chrisvoncsefalvay/vaers-outcomes huggingface dataset:
equilibrium seem to be a little bit of balance; nose is running; Stomach is loose; didnt feel good; could not raise his arm over his shoulder last night; experienced a lot of pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (equilibrium seem to be a little bit of balance), RHINORRHOEA (nose is running), ABDOMINAL DISCOMFORT (Stomach is loose), MALAISE (didnt feel good) and VACCINATION SITE MOVEMENT IMPAIRMENT (could not raise his arm over his shoulder last night) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00FBZ1A and 036A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Apr-2021, the patient experienced BALANCE DISORDER (equilibrium seem to be a little bit of balance), RHINORRHOEA (nose is running), ABDOMINAL DISCOMFORT (Stomach is loose), MALAISE (didnt feel good), VACCINATION SITE MOVEMENT IMPAIRMENT (could not raise his arm over his shoulder last night), PAIN (experienced a lot of pain) and HEADACHE (Headache). At the time of the report, BALANCE DISORDER (equilibrium seem to be a little bit of balance), RHINORRHOEA (nose is running), ABDOMINAL DISCOMFORT (Stomach is loose), MALAISE (didnt feel good), VACCINATION SITE MOVEMENT IMPAIRMENT (could not raise his arm over his shoulder last night), PAIN (experienced a lot of pain) and HEADACHE (Headache) outcome was unknown.            No concomitant drugs. Treatment included Dayquil. Consent for safety to follow-up was received, preferably via phone
Patient is 17 years old but received Moderna that is indicated for 18 years and older.
No additional AE; Expired GARDASIL 9 (T036444 / 04/09/2024) was administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-APR-2023, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, lot #T036444, expiration date: 09-APR-2023 (also reported as 04/09/2024, conflicting information), administered for prophylaxis (dose, strength, and route of administration were not provided) (expired product administered). The patient was not reporting signs/symptoms of adverse events (no adverse event).
L arm pain, swelling, redness, warmth.  Malaise, fevers developing within 48-72 hours.
Information has been received from a consumer concerning her 6 year old daughter with constipation and a history of respiratory syncytial virus infection (RSV), who when she was a year old, on 27-AUG-2002, was vaccinated with a first dose of VARIVAX.  The reporter indicated that on 17-JAN-2008, the patient developed a spot on her face that she kept itching, and was given diphenhydramine (BENADRYL) to help with the itching.  The next morning (18-JAN-2008), the patient woke up with "a bunch of red spots on her face".  The reporter indicated that on the same day (18-JAN-2008), she went to the hospital, had a culture done (unspecified), and was diagnosed with herpes zoster.  The shingles were reported to have been on her ear, face, gum line, throat, chest, and neck.  The reporter indicated that the patient had an ear infection in the right ear due to the shingles and was given a form of acyclovir and penicillin.  The reporter indicated that the patient had an allergic reaction to the penicillin.  She described the reaction as the patient would pass out, had cramping, and vomiting.  The reporter indicated that on unspecified dates, the patient was hospitalized twice.  The first hospitalization was reportedly for 5 days, and the second hospitalization for 8 days.  It was reported that while in the hospital (date and hospitalization not specified), she developed bronchitis.  The reporter stated that on 11-FEB-2008, the patient was going back to the hospital "because she had not been on medication for a couple days".  Additional information from the reporter on 14-FEB-2008, indicated that the patient was back in the hospital for 14 days so she could receive medication intravenously (specific medication not reported).  The reporter stated that "the physicians are testing her immune system to see why she still is having trouble getting rid of the shingles".  The reporter also indicated that the patient is starting to get depressed because of the shingles on her face.  Additional information from the physician's office indicated that they had no record of vaccinations being administered at that office, and that she was last seen in their office in 2006.  At the time of this report the patient had not recovered.  A product quality complaint was not reported.  It was reported that the patients brother (WAES# 0802USA026660), with a history of pneumonia (hospitalized, 02-JAN-2000), who was 10 months of age when a sibling received VARIVAX on 09-DEC-1999.  In January 2000 (date not specified), he was hospitalized for full blown varicella.  It is indicated that the patient has developed lung problems, skin problems, allergies, and asthma. 3/4/08-records received for DOS 1/18/08- Varicella Zoster-mandible. dermatitis questionalble stap vs strep vs virus etiology. with gingivistomatitis. Right otitis media, asthma exacerbation, vomiting. constipaion. Presented with 'mosquito bite' on right cheeck with itiching 2 days ago C/O right otalgia, heaving diarrhea.
