chrisvoncsefalvay/vaers-outcomes huggingface dataset:
an aftertaste in his mouth; the headache got worse despite taking Tylenol.; nausea; headache; Body soreness in his arms & legs; fever; body aches / body soreness in his arms & legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Body soreness in his arms & legs), DYSGEUSIA (an aftertaste in his mouth), HEADACHE (the headache got worse despite taking Tylenol.), PYREXIA (fever) and MYALGIA (body aches / body soreness in his arms & legs) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Janseen & Janseen vaccine (Janssen as his primary vaccine on 10Apr2021) on 10-Apr-2021. Past adverse reactions to the above products included No adverse event with Janseen & Janseen vaccine.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced PAIN IN EXTREMITY (Body soreness in his arms & legs), PYREXIA (fever) and MYALGIA (body aches / body soreness in his arms & legs). On 12-Dec-2021, the patient experienced HEADACHE (headache). On 13-Dec-2021, the patient experienced DYSGEUSIA (an aftertaste in his mouth) and NAUSEA (nausea). 13-Dec-2021, the patient experienced HEADACHE (the headache got worse despite taking Tylenol.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in December 2021 for Headache, Fever and General body pain, at a dose of every 6 Hr; PARACETAMOL (TYLENOL [PARACETAMOL]) on 12-Dec-2021 for Headache, Fever and General body pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) on 13-Dec-2021 for Headache, Fever and General body pain, at an unspecified dose and frequency. On 12-Dec-2021, HEADACHE (headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Body soreness in his arms & legs), PYREXIA (fever) and MYALGIA (body aches / body soreness in his arms & legs) was resolving and DYSGEUSIA (an aftertaste in his mouth), HEADACHE (the headache got worse despite taking Tylenol.) and NAUSEA (nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   NO Concomitant drug reported.
was inadvertently administered a dose of PROQUAD instead of a dose of MMR II; was inadvertently administered a dose of PROQUAD instead of a dose of MMR II; This spontaneous report was received from a medical assistant referring to a 52-years-old patient of an unknown gender. Concomitant medications included sterile diluent. Information about the patient's pertinent medical history, previous drug reactions and allergies were not provided.   It was reported that on 10-JUL-2019, the patient was inadvertently administered a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) by subcutaneous route, in the right arm, for prophylaxis, lot number R026350 and expiration date 15-MAR-2020; instead of a dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) lot number and expiration date were not provided (interchange of vaccine products and wrong product administered). By the time of the report, the patient's outcome from the event was not provided.  The causality assessment between measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) and the occurred event was not provided.
Large area of erythema near the site of injection appeared with multiple vesicular lesions.  2 days later the lesions have crusted and scabbed over, however a more dissemineted rash began to appear covering my son's back, face, and chest.
Diarrhea, sweats, fatigue,  head feels woozy and light headed , low blood pressure, stomach cramps
Initially:  Severe arm pain at the site immediately and then within minutes of vaccine: hearing loss and then tunnel vision to vision loss to feeling that could pass out: Hearing and vision came back in about 5-10 min and with taking off sweatshirt at that time  12 hours later: 101 fever and chills
Raised hot sore large hive under injection site 8 days after vaccine #1 Same reaction on different arm 2nd dose.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 24-OCT-2013, the patient was vaccinated with ZOSTAVAX (lot # J000433 and expiry date 11-APR-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would had been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his records didn't indicate when he received each lot but he was calling further for the data. He also could not identify, at this time, which Lot# was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
8/01/21  0100: severe abdominal pain 8/01/21  1000: went to Emergency Dept, diagnosed with gallstones and gallbladder inflammation, discharged home 8/01/21  1800: severe abdominal pain 8/02/21  0800: returned to Emergency Dept with severe abdominal pain, admitted for pain control and antibiotics overnight 8/03/21 : underwent cholecystectomy (necrotic gallbladder) ______________________________________________________________________________________________________________________________________ 1/10/22   0900: severe chest pain radiating to jaw, 911 called, diagnosed with STEMI 1/10/22  1000: admitted through ED to Cath lab for evaluation (angioplasty performed and 2 stents placed), then admitted to cardiac ICU 1/11/22  0800: returned to Cath lab for severe chest pain radiating to jaw overnight, transferred to another hospital
left retinal necrosis started 1 hour after getting covid vaccine. now admitted to the hospital trying to sort out other viral causes of same.
severe pain left shoulder for 5 days, limited movement of left arm for 5 days, redness and hives left arm for 4 days, cold symptoms, nausea, chills, shakes, dizziness for first 48 hours, shortness of breath and body aches
On 1/10/22 patient did not receive COVID-19 Moderna booster as requested and was injected with empty syringe in error.  Patient was followed up with and received correct COVID-19 Pfizer vaccine booster on date entered.
