chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Same day (day0) : swollen orange sides of tongue. Swollen at injection sight. Day1: labia swollen and orange, tongue no longer swollen but tongue can only go to the right. Swollen at injection sight. Day2: pimple like rash on upper arms, swollen labia resolved, tongue still deviated to the right. Swollen at injection sight. Day 3: pimple like rash on thighs, rash on on upper arms resolved, tongue deviates to the right, Swollen at injection sight. Day 17: tongue still deviates to the right, small nodule remains at injection sight
A 5 year old developed whelps after receiving the COVID vaccine on opposite arm from administration.  Whelps were 5 hard nodules. Patients mother noted developed shortly after injection. No other symptoms present. BP 103/58, HR 80.  No SOB.
8/29/17: Patient received DTaP as routine vaccination in left thigh. Also was treated for acute otitis media with injection of ceftriaxone 1ml into right thigh and 0.6ml into left thigh. 8/30/17: In the morning, mom noticed his left leg was swelling. Throughout the morning at daycare, the daycare provider noticed that he was favoring the left leg and would not put weight on the leg. He also was fussy.  When mom picked him up from daycare in the afternoon, she noted that the swelling of his left thigh was worse, he seemed to be in pain and would not bear weight. There was no erythema or drainage from any wounds, but the thigh was hot.
Symptoms: c/o dizziness, palpitations, tremors, chills. HR 132. Other vitals stable.  Intervention: Rest, reassurance, warm water, HR down to 98. Stabilized.
SEIZURE; This spontaneous report received from a consumer via media via a company representative concerned a 27 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date it was reported that, "No vac for me. Medical freedom. My girlfriend's son got the J and J. 27/diabetic and had a seizure the next day." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220245766-covid-19 vaccine ad26.cov2.s-seizure. 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). Therefore, this event(s) is considered unassessable.
tested positive; tested positive; being a little tired/she was tired after it; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: 30Apr2021) solution for injection, via an unspecified route of administration on 15Jan2021 at a single dose for Covid-19 immunization. Medical history included hearing aid. There were no concomitant medications. The patient reported she received her first dose on Friday 15Jan2021 and she lost her sense of smell and taste on Sunday 17Jan2021 and she went and got tested today, Monday 18Jan2021 and her rapid test was positive (Covid test). her taste and smell ability disappeared. She stated that yesterday at 3:30PM all of sudden that her taste and smell ability disappeared. Stated that she just had a rapid test done. Stated that she had not felt bad and had no symptoms before the shot. Patient wanted to know if they had any reactions like this. Stated that she will know more when the test comes back, and she will hear shortly. Patient stated that she was tired after it (Jan2021). She was being a little tired. Stated she has a hearing aid which she had prior to getting the vaccine. Outcome of the events lost her sense of smell and taste/her taste and smell ability disappeared were not recovered, while outcome of the other events was unknown.  No follow-up activities are needed. No further information is expected.
Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information were not provided.
pt recvd vax & approx 2-3 mins later pt fainted & fell off chair on which was seated; did hit back of head on floor; pt was placed in prone position;
I had a swollen throat lymph node that started about 30 mins after the vaccine on my way home it lasted about 24 hours. I took some allergy meds and I was able to breathe and swallow easily so I wasn't too concerned. After 24 hours it was pretty much gone.
On 09/07/2016 he had a fever in the morning; later in the afternoon right thigh was red at injection site, about size of tennis ball; previous shots only about size of golf ball. On 9/08/2016 entire thigh was swollen in the morning almost twice the size of other thigh; redness had spread over entire front of thigh; thigh was very firm; several hours later child was limping; gave TYLENOL and applied ice packs on and off that day and following day. 09/09/2016 thigh still hard and swollen, red patch spread to side and back of thigh; gave TYLENOL for pain and applied ice pack again. 09/11/2016 thigh redness and hardness has gone away, however thigh was still noticeable larger than other thigh.
After 2nd inj, extreme fatigue began that day & improved after one week. On 2nd day after injection, developed 1.) L neuropathic facial pain-severe 2.) L otalgia & parietal headaches. MRI noncontributory 3.) imbalance -falls to the L when walking now (referred to neurologist now for further eval
I received the vaccine at 3pm and initially felt well up until 10pm where I started to get a back ache. Around 3am I was in 10/10 unbearable pain just along my entire spine. It felt as though someone had beat my spine with a baseball bat. It was very hard to walk, I took 1,000 mg of Tylenol, 800 mg of Ibuprofen, CBD oil, and 50 mg of Benadryl to try and get to sleep and relieve some of the pain. I then woke up at 7am in excruitiating pain still only along my spine. I tried to get up to use the restroom and couldn't walk because of the pain. I was crying in the fetal position my husband actually had to lift me back up into bed. I again took all the stated medications and tried to fall back asleep. I have never had pain like this before (have a history of a spinal fusion from 2003).
