chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in an unspecified number of adult patients who received Shingrix for prophylaxis. On an unknown date, the patients received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patients experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were unknown. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix. Additional information received as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected adult as per vaccine indication. The 6 to 7 patients experienced large red fist size bulls eye at injection site. The reporter agreed to follow up from GlaxoSmithKline. This was 1 of the 4 linked cases reported by the same reporter.
no adverse event but received the wrong vaccine.  Should have received the Pfizer Bivalent
Information has been received from a Registered Nurse referring to a 4 month old male patient. On 25-MAR-2016 at 16:08, the patient was orally vaccinated with his second improperly stored (Temperature: 32F - Time Frame: 5 minutes) dose of ROTATEQ (lot # L013202, dose was unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Shot administered Wednesday morning. Sore arm, but not particularly bad. Thursday and Friday I was feeling a little fatigued, and took a nap (very unusual for me) Friday. That night i felt a little strange, light-headed.  Saturday around 10 AM I developed a moderate headache, and then was mildly short of breath, and most concerning, a little bit of afib. My heartbeat was steady (nothing like the afib I first had about seven years ago or so), but I missed about seven or eight beats in a minute (my pulse is usually around 60). That was not regular. My wife thought I might be having a migraine (I have had about five in my life), but if so it was very mild. On her advice I had about a quart of water over a couple of hours, and both symptoms resolved. Currently fine.
Pain at injection site on upper left arm; high part of shoulder; pain radiated down entire left arm for 5 days including pain in muscle of left arm above the elbow; including pain in left wrist; all of the side effects were not present prior to the vaccine which I received at medical center.
No s/s- Treatment consist of informing pt's mother-we called family next day to check on child was reported to be fine. Without s/s of fever or redness (L) arm.
Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days; Administered moderna vaccines beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccines beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Products were reported.  It was mentioned in the report that the vaccines were tend to store with 1 to 3 bottles in the fridge to thaw out and to be ready for the patients when needed and at worst scenarios vaccines would have been in the fridge for about a week if no one came in to be vaccinated.  No Treatment information was reported.
My mother received a flu shot and a pneumonia shot, in different arms, during a regular annual visit to her physician. Ever since, she has been experiencing intense pain in both arms, and even three weeks later she is unable to lift them more than slightly and has difficulty driving, getting dressed, cooking and other activities of daily living. She has started going to the chiropractor and she is taking NSAIDs to help with the pain, but to minimal effect.
Nearly fainted after GARDASIL #1 (After watching sister faint). Recovered within 10 min of laying down - Did not lose consciousness.
At 2:08PM the client stated it was "hard to swallow." Vitals obtained at 2:09PM were as follows: BP 158/98, HR 106, O2 98%. RN offered the client Benadryl IM. The client agreed. RN responded for additional support. The client reported that her "mouth is dry, and it's hard to swallow." The client consented to receive Benadryl IM. RN administered Benadryl 50mg IM (Lot# 020020 exp 02/2022) in the left deltoid at 2:12 PM. The client denied any shortness of breath or dizziness. Reported that her throat was very dry. Repeat vitals obtained at 2:15PM were as follows: O2 95%, HR 98%. The client stated she began to feel saliva in her throat and reported "struggling less to swallow." At 2:18PM the client requested water and stated her throat felt better. RN advised the client to take only a small sip of water. The client reported being able to swallow the small sip of water without difficulty. Blood pressure obtained at 2:19PM was 136/86. At 2:21PM the client reported "a little bit of dryness, the saliva is back." Repeat vitals obtained at 2:24PM were as follows: BP 140/96, HR 96, O2 95%. The client reported "normal dryness" of her mouth and throat. Repeat vitals obtained at 2:30PM were as follows: BP 142/88, HR 96, O2 96%. The client reported that the dryness continued to feel normal and the client denied any other symptoms. RN provided education regarding s/s of anaphylaxis, when to seek EMS, and to follow up with a doctor regarding her blood pressure. The client voiced understanding of this education. Repeat vitals obtained at 2:40PM were as follows: BP 142/88, HR 96, O2 95%. The client denied any current symptoms and stated that the dryness felt normal. The client stated her mother was outside and was going to drive the client home. The client stood up from the anti-gravity chair and ambulated unassisted with a steady gait out of the observation area at 2:42PM.
