chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's neighbor. The age at vaccination was not reported. The reporter stated that the patient got shingles right after getting her shingles vaccine. The follow-up would not be possible as no contact details were available.
Patient received vaccines afternoon of 11/21/2022. Patient's mother called back on 11/22/2022 around 3:00 PM reporting that patient was experiencing a fever of 100.7 and a rash to bilateral hands that started at midnight. Mother shared that patient's friends are also sick/running a fever. Discussed with mother that patient had also received a fresh tattoo to left forearm that could be contributing to this as well. Recommended if symptoms worsen to report to urgent care as we would be out of office over the long holiday weekend. Spoke with patient on 11/29/2022 in regards to side effects - patient reports that her rash and fever cleared on the afternoon of 11/24/2022. States that in addition to fever and rash she had also experienced intense body aches, which also subsided afternoon of 11/24/2022.  Reports that this was her very first tattoos two days prior to vaccines, a known lamictal allergy, and gabapentin was a new medication 7-14 days prior to vaccinations. Denies any other symptoms that took place nor any other potential contributing factors to said side effects. Patient reports that she is feeling fine and back to normal as of 11/24/2022 and has no other issues to report.
ocular migraines; vision will just get blurry/patterns that move, usually just a blurriness; it's like looking through wax paper; stress; stress seems to make it worse; chronic illness; the second dose on May 28 2021 and the first dose on May 6 or 7 2021; This spontaneous case was reported by a patient family member or friend and describes the occurrence of OPHTHALMIC MIGRAINE (ocular migraines), VISION BLURRED (vision will just get blurry/patterns that move, usually just a blurriness), VISUAL IMPAIRMENT (it's like looking through wax paper), STRESS (stress) and CONDITION AGGRAVATED (stress seems to make it worse) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic fatigue syndrome. Concomitant products included GLUTATHIONE and INSULIN GLARGINE (LANTUS SOLOSTAR) for an unknown indication.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the second dose on May 28 2021 and the first dose on May 6 or 7 2021). In June 2021, the patient experienced OPHTHALMIC MIGRAINE (ocular migraines), VISION BLURRED (vision will just get blurry/patterns that move, usually just a blurriness), VISUAL IMPAIRMENT (it's like looking through wax paper), STRESS (stress), CONDITION AGGRAVATED (stress seems to make it worse) and ILLNESS (chronic illness). At the time of the report, OPHTHALMIC MIGRAINE (ocular migraines), VISION BLURRED (vision will just get blurry/patterns that move, usually just a blurriness), VISUAL IMPAIRMENT (it's like looking through wax paper), STRESS (stress), CONDITION AGGRAVATED (stress seems to make it worse) and ILLNESS (chronic illness) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the second dose on May 28 2021 and the first dose on May 6 or 7 2021) outcome was unknown.            Concomitant product also included unspecified 150 mg thyroid medication. The first dose was given on 6 or 7 May- 2021.  It was reported that Patient received 3 doses of the Moderna COVID19 vaccine last year sometime. Patient started to experience the symptoms two weeks after the second dose around the 14- Jun-2021. The symptoms were ongoing now it was more frequent. No treatment was given to the patient.   This case was linked to MOD-2023-729356 (Patient Link).
Patient given Kinrix vaccine which expired on 8/26/22.  No adverse events observed at time of administrations.
Initial misuse report received from a health care professional on 07 February 2014.  An adult patient (date of birth, age and gender was not reported) had received a dose of DAPTACEL instead of ADACEL. No adverse event was reported. Documents held by sender: none
Information regarding PREVNAR was received from a healthcare professional regarding a patient who received PREVNAR subcutaneously instead of IM and was diagnosed with subcutaneous atrophy secondary to vaccination. The patient received a dose on an unspecified date. On an unspecified date, the patient was diagnosed with subcutaneous atrophy secondary to vaccination. The patient received PREVNAR subcutaneously instead of IM. The outcome is unknown. No additional information was available at the time of this report.
I experienced "shocks" of pain in and around my face and forward part of my head every few minutes throughout the first day. Practitioner at urgent care clinic prescribed diclofenac which did seem to help. Pain had run its course after 2 days.
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage.  Patient presented mild pain at injection site.
My back started hurting really bad and I couldn't figure out why. Then, I developed a sore throat, runny nose, sneezing, and coughing. I took an at home test 12/5/22 and tested positive. I contacted my doctor, and he prescribed 5 days' worth Paxlovid, Prednisone, and Azithromycin. I am feeling much better now.
Wheezing, asthma, unable to sleep because of difficulty breathing. Treated with OTC inhaler (epinephrine). Symptoms gradually subsided over a period of 3 weeks.
