chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L027076 and expiration date 25-MAY-2017, lot # M019706 and expiration date 24-OCT-2017, orally; exact doses were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 34.4 Fahrenheit degrees (F) for 10 minutes on 11-MAR-2016, 35.6 F for 10 minutes on 03-AUG-2016, 35.6 F for 10 minutes on 20-AUG-2016, 35.6 F for 10 minutes on 23-AUG-2016 and 35.6 F for 10 minutes on 26-AUG-2016 before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Chest pain and heaviness  Body aches Headache  Sore throat  Fatigue
hx of migraine headaches (dx in 1988). SX of pain behind eyes and in temple area occured in spring usually; since 2002 has noted increased frequency (occuring about 3 times per week)lasting 2 hours, associated with nausea, no vomiting; pain relieved with motrin. States in last 3 months (since 2/07) the headaches are now associated with dizziness (room spinning), photophobia, nausea and vomiting. Continues with pattern of occurence--about 3 times per week. Tylenol decreases symptoms.   bilateral hand and wrist pain. Numbness at night--improved with use of splint. Dx with carpel tunnel (per pt) in 2005   in 2000 pt began to have right hip pain (lateral aspect) which is constant, a level 4/5 out of 10. The pain increases with climbing stairs, prolonged walking, standing or sitting (the pain increases to a 10/10). The pain can last up to 48 hours. Use of heating pad helps iwth the constant pain. Pt has injections which improves ability to perform activities for longer periods of time. Pain limits social/recreational activities
Dull pressure, (not painful) in the back of head (Noticeable beginning April 1st, pretty an everyday thing. Tired, periods of difficulty concentrating, (still functional but very noticeable) Brain fog - hazy (Noticeable beginning April 1st / currently ongoing) Not depressed but a sense of heaviness (due to being tired and brain fog (Began noticing April 1st  / currently ongoing Weight loss (6 lbs since receiving the vaccine) (noticed gradual weight loss beginning April 1st) Difficulty controlling glucose levels (Extremely high in the mornings as compared to pre vaccine - everyday since April 1st) A light ringing in ears (Duration - all the time)
This is a spontaneous report from a contactable infectious disease pediatrician. This pediatrician reported similar events for five patients. This is the third of five reports. A patient (of 2, 3 or 4 years of age and gender unknown) received a dose of PREVNAR 13 on an unspecified date. Relevant medical history and concomitant medications were not provided. On an unspecified date, the patient developed a skin reaction and skin swelling. The pediatrician reported that one of their practices was seeing an increase in the amount of skin reactions to PREVNAR 13 in 2, 3, and 4-year-olds with the vaccine. The skin reactions were greater than 2.5 inches in diameter and they were seeing approximately five children a week with this type of swelling. The outcomes for the events were unknown.
COVID breakthrough report. I received my booster shot on 11/16/2021 and my adverse event started on 05/11/2022 I had a scratchy throat in the evening at 05:00PM ET the next day I had fever, chills, sore throat, stuffy head, runny nose and a headache. I have asthma and it triggered more when I contacted COVID. I called my doctor and he prescribed me medication for asthma and for COVID. He called in prescription for antiviral medication. On May 12/2022 I tested positive for COVID.
It woke me up about 2 am I had a severe headache and some shortness of breath. I checked my blood pressure and it was 80/40 with pulse of 42. So I went to get something to drink and went back to bed, I thought I was dehydrated. Over the next few days I felt real tired and washed out and with more shortness of breath. They did an EKG and went to a Cardiologist and he thought my thyroid was off, he wanted to watch and change medication to see if it will help. I started to get worse and they CT Scan of my chest with my PCP and they found bilateral PE. I was hospitalized for a  day and sent home with medication and right now I'm still out of work. I go back to the Dr. on the 23rd to see if they will let me go back to work.
Entire upper arm red, warm to touch, swollen 10x 6 cm area, painful to touch. Patient was advised to use alternate heat and ice to injection site use Tylenol/ibuprofen prn and Benadryl q 6 hours prn and to follow up if no improvement.