A number of pt got sick p/vax; had sx of swollen inj site 910" in diameter), tachycardia, resp distress, fever of 103, chills & shoulder pain for 7 days;
Initial report received from a healthcare professional on 29 October 2014. Based upon follow-up information received on 20 January 2015, the event has been upgraded to serious. A 71-year-old female patient had received an intramuscular first dose of FLUZONE HD, (batch number U5042AA, expiry date 14 May 2015) in left deltoid on 08 October 2014. The patient's illness at the time of vaccination was not reported and had no history of allergies. It was stated that the patient had not previously ever received FLUZONE HD, but has had several standard Flu vaccines. On 08 October 2014, "a couple of hours" after vaccination, the patient experienced fever, pulse of 110, and chest pain. The patient was sent to emergency room and evaluated by physician which showed no diagnosis, no findings at ER, and was discharged home. Complementary investigations and treatments were not reported. On an unspecified date, the patient had recovered. Follow-up information for this unsolicited case was received from a physician on 20 January 2015. Based upon this new information, which contains emergency room records, the case has been upgraded to serious. The patient's medical history included COPD, hypertension, type 2 diabetes, nausea, hyperlipidemia, rheumatoid arthritis, fibromyalgia, GERD, hypothyroidism, gout, and irritable bowel syndrome. She was a former smoker, and was allergic to DILAUDID and chocolate. Concomitant medications included lisinopril, gabapentin, hydralazine, COREG, allopurinol, colchicine, ocular lubricant, latanoprost, ADVAIR, multivitamin, mometasone, vitamin D, omeprazole, atorvastatin, zolpidem, SYNTHROID, metformin and TYLENOL. The patient denied symptoms prior to vaccination. Shortly after vaccination, she experienced fever with chills, rigors, shortness of breath, chest tightness, right lower quadrant pain, nausea, and severe headache. She presented to the emergency room, where diagnostic testing, including white blood count, lactic acid level, urinalysis, CT of the abdomen, and Influenza testing, were all negative. A chest x-ray showed some atelectasis, but was otherwise negative. Temperature in the emergency department was 39.3 degrees C. Review of symptoms revealed weakness and tiredness, chest tightness, right lower quadrant abdominal pain, nausea, and generalized soreness. Physical exam was essentially normal. The assessment was that the patient had "possible vitals fever", likely an episode of fever following Influenza vaccination with no evidence of active infection. The plan was to observe the patient and offer supportive care, and then discharge once her fever improved. According to the reporter, the event recovered on 10 October 2014. Documents held by sender: ER record.
redness; rash; This case was reported by a other health professional via call center representative and described the occurrence of erythema of extremities in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 29T59, expiry date 1st October 2021) for prophylaxis.   On 22nd July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 24th July 2019, 2 days after receiving Shingrix, the patient experienced erythema of extremities and rash. On an unknown date, the outcome of the erythema of extremities and rash were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities and rash to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in left arm. The patient reported that a patient received the first dose of Shingrix and this morning she noticed, approximately two inches from the injection site, redness with a rash. The reporter had consented to follow up. There was discrepancy in the age group reported in source document (infant) and in database it was elderly as per DOB, also there was discrepancy in the outcome of the event, in the source document it was reported as recovering/ resolving and in the database it was reported as not recovered/ not resolved.
15 after vaccine, person describes pain radiating to head/wrist (L) arm - Tdap. No redness noted. Advised to seek medical attention due to controlled epilepsy. F/u 10/6/11 reports MD Dr possible minor reaction to Flu.