Left arm injection site, with drainage.,  states has been draining since injection.  Injection site with scabbed area, with small amount of clear drainage noted, warm to touch. States when swells, he periodically expresses the site and notes fluid
Says she tried to get up and her "legs either got weak or legs stopped working"; Felt like she fainted/around 4AM she woke up and was "sitting on toilet and out of clear blue, got a wave of dizziness and; could not sleep; after the 2nd dose she felt tired by bedtime; nausea that hit me like ton of bricks"; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Says she tried to get up and her "legs either got weak or legs stopped working"), DIZZINESS (Felt like she fainted/around 4AM she woke up and was "sitting on toilet and out of clear blue, got a wave of dizziness and), INSOMNIA (could not sleep), FATIGUE (after the 2nd dose she felt tired by bedtime) and NAUSEA (nausea that hit me like ton of bricks") in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 038A21A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included METOPROLOL for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Says she tried to get up and her "legs either got weak or legs stopped working"), DIZZINESS (Felt like she fainted/around 4AM she woke up and was "sitting on toilet and out of clear blue, got a wave of dizziness and), INSOMNIA (could not sleep), FATIGUE (after the 2nd dose she felt tired by bedtime) and NAUSEA (nausea that hit me like ton of bricks"). At the time of the report, ASTHENIA (Says she tried to get up and her "legs either got weak or legs stopped working"), DIZZINESS (Felt like she fainted/around 4AM she woke up and was "sitting on toilet and out of clear blue, got a wave of dizziness and), INSOMNIA (could not sleep), FATIGUE (after the 2nd dose she felt tired by bedtime) and NAUSEA (nausea that hit me like ton of bricks") had resolved.            The concomitant medicines also include turmeric, proton pump inhibitor, Statins at night, supplements(not specified)   This case was linked to MOD-2021-273346, MOD-2021-125560 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: AE outcome updates as Resolved. On 22-Sep-2021: Follow up
Two to 3 weeks after the vaccine, I had restless leg syndrome, it felt like my legs were going to cramp at night unless I move  them, it would happen consistently  for about a week , it would stop and then come back . It still is going on I just found home remedies to fix it for now and my doctor has recommended, like warm or cold compressions, like a heating pad.
PATIENT HAD NO ADVERSE EVENTS,  BUT WAS GIVEN ADULT DOSE OF ENGERIX B (20MCG) FORMULATION , WHEN SHE SHOULD HAVE RECEIVED ENGERIX B 10MCG
This spontaneous report was received from a female patient of unknown age regarding herself. Concurrent condition included allergy to preservatives (unspecified). No medical history and concomitant medication were reported. On unspecified day in 2009 (reported as 6 years ago), the patient was vaccinated with pneumococcal vaccine (23-valent) (manufacturer unknown) (dose, route. lot number and expiration date were not reported). On unspecified day in 2009 (reported as 6 years ago), the patient had an allergic reaction to the pneumococcal vaccine (23-valent) (manufacturer unknown). At the time of vaccination the patient was informed by her physician that the pneumococcal vaccine, (23-valent) (manufacturer unknown) was packed in preservatives. The outcome of an allergic reaction was not reported. The relatedness between the event and pneumococcal vaccine, (23-valent) (manufacturer unknown) was not provided. No product quality complaint was filled. Additional information is not expected as the patient did not complete the report and decline to provide the contact information.
patient 29 weeks pregnant and not followed by our facility for OB care. RN performed PPD reading and noticed patient was not immune to varicella due to recent titers drawn for nursing school. checked with another resident to see if okay to give immunization. Varicella administered without verifying pregnancy status. Manufacturer contacted for outcome and patient contacted and counseled on low risk of fetal abnormalities. Attending and supervisor also notified, No reaction noted.
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient reported arm and hand tingling within 1 minute of the injection. She was provided ice for her arm and asked to stay in the store for observation for 30 minutes. She reported 30 minutes later that the ice had improved her symptoms. She reported no numbness, only tingling. Patient successfully left the store 30 minutes after her injection and instructed to continue to ice as needed.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult female patient who received HAVRIX (batch number 3C7ZG, expiry date 29th January 2021) for prophylaxis. On an unknown date, the patient received the 2nd dose of HAVRIX. On an unknown date, immediately after receiving HAVRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that, the patient experienced pain during administration of HAVRIX. Pain spreads down the hand and then subsided. The patient did not experience same symptoms during the 1st dose. The reporter gave consent to follow up. This case was 1 of the 3 linked cases, reported by same reporter.