Started getting bruising in leg,Bruising particularly under toenails; 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 CONTUSION (Started getting bruising in leg,Bruising particularly under toenails) 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, 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 CONTUSION (Started getting bruising in leg,Bruising particularly under toenails). At the time of the report, CONTUSION (Started getting bruising in leg,Bruising particularly under toenails) outcome was unknown.            No concomitant medications were provided by the reporter.   Treatment information was not provided.
diarrhea and vomiting. She reports vomiting has resolved. Diarrhea persists and is 10-15x/day since. She has taken Excedrin and Imodium with minimal improvement. She states the night before she ate shrimp and scallops that she made at home. None of her family members were sick.
Sore arm; Head was tingling every once in a while; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PARAESTHESIA (Head was tingling every once in a while) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PARAESTHESIA (Head was tingling every once in a while). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PARAESTHESIA (Head was tingling every once in a while) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
8 x 8 inch swollen red firm mass not hard and not hot to the touch.
Awoke next morning with a sharp head ache.  Mostly behind the eyes, but it traveled to my fore head and also to the back of my head. It was intense.  During the the 24 hours I used aspirin to treat it.  I awoke at 7am 4/15 and it was gone.
Patient came in with mother and had appointment for both the COVID-19 booster (Pfizer) and seasonal flu vaccine (Flucelvax). The patient and both vaccines were verified to be correct before administration with both the patient and guardian. Both vaccines were administered properly to the left deltoid. After the vaccines were administered, patient displayed no signs of distress. The guardian (mother) was vaccinated in the same manner confirming each vaccine before administration. Both patients were waiting for the administrating pharmacist to complete the vaccine cards. There was commotion as the cards were being completed and the vaccinating pharmacist was preparing shots for different patients. The patient in question was laying on the ground and we immediately contacted 9-1-1. The vaccinating pharmacist grab an Epipen out of the emergency response bag and ran to establish contact with the patient. Encouraged the patient to sit upright and the store manager offered complimentary waters as the paramedics were en route. Once paramedics arrived, responsibility was transferred to the paramedics. Patient and guardian were both escorted out by the paramedics.
Discomfort and pressure felt in the bladder; Bleeding from her bladder; Passing clots; A spontaneous report  was received from a consumer concerning a female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced discomfort and pressure felt in the bladder, passing clots, and bleeding from the bladder.  The patient's medical history is unknown. Concomitant medication includes blood pressure medication, cholesterol medication, thyroid medication and aspirin were reported.  On 11-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) for prophylaxis of COVID-19 infection.   No adverse events after the first dose were reported.   On 10-MAR-2021, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031L20A) for prophylaxis of COVID-19 infection.  On 12-MAR-2021, the patient experienced discomfort and felt pressure in the bladder. She was also passing clots and had CAT scanning which reports as she has many clots in the bladder. She took medicine and was on observation for 48 hours, after which the clots were gone in the scanning and the bleeding stopped.  Laboratory tests included CAT scanning, which found that there were more clots in the bladder.  The treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not applicable she completed both the doses.  At the time of this report, the outcome of the events were resolved on 14-MAR-2021.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Rec'd routine 4 mo immunizations in office 5/8/12 at clinic. Became increasingly fussy in early P.M. Seen at eve. clinic same day, afebrile; (Rt) leg with redness & edema about 2-3" x 2-3" & induration about 1 1/2" x 1 1/2" at site. Tx: TYLENOL q4 hours/warm compresses.
Approximately 1 week after shingles vaccine developed sore throat and was told 'strep'. Week of Dec 21, 2009, had an intestinal illness; Jan 10 and 11, 2010, legs began hurting. Jan 13 increase in leg pain. Jan 14 developed numbness in face and eyes. Jan 15 went to Hospital and was transferred to Medical Center with diagnosis of Guillian-Barre Syndrome. Treatment included plasmapheresis.
12/1/2021 pharmacy given booster dose Moderna 12/2 reported developing rash 12/11/2021 ER Notes: 42-year-old female with complaints of facial swelling and rash for 2 days. Patient is no prior history of allergic reactions. Patient received third booster dose of COVID-19 vaccine 10 days ago. She complains of itching in her throat with no difficulty breathing. Patient does complain of occasional cough. Denies any fever or chills at home. No prior history of respiratory issues. 12/13/2021 ER Notes: Patient admitted to the Hospital for diffuse rash. Dermatology was consulted. Biopsy was obtained and started on steroids. Found to have DRESS syndrome. Liver function test were trended, plateau. Discussed additional night of observation versus discharge with close outpatient follow-up. Patient requested close outpatient follow-up.
10/28/08 Mother states rash all over body, whiny and not sleeping x 1 week. 10/28/2008 rapid strep culture neg. 10/30/2008 throat culture obtained 10/28/2008 reported moderate normal flora.
sore throat; left arm irritation; some body aches; Low grade fever; fatigue; off-balanced; dizzy; This spontaneous case was reported by a physician and describes the occurrence of BALANCE DISORDER (off-balanced), DIZZINESS (dizzy), OROPHARYNGEAL PAIN (sore throat), LIMB DISCOMFORT (left arm irritation) and MYALGIA (some body aches) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041M20A and 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced BALANCE DISORDER (off-balanced), DIZZINESS (dizzy) and MYALGIA (some body aches). 23-Jan-2021, the patient experienced LIMB DISCOMFORT (left arm irritation), PYREXIA (Low grade fever) and FATIGUE (fatigue). On 10-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, BALANCE DISORDER (off-balanced), DIZZINESS (dizzy), LIMB DISCOMFORT (left arm irritation), MYALGIA (some body aches), PYREXIA (Low grade fever) and FATIGUE (fatigue) had resolved and OROPHARYNGEAL PAIN (sore throat) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included, an unspecified medication was reported.  Treatment information was not provided.Action taken with mRNA-1273 in response to the events was not applicable.
