chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Onset of shingles symptoms 5 days after vaccine.  Initially headache/fatigue, then developed rash primarily along inner left arm from forearm to upper arm,  Tingling, burning pain at rash site.   Also some rash, to lesser extent, on left torso in a line just below waistline from abdomen to lower back. Visited doctor's office 5/17/21 as rash/discomfort worsened.  Obtained prescription steroid cream, and OTC medication (Allegra D & Pepcid) to alleviate symptoms.  Treatment just started today, so outcome and duration are unknown at this time.  I was previously vaccinated for shingles about 1.5 years ago.
Chills, Nausea, Fever, Aches, Diarrhea, Headache - unable to work for 2 days - symptoms milder but still linger 5 days later
Information has been received from a healthcare worker (medical assistant) concerning a 60 week old child. On 16-MAR-2015 the patient was vaccinated with a 0.5 ml dose of MMR II (lot # J002866, expired date 12-MAR-2015) subcutaneously in the left lower thigh. No adverse effects reported at this time. Additional information is not expected as we were not permitted to contact the reporter.
A report was received from a health care professional on 16Oct02, concerning a 3 year old male vaccinee who was inadvertently administered 0.5ml Fluvirin IM into vastus lateralis on the 14Oct02. On 14Oct02, the vaccinee suffered a medication error by receiving 0.5ml Fluvirin into the vastus lateralis. The infant had not experienced any adverse events at the time of the report but was being closely monitored. There was insufficient information to determine the reporter's causality assessment. PJP200200609, PJP200200670, PJP200200669, PJP200200668, PJP200200667, PJP200200666, PJP200200665, PJP200200664, PJP200200662, PJP200200663.
On 6/25/98 pt received Varivax, on 10/4/00 had chicken pox with approximately 100 lesions. Treated with Benadryl and Tylenol.
Tested positive 11/5, ED to hospital admission, 11/8 with CT showing findings most consistent with multifocal pneumonia, 11/11 dx updated to include Acute hypoxic respiratory failure, 11/12 CT Worsened patchy opacities throughout the lungs, most prominent in the right upper thorax. 11/13 The patient is currently maintained on remdesivir, Decadron 10 mg, Baricitinib. 11/16 CT confirms onset of COVID pneumonia, 11/17 The patient is currently maintained on Ceftin, baricitinib, Decadron with Decadron day #6 and baricitinib day #6 also. 11/21 The patient is currently maintained on baricitinib.  11/22 CT Persistent diffuse bilateral pulmonary infiltrates. 11/28 CT Aeration shows minimal improvement
Generalized body itchy/red/hot rashes with bumps. More severe around neck/shoulder/back area.  As needed benadryl and zyrtec taken.   Symptoms has developed daily since 12/07/2021 after daily zyrtec has worn off.
Numbness starting from the injection site (upper left arm) and surrounding area, noticed about a week after the shot. Then numbness continued progressing down my upper arm, and into the front of my lower arm. This is accompanied by pins and needles kind of tingling and an intermittent heavy aching feeling along my entire left arm (picture the feeling of dental numbing wearing off).   On 4/14/2021, I noticed the numbness is now also in my left thumb.  Arm appears to function normally at this time, but worried about the increasing loss of sensation.  Went to doctor who performed a complete blood count and recommended monitoring  as she felt nothing could be immediately done.
Pt was given 3rd dose of Heplisav. Vaccination series is only 2 doses. Pt was notified of error.
drew up 0.3ml and injected instead on 0.5ml I called her back in after I realized it and administer 0.2ml more in same arm
After both vaccinations, the next day had a fever of 99.5 or higher, chills, body aches, injection site soreness, pain and swelling, dizziness, nauseated, fatigued, extreme headaches.
Red rash and swelling at injection site. Rash , burning and itching on hands and body, fatigue, Headache, Roof of mouth hurts
p/vax pt devel fever & had cramps x 6hr occurred 5hr p/vax;
I woke up Friday, April 2, with a bad headache and crushing fatigue. Spent the day in bed. The next day, the headache was gone, but the fatigue continued and my back started hurting. The day after that, Sunday, I will still very tired until about 7:00 p.m., when I turned a corner and felt better. On Monday, I felt well upon waking, but lagged in the afternoon and went back to bed. On Tuesday, I was much better. I continued with occasional bouts of fatigue (2-4 hours each) for two weeks following the injection. I have been well since.
