chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives generalized all over her body; Allergic reaction; This spontaneous case was received on 08-Jan-2021 from other non-health professional (consumer) via Med Communication (reference number: SEQW21-00106) and concerned a female patient of an unknown age.  The patient's medical history and concomitant medications were not reported.  On an unspecified day in Feb-2018, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent, dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On an unspecified day in Feb-2018, four hours after receiving Flucelvax Qudrivalent, the patient had hives generalized all over her body. The patient experienced an allergic reaction. It was not anaphylaxis. The patient was treated with Benadryl (diphenhydramine hydrochloride) and the reaction was resolved within 24 hours. The reporter wanted to know what was the ingredient that caused the allergic reaction.  On an unspecified date in Feb-2018, the patient was recovered from the events.  The reporter assessed the events as related to Flucelvax Quadrivalent.  The case was assessed as non-serious.  Company comment: The events of allergic reaction and 'hives' are assessed as related to Flucelvax Quadrivalent.; Reporter's Comments: The reporter wanted to know what was the ingredient that caused the allergic reaction.; Sender's Comments: The events of allergic reaction and 'hives' are assessed as related to Flucelvax Quadrivalent.
dimple or atrophy in arm muscle at vaccination site approx 1" in diameter. Accompanied by continuing tenderness in upper arm near vaccination site particularly triceps area.  No treatment sought. No change for better or worse.
I experienced a metallic taste in my mouth within 10 minutes of receiving dose 2. Felt fatigued for days and achy.
believes it has to do with shingles/4 weeks after the second injection, she felt like she had the shingles, which she has had./Caller had the symptoms where she had the shingles, between shoulder and vertebrae; like burning ice; sort of itchiness; there's something going around her skin or something.; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (believes it has to do with shingles/4 weeks after the second injection, she felt like she had the shingles, which she has had./Caller had the symptoms where she had the shingles, between shoulder and vertebrae), BURNING SENSATION (like burning ice), PRURITUS (sort of itchiness) and VACCINATION COMPLICATION (there's something going around her skin or something.) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A, 036521A and 071F211A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (believes it has to do with shingles/4 weeks after the second injection, she felt like she had the shingles, which she has had./Caller had the symptoms where she had the shingles, between shoulder and vertebrae), BURNING SENSATION (like burning ice), PRURITUS (sort of itchiness) and VACCINATION COMPLICATION (there's something going around her skin or something.). At the time of the report, HERPES ZOSTER (believes it has to do with shingles/4 weeks after the second injection, she felt like she had the shingles, which she has had./Caller had the symptoms where she had the shingles, between shoulder and vertebrae), BURNING SENSATION (like burning ice), PRURITUS (sort of itchiness) and VACCINATION COMPLICATION (there's something going around her skin or something.) outcome was unknown.            No Concomitants were reported. No treatment drugs were reported.   This case was linked to MOD-2021-386953, MOD-2021-386572 (Patient Link).
Four days after receiving my first dose, I developed hives covering my chest. These particular hives disappeared within a few hours, but following that first outbreak I continued to have hives every day for 10 days. The hives would occur at different times on all parts of my body, including  my face and the palms of my hands and the bottoms of my feet. The hives were often itchy. There seemed to be a contact component, in that pressure on my skin would cause the hives to occur in a given spot, though contact may not have been the reason for all of the hives. At times, my entire torso would be covered, and when I woke up in the morning, my legs were often impacted. To treat the hives, I took Benadryl at night, which is often when the hives were worst, though I would still wake up with hives in the morning. It is difficult to say if the Benadryl was effective. On April 19th, I woke up with hives on my legs, but these disappeared after a few hours, per usual. I didn't develop any more hives throughout the day or evening, and as April 20th have not developed any more hives. Over the course of the 10 days, I considered whether external allergens may have been the cause of the hives, but numerous measures taken to alleviate the situation did not result in any change. (And the pollen on the trees outside eventually dissipated though the hives did not.) During this time, I also experienced some mild chest pain and coughing. I had a Covid-19 test on April 14th that returned a negative result on  April 16th.
red itchy rash on right arm, swelling and pain.  this began about 10 days after receiving the vaccine.   these symptoms have persisted despite use of topical hydrocortisone cream and benadryl.
