chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning an approximately 6-week-old patient who was vaccinated PO with the first dose of Rotateq. It was reported that the patient subsequently developed vomiting, diarrhea and fever. Unspecified medical attention was sought. It was not certain if the patient's events were related to Rotateq because the patient was sick with acute gastroenteritis at the time of vaccination. At the time of this report, the outcome was unknown. Additional information has been requested.
Patient received the vaccine and was observed in the post vaccination area for 30 minutes.  He then went upstairs to his apartment and returned approximately one hour later.  He sat in the lobby and looked somewhat ill.  He was questioned by house staff and said that he was ok.  He then lost consciousness and slumped in his chair.   Medical staff was notified and he was still unresponsive.  He was lowered to the floor and upon assessment, he had no pulse or respirations.  CPR was begun with bag mouth ventilation and subsequently chest compressions.  He received 50mg of IM Benadryl and 40mg of Solu Medrol IM.  He still had no pulse and he an AED pads were applied.  AED analysis indicated a shockable rhythm and one shock was administered with return of pulse.  He remained unconscious and ventilation was continued until EMS arrived.
I experienced my face became red and tingly within 30 seconds of getting the vaccine. I felt like I was having a hot flash with nausea that lasted short term. The nausea lingered for 5 days.
One day after vaccine, it was reported the pt had loss of consciousness, then was sleepy for about 10 minutes. Temperature was 99.2 AX. No color change. No seizure activity. Was in very hot house without air conditioning and then event occurred. Recovered without treatment. Was seen in ER after event and then the MD'S office.
Within one hour of receiving vaccine, patient had sudden onset of chills, profuse sweating, back stiffening, dizziness, sore throat, nausea, shortness of breath, arm tingling and intense muscle and bone pain. Patient was taken to ER. Vital signs upon arrival to ER: Blood pressure of 110/69, Oral temperature of 105, respiration of 16/minute. Treated with I.V. saline infusion, metoclopramide(REGLAN) 5mg/1mL (10mg given), TYLENOL 1000mg, SOLU-MEDROL 125mg /2mL (125mg), BENADRYL 25mg, and famotidine 20mg. Symptoms resolved upon discharge from ER.
Patient after being vaccinated is in the observation area when he reports that there's itching in the arm L +, arm that was vaccinated.
Loss of bladder control; Loss of bladder control; Cramping in abdomen and lower back; Cramping in abdomen and lower back; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 05Aug2021 at 08:15 AM (age at vaccination was 50 years) as DOSE 1, SINGLE for covid-19 immunisation at public health clinic/veterans administration facility. The patient was not pregnant at the time of vaccination. Medical history included allergy to bananas, watermelon, tomatoes from an unknown date and unknown if ongoing. No other vaccines were received within four weeks to the administration of bnt162b2. Concomitant medications included multivitamin, pantoprazole sodium sesquihydrate (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]), boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN); both taken within two weeks for an unspecified indication, start and stop date were not reported. The patient previously received amoxicillin, kefzol, aspirin and experienced allergies. On 05Aug2021 at 05:00 PM, the patient experienced loss of bladder control for 4 days, cramping in abdomen and lower back. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The outcome of the event loss of bladder control was recovered with sequelae on 10Aug2021 and outcome of other events was recovered with sequelae on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
15SEP92 AM red blotchy itchy areas between fingers on hands-area progressed to eblows & stopped; 16SEP92 AM red blotchy itchy areas between toes both felt progressed to knees & stopped; blistery look;
I had visual aura with migraine which is a normal event for me. This time, however, it was accompanied by confusion and memory loss that lasted about 15 minutes. I couldn?t say names of people known to me or read a list on my counter. In 25 years of migraines I have never had these symptoms with my migraine.  I took an over the  counter migraines medicine which resolved the symptoms.
