid (Not Specified). SHINGRIX was discontinued. On an unknown date, the outcome of the swelling of fingers, numbness in fingers, grip strength decreased and serum total protein increased were unknown. It was unknown if the reporter considered the swelling of fingers, numbness in fingers, grip strength decreased and serum total protein increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 83 or 84 years old. The patient developed extreme swelling in the fingers of both hands, fingers were so numb and difficult to handle objects. The patient had an emergency room visit and was given steroid and the symptoms resolved then came back. The patient visited a different Doctor of Medicine (MD) and they did know what it was, but drew blood and found elevated blood protein. The patient was not going to get the second shot of SHINGRIX and would like to find out more information. At the time of reporting, the patient's initials and date of birth and SHINGRIX vaccine batch number and expiry date were unknown. Lab Comments: On an unknown date, the patient had elevated blood protein.
Injected patient and about 2 minutes later he started became distressed.  He was moaning and said he didn't feel well.  I went to sit next to him and he stated that he had blurred vision and couldn't see. He also stated that his hearing was muffled.  I guarded him while he sat to make sure he did not fall over and injure himself.  Soon after he became nauseated and vomited two to three times.  Almost immediately he felt better and recovered quickly.  I offered a bottled water for him to sip on.  I called his mother to advise of Pt's condition.  I kept Pt a total of about 30 minutes after the incident. I called mother and she spoke to pt. and they agreed it was okay for him to leave. EMS was not alerted nor did Pt need any First Aid or CPR. I called Pt and spoke to him at 5:00 PM this evening and he was feeling well.
After first shot my daughter had mild fever (101) that lasted one day.  She is a kid who typically runs warm -99-100.   Almost immediately after 2nd shot she was lethargic and mild fever. Gave her motrin.  She woke up the night of shot in the middle of the night with very high fever. Gave her water, cold cloth, motrin etc and fever came down to 101-102 and persisted for 2 days.  She spontaneously vomited around 48 hours after the shot over the course of 1 hour.   Within 4 days she was fine.   I just wanted to report her side effects because her side effects seem atypical compared to most other kids side effects, at least anecdotally and based on what I read to expect online.   Had I known such a high fever was possible I would have kept her fever reducers consistent and not let them lapse the night after shot.
Knot at site of injection developed and has persisted, has enlarged over time and persists 1 year later when re-evaluated on 9/23/2014.
While providing covid-19 vaccines. I administer a vaccine to the patient at 10:01 am without incident and the child sat down in the observation area. One minute later the child was observed with jerky movements of upper and lower extremities. Myself and another nurse assisted the child in the supine position and stayed monitoring her.911 was called along with the child's mother and teacher. After 3 minutes, the child regained consciousness and she was assessed for safety. Vital signs taken: BP: 92/60, Pulse: 94. Child was alert and oriented times three. Child mentioned she had not eaten that day. The paramedics arrived at 10:17 am and took over child's care. Mother arrived at 10:21 am and accompanied child to hospital via paramedics
14hr p/vax pt woke up w/very sore arm @ inj site;pt had chills & a terrible h/a that got progressively worse;had trembling, felt cold, had aT101.1;had diarrhea, hyperactive bowel sounds, lungs clear;T went down to 100.6 & felt better;
Pt. states that after receiving the 3rd dose of Moderna 12/15/2021, started experiencing symptoms 12/16/2021 of jaw swelling (Left) and swelling lymphnoids throughout the neck. Primary visit 12/16/2021, recommendation of Steroid shot for swelling along with At-Home compress to reduce swelling. Pt. still experiencing symptoms.