Patient & mom were discussing history of fainting with HPV vaccine prior to vaccination. COVID-19 (Pfizer (2)) dose 2 was administered to patient-seconds (~20-30) later patients head fell back. Mo thought he was joking. Patient then arched back, tensed up and fell out of his chair. Mom was closest to him and tried to protect his head from the wall/floor. Patients eyes were rolled back. Mom was blocking view, but appeared patient was mildly convulsing. Mom said she felt it. Patient was slightly disoriented but smiled one he was off floor. Whole event was less than 1 minute. Advised patient to stay for at least 20 minutes near pharmacy. They soon appeared fine after event. Patient had "hardly" eaten all day and ate cookies & chocolate milk after event. Mom was advised to call peidiatician in AM & ''seek emergent help if event occurred again.
SWELLING OF LIPS x 3 different occasions since the second dose. My lips got puffy and tingly, they were red, swollen and very irritated for days after the initial second dose and then again two different occasions during the month of February. Treatment was taking antihistamine when I got home. After the third reaction of lip swelling I called my primary doctor to let him know about my symptoms and he recommended an over the counter anti-histamine, which I am currently taking.
a lot after she received the vaccine; Slight headache; pain in the injection site; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FREQUENT BOWEL MOVEMENTS ( a lot after she received the vaccine), HEADACHE (Slight headache), VACCINATION SITE PAIN (pain in the injection site) and NAUSEA (Nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Inflammatory bowel disease (with constipation).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced FREQUENT BOWEL MOVEMENTS (a lot after she received the vaccine), HEADACHE (Slight headache), VACCINATION SITE PAIN (pain in the injection site) and NAUSEA (Nausea). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) on 08-Feb-2021 for Vaccination site pain, at an unspecified dose and frequency. On 09-Feb-2021, HEADACHE (Slight headache) had resolved. At the time of the report, FREQUENT BOWEL MOVEMENTS ( a lot after she received the vaccine) and NAUSEA (Nausea) outcome was unknown and VACCINATION SITE PAIN (pain in the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for nausea included ginger ale and coffee.  Concomitant medication was not reported.
Bronchitis; Strep throat; Influenza B; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis), PHARYNGITIS STREPTOCOCCAL (Strep throat) and INFLUENZA (Influenza B) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced BRONCHITIS (Bronchitis), PHARYNGITIS STREPTOCOCCAL (Strep throat) and INFLUENZA (Influenza B). At the time of the report, BRONCHITIS (Bronchitis), PHARYNGITIS STREPTOCOCCAL (Strep throat) and INFLUENZA (Influenza B) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. The patient was prescribed with Amoxicillin, Mucinex and Prednisone.
Sore arm, nauseated and a flare up of my autoimmune disease after the 1st dose. After the 2nd dose I woke up early the following morning with the chills, a fever, achy all over my whole body, very nauseated and a worse flare up of my autoimmune disease.
it caused her 2 spinal compression fractures to re flare up; in a great deal of pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: SPINAL COMPRESSION FRACTURE (medically significant), outcome "unknown", described as "it caused her 2 spinal compression fractures to re flare up"; PAIN (non-serious), outcome "unknown", described as "in a great deal of pain". Clinical course: I have a friend who had the latest Pfizer booster in late Nov2022 and claims it caused her 2 spinal compression fractures to re flare up and now is in a great deal of pain. Can the booster cause this kind of reaction? I just had it also and had no reaction this time. I realize everyone reacts differently.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pt complained of developing an "aura" that he associates with pre seizure sxm initially followed by shaking. He took an additional dose of Keppra 1000mg & then stated that his throat felt like it was closing  Epipen SQ injection given R thigh @ 6:07 pm. (VS 99% RA P 78 BP 158/90) 6:13pm pt walked to chair verbalized he felt better. 6:17p O2 Sat 99% P83 6:19 BP 160/98 P78 O2 sat 99%
ABO UT  THREE DAYS AFTER THE SHOT I STARTING ITCHING ,BUT I DIDNT SEE THE RASH UNTIL FIVE DAYS AFTER THE SHOT  MY DAUGHTER HAS A PICTURE ON HER PHONE .
Patient had cold symptoms at time of administration. 24-36 hrs after administration patient's cough worsened, nebulizer treatments started -> cough has progressed and patient is currently being treated with azithromycin and prednisone.
Woke the next morning and experienced blackouts but it resolved after lying down and a few hours later. Felt very cold for 48 hours. Fatigue and injection site soreness. Slight nausea, sore throat and chest congestion. Heavy chest and my skin hurts. Stiff neck.
