chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the vaccine increasing immune system, MS flare up; This is a spontaneous report received from contactable other health professional. A 46-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Uveitis" (unspecified if ongoing), notes: symptoms from previous diagnosis of Uveitis; "eyes light sensitivity: Photophobia" (unspecified if ongoing), notes: symptoms from previous diagnosis of  eyes light sensitivity; "inflamed" (unspecified if ongoing), notes: symptoms from previous diagnosis of inflamed; "painful" (unspecified if ongoing), notes: symptoms from previous diagnosis of painful; "had feeling like something crawling on" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MULTIPLE SCLEROSIS RELAPSE (medically significant), outcome "unknown", described as "the vaccine increasing immune system, MS flare up".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event multiple sclerosis relapse cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
This case was reported by a nurse via sales rep and described the occurrence of fever in a adult female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever and diarrhea. On an unknown date, the outcome of the fever and diarrhea were unknown. It was unknown if the reporter considered the fever and diarrhea to be related to Shingrix. Additional details were reported as follows: The reporter said that the patient had fever and diarrhea severe enough to visit an urgent care after receiving a dose of Shingrix.
Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 9:20 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 9:26 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 44.12.  No concomitant medication was reported by reporter.  On 21-MAR-2021, Excursion time was 9 AM,10 AM,11AM  at temp of 34,32,34 respectively , total doses given for the day was94, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 16-MAR-2021, vial was moved to clinic on 21-MAR-2021. Vaccine BUD date was 15-APR-2021. Number of vials sent to clinic was 10.The batch no. of Product was 003B21A.  On 14-FEB-2021, Excursion time was 9 AM,10 AM,11AM,2 PM,3 PM  at temp of 32,32,32,35,35 respectively , total doses given for the day was162, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. Vaccine BUD date was 10-Mar-2021. Number of vials sent to clinic was 30.The batch no. of Product was 031L20A.     It was reported that patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Vial was punctured right before administration.   No treatment medication was reported by reporter.   This case was linked to MOD-2022-566976 (Patient Link).
1:25pm Immediately after receiving vaccines, patient's limbs were in a sustained fully extended position with an arched back. He also had his head turned to the right and the right arm extended out. The episode lasted about 30 seconds. He then sat down and appeared pale. Mother reports he only ate one balleada (1 tortilla with beans) for lunch.   1:35pm  When I (Dr.) saw him, he appeared pale and clammy.  He also complained that he was having trouble seeing and was unable to answer my questions regarding where he was, his name, or how old he was.  Initial blood pressure taken with a child cuff at 1:30pm was 61/35 with a pulse of 61.  At that point, patient was given a juice which he quickly drank.  Immediately after drinking the juice, his color started returning and he was able to answer basic questions including his full name, his birthday and where he was.  When asked questions regarding his family (how many siblings he had and how old they were), he was unable to answer them.  At this point, he also still feeling dizzy.  We continued to observe him and rechecked his blood pressure at 1:37.  At that time it was 94/57 and patient was beginning to feel back to normal.  Patient continued to be observed in clinic and blood pressure was retaken again at 1:51pm at which time it was 115/58 with a pulse of 72.  At that time, patient denied feeling dizzy or nauseous and mom felt that color was back to normal.  However, patient continued to complain that he felt very sleepy.  I examined patient's heart and it was RRR without any murmurs.  Patient was able to walk across clinic with normal gait and without dizziness.     At that time, neurology was contacted and patient continued to be observed.  At 3pm, neurology still had not called back but patient was completely back to baseline and sleepiness had resolved.     Return precautions discussed with mom including any recurrence of symptoms.  Mom instructed that if symptoms recurred, she needed to take patient to ER.  Appointment also made for well child check on Monday 1/27/20.  Mom also instructed that we would call her with any further instruction after we talked to neurology.
Given both single dose H1N1 and seasonal flu vaccine (with H1N1), one in each arm.