A 91 Y.O FEMALE RECEIVED COVID-19 VACCINE ON 01/05/21 AT 11:30AM. FOUR DAYS AFTER THE VACCINATION ON 01/09/21 AT 3:15 PM, SHE CALLED HER DAUGHTER AND TOLD HER THAT HER MOUTH WAS NUMB, LEFT SIDE OF THE MOUTH WAS DROOPING, SO AS HER EYLID. AT ABOUT 5 PM THAT DAY, PATIENT ARRIVED IN TMH ER VIA AMBULANCE. ER DOCTOR RULED OUT HEART ATTACK OR STROKE. PATIENT WAS DIAGNOSED WITH BELL'S PALSY. WAS SENT BACK TO WESTMINSTER OAKS THAT DAY WITH CORTICOSTEROID AND EYE OINTMENT THAT WAS PRESCRIBED BY THE DOCTOR. (INFORMATIONS REPORTED TO ME BY THE DAUGHTER AND THE PATIENT HERSELF) AS OF 01/19/21, PATIENT IS STILL RECOVERING. SPOKE WITH THE PATIENT TODAY  01/19/21, PATIENT STATE SHE STILL HAS THE SIGNS AND SYMPTOMS OF THE BELLS PALSY, BUT SHE SAID SHE'S GETTING BETTER. SHE ALSO STATES THAT TODAY IS THE LAST DAY OF HER CORTICOSTEROID TREATMENT.
Tingling pressure in the head; Brain fog; Difficulty with word finding; Lightheaded/ dizzy; Headache, head pressure; Fatigue low energy; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling pressure in the head), FEELING ABNORMAL (Brain fog), APHASIA (Difficulty with word finding), DIZZINESS (Lightheaded/ dizzy) and HEADACHE (Headache, head pressure) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Egg allergy (Egg sensitivity). Concomitant products included ZINC, WITHANIA SOMNIFERA (ASHWAGANDHA [WITHANIA SOMNIFERA]), VITAMIN B COMPLEX (B COMPLEX (B50)) and MAGNESIUM for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PARAESTHESIA (Tingling pressure in the head), FEELING ABNORMAL (Brain fog), APHASIA (Difficulty with word finding), DIZZINESS (Lightheaded/ dizzy), HEADACHE (Headache, head pressure) and FATIGUE (Fatigue low energy). On 17-Mar-2021, PARAESTHESIA (Tingling pressure in the head), FEELING ABNORMAL (Brain fog), APHASIA (Difficulty with word finding), DIZZINESS (Lightheaded/ dizzy), HEADACHE (Headache, head pressure) and FATIGUE (Fatigue low energy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow - up was received on 22-Jun-2021 contain significant information.New reporter was added, updates of patient demographics, medical history and added Concomitant medications, vaccine batch/lot number, Outcome of the events unknown to recovered /resolved.
Pt got only adjuvant portion; Pt got only adjuvant portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number ce45h, expiry date 1st October 2022) for prophylaxis.   On 11th November 2021, the patient received Shingrix. On 11th November 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not mention if it was regarding 1st or 2nd dose of Shingrix. The reporter consented to follow up.
The second day after the shot I experienced muscle aches, fever of 103, chills, nausea and abdominal pain. This went on for 2 to 3 days after the vaccination.   The fever and chills went away after a few days but the abdominal pain did not? I kept feeling lots of pressure in my upper abdominal area. I started throwing up stomach acid and bile and had a hard time keeping any food down.  I then went to the emergency room at Hospital on 9/8/2021. They started mixing Covid negative patients with Covid positive patients, there were dried blood stains in the waiting area after triage, it was very obvious that the people there were overworked and understaffed and the patients were paying the price for it.  I tried to call  ER hospital in the same area and they said they were so packed with Covid patients that they could not help me. As was a smaller ER.  I couldn?t stop throwing up at the ER but I also didn?t want to be surrounded by Covid positive patients so I left the ER due to the fact that they told me they couldn?t run the CT scan they wanted for another five hours because they were busy and also another nurse told me that they straight up did not have room for me to begin with.  The following day I made an appointment with my primary care provider. He gave me a bunch of medication for acid reflux and that was about it. He told me it would probably be best for me to try and follow up with a gastroenterologist for more in-depth help.  I am still waiting to see gastro as we speak. My blood pressure has been up and down and I am still sick to my stomach with upper abdominal pain.