4 mo old - 3" circular blotchy raised rash over area, some of the rash spread down thigh, no pain, erthematous site--> DPT
This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a health professional and a physician concerning an 18 year old female patient with drug hypersensitivity to morphine, convulsion disorder, graves disase, bipolar disorder and anxiety who on 25-MAY-2007 at 7:30 am was vaccinated in left arm with a second dose of GARDASIL (lot # 0212U). One hour after the injection the patient experienced tingling of her right and left fingers, hands, lips and bridge of her nose and eyelids, left arm sorness, and headache. On 25-MAY-2007, the patient recovered from tingling of her right and left fingers, hands, lips, and bridge of her nose and eyelids, left arm sorness and headache.The patient sought unspecified medical attention. No further information is available. Additional information is not expected.
Pt had two vaccines administered on left arm; DTAP #4  and HIB #4 on 3/11/2003. Pt came in on 3/13/2003 with left arm swollen, red, hot and small blisters on arm. Dr prescribed Benadryl and Keflex.
Sore throat, head ache, fever, pneumonia, chest pain, cardiac arrhythmia.
first dose was administrated 800 days ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 800 days before day of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. No patient's identifiers were provided. No lot number nor expiration date were provided. No vaccination date was provided. The patient was late for the second dose of Shingrix, which led to incomplete course of vaccination. No adverse event was reported. The reporter did not consent to follow up.
Information has been received from a pharmacist concerning a 26 year old female patient. No concomitant medications, pertinent medical history, and drug reactions and allergies were involved. On 04-NOV-2016 the patient was vaccinated with GARDASIL (dose, frequency, lot number and expired date were unknown) subcutaneously. The pharmacist reported that on unspecified day of November 2016 the patient experienced a "red, swollen lump" at the site of injection. The pharmacist reported that the patient stated "it was getting worse" and that the patient stated she intended to see her unspecified healthcare provider. The pharmacist reported that the patient "has big arms" and that it was possible it did not reach the muscle and might have been administered into the subcutaneous. Additional information has been requested.
Patient reporting pain in chest/shoulder that radiates to his neck, described as aching like a muscle. Normal vital signs at time of encounter. No acute distress. Did not appear ill or as if he was experiencing a severe systemic adverse reaction.
None. 11/25/15 T/C contacted mom for f/u to check status of child, child doing well, denies any problems and he is well.
Information was received from a physician concerning a 3 month old female, with on allergies, who on 29 Nov 2006 was vaccinated with a second oral dose of rotavirus vaccine. Concomitant therapy included nystatin, for thrush. On 30 Nov 2006 the patient developed vomiting and diarrhea. The patient then became dehydrated and had to be hospitalized. The patient had tested positive for rotavirus. The patient was confirmed to have rotavirus and pneumonia. The physician indicated that the patient may have possible severe combined immunodeficiency syndrome, but at the time of the report testing was ongoing to verify the diagnosis. The patient was in respiratory distress and was on oxygen. At the time of the report the patients symptoms had not resolved and were getting worse. At the time of the report the patient was still intubated and was in the intensive care unit. No product quality complaint was involved. No other information was provided. The patient's experiences were considered to be disabling and other important medical events by the reporter (OMIC). Additional information has been requested.
This spontaneous report as received from a currently 72 years old female consumer with no drug allergies refers herself. The patient's medical history included spinal surgery in 2004 resulting in nerve damage. The patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) about 5 years ago (in approximately 2007). Concomitant medications included LYRICA and unspecified pain medication. The patient had had shingles twice since receiving ZOSTAVAX. She was not sure of the exact dates of the shingles, but thought that they were within the last three years (one case could have been two years ago (in approximately 2010) and the other case about three years ago (in approximately 2009)). She was treated for the two cases of shingles, treatment unspecified. About 2 months ago (in approximately June 2012) she developed a headache and currently the consumer was experiencing swollen glands, became dizzy and lightheaded, sick to the stomach with a low grade fever and had one vesicle on the inside of her elbow that was itchy (exact start date unspecified but within two months). No current treatment was noted. The headache was reported to have resolved (date of resolution unspecified). The outcome of swollen glands, became dizzy and lightheaded, sick to the stomach with a low grade fever and one itchy vesicle on the inside of her elbow was reported as not recovered. The patient sought medical attention by office contact. Additional information has been requested.