C/O nausea, earache, sore throat, H/A, all over H/A, muscle aches, sinuses clogged up, nose stuffy, runny eyes. Hx of getting cold reaction after seasonal flu shots also. Client has not sought Doctor's care yet. Given resources if no improve or get worse.
So, my headaches have been sporadic, but frequent. Mostly headaches. Shortly after I got my vaccine, within a couple days it occurred. It was enough to be noticeable since I don't normally get them. Then in June I started to get really severe headaches behind my right eye it seemed. I am sensitive to light when it happens. It has been happening now for 3-4 weeks sporadically; the more intense headache pains, that is. The headache from the beginning was different. So, I contacted my doctor's office and had an appointment in May 2021 sometime and they are still investigating my symptoms. I am also seeing my PCP at the end of this month as well. Every once in a while, I still get one of those new painful headaches randomly but it's hard to pinpoint when it happens.
This spontaneous report as received from a pharmacist via a company representative refers to a female patient in her 80's, with a preexisting illness in which she was passing out a few times daily. No information regarding the patient's concomitant medications, drug reactions, or allergies was provided. On an unknown date in 2017 (reported as "within the last two weeks"), the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not provided). On an unknown date in 2017, after receipt the vaccine, the patient passed out while in the pharmacy. She did not seek medical attention. It was reported that no measures were taken. No treatment was given for the adverse event. On the same day, shortly after passing out, the patient woke up and went home (outcome: resolved). The relatedness between the adverse event and ZOSTAVAX was not provided. Upon internal review, the adverse event of passing out was considered to be medically significant. Additional information has been requested.
serious arthritis in all joints doc gave me steriod pack and pain lessoned then  some arthritis pain came back and affected the shape of my finger on right hand and tonight my left foot toe and the palm of my right hand
106 degree fever; A spontaneous report  was received from a consumer concerning a 45-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed 106 degree fever/hyperpyrexia.  Medical history or concomitant product use was not reported.  On 26 Feb 2021, the patient received their first of  two planned doses of mRNA-1273 (batch number: 029a21a) intramuscularly for prophylaxis of COVID-19 infection.   On 26 Feb 2021, the patient developed 106 degrees fever that lasted one day. Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event,106 degrees fever, was considered resolved on 27 Feb 2021.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot# K008333 with expiration date 10-MAR-2017, L007559 with expiration date 01-JUN-2017, and L004743 with expiration date 01-JAN-2017 (dose and route of administration were not reported). No information on patients' concomitant medications was provided. No adverse symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
couple of nights ago, the pain in her toes; could not sleep; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Feb2021 (Lot Number: EL9267) at the age of 73-year-old as DOSE 1, SINGLE for covid-19 immunisation; lidocaine (ASPERCREME [LIDOCAINE]), via an unspecified route of administration from an unspecified date (Lot numbe: 170112 also reported as 17D112, expiry date: Apr2020) to Feb2021, at unspecified dose for pain in her toes. Medical history included neuropathy peripheral, diabetes, pain in her toes, a burning pain like a blister, lung cancer 10 years ago. Concomitant medication included metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported (she has been on it 10 years plus). The patient said that 2 weeks prior to receiving the vaccine, she used Aspercreme to treat the pain in her toes, on the middle three toes on her foot. The Aspercreme takes the pain away. It is like a burning pain like a blister. She stopped using Aspercreme after receiving the vaccine and wants to know how long she should wait to use it again. She stopped using anything that she didn't normally use. Aspercreme: she hardly ever uses it. She only uses it for pain like that. She only did it because she was in such pain. She thought she would give it a whirl and it worked. She puts it on once and the pain goes away. She last use Aspercreme two days before getting the vaccine. It has expired, but it worked. The lot number is 170112 or it could be 17D112. She had stopped using it because she read an article. She has been following the COVID vaccine and the article said not to take Tylenol or Advil. She was not sure if the Aspercreme would have similar ingredients and didn't want to interfere. She said she was just concerned since a couple of nights ago, the pain in her toes was so bad she could not sleep. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Information has been received from a literature article concerning a 19 year old female patient developed uveitis, elevated intraocular pressure (IOP), retinitis and vitritis, following administration of GARDASIL, ZOSTAVAX and M-M-R II. The patient had as a pre-existing conditions cat scratch disease. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 113 days (range 0-476 days); time to onset was unknown in 1 case; the time to onset in this case was of 0 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. Uveitis following vaccination has been previously reported. ZOSTAVAX has been associated with both exacerbation of preexisting uveitis and de novo cases. Two cases of acute retinal necrosis associated with varicella vaccination have been reported. It is unclear whether the etiology of uveitis was related to inoculum with live attenuated varicella viral particles or whether it was caused by resurgence of preexisting dormant varicella virus. In most cases the uveitis followed a clinical course similar to typical cases of herpes zoster ophthalmicus. This was in contradistinction with other case reports of MMR vaccination and uveitis where the uveitis was limited to a delayed anterior chamber reaction. The possibility that other vaccines which were simultaneously administered in two cases cannot be excluded as the cause of uveitis. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.