This spontaneous report was received from an administrator of vaccine, referring to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with one dose of improperly stored ROTATEQ (lot# M032643 with expiration date 04-MAR-2018; route, dose unknown) for prophylaxis. The vaccines were exposed to temperature excursion of 32 up to 35 (33.8) degrees Fahrenheit for 34 minutes, 32 up to 35 (35) degrees Fahrenheit for 5 minutes, 47 up to 77 (47.6) degrees Fahrenheit for 3 hours and 27 minutes, 32 up to 35 (35) degrees Fahrenheit for 5 minutes, 47 up to 77 (49.1) degrees Fahrenheit for 23 hours and 50 minutes, 47 up to 77 (48.7) degrees Fahrenheit for 24 hours, 47 up to 77 (49.4) degrees Fahrenheit for 9 hours and 47 minutes. No adverse effects were reported. There were no previous temperature excursions. Data logger was involved. No product quality complaint (PQC) was involved in this case. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1801USA009598.
CHILLS, FEVER, LEG PAIN GETTING WORSE, NAUSEA, RASH, BODY ACHES
Chills approximately after 6 hours, fever after 8 hours gradually increasing through the night to reach 104. Chills, sweats, vomiting lasting all night. Fever went down to 102.5 after 12 hours, subsiding after 24 hours. No medication taken to reduce the fever. Fatigue and nausea lasted 48 hours.  It was the first time I had a flu shot combined with another shot, and I think it maybe why I had such a strong reaction. I did not have strong reactions to the 1st and 2nd Covid vaccines (both Moderna), ans I usually do not have a reaction to the flu shot except for a sore arm for a few days.
About five days after receiving the Moderno booster, I began experiencing random itchy spots on my skin. Thinking it was just allergies or a dry skin I ignored it, until three days later I started breaking out in random batches of hives all over my body. The hives were hot, stinging and extremely itchy. For the first week they did not respond to antihistamine pills like Zyrtec or Claritin and I was beginning to get desperate. I started doing online research about what might be causing them and trying to remember what I had done differently to start experiencing them. I have no previous health conditions, no unknown allergies, I had done nothing differently to my skin, and had not started using any new soaps or shampoos, etc.  I contacted an online doctor, and showed them pictures of my hives. They agreed it indeed looks like an allergic reaction to some sort of substance and recommended I continue on the anti-histamines or seek further help from an allergist. Due to having poor insurance I decided to wait it out a few more days. Fortunately after about a week and a half the antihistamines seem to start helping. They seem to take the hives away at least 60 to 70%.  I have been continuing them since. A couple times I have purposely not taken my Claritin pill to see what happens, and like clockwork the hives return within 24 hours if I do not take an allergy pill. Right now I am able to cope because the antihistamine pills seem to work as long as I take them faithfully. That I am frustrated and concerned that this even has to happen. I have never had hives in my life. At first I did not even know what these patches of redness were . I have racked my brain trying to think of what could?ve caused them, and it finally dawned on me the only thing that I had done substantially different in the days following my hives outbreak was get the Moderno booster shot. The first two shots did not bother me and I had zero side effects so it never dawned on me that it could have been the booster. But after doing further research online and finding several blogs and posts from other people in their 20s, 30s, and 40s having the same mysterious outbreak after the booster specifically, I knew that?s what it had to be. All of them were like me, no previous health conditions or allergies and in perfect health.  I am not anti-VAX by any means, obviously I got all three shots and I?m fully vaccinated with all the others. I am however frustrated that this is not a listed side effect since so many people are apparently struggling with it, and I?m now concerned that the booster has had a negative affect on my immune system.  I will be opting out of all future COVID-19 booster shots for this reason and it will be informing friends and family of this reaction, since they can all obviously see it since now I have a red giant unsightly blotches all over my neck, face and body..
Patient had a reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient had a reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient had a reaction). At the time of the report, VACCINATION COMPLICATION (Patient had a reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment medications were reported
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Nausea, flu-symptoms, body aches the day after vaccine was received, then went away after 1 week. Then all pain went to back, and has not gone away.
Pt experienced a decrease in appetite, poor fluid intake, fretfulness, drowsiness and fever of 105.
Patient said shortly after vaccination had following sx: 1. Blurry vision, 2. Numbing forearm, 3. Numbing arm and leg (left) vision got better shortly after forearm also, leg and arm (left) was also getting better. Patient left and said would call if needed.
L deltoid large area of induration, swollen, epi pen 6-10cm diameter.
PATIENT GOT HIVES 2 DAYS LATER SHE TOOK CLARITIN FOR IT AND IT WENT AWAY THEN TODAY 3/1 HER FACE WAS RED AND WARM.