Dizziness, such that I couldn't stand Vomiting Body aches Headache Chills Subnormal temperature Diarrhea  Started the morning after the shot and continued for 2 days
Patient came to pharmacy on 6/24/13 with a deep red area about 3 inches in diameter and a lighter red area about 10 inches in diameter arm was hot to touch and swollen.  Called patient dr and they saw her immediately and marked diameter and told her to come back if progesses also gave her antibiotics.
L/deltoid, localized induration/ecchymosis/systemic viremic sx's, including neck stiffness. By 3rd day, sx's resolving.
12/26/2020 vaccination. 4-5 hours later I suddenly got achy, sore, painful arm. Couldn't lift arm. body aches, chills, could feel it in my back from shoulder to shoulder when had vaccination. I started to feel 'like i had something/ flu. 'Something isn't right'. I had every single side affect that was listed; HA, pain in side of head, stiff, painful, body aches, couldn't control pain period. Tylenol. BC powder for HA. *history of aneurisym. Check in with doctor time to time; headaches. 'weathered the storm' tried to go to sleep. NO SOB. had major fatigue, body aches, CRAZY nausea. These symptoms last for a week and a half. Were unable to work.  talking to doctors, not able to come to conclusion on what was happening to me. Questions regarding 2nd shot. couldn't eat for almost 2 weeks. My nausea is so bad, i am scare to eat.
Sudden onset of deafness of the right ear. 9 days after having received the first dose of  Heplisav-B, I woke up with pressure and ringing on both ears. The symptoms continued on and off for a couple of days. On day three, the symptoms were gradually getting worse, and by the end of day 3, at around 10:00 p.m., I discovered that I had completely loss hearing on my right ear. I went to Urgent Care on August 1, 2023, and the doctor confirmed I could indeed not hear out of my right ear and ordered a hearing test, and a referral to an ENT specialist. I had the hearing test done on August 1, and also saw the ENT doctor on the same day. Both hearing test and ENT doctor confirmed total hearing loss. My middle ear was very swollen.  The ENT doctor gave me an injection of steroids right into the ear, and prescribed  predniSONE 20mg tablets, to take 3 tablets (60mg) once a day for 10 days.  The first 3 tablets were taken at night, the same day I received the injection in the ear.  I have taken predniSONE for 7 days and today I started hearing a little bit (~20%) out of my right ear.
Instructed to apply ice for 20 min every D 2 hrs, return to clinic if condition doesn't improve or gets worse. (Red rash swelling to thigh).
2nd Vaccination was not Moderna brand; Blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision) and WRONG PRODUCT ADMINISTERED (2nd Vaccination was not Moderna brand) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VISION BLURRED (Blurry vision). On 03-Mar-2021, the patient experienced WRONG PRODUCT ADMINISTERED (2nd Vaccination was not Moderna brand). At the time of the report, VISION BLURRED (Blurry vision) and WRONG PRODUCT ADMINISTERED (2nd Vaccination was not Moderna brand) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       MD told to patient to pre-medicate with Benadryl and Advil prior to 2nd Vaccination.
Hallucinations, Myalgia, Fever, per pt: "flu-like symptoms, chills, fever, tiredness and headache". Took 1 day off from work.
Hx. Of severe headache on 1st dose of Moderna, throat swelling and difficulty of swallowing on 2nd dose and observed for 45minutes, but pt. Doesn't remember receiving any treatment/medication
#Muscle twitching - Symptoms started with left arm myalgia and gradually progressed to muscle twitching over the last 2 days - Eyebrows, upper/lower extremities and neck twitching
Still very sensitive to light; Pain is horrendous; Headache every day; Had both vaccines prior Shingles/Suspected vaccination failure; Shingles in left eye; Got shingles on face; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In November 2022, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced photophobia, pain and headache. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, shingles and headache were unknown and the outcome of the photophobia and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, photophobia, pain and headache to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 12-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she received both the doses of Shingles vaccine. The patient stated that after received Shingles vaccine the patient experienced shingles on his/her face in his/her left eye. The patient reported that still very sensitive to the light and the pain was horrendous. The patient had a headache every day. The patient stated that it was terrible. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
pt recv vax & pt's mom reported pt's lt arm is swollen to twice the size of the rt arm; mom took pt to ER
No other AE; HBP calling to report an administration of PEDVAXHIB  following a temperature excursion.; This spontaneous report was received from an other and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W034363, expiration date: 14-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided). On 13-JUL-2023, this vaccine underwent temperature excursion (Product storage error). No additional adverse events were reported.