Strong muscle pain in arm/shoulder/armpit causing immobilization of entire left arm for 3 days.
Administered PENTACEL and HIB and child needed PENTACEL and PREVNAR.
Myalgia, Fever, NauseaVomiting, Injection arm swelling
The VR has a history of vagal response to immunizations and blood.  The VR had the vaccine without incident and went to the observation area.  The VR was then sitting with his wife when he "was thinking of the vaccine" and he became unresponsive.  I was called to the site.  The VR was pale, cool, and diaphoretic.  The VR became responsive and was assisted to the cot where he laid flat.  The VR's wife states that this is typical behavior and response for him.  An ambulance was called by the paramedics that were on scene in the observation area.  The VR refused transport.  The VR was given water and candy and was able to ambulate without difficulty.  VR remained in the observation area for 40 minutes and then discharg
SEVERE chills - unable to get warm; constant shivering, major muscle aches, sweats, shaking
feels like she has the flu; feels terrible; whole body aching/e verything hurts; can hardly walk; a headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feels like she has the flu), FEELING ABNORMAL (feels terrible), PAIN (whole body aching/e verything hurts), GAIT DISTURBANCE (can hardly walk) and HEADACHE (a headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ALPRAZOLAM (XANAX), OXCARBAZEPINE (TRILEPTAL) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (feels like she has the flu), FEELING ABNORMAL (feels terrible), PAIN (whole body aching/e verything hurts), GAIT DISTURBANCE (can hardly walk) and HEADACHE (a headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (feels like she has the flu), FEELING ABNORMAL (feels terrible), PAIN (whole body aching/e verything hurts), GAIT DISTURBANCE (can hardly walk) and HEADACHE (a headache) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
Burning eyes, attempted to ice eyes no relief, no current access to eyedrops. currently ongoing for 90 minutes with no relief
Patient became light headed,  her vision went and she was staring off, became pale.  Lasted for a brief period.  No syncope.  Resolved with laying down and drinking some juice.  Completely resolved within 15 minute
Patient complained of swelling in his neck.  Patient stated that this happens when he takes the flu shot also.  Problem: swelling.  A 24 /o patient complained of swelling around the neck.  Nurse observed patients neck.  no redness noted.  patient had no distressed.  Patient stated that he has swelling in his neck when he takes the flu shot.  1020 am vitals was taken BP 146/102, HR 85, RR 16 Temp - 97.2 02 Sat 98%, no sign of distress.  Nurse observed patient for 30 mins.  1040 am vitals sign BP 147/95, HR 80, RR 16, 02 Sat 98%   Patient stated that he felt better 1055 am patient was discharged with family. 03/17/21
Right deltoid arm/3 cm erythema/tender on 9/29-9/30/16.
upper lt amr red & swollen area w/papules (8cm x 21cm); c/o urticara wrist pain; area warm to touch;
Information has been received from a physician concerning a female who was vaccinated with Gardasil and experienced hives.  The patient sought unspecified medical treatment.  Additional information has been requested.
Information has been received from a registered nurse concerning a female patient who on 06-OCT-2006 was vaccinated in the right arm with the first dose of HPV (lot # not provided). On 06-OCT-2006, the patient experienced lightheadedness and numbness in her left arm. Unspecified medical attention was sought. Subsequently, that same day the patient recovered from lightheadedness and numbness in her left arm and was able to leave the office. Additional information has been requested.
Pt was laying down for 2nd Covid vaccination as she fainted for 1st Covid vaccination. After 2nd vaccination was given- she had a vaso vagal reaction.  BP 102/72 Pt has had 4 episodes of ears ringing & pressure both sides of head.  Recommended to see her primary Dr. after leaving clinic.
The symptoms began 20 min after administration of the vaccine. The symptoms were: throat tightening and tongue swelling which self-resolved within 15 min. He did feel that there was difficulty swallowing which persisted. He had a sneezing fit when he got back to the vaccine clinic. He got very anxious. He felt that his hand was swelling and was cold. He felt that he was having itching in his arm where the vaccine was given.He was in his car when the symptoms began so he turned around and went back to hospital. His BP 153/98, HR 128. At this point, he felt that he had no blood in his hands and he felt he needed to do deep breathing. He was observed for 1.5 hours and the symptoms self-resolved with the exception of his HR which has persistently been > 100. He feels very anxious. No treatment was given. He has no symptoms at this moment, 3.5 h after vaccine administration.