Initial unsolicited report received from pharmacist via Pfizer (manufacturer report number: 2016572528) on 17 Jan 2017. This case involves an elderly male patient (age was not reported) who was vaccinated with a second dose of Fluzone HD (batch number: UI637AA, expiry date was not reported) via intramuscular route in left arm and 0.5 ml second dose of Pneumovax 23 (batch number: L034335, expiry date: 18 May 2017) via intramuscular route in right arm/ deltoid on 30 Aug 2016 at 01:43 pm. Patient medical history and concomitant medications were not reported. On 30 August 2016, same day post vaccination, the patient developed rash. On an unspecified date, the patient was hospitalized and thought to have Guillain-Barre syndrome, but was later diagnosed with West Nile virus and also experienced burning sensation at injection site (not specified which vaccination site). The patient also required ER/doctor visit. Lab data and corrective treatment was not reported. On an unspecified date, the patient was recovered from the event West Nile viral infection and rash but patient was not recovered from burning sensation (reported as now only complained of burning sensation as injection site). Patient was discharged from hospital after three days of admission. List of documents held by sender: none. Sender's Comments: Around 74 years old male patient received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE with PNEUMOCOCCAL (POLYSACCHARIDE) (23 SEROTYPES) VACCINE and on same date experienced rash and was later diagnosed with West Nile viral infection, he also had Burning sensation at site of injection. Details regarding relevant medical history, investigation reports, previous vaccination history, concurrent condition, and concomitant medication are needed for complete assessment of the case. Based on the available information, no conclusion can be drawn.
no adverse event; Improper stored administered vaccine; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent condition were not reported. Concomitant therapies included sterile diluent. On 09-JAN-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R014690 and 23-MAY-2020 (strength, dose, route were not reported) for prophylaxis, for following a temperature excursion (product storage error). No additional adverse effects reported and no product quality complaint. The vaccine stored at highest temperature above 47-degree Fahrenheit/ 9 degree Celsius (14C) at time frame 9 hours. There was no temperature excursion and digital data logger yes.
Post vax, the pt experienced acute paranoia. The annual follow-up indicates that,"not sure if persistent hypothyroidism was triggered by the hep b vaccine."
pain at the injection site; experienced a red, painful spot; experienced a red, painful spot,the area is a little sore; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2022, the patient received the 2nd dose of Shingrix (intramuscular). In July 2022, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain, redness and pain. On an unknown date, the outcome of the injection site pain and redness were recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, redness and pain to be related to Shingrix.     Additional Information: GSK receipt date: 15-Jul-2022 Reporter's comment: The patient received suspect vaccine on unknown arm. The reporter reported that few days later after 2nd dose patient experienced a red, painful spot about 2 inches below the injection site. The area was a little sore. The patient had nothing else to report.
Vaccine given 3/17 @ 1150am. Started itching  on hands and feeling SOB and CP 3/17 @ 1220. Brought to ER by EMS 3/17 @ 1255. ER did not note a rash but patient was scratching when arrived and examed no angioedema/wheezing/or strider. Was given po diphenhydramine 25mg x 1 and famotidine 20mg po x 1. Sx resolved.
Patient stated after receiving the 1st dose of Pfizer 10/25/2021, she experienced symptoms 10/26/2021 of "pins & needles" feeling starting in the right arm from elbow to fingertips moving into the left arm to fingertips. Both hands and calves have a tingling feeling lasting to current. Muscle aches and heart palpations. Primary communication recommendation for follow-up report.
Flu vaccine given 12/27/06 at 1:30. Mother stated felt warm and fussy that day at 5:00. On 12/28 at 2am had fever and gave Tylenol and seemed ok when woke up that am was running and fell on milk bottle in his mouth. Hit nose. Immediate started seizure and carried to ER by rescue squad. ER had difficulty controlling seizure. Child was airlifted to medical center. Talked with mother on 1/10/07 states child was ok now. Not on any medications. No more seizures. No problem with any prior immunization. Child did have seizure once before at 11 months of age. It was very brief and did not require MD visit. Mother informed MD of this. Brother has febrile seizure.  03/15/2007 MR received from treating hospital for c/o of seizure activity following flu vax.  Upon arriving home from appt., mother noted child had a fever and cough. The following morning, child began having generalized seizure activity and EMS was called.  Seizure activity reduced with Ativan, but had several episodes each responding to treatment. Child was transfered to current hospital. Seizure activity stopped and child was discharged the next day.  Assessment: RSV and febrile seizure with atypical presentation.