SVT Feb 1, 2021; near syncopal Feb 8, 2021; ER with chest pain Feb 17, 2021; increased POTS symptoms with visit to Cardiologist Feb 2021; EKG and echo obtained; started on Florinef March 2021; low b12 and D found April 2021; ER April 28, bedridden with extreme fatigue and zero appetite April 28-May 5, 2021.  Saw Neurologist May 2021.  Started Mg and salt tabs.  MRI brain August 4, 2021 to r/o pituitary lesion d/t migraines and worsening POTS symptoms; b12 and vit D levels corrected after oral replacement x 90 days.
I have a hard lump about 1 1/2 inches from the site of my second moderna Covid vaccination injection site and although the initial  redness is gone I still have the same size lump and it?s been over a week since my vaccination. The nurse injected the vaccine more laterally than straight  into the muscle. I am wondering if the vaccine is collected there  and not being absorbed, or if it is some other problem... like cellulitis? it hard raised oval lump appeared one day after my vaccine. It does not meet the criteria given for ?Covid arm? (which is that the lump  would be on  the vaccination site -,mine isn?t- and that it would show up 5-6 days after the vaccination. Mine showed up the day after and has not softened or abated.
pt recv vax & exp 2x2 inch erythema @ the inj site;medical attention was sought;given DPH;reporter felt erythema @ inj site was not r/t vax;
At an event on 09/23/2022 where multiple people tested positive. I was experiencing what I thought were fibromyalgia symptoms but tested due to having my covalent vaccine scheduled and tested positive 09/26/2022. While I was waiting for call from PCP began having extreme fatigue. Spoke with PCP the afternoon of 09/26/2022 and was prescribed paxolovid. Began Paxolovid on the evening of the 26th and had headache. Woke up on 09/27/2022 headache was much worse and began having congestion. 9/27-9/30 Symptoms continued. Headache improved but developed a productive cough. Also began sneezing around this time but unsure of exactly when. Symptoms greatly improved over the weekend and even tested negative. On 10/7 I was supposed to go see my mother and tested to be sure. Test reflected a slight positive line.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2022 at 4:59 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Feb-2022 at 4:59 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Ethnicity of the patient was reported.  Concomitant medication of the patient was not reported.  The patient was administered vaccine past its 30 days expiry date. Vaccine administration time was given as 16:59:16.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
Swelling in arm and pain following administration.  Dr. diagnosed her with phlebitis and prescribed Bactrim DS & Prednisone.
Td given 3/27/03. On 3/29/03, patient experienced rash from head (with hives on face) to lower abdomen. Fine red bumps. Also had large red area at site of injection. Temperature 101. Next day rash gone and temp 99. On 3/31/03, no more problems.
FEVER OF 102.7F; NAUSEA; VOMITING; CHILLS; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included not asked. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805618 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102.7 F. On 09-MAR-2021 19:45, the subject experienced fever of 102.7f. On 09-MAR-2021 19:45, the subject experienced nausea. On 09-MAR-2021 19:45, the subject experienced vomiting. On 09-MAR-2021 19:45, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 102.7f, nausea, vomiting, and chills. This report was non-serious.
severe body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (severe body aches) in an elderly male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (severe body aches). At the time of the report, MYALGIA (severe body aches) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Pt given VZV, MMR, KINRIX->went to 2nd floor of building w/ mom-was playing and then fell down per her mother and then was shaking. No loss of consciousness per mother. No loss of bowel/bladder control. Questionable seizure, but no postictal phase. Neuro exam normal pt was examined & was asymptomatic.
Patient stated that right arm (pneumonia given in) somewhat pink in color and swollen where injections was given.  It was recommended for them to apply ice....if temp. or difficulty in breathing notify physician
1 of 2 pts immunized from the same vial who exp a fever following vax; pt also recv OPV; devel a fever of 103; no other sx; rx APAP & cool bath; pt recovered;
Patient said he had heart palpitations that started after the vaccinations and continued the second day.  Patient also felt very exhausted.
Pt. came in 9-30-17 with a rash under the injection site, size about 4 x 5 inches. Started 24 hrs after immunization, red and raised.
ABNORMAL BLEEDING; This spontaneous report received from a consumer concerned two patients of unspecified age, sex. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter was told that two other patients experienced abnormal bleeding by her physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of abnormal bleeding was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211032981.; Sender's Comments: V0:20211034387-Covid-19 vaccine ad26.cov2.s  Abnormal bleeding. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 45-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients.  No treatment information was provided.