Per my Doctor; I can hear a murmur when I listen to your heart. I have no record of hearing this previously. I suggest scheduling an ultrasound of your heart (echocardiogram).
vaccine given 7/9/21 patient admitted to local Hospital then transferred to another Hospital and finally transferred to a final Medical Center ICU 7/15/21 with liver failure
Developed allergy to whey (dairy) that was not previously known.  Allergist stated it could have been triggered by viral infection or COVID vaccine.
4PM lt arm starting itching, noted sl inflammation & edema; 130PM 29MAR96 lt arm hot to touch, painful, edematous w/mod inflammation still w/ c/o itching
The first SHINGRIX vaccination was give 2 months prior with no side effects. On 10/22/18, patient stated to pharmacy that the second dose caused her to have joint pain all over. She became exhausted and tired. She had a 3 inch red spot at site of injection. Patient went in to see her PCP and was prescribed an antibiotic in case of infection. Patient presented to pharmacy a few days later on 10/24/18 and red spot seems much improved.
Guillain Barre. Belame partially paralyzed. Was in ICU x 1 week. Received IVIG and currently in PT. Up to 6 months for a full recovery. Follow up 7/16/05: Still have dialated pupil and reflexes are not fully recovered. Weakness. Doing much better than before.
SYMPTOMS OF ACHING, REDNESS, AND SWELLING AT THE INJECTION SITE (LEFT ARM); SYMPTOMS OF ACHING, REDNESS, AND SWELLING AT THE INJECTION SITE (LEFT ARM); SYMPTOMS OF ACHING, REDNESS, AND SWELLING AT THE INJECTION SITE (LEFT ARM); UNABLE TO SLEEP DUE TO DISCOMFORT; UNABLE TO SLEEP DUE TO DISCOMFORT; This case was reported by a consumer via other manufacturer and described the occurrence of injection site swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tofacitinib citrate (Xeljanz) (batch number unknown, expiry date 31st December 2022) for rheumatoid arthritis.   Concurrent medical conditions included diverticulitis (diagnosed with diverticulitis on 15th October 2020), renal cyst and rib fracture (had 3 broken ribs). Concomitant products included minocycline hydrochloride (Minocycline), hydroxychloroquine, gabapentin and lisinopril and hydrochlorothiazide.   On 19th November 2020, the patient received Shingrix. On 20th November 2020, the patient started Xeljanz 5 mg twice daily (10 mg daily). In November 2020, less than a week after receiving Shingrix and an unknown time after starting Minocycline, the patient experienced injection site swelling, injection site erythema, injection site pain, sleeplessness and discomfort. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site pain, sleeplessness and discomfort were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain, sleeplessness and discomfort to be related to Shingrix.  Additional details were provided as follows: The CT scan results showed cyst on kidney and three broken ribs. The patient experienced symptoms of aching, redness, and swelling at the injection site (left arm). The patient was unable to sleep due to discomfort.  The patient stated that he/she would need a left knee replacement soon, physician was aware of medical conditions.
Patient developed vesicular rash in a dermatomal distribution 2 days later in same thigh and including the site  where vaccine was administered, which was confirmed by PCR to be varicella zoster (shingles). Patient has no known history of varicella infection, but did receive varicella vaccination one year prior.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 72 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
blisters inside of his mouth and on the palate of his mouth; This spontaneous report was received from a male physician in his 30s reporting on himself. The patient's medical history included blisters in his mouth. In approximately July 2021, "about two months ago", the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and lot # not reported). Concomitant therapies included covid-19 vaccine and another routine vaccine.  On an unspecified date in approximately July 2021, the patient experienced small blisters inside of his mouth and on the palate of his mouth. The patient stated the blisters lasted for about 1 month after vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). He also stated that he had an endoscopy around the same time he received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). At the time of the report, the patient had recovered.  The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
pt recv vax 16MAY96 & 1JUN96 pt devel chickenpox on the face, trunk, & extremities w/over 200 lesions & a fever;pt was hosp;5JUN96 pt fever had resolved & some of the lesions had crusted over;
I got the vaccine around 10 in the morning, about 5 and 5:30, I went upstairs and noticed my joints hurting, I went to the bathroom and brush my teeth. By the time I was done brushing my teeth, I didnt want to go back down the stairs as I was in pain. It was too early to go to bed. I hurt all over, every joint in my body. Shortly after that I started getting really cold. I had my winter coat on. Then I put a blanket over top of me too. I sat there like that all evening, and I went upstairs and my joints were still hurting, at about 10:30. So cold, I got out a winter gown. During the night, I awoke several times, I was hurting and sweating all night long. Then yesterday, I got up and my joints were better, but not good yet. Seemed like I was better, but my hip and my knees hurt and the muscle on both thighs hurt. I put some blue ice on my sore muscle.