Tested positive for COVID after vaccines; tested positive for COVID after vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years, as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 1, single (Batch/Lot number: unknown) and (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 16Apr2022, outcome "unknown", described as "Tested positive for COVID after vaccines"; COVID-19 (medically significant) with onset 16Apr2022, outcome "unknown", described as "tested positive for COVID after vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Apr2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd vax & devel a full-body rash approx 18 days later;No further details were provided;
Black out; Bloody head; Bloody nose; Very dizzy; Could not walk; felt unusually tired for mid afternoon that day; A spontaneous report was received from a consumer concerning a 55-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt unusually tired for midafternoon/fatigue, experienced a black out/loss of consciousness and woke up face down with a bloody nose/ epistaxis and head/head injury, was very dizzy and couldn't walk/gait inability.  The patient's medical history was not provided. Concomitant medications included dolutegravir sodium;lamivudine, pregabalin, and modafinil for unknown indication.  On 19 Feb 2021, approximately two days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 21 Feb 2021, after receiving mRNA-1273, the patient felt unusually tired for midafternoon that day. The patient had suffered from chronic fatigue issues but never felt more tired than usual at that point in the day. The patient then experienced a black out and woke up face down with a bloody nose and head. The patient felt very dizzy, was not able to walk and crawled to their mattress and fell asleep. The patient managed to get himself to the Emergency room, a CT scan of the head was performed, and it was revealed that the patient had a fracture that had occurred before the vaccine and was not related to the vaccine. The doctor thought the vaccine however maybe related to the blackout or have exaggerated a concussion and have caused these delayed symptoms. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the event experienced a black out was resolved at the time of this report and the outcome of the events, felt unusually tired for midafternoon, woke up face down with a bloody nose and head, was very dizzy and couldn't walk was not reported.; Reporter's Comments: Based on reporter's causality and patient's skull fracture that had occurred before the vaccine the event is assessed as unlikely related to mRNA-1273.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-057947:Second Dose Case
Ringing in ears starting 2 days after vaccine.  Lasted about 3 weeks.
Information has been received from a physician's assistant concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot#650453/0791P).  Subsequently the patient developed a fever, and injection site swelling, pain and redness.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  The reporter expressed a concern about the lot number.  No product quality complaint was involved.  The records of testing prior to release of this lot have been checked by the Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released. In addition, a review of Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill.  Additional information has been requested.
Localized erythema at site of injection 4 x 14 cm of the PNEUMOVAX.
Was diagnosed with covid virus; Was diagnosed with covid virus; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported that a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Just before the second dose, the patient was diagnosed with COVID virus. It had been about 90 days and the pharmacist wanted to know if they can give the second dose or does patient have to start over with the first dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Injection site red, warm to touch, very sore and tender even to front and down arm and upward thru neck day after shots. Given antibiotics as preventative. PNEUMOVAX 23 and FLUVIRIN MDV in (L) arm.
I had a rash on the inner arm and on my hands. I took a Benadryl, and then the rash started to recede.
fainted; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to Moderna on 11-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.    On 26-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (fainted). At the time of the report, SYNCOPE (fainted) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported. The patient received both doses and one was on 26 May 2021. The patient stated that between 7-10 days post vaccine he fainted 3 times in one day. He was concerned that this might happen to him again, but he doesn't know for sure when and this was causing him lot of frustrations. As a healthy man he doesn't think he should faint from getting a vaccine. He also stated that the pharmacist told him there was no reason for him to get side effects from the moderna vaccine since he was a health man.  Very limited information regarding this event has been provided at this time. Further information has been requested. Patient medical condition may be of relevance regrading the event occurrence.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Patient medical condition may be of relevance regrading the event occurrence.
AFTER RECEIVING FLU INJECTION, PATIENT HAD AN IMMEDIATE HEADACHE, BLURRED VISION.  BLURRED VISION LASTED APPROXIMATELY ONE HOUR.
Pt. says arm is still sore and she cannot lift it above her head. Pt. will see MD Tue 11/8.
Pt marked on VAR that they have gotten dizzy in the past from vaccinations, she said she has never fainted but has gotten dizzy after some vaccines and blood draws. Pt received vaccination and said she was feeling fine. Pharmacist walked pt out to waiting chair and went into pharmacy. A few minutes later another customer alerted pharmacy staff that the patient slumped over and passed out in the chair. By the time the pharmacist ran out she was alert again. EMT's were called and the pt decided to go to hospital because her blood pressure was low and she was still feeling faint. Pt returned to pharmacy a few hours later to pick up her prescription and said she felt fine.