A large welt appeared over the injection site about 3 1/2 inches square.  The next day it traveled down the arm to the inside of elbow.  It was hot to the touch and extremely itchy. It lasted until day 10.  I consulted with my GP today who told me to fill out this form.
within 10 minutes pt c/o hot flashes - headache upset stomach -  moved to exam room - red blotchy rash, back of  neck/ upper chest area. BP 142/82 HR regular 80 resp 20 non labored  given 25mg Benadryl  oral and 2 -220 mg Alleve for headache pt observed for one hour- rash gone BP130/80  Headache from a 10 to a 5  no dizziness on moving from table to chair or standing -  pt advised not to drive due to benadryl  coworker picked her up pt walked to lobby on her own.
chills; temperature of 99.1; achiness/Achy the whole; tired; I was little like weak; This is spontaneous report received from Pfizer Sponsored Program. A contactable female consumer (Patient) reported herself. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 29Mar2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, 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 immunization and had injection site pain. The patient received 2nd dose of Pfizer vaccine Sunday March 28th had reactions that lasted until Monday the 29th including: a temperature of 99.1 which lasted a few hours, chills, achiness, tired on an unspecified date in Mar2021. The side effects started quicker than when receiving the 1st dose, at which time she had injection site pain and muscle pain. Overall a feeling of being slightly unwell. The patient would like to know how long they should quarantine before seeing friends and family. The patient stated, "she just had her second dose of Pfizer she did have reaction 'actually' that after noon, she had it in the morning and it lasted until, she had it Sunday, Monday night, even yesterday she was little like weak and whatever but no fever no nothing. She had 98.9 which was really not a fever. Chills, achy the whole you know, not nauseous, no diarrhea but just very achy and chill. She had a really silly question on she had it obviously this week was there a quarantine. If the patient didn't stay at quarantine but it didn't say not to. So she was not sure what to do. Her husband and she both had the second dose. The patient underwent lab test and procedure included Body temperature with temperature of 99.1 (high) on 29Mar2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Chills, Loss of arm movement, very sore, rash on arm. Chills and loss of arm movement lasted day of vaccine. Soreness and rash lasted 3 days.
Warm red area approximately 3 inches wide by 4 inches long around injection site , spread up towards shoulder and down arm causing forearm to be red and blotchy, treatment to monitor
Pt went to the doctor and received the wrong shot and it's the same. She doesn't sleep well, doesn't eat well, had a seizure, cries in pain. Only got 3 of the 4 shots and the Hep B too early.
pt recvd vax & exp a truncal & facial rash which lasted 1 day;
Initial misuse report received from a health care professional on 03-Oct-2013. A 33 year old patient whose gender, medical history and concomitant medications were unknown, received a dose of FLUZONE HD (lot number, route and site of vaccination were unknown) on an unspecified date. Mot patients did not experience any material increase in local or systemic adverse events, but some might experience. List of documents held by sender: none
Shot was received on Friday, August 17, 2007 at approx. 3:30 p.m.     On Monday, August 20, 2007 while at school, my daughter developed sudden blurred vision, dizziness, suddenly turned very pale and almost passed out at school.  The nurse called me (her mother) at work and advised that she be checked out of school.  Upon arriving home, she immediately went to bed and slept for about 4 hours.  When she woke, she was still very pale, and felt extremely weak.  She had no appetite and went back to sleep and slept through the night.  I kept her home from school on Tuesday August 21, and she continued to sleep for most of the day, only waking twice and ate very little.  She awoke at about 7 pm and stated that she felt a little better and was able to eat a little dinner.  She went back to bed again and slept throughout the night.  When she awoke today, Wednesday August 22, she finally felt well enough to go to school and managed to stay there throughout the day.  Her appetite has improved, her skin is more flush and she is a little more energetic.
Pt returned to clinic 2AUG91 w/swollen red, tender lt upper arm; No node; full vol ROM, area of 4.6 in of redness @ swelling;
Pt was given his second dose 5 days early.  Dose was supposed to be given on 6/16/21 and instead a medication error occurred and the patient received the vaccine early.
small hives on the trunk of her body, under her right breast, and bilateral thighs; Metal taste in mouth; This case was reported by a consumer via call center representative and described the occurrence of taste metallic in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th November 2022, the patient received the 1st dose of Shingrix. On 29th November 2022, immediately after receiving Shingrix, the patient experienced taste metallic. In January 2023, the patient experienced hives. On an unknown date, the outcome of the taste metallic was recovered/resolved and the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the taste metallic and hives to be related to Shingrix.     Additional Information: GSK receipt date: 26-JAN-2023 Reporter comment: The reporter was the patient. The patient received her first dose of Shingrix experienced a metal taste in her mouth right after. The metal taste had resolved. The past 7 to 10 days, the patient has been experiencing small hives on the trunk of her body, under her right breast, and bilateral thighs. The reporter consented to follow up. Reporter/ patient gave consent to follow up with HCP (pharmacy).