Headache, Myalgia, Fever, NauseaVomiting, Swelling on left eye, Fatigue  Narrative:
Patient fainted 5-7 minutes after vaccination. Hit head called 911-paramedics said everything ok. Waiting to follow up with MD. MD stated BP decreased from flu shot taken him have to lay down.
Vaccination site is swollen; Vaccination site red; Nausea; Headache; swollen all the way down to her elbow; red all the way down to her elbow; pruritis; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site is swollen), VACCINATION SITE ERYTHEMA (Vaccination site red), NAUSEA (Nausea), HEADACHE (Headache) and PERIPHERAL SWELLING (swollen all the way down to her elbow) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site is swollen), VACCINATION SITE ERYTHEMA (Vaccination site red), NAUSEA (Nausea), HEADACHE (Headache), PERIPHERAL SWELLING (swollen all the way down to her elbow), ERYTHEMA (red all the way down to her elbow) and PRURITUS (pruritis). At the time of the report, VACCINATION SITE SWELLING (Vaccination site is swollen), VACCINATION SITE ERYTHEMA (Vaccination site red), NAUSEA (Nausea), HEADACHE (Headache), PERIPHERAL SWELLING (swollen all the way down to her elbow), ERYTHEMA (red all the way down to her elbow) and PRURITUS (pruritis) outcome was unknown. Not Provided          Concomitant medications were not provided Treatment information was not provided.
A company representative reported that a physician reported that on an unspecified date a patient (not otherwise specified) was vaccinated with the pneumococcal 23v polysaccharide vaccine (Lot# not provided).  The patient developed cellulitis and was treated with unspecified anti-inflammatory medication.  Subsequently, the patient recovered from the cellulitis.  Addition information has been requested.
This spontaneous report as received from a physician refers to an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with RECOMBIVAX HB (dose, route and lot numbers were not provided). The physician stated that approximately 4 or 5 doses of RECOMBIVAX HB were administered to patients after improper storage. No adverse effects were noted. This is one of two reports from the same reporter (MARRS# 1408USA011394). Additional information has been requested.
Fever, headache,  body aches.  On 2/26/21 at 2:45pm, Fever of 103, treated with Tylenol and then Motrin at healthcare provider?s recommendation.  Continuing lower grade fever until 2/28/21 at 12:00 pm.
Service member reporting that he has residual pain in right arm (dominant arm) since receiving ANTHRAX #1 and HEP B, and HEP A (separately vaccines) all in the right arm on 6 March 10. He also received the injectable H1N1 vaccine in the left arm and the intranasal FLUMIST. He reports no significant local reaction, but had pain in the right arm with activity and certain movements. He did develop a "lump" in the right arm which has now resolved. Five months later, he continues with the same amount of pain in the arm as when first injected. The pain has not worsened but it has not improved. At rest the arm is pain free. Writing or typing does not cause discomfort. However, pain occurs with activity such as lifting an object or opening a door and also with certain positions, such as bending arm backwards past the shoulder. Pushups cause "excruciating pain," and he has received a profile for th P.T. Test. At time the pain radiates down the top of the right arm to the wrist. He reports no point tenderness. The radiation subsides when activity ceases, but the upper deltoid aches for many hours afterwards. He has taken no medications because he "didn't know what to take". There are no visible abnormalities. He states the arm is weaker since he cannot lift weights or perform many activities. He says he does not see any muscle atrophy.
presents to hospital EC with SOB, cough and chills; has underlying hx of COPD
Missed the 2nd  dose of Modera vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the 2nd  dose of Modera vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the 2nd  dose of Modera vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the 2nd  dose of Modera vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Nauseous the evening that I got the vaccine. Following day vomiting and severe dizziness. Third day nauseous and moderate dizziness.