IBS flare up; This spontaneous case was reported by a patient and describes the occurrence of IRRITABLE BOWEL SYNDROME (IBS flare up) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 immunisation.     Concurrent medical conditions included Irritable bowel syndrome.   In 2022, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (IBS flare up). The patient was treated with VEDOLIZUMAB (ENTYVIO) for Irritable bowel syndrome, at an unspecified dose and frequency. At the time of the report, IRRITABLE BOWEL SYNDROME (IBS flare up) had not resolved.            No concomitant medications were reported.  The patient started treatment with Moderna COVID-19 vaccine on an unreported date in Feb-2021 and Mar-2021, and then summer and then winter 2022/2023, every 6 months for a total of 5 shots with Moderna for COVID-19 immunisation. It was reported that the patient had irritable bowel syndrome, and a month after each shot, she would flare up.  The patient reported that the physician said lymphocytes were asked to generate antibodies and there was no wonder that's when the flare ups happened. Her gastroenterologist said it was a different cause and she started to flare in the winter of 2021.  The patient was on Entyvio for irritable bowel syndrome. The patient reported an irritable bowel syndrome flare up comes every 30 days after she stops the steroid. She started to flare 3 days before taking Entyvio.   This case was linked to MOD-2023-745444, MOD-2023-744592 (Patient Link).
pruritic rash on her back; This case was reported by a physician via sales rep and described the occurrence of itchy rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 1 day after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced mildly pruritic rash on her back. The reporter agreed for the follow up and would like guidance on series completion.
Please note, 1st dose on Feb 11, 2021 - Sweating and stomach issues 4 hours after shot- EL9261.  And problems waking up gasping for air when first falling asleep at night.  (I did not think that these were related to the vaccine, but did not have these symptoms before the shot.     14 minutes after the shot (2nd dose - on March 4), my heart started racing, hands started shaking and I could not swallow, my color was pale also.  (Medical officer came and assisted.) It happened a total of 4 times over an 1.5 hour period.  The medical officer said that I was having an Adrenalin response.  I was given pepsid and claritin. (I had to take it for 4 days).   After that I did not have any more episodes.  The problems waking up gasping for air (since the first shot on 2/11) stopped after taking the pepsid and claritin also.  I had no other symptoms.
Two weeks later, I had chest pain and incredible sound sensitivity. The sound sensitivity and anxiety lasted another week. Then, I had extreme pressure on my chest and squeezing, cold and clammy, felt like I couldn't breathe. Went to be tested to see if I had Covid. It was negative. In the next several weeks, I was very sick with retching, nausea, lack of appetite, and extreme fatigue and weakness. Extreme unexplained anxiety. My legs really started to become extremely week. I could barely hold my body. Atrophy of the muscles in my legs. Extreme pain in arms and  legs. Legs turning ice cold. Feet burning and turning numb. Numbness and popping of my right leg resulting in a limp and inability to use that leg well. I saw cardiology and tests were normal. I saw pulmonary and tests were normal. Both specialists noted that I had a wide gait and a limp on one side. I think the wide gait was because I was so dizzy and unstable. I've had months and months of weakness fatigue, numbness, burning, tingling, muscle twitches, brain fog, dizziness, vision problems, problems walking, and very low blood pressure. Problems feeling walking and feeling my legs in cold weather. Complete lack of feeling in the cold. Saw neurology. Tests so far are normal. Tested by Dr., a long haul researcher, and diagnosed with vaccine induced long haul syndrome.
I had swelling and pain under left arm in armpit area; I had swelling and pain under left arm in armpit area/Strange pain in my left lower leg as well; Face/ body hives, rash and body itching; Multiple allergic attacks over the last 3 to 5 days.; Hives all over body face; Body rashes; Skin irritation all over body; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 37-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6206) via an unspecified route of administration, administered in Arm Left on 15Mar2021 (at the age of 37-years-old) as dose 2, single for COVID-19 immunization. Medical history included known allergies: latex, adhesive tape (just local skin irritation) and asthma at time not chronic from an unknown date and unknown if ongoing. Other medications within 2 weeks of vaccination were vitamins and inhaler as needed. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6201) via an unspecified route of administration, administered in Arm Left on 22Feb2021 (at the age of 37-years-old) as dose 1, single for COVID-19 immunization. No COVID prior to the vaccination. No COVID tested post vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021, the patient experienced multiple allergic attacks over the last 3 to 5 days, this included hives all over body face requiring two ER visits, body rashes, hives and skin irritation all over body. She never had any such reaction before. I also had no new products, food or any other items at the time of this event. On 18Mar2021, at 19:00, she had swelling and pain under left arm in armpit area, strange pain in left lower leg as well and face/ body hives, rash and body itching. The patient received treatment for the adverse event in the form of medication and ER observation. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Information has been received from a registered nurse concerning "about 18 patients", who, on an unspecified date, were vaccinated with a dose of Gardasil.  Subsequently, the patients experienced pain and burning while receiving Gardasil.  At the time of the report, the patients' outcomes were unknown.  No product quality complaint was involved.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a registered nurse concerning about 18 patients who are under 18 years of age, who within the last four months, were vaccinated with a dose of GARDASIL. Subsequently, the patients experienced pain and burning at the injection site while receiving GARDASIL, symptoms last approximately 30 minutes. The nurse reported that "none of the symptoms are sever enough to warrant medical attention. At the time of the report, the patient outcomes were unknown. No product quality complaint was involved. Attempts are being made to obtain additional identifying information to distinquish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.