shakiness; achiness; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakiness), MYALGIA (achiness) and CHILLS (chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 063B21A and 006B21A) for COVID-19 vaccination.     no medical history provided by the reporter.  Concomitant products included TRAZODONE, ALPRAZOLAM (XANAX) and VITAMIN D3 for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced TREMOR (shakiness), MYALGIA (achiness) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 UNK. At the time of the report, TREMOR (shakiness), MYALGIA (achiness) and CHILLS (chills) outcome was unknown. Not Provided
Headache, Myalgia, Fever, NauseaVomiting, inj site discomfort x3 days; chills, fever, HA, myalgia, fatigue, nausea x3 days Narrative:
No additional AE information reported; The patient went to her local CVS to receive the PNEUMOVAX 23 vaccine on 20Sep2021 at 2:46pm. She was inadvertently given PREVNAR 13.; This spontaneous report was received from a 68-year-old female patient reporting on herself.  The patient's historical vaccines included varicella zoster vaccine live (oka/merck) (ZOSTAVAX) and pneumococcal vaccine conj 13V (CRM197) (PREVNAR 13). There was no information about her concurrent conditions, concomitant therapies or medical history provided.  On 20-SEP-2021 at 14:46, the patient was supposed to received dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) but was inadvertently given pneumococcal vaccine conj 13V (CRM197) (PREVNAR 13) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (wrong vaccine administered). There was no additional adverse event reported.
Initial pregnancy report received on 13-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA225861 (same reporter). This case involves 38-year-old female patient who was exposed to 0.5 ml dose of vaccine ADACEL (Batch number: U5979AA and expiry date: 13-Jun-2020) (dose in series and route was not reported) in the left deltoid on 09-Aug-2018, in context of received injection that was out of shipping stability and this patient was pregnant and was 26 weeks 5 days pregnant and vaccinated. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The patient exposed to vaccine at 26 Weeks 5 days of pregnancy. The date of last menstrual period was not reported. The estimated due date was Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage as the patient received injection that was out of shipping stability. It was also a case of vaccine exposure during pregnancy. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by the sender: None.
Vaccine given IM In (L) arm. (L) arm red, swollen with 4 draining blisters. Clear fluid noted from blisters. Most of upper arm red/indurated but not tender. Vesicles clustered around site of Hep A injection.
I have been nauseated; Had headaches off and on; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 09Mar2021 at 16:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. On 10Mar2021 at 04:00, the patient experienced have been nauseated, had headaches off and on and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent nasal swab (SARS-CoV-2 test) and the result was negative. The clinical outcome of the events have been nauseated, had headaches off and on and fatigue was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Fever greater than 101 less than 103 developed 7 days after vaccination. This was followed by a pink maculopapular rash 3 days later, intially started on face and spread to torso and then extremities.  Child is also more fussy than previously.
Had 2 complex febrile seizures 1st about 17 hrs and 2nd 24 hours after vaccine given. Next day some mental status changes.
Rash 1-2 days after receiving MMR (1) and Varicella (1).  Patient had been on day 5 of Zithromax when received vaccines (9/2/08).  Mac pap and vasculitic rash (latter on extremity).