Rash appeared and was noticed the morning after.  Round red patch in appearance. Resolved by day 3.
Racing heartbeat; palpitations; Shortness of breath at rest; This is a spontaneous report from a contactable nurse. This 31-year-old non-pregnant female nurse reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via intramuscular route of administration on 28Apr2021 at 12: 00 PM on left arm as dose 2, single for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient had no allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via intramuscular route of administration on 07Apr2021 at 12:00 PM on left arm as dose 1, single for COVID-19 immunization. No other vaccine was received in four weeks and no other medications in two weeks. The patient did not have Covid prior vaccination and was tested for covid post vaccination. On 12Aug2021 the patient's  heartbeat was racing, palpitations and had shortness of breath at rest. On 12Aug2021 Nasal Swab rapid antigen result was negative. No treatment was received. The event outcome was unknown.  The lot number for the vaccine, BNT162B2, was not provided and would be requested during follow up.
Started giving RATATEQ by mouth, noticed that pt. started having redness around mouth, eyes, right ear & blotchy redness on scalp.  Gloves were latex therefor took them off, washed hands & by the time I got MD to view the redness was gone.  Dad informed me that mom had a latex allergy.  MD told to try again without latex gloves.  Attempted redness appeared again just slightly.  I stopped, got MD, and redness was gone again by the time MD arrived from next door.  Attempted one more (per MD who was present) time & noticed a small amount of redness by ear.  Stopped. Redness by ear subsided within 12 mins.   No more given. Pt. never had any increased woe or shortness of breath observed.  Gave other vaccines in presence of MD- 0 RXNS noted.  Put allergy sticker on chart for questionable latex allergy & ROTATEQ allergy so no more ROTATEQ will be given.
Developed fever, headache and generalized body aches. Still getting IV antibiotics. 9/13/06-Records received for DOS 7/3-7/4/06 DC DX: Osteomyelitis 2 weeks prior to admission received tetanus booster and shortly thereafter developed a fever that persisted for approximately 10 days. Fever was undulating and at max at one point of 106. Initially diagnosed with viral syndrome but fever persisted, sent to PMD for CBC, ESR and blood cultures. Blood culture revealed positive for Staph. aureus and instructed to go to ER where he was afebrile WBC 5.2 with no left shift and mildly anemic, SED rate 70. Received Vancomycin and Gentamicin. Developed flushing with Vancomycin which was alleviated with Benadryl.  Allergies: Penicillin and Cephalosporins cause anaphylactic reaction Hospital Course: Remained afebrile throughout his stay. Only issue occurred 3 days into hospitalization developed a swollen erythematous and warm right elbow, investigated and osteomyelitis ruled out.  X-ray of right elbow obtained to rule out osteomyelitis due to increased erythema, warmth tenderness-deemed to be probably olecranon bursitis, not osteomyelitis and a CMP was performed which was WNL.  PICC line inserted for home care. EKG: 1 PVC and some sinus arrhythmias benign in nature. Follow-up with cardiology in 6 months.
Administered Rotavirus vaccine IM instead of PO as advised by manufacturer instructions. No known adverse effects reported by parent.
On 1/30/2021, I developed a mild headache followed by an acute change in my vision.  I went to  the emergency room 24 hours later after the symptoms had not resolved and was found to have a left superior quadrantanopia and a 2.3cm x 1.9cm hemorrhage in my right occipital lobe. I was admitted to hopsital and discharged today 2/3/2021.   My headache has resolved but I continue to have a visual field deficit.  I had been scheduled to receive the second dose of Moderna on 2/1/2021 but was unable to receive it due to my hospitalization.