Information has been received from a physician concerning a 9 year old female patient with a diagnosis of nephrotic syndrome and no known drug allergies who on Feb 3, 2003 was vaccinated in the left arm with a first dose of pneumococcal vaccine 23 polyvalent (lot# 644107/0955M). Concomitant vaccinations the same day included influenza virus vaccine (Flushield) in the right arm. Other concomitant medication included prednisone. There was no illness at the time of vaccination. In the am of Feb 4, 2003 the patient experienced intermittent numbness and tingling of both feet for one day. Unspecified medical attention was sought. It was unknown if intervention was required. Follow up information from the physician indicated that no treatment or evaluation was necessary and that spontaneous resolution occurred. There were no diagnostic tests or laboratory results. The patient recovered on Feb 4, 2003. No further information is expected.
I received my first dose of Pfizer COVID-19 vaccine on 8/21/2021. Three days later, on 8/24/2021, I began getting itchy skin in the area of the left side of my abdomen. On the left midsection of my torso, I had itching and small bumps to the left of my spinal column. Over about the following two weeks, the bumps enlarged, though the itching was then less pronounced. By around 9/1/2021, I had a constant burning, painful sensation in the affected area. At this point, the lesions had blistered and were seeping clear fluid. The discomfort was at its worst around 9/6/2021, and they finally crusted over and stopped oozing around 9/8/2021. During my illness, I constantly applied calamine lotion to the lesions. I had a virtual appointment with my PCP on 9/10/2021. She said that it was likely shingles with encrusted lesions. She said that since so much time had elapsed since the onset of symptoms, I was not eligible to receive Valtrex. However, she did give me gabapentin for pain relief. I only took the gabapentin twice, because the pain became more manageable afterwards. I continued to go through the recovery process. The pain finally stopped around 9/17/2021. Eventually, the sores healed, and I still have residual scarring on the left side of my back.
Patient could not sleep due to pain that radiated up neck and down arm. Pain improved but still uncomfortable for at least 5 days. Patient left for another country for 2 week. Pain was tolerable during this period. Radiating pain returned upon return.
I went into my family doctor for a checkup and she noticed an extra heartbeat on the exam. She hooked me up to an EKG which showed the extra heartbeat as well. I was referred to a cardiac group and they sent me a heart monitor that I wore for 5 days. The results showed minor extra heartbeat and ventricular ectopy of 3.3% and ventricular couplets of 2. I received a report from my doctor who indicated that the condition did not need to be medicated but would be monitored. I had a stress echo 4 years prior for having a kidney removed and it was perfectly normal.
Pt. actually seen 5/6/2015 at noon; local reaction- 8cm area of erythema, warm to the touch, very hard but not painful unless pressure was applied. No treatment required.
CELLULITIS LT UPPER ARM 2ND DEGREE STARTED ON 3-12-06 REC'D IMMUN ON 3-10-06. ROCEPHIN 1 GRAM GIVEN IM TODAY AND THEN KEFLEX STARTED WILL RECK 3-14-06.
Whole upper arm swelling, pain, redness at time of E.R. admin. Doctor found lymph node was swollen. Put on IV Abx ROCEPHIN in hospital for two days. Oral KEFLEX after. Massive swelling, pain, infection within 48 hours after inj.
malar rash; fever of 102.9/ temp of 99.7; This is a spontaneous report from a contactable nurse. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date unknown, via an unspecified route of administration on 10Jan2021 at 10:30 at a single dose for COVID-19 immunization. The patient had no medical history. The patient had no other vaccine in the last four weeks or other medications in last two weeks. The patient had no known allergies. The patient's concomitant medications were not reported. The patient developed a malar rash with a fever of 102.9 for 48 hours. 6 days later the patient developed second incident of a malar rash and temp of 99.7. The events started on 10Jan2021 at 22:00. No treatment received. The patient did not recover from the events. The patient was not tested for COVID prior and post vaccination.  Information on the Lot/Batch number has been requested.