Tenderness in injection site; This is a spontaneous report from a non-contactable Other HCP (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EJ1685, via Intramuscular route of administration on 23Dec2020 11:15 at single dose on left arm for COVID-19 immunization. Medical history included Gastrooesophageal reflux disease (GERD), Postpartum Depression. Concomitant medication included sertraline. The patient previously received nickel, amoxicillin, penicilline, hepatitis b vaccine and had allergies. The patient had not received other vaccine in four weeks. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient experienced Tenderness in injection site on 24Dec2020. The outcome of the event was resolving.  No follow-up attempts are possible. No further information is expected.
FEVER, PAIN ON THE LEFT HAND SIDE OF MY BODY, CAME BACK TO SEE DOCTOR ON 02/14/2019 COMPLAINING OF SORE THROAT, FEVER, HEAD ACHE AND EAR ACHE. SHE SAID I HAD A PHARYGITIS, LEFT OTITIS EXTERNA TO STAY HOME UNTIL 2/17/2019. BY SATURDAY I FELT HEAD BOILING AND MY EAR WAS BLOODY COLOR AND MY EYE AND LEFT SIDE OF MY FACE WAS PARALYSED. I WENT TO SEE A DOCTOR 02/18/2019 AT 1:30. SHE GAVE ACYCLOVIR, ERYTHOMYCIN  AND DELTASONE MEDICATION. DOCTOR TOLD ME I HAD BELL'S PALSY BUT I AM NO DOCTOR BUT ALL THAT HAD HAPPENED TO ME IS BECAUSE OF THE VACCINE.
Patient received vaccine at 10:23 am and parked and instructed to wait 30 min due to prior reaction to bee stings. At 10:47am patient reported feeling a flushed and reddened face, "blurry eyes", and lightheadedness.  Assessment VS as follows BP 150/70 HR 70 - SR skin- warm and dry SpOx-99 % This reaction was not like a typical bee string reaction. She denies restricted airway and throat tightness.  Talking in a normal rate and rhythm.  Advised patient that we will call EMS for transport to a higher level of care, however patient refused.  This patient was instructed to remain onsite for further observation and she agreed. She was accompanied by her spouse who was the driver. She reported that she will return home and take benadryl or the epi-pen if condition worsens. She will contact her doctor and report her experience today. Patient felt recovered and decided to leave after 30 additional minutes.
Chills, body aches, headache, nausea, light-headed the 3 days after the 2nd vaccine shot. Three weeks later, inflammation and pain in both hands/wrists that has lasted over 2 weeks and pain and inflammation in knees that has been lasting over 1 week.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 08-MAY-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "2", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
No adverse effects identified - patient rec'd second Menactra 3 weeks after initial dose. Hx of 1st dose unknown to patient and provider. Menactra mandatory for incoming students at University. Student signed vaccine consent form and authorization of payment - unaware he had had vaccine. No documentation with him.
1st dose in 2019, 2nd dose June 14, 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received 1st dose of Shingrix in 2019).   On 14th June 2022, the patient received the 2nd dose of Shingrix. On 14th June 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments: The reporter was patient's wife.   The reporter stated her husband received his first dose of Shingrix in 2019. Her husband received a second dose on 14th Jun 2022. The reporter did not wish to provide any other information. The reporter did not give consent to follow-up. Additional Supportive Information: The patient received 2nd dose later then recommended interval, which led to lengthening of vaccination schedule
nausea/Nauseated; severe diarrhea; Her arm is sore; She is not feeling well; This is a spontaneous report from a contactable other HCP (patient).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 11:00 at single dose for COVID-19 immunisation.  The patient medical history and the concomitant medications were not reported. She worked in a hospital. She got the vaccine at 11:00 and within an hour she had severe diarrhea. She hasn't thrown up. It is like a bowel prep. She was nauseated, not really bad but it was annoying. She can smell. She was not weak. Her arm was sore but that was normal. Following administration of the vaccine she experienced severe diarrhea and now nausea. She can't take Imodium, so she took Kaopectate. She was out for breakfast and then this happened. She has never had anything happen like this before. She was not feeling well. The onset date of events was 07Jan2021. She reported that the diarrhea was now gone. The outcome of diarrhea was recovered, of other events was unknown. Treatment received for nausea and diarrhea.   Information on the lot/batch number has been requested.