Sharp pain in right side of abdomen near appendix; bloating; distended abdomen; flatulence. Discomfort began 3 hours post vaccine.  Peak discomfort lasted for 10 hours.  Subsided  overnight. Almost gone 20 hours post vaccine. Alka Seltzer & Tums
Information has been received from a nurse and a physician concerning a female (age not reported) who, on an unspecified date, was vaccinated with a 0.5 mL dose of GARDASIL into the gluteal.  There was no concomitant medication.  Subsequently, the patient developed notable pain at the injection site.  Outcome was not reported.  The patient sought medical attention in the office.  Additional information has been requested.
I received the shot in the left arm. Sat for 15 minutes with staff and felt perfectly fine. Started to drive home and in 5 minutes began to feel tingling in mouth, tongue, lips face and itching in throat. Kept checking lips and tongue to see if they were swelling,  (which they were not). Event lasted about 15-20 minutes and then subsided after 40 minutes. Itching in throat lasted 24 hours. Whole body felt itchy the next few days.
Episode of high fever (104.5 R), mottling, problems breathing, no sz; taken to ER & observed, d/c w/no tx;
R deltoid swelling at injection site; erythema, warm to touch; swelling from R deltoid to elbow; seen in ED - dx cellulitis; crusting at injection site; PO Keflex rx by ED for 10 days; per father, has resolved as of 12/14/15.
PT RECEIVED FIRST DOSE OF MODERNA. PARENTS WERE GIVEN CONSENT FORM. PARENTS UNDERSTOOD THE RISK. APPROVED BY MEDICAL CONSULTANT
joint swelling/pain; joint swelling/pain; mild fever (99.4-99.9); Chills; Nausea; Headaches; Body aches; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 42-year-old male patient received bnt162b2 (BNT162B2, formulation; solution for injection), via an unspecified route of administration on 19Feb2021 10:00 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE (at the age of 42-year-old) for covid-19 immunisation. Medical history included high blood pressure, sleep apnea and Known allergies: Gluten, some melons from an unknown date and unknown if ongoing. Concomitant medication included metoprolol succinate taken for an unspecified indication, start and stop date were not reported (received within two weeks of vaccination). The patient had not received any other vaccine within 4 weeks. The patient experienced mild fever (99.4-99.9), chills, nausea, headaches and body aches on 19Feb2021 at 19:00. The patient experienced joint swelling/pain on 22Feb2021 (on day 4). Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID since the vaccination. No treatment received for events. The patient underwent lab tests and procedures which included body temperature: 99.4-99.9 on 19Feb2021. The outcome of events reported as recovered in Feb 2021.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Injection date: 6/13/2003 Pain at injection site: 6/13-30/03, 7/2/03-present. Swelling at injection site: 6/16-23/2003.
Patient received expired vaccine. Expired 3/26, received 3/30. Patient will not seek revaccination.
After arriving home from the doctor patient was fussy and tired. She refused to eat anything and was lethargic. Around 5:00pm she felt warm, so I took her temperature. Her fever was 100.6°. She suddenly started throwing up profusely and having diarrhea at the same time. I thought she was done and got everything out of her system when she started to throw up more. By now it was 6:00pm and she couldn?t keep her eyes open. She normally goes to sleep around 7:30pm, so it was early for her to be so tired. I put her to sleep in her crib. Around 9:30pm she is woke up screaming and throwing  up in her crib and also had diarrhea in her diaper. I took her temperature and it was 101.6. I gave her children?s Tylenol for the fever and she went back to bed 90 minutes later. The next morning she had  an 100° temperature and had diarrhea throughout the day, no appetite, and was lethargic.  We monitored her temperature all day and it stayed around 99.5°, but jumped to 101.1° around 6:00pm.  Around 7:00pm she threw up again. The next day she still had diarrhea and her temp was around 99.9°.