Fever blister; A spontaneous report was received from a consumer concerning a 62-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed a fever blister.  The patient's medical history included fever blisters and high blood pressure. Concomitant Products known to have been used by the patient, within two weeks prior to the event, included lisinopril.  The patient received their first of two planned doses of mRNA-1273 (Lot number 025L20A) on 03 Jan 2021 in the left arm for prophylaxis of COVID-19 infection.   A consumer called to report she had received the Moderna COVID-19 vaccine on 03 Jan 2021 and got a fever blister on 05 Jan 2021.  Treatment for the event was not provided.    Action taken with mRNA-1273 in response to the eventswas not provided.   The outcome of the event, fever blister, considered as unknown.  The reporter did not provide an assessment of the event, fever blister.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded
Rec'd vaccination 11/14/16 left deltoid, on 11/15/16, front of left arm (not deltoid where vax was rec'd) raised, red, warm to touch - patient says it's itchy, but is solid and extends from just underneath the shoulder to the inner elbow of Left arm. Injection site is not affected.
Feel absolutely horrible; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feel absolutely horrible) 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, the patient experienced MALAISE (Feel absolutely horrible). At the time of the report, MALAISE (Feel absolutely horrible) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No Treatment information was reported.
allergic reaction; Rash; Injection site erythema; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a elderly female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced allergic reaction, injection site rash and injection site erythema. On an unknown date, the outcome of the allergic reaction, injection site rash and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, injection site rash and injection site erythema to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient developed an allergic reaction to the flu vaccine, a red rash at the injection site that appeared to be getting bigger every year (every time the patient received the vaccine). The reporter specified, it had been more than 5 years since the patient had flu vaccine. The patient's physician recommended they no longer get the flu vaccine. The reporter consented to follow up. The reporter had no further information to provide.
On 3/9/2021 the patient presented to the ED with leg weakness and was unable to walk that morning secondary to pain in her right hip. She reported falling the night prior.  Upon admission, she was found to have a developing pneumonia infection. Reason for admission: possible stroke.
Client received Moderna mRNA 1273 on 1/29/2021.  Client received Pfizer BioNTech for a second dose on 2/26/2021.  Client notified of error, all questions of client answered.  Client advised to not receive an additional COVID-19 vaccination at this time.
Confirmed varicella - 9/11/12 multiple pox over back, chest, thighs, groin, buttocks.
Patient became unresponsive. 8/24/02 was transported via EMS to hospital. Treated for seizures (history of seizures) and cellulitis of leg from immunization.
Numbness and burning of hands and feet EMG cannot rule out Guillain Barre. Neuro consult. Neurontin. 2 /15/07 Received medical records from PCP which included partial neuro records.  Letter faxed to neuro to request medical records.  PCP records reveal patient seen on 1/30/07 & had experienced numbness of hands & feet x 5 days.  Cold s/s had improved.  Exam revealed purplish fingertips which waxes & wanes.  Bottoms of feet now tingling.  Patient returned 2/1/07 & numbness & burning had intensified.  Gait & strength were WNL.  Dx by PCP w/sudden onset peripheral neuropathy.  Discussed w/neuro who felt could be GBS s/p flu vax on 1/12/07 & eval was arranged.  Tx w/neurotin.   Neuro consult reveals patient now complained of leg weakness & he had difficulty on stairs.  Intermittent blurred vision.  Exam revealed mildly weak toe extensors & DTRs absent in ankles bilaterally.  Decreased pinprick sensation bilaterally.  Tandem walking was slightly difficult.  Neuro felt possibly GBS but dx would depend on EMG/NCS & CSF studies. 2/26/07 Received medical records from neurologist which reveal patient initially seen 2/5/07 for numbness & tingling of hands & feet.  Returned 2/6/07 for LP & EMG/NCS.  Returned 2/13/07 & neuro felt exam unchanged.  FINAL DX: No definitive dx given but Neuro felt dx was asymptomatic diabetic neuropathy which became symptomatic due to flu shot rather than GBS.
03/04/2019 diagnosed with pneumonia. Confirmed by x-ray. Treatment with antibiotics, LEVAQUIN. Cough syrup, Promethazine. Lots of rest. Symptoms were hacking and retching cough. Running nose and congestion. Fever and chills. Weakness.