Left arm, rash and redness, started about 3 hrs after immunization, continued with swelling and nose and sinus congestion.
This spontaneous report was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 15-APR-2015, the patient was vaccinated orally with a dose of 2 ml of ROTATEQ 10 unit dose tube, lot # K000487, expiration date 27-SEP-2015. This vaccine was improperly stored exposed to four temperature excursions, one for a sum of 48 hours with a lowest temperature recorded as 1 degree C; other for a sum of 72 hours with a highest temperature recorded as 9 degrees C; another for a sum of 24 hours with a lowest temperature recorded as -1 degree C, and the last one for a sum of 48 hours with a lowest temperature recorded as 0 degrees C. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator(R)". No adverse effects were reported. There was no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Lot of pain; Covid-19; Covid-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 4180478 (Company).  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1166040) till 2022 at single dose pen, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Covid-19"; PAIN (non-serious), outcome "unknown", described as "Lot of pain". The action taken for adalimumab was dosage permanently withdrawn in 2022.  The reporter's assessment of the causal relationship of "covid-19" and "lot of pain" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causality: The reporter's causality for the event of Covid-19 and Lot of pain with Adalimumab Solution for Injection was Not Provided. The reporter's causality for the event of Covid-19 and Lot of pain with Pfizer BioNTech Covid-19 vaccine (Tozinameran) was Not Provided. Company's opinion was that the causality for the event of Covid-19 and Lot of pain with Adalimumab Solution for Injection was Not Provided. Company's opinion was that the causality for the event of Covid-19 and Lot of pain with Pfizer BioNTech Covid-19 vaccine (Tozinameran) was Not Provided. Assessment Results: Humira-Covid-19, Non-Health Care Professional, Global Introspection, Not reported. Pfizer BioNTech Covid-19 vaccine-Pain, Non-Health Care Professional, Global Introspection, Not reported. Humira-Pain, Non-Health Care Professional, Global Introspection, Not reported. Pfizer BioNTech Covid-19 vaccine-Covid-19, Non-Health Care Professional, Global Introspection, Not reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per the available information the events drug ineffective,suspected covid-19 and pain are possibly related to the suspect.
sore injection site arms; felt slightly fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 001B21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu Shot and Flu Shot. Past adverse reactions to the above products included Fatigue with Flu Shot; and Vaccination site pain with Flu Shot.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued). At the time of the report, VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   The patient reports that she and her siblings each received 5 Moderna vaccinations and that they love Moderna The patient then goes on to say that she and her siblings had no side effects to the Moderna vaccine except they had sore injection site arms and felt slightly fatigued. Just like with a Flu Shot. Arm was sore for a day.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-710705 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710705:1 out of 5 siblings
mom reports pt recvd HBOC in 1989; 2 days later devel t105 taken to ER-rx unk; fever persisted; MD visit-rx w/ATB; fever persisted off & on 2 mos w/sore throat & leg cramps; 1990 difficulty hearing noticed; MD visit dx deafness in rt ear;
Injection site red, hot to touch, swollen/knot warmth, itchy for 2 days. Arm sore
I experienced a very sore arm for about two days after injection on 12/29/2020-12/31/2020  By 1/6/2021 I had noticed near the injection site it was red and inflamed. It was slightly itchy, but I put some cortisone cream on it, kept an ice pack on it and went on with my day. 1/10/2021 during the evening I noticed my arm really warm and the rash had then raised to a more hive/welt like look to it. Still not too itchy but still concerning. On 1/11/2021 It was still red and swollen so I had a PA-C that works near my office take a look at it and they said I should report it accordingly to be safe.
Hib-HepB and MENACTRA incorrectly ordered. Hib and MENACTRA were given. Manufacturer called since patient was too young to received MENACTRA. Pt needs to return for MMR and Varicella.