After 4 mo immunizations had fever of 104, 24 hrs later went to ER for work up.
DEATH; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. 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) dose, 1 total, 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 patient died from the vaccine due to unknown cause of death and could never got the second shot. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210667006- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Death. This event is considered unassessable. The event 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Pt had flu vaccine on 11/17/2015. Stated no allergies and never had flu vaccine previously. Presented to clinic on 11/18/15 stated started to have severe itching 2 hours after vaccine. No other symptoms on exam - no hives or edema/swelling. Appears to allergic reaction from flu vaccine.
Within four hours, noticeable pain in left arm that traveled to the left side of neck. Later a headache which continued for 24 hours. Extreme body aches and tiredness. I could not sleep due to muscle aches, so took TYLENOL (500 mg). The next morning, TYLENOL. Continued muscle aches, shivering, headache, stomach upset, diarrhea, no appetite. I stayed in bed. The second day, a slight headache, body aches continued and very tired. Arm and neck still painful. Appetite was better, but not regular. Third day (today) arm and neck muscle pain, no energy, better appetite. During this period I was taking CLARITIN 5 mg and Meloxicam 7 mg. I informed doctor and was told these were considered "normal" viral type reactions.
Patient stating arm is hurting down in the bone. States that it comes and goes but is deep pain. She didn't want to treat it with over the counter NSAID or Tylenol. She stated that the pain is bearable but an annoyance. Patient states that the pain goes away when she lays on her arm.
MMR WAS GIVEN ON RIGHT GLUTEAL AREA IM (12/14/2008) AND TODAY(12/16/2008) CELLULITIS IS PRESENT 11CM X 9.5CM ON RIGHT BUTTOCK AND ERYTHEMITUS, RED, ITCHY RASH AROUND BOTH EYES ALSO PRESENT. PT WAS PLACED ON KEFLEX 250MG BID FOR 10 DAYS AND PRELONE 10CC BID FOR 7DAYS. PT TO RETURN TO CLINIC TOMORROW FOR RE-CHECK
Began running fever, almost immediately. Continued running fever of 100.6 - 101.3 for next two days.
Explosive gut wrenching diarrhea 5 times within the last hour.  This is very comparable to food poisoning.  I did feel slightly nauseous about 4 hours prior to this but it never got to the point of vomiting.  Hopefully the diarrhea subsides by early morning or I will go to the emergency room for intravenous fluids.  The previous two vaccines only resulted in 2 days of chills for me which was manageable.
6 days after receiving the Moderna vaccine the patient went back into atrial fibrillation.
Fell asleep on couch and woke up at 11:30 pm to horrendous itching on inside of both upper arms. Since I have had this itching problem since April (second does 01/28/2021 which was three months prior and NO itching after first vaccine , one month .earlier, 12/29/2020 Took benedryl and went to bed. Up almost all ight. The itching was unbearable, even ice packs on it did not relieve it.  Slept another 10 hours finally. When I woke up, itching was not as bad, but felt like I was hit by a truck. I do have Hashimotos,which have been taking Levothyroxine for 30 years.
Pt received Janssen Primary series and Moderna Booster  2mins post vaccination pt reported dizziness Vitals: 137/88, 76, 16 Placed in a recovery position, VSS Pt stable and released from the vaccination site.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The reporter stated that on 26-JUN-2014, the patient received the first dose of GARDASIL (0.5 ml, intramuscular, anatomical location and lot number were not reported), on 13-NOV-2014 received the second dose of GARDASIL (0.5 ml, intramuscular, anatomical location and lot number were not reported) and on 08-JAN-2015 received the third dose of GARDASIL (0.5 ml, intramuscular, anatomical location and lot number were not reported). No adverse effects were reported. Additional information has been requested.
pt recv vax 7MAY96 & 23MAY96 pt devel 17 lesions;the reporter felt that the lesions were r/t the vax;
pt recv 2 doses of vax 1OCT95 & 18DEC95 & lab eval on 10JUL96 revealed a negative titer;