Patient family called on 4/23/2021 and reported that patient was hospitalized on April 9th and 13th , 2021 for blood clot in the lungs after taking the Johnson & Johnson covid-19 vaccine on 3/09/2021. During the time of the report patient's family state that patient was stable and she is doing okay.
Patient states he developed a red raised rash on his right arm at the brachial site, 3 red raised welts or hives.  On his right abdomen he had a more extensive red raised rash/hives with white center this did not spread out onto the skin he stated.  He applied Benadryl cream to the areas and was gone the next day.  Patient received his flu shot in his left arm.
This case was reported by a consumer via call center representative and described the occurrence of shivering in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 9 hrs after receiving SHINGRIX, the patient experienced shivering. The patient was treated with ADVIL. On an unknown date, the outcome of the shivering was recovered/resolved. It was unknown if the reporter considered the shivering to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced extreme shivering during night approximately 9 to 10 hours after receiving SHINGRIX vaccine. The shivering was subsided after taking ADVIL. (Approx 45 min. after taking the ADVIL). The shivering was lasted approximately 2 hours from 1:30 to 3:30 am. The reporter was asking could the drug be the cause. The reporter said should they expect a similar reaction after taking the 2nd shot. The reporter asked was it safe to take the 2nd shot if the 1st causes the shivering.
Information has been received from a pharmacist concerning a male patient in his 60's with hypothyroidism who on 17-JUL-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included levothyroxine Na and testosterone.  On approximately 29-JUL-2007, the patient experienced headaches.  The patient's headaches persisted.  Additional information has been requested.
tiredness; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 16Apr2021 at 08:45 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not have allergies to medications, food, or other products. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN), fluticasone propionate (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL), all for unknown indication, from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ED6955) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 08:45 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 08:45, the patient still experienced tiredness, chills and fever. Chills and fever at least twice a day. The patient was told that it should only last for 2 days, but it was day 4. Therapeutic measures were not taken as a result of the event.  Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events tiredness, chills and fever was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse referring to a unspecified patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX23 0.5 ml, intramuscular (dose # unknown) post supported excursion (incorrect product storage). Nurse was not able to say which lot number the administered PNEUMOVAX23 dose came from (Lot K006681, Exp. 21-OCT-2015 and Lot K018528, Exp. 14-APR-2016 were both involved in supported excursion). No adverse effects reported. No product quality issue (PQC) involved. Additional information has been requested.
Member woke up in the morning and was unable to hear out of his right ear. No sinus congestion, rhinorrhea, sore throat. No evidence of infection of effusion. Put on Methylprednisolone 4 MG.
Patient developed COVID-19 requiring hospitalization post-vaccination. She had also received a dose of Regen-COV (Regeneron) while inpatient.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 13-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5ml injection, lot# L026553, expiration date: 16-JUL-2017 (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 Celsius degree for 1 hour and 36 minutes and also at a temperature of -12.3 Celsius degree for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
hives devel hrs p/nl check up & vax; exam this evening is quite nl but for giant generalized urticaria; hives resolved by 1NOV92;
a fever of 99.5; body chills/chills; Not feeling well; Body itch; Pain; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable healthcare professional (patient). A 36-year-old male patient received BNT162B2 (lot number: not provided) solution for injection, via an unspecified route of administration on 15Dec2020 at a single dose for an unspecified indication. Patient has no medical history. There were no concomitant medications. The patient reported having a fever of 99.5 and body chills/chills after getting the Covid vaccine yesterday (15Dec2020). This was the first dose. The patient reported he was not feeling well, he had body itch, and pain on 15Dec2020. Patient stated he was just trying to think, he actually was feeling like drinking a lot of water and probably have some Tylenol. He asked if he should have the Tylenol or not really. The reason he was calling was because he was trying to figure out what was going on with his system before he do whole 8 to 10 minutes thing. He asked if this was required to find out if he could just drink some water and just take the Tylenol. He just wants the answer before he goes any further. Patient reported he was taking Tylenol for fever and chills. He reported he was in pain and he just needed to see if everything was alright. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
I will be calling back to provide lot number information.   Shortly after getting vaccine in mid September I noticed my hand was swelling. I thought I had strained my hand. I took a couple of advil and it kind off went away but it started getting worse. My knuckles started getting worse.  I got my next vaccine and i didn't have any complication with that one. I went to the doctor and showed him my hands. That it was not arthirtis. I noticed it was Mid September when my hand started bothering me.