On 24JUN92 pt was seen in clinic, knot on lt arm (deltoid area) black & blue area, sore to touch;
Frequent large bowel movements, feeling of nausea, painful muscles, fatigue, possible fever (felt cold & clammy and sometimes sweaty.  Headache at base of neck. Diarrhea a couple of times.  And RIDICULOUSLY high blood sugars (which usually occur when I get sick).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures, Paxlovid from 06Jan2023 to 10Jan2023, were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report received from a patient concerned a 27 year old female. 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 and batch number: 1855835 expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2022 for prophylactic vaccination. No concomitant medications were reported. On MAR-2022, the patient experienced arm still swollen, bruise on arm, feels like there are fire ants in my left arm where got the shot, left arm hurts, nausea, throwing up, and fever. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm still swollen, bruise on arm, left arm hurts, and feels like there are fire ants in my left arm where got the shot, and the outcome of nausea, throwing up and fever was not reported. This report was non-serious.
Patient fainted following the administration of the above vaccines. RN monitored patient - took vitals and was assessed by Health Department Pediatrician. Patient was monitored for 30 min.
Narrative:  Patient received COVID-19 vaccine in clinic. Reports he looked down at his arm, vision went dim and passed out. Rapid response was called. RN initially noted arm swelling; not mentioned in ED evaluation. First sternal rub resulted in no response. Pulse hard to palpate. Responded to second sternal rub and transferred to ED per rapid response team. ED provider noted patient back to normal self in ED. Patient reports no symptoms prior to this episode. No shortness of breath. No chest pain. No history of passing out. No recent illness. Normal EKG. Unremarkable orthostatic vital signs. Final diagnosis of vasovagal syncope. Discharged to home with no specific follow-up required.
Patient warned of previous vaso-vagal syncope. Patient was placed in supine position for vaccine administration and about 1 min afterward became anxious and passed out. He was unconscious for 10 sec and awoke, sweaty, weak. He was not confused, did not seize or lose bowel/bladder continince.
I'm trying to hurry. They want to time me out; THIS IS URGENT! I may have an idea why women between the ages of 18 and 48 have developed blood clots after receiving the J & J COVID vaccine.  Female hormone levels may be the reason. I suffered from migraines until my internist took me off birth control pills. He explained that in rare cases, women had blood clots, often resulting in stroke. The common denominator was that they suffered from migraines, and that they were taking birth control pills. I stopped taking them immediately, and my headaches resolved. I searched this site to find an email address to send you this information, but there was none. So I had to use this site.
Health Dept. employee. Reports two previous 2 day periods in June 2002 and in October 2002 where she experienced palpitations with occassional shortness of breath. She did not see a physician for these episodes.  She reports experiencing palpitations beginning 2 days following receipt of the smallpox vaccine (2/10/03) and this lasted until approximately 2 wks ago. She reports that she has not noticed any palpitations for approximately the past two wks. Significant family history-  mother died from MI at 62yo Father had first of many MI's at age 42yo and has had 2 bypass surgeries since. Father's family strong history in many members of cardiac disease early in adulthood.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 18-JUL-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number and expiry date were reported as H014561 and 21-MAR-2014 respectively, dose and route unspecified) which was not supported by stability data. It was exposed to five cycles of a low temperature range from 32 degrees Fahrenheit (F) to 34 degrees Fahrenheit (F) for a total time of 96 hours. No concomitant therapy was reported. No adverse effects were reported. This is one of the two reports from the same source. Additional information has been requested.
insomnia; pain in the left arm; fatigue; general body pain and aches; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Oct2021 10:00 (Lot number: FF841) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA, administration date 06Oct2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6199, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM, Route of Administration: Intramuscular), administration date: 23Mar2021, when the patient was 42 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 04Mar2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset 20Oct2021 16:00, outcome "recovering", described as "insomnia"; PAIN IN EXTREMITY (non-serious) with onset 20Oct2021 16:00, outcome "recovering", described as "pain in the left arm"; FATIGUE (non-serious) with onset 20Oct2021 16:00, outcome "recovering", described as "fatigue"; PAIN (non-serious) with onset 20Oct2021 16:00, outcome "recovering", described as "general body pain and aches". Therapeutic measures were not taken as a result of insomnia, pain in extremity, fatigue, pain. Additional information: Other vaccine 4weeks product Influenza, other vaccine 4weeks vaccine date 20Oct2021. No Covid prior vaccination, Covid not tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Seizures requiring one week hospitalization with multiple medications to control. Seizures lasted 2 months despite Dilantin and Keppra. In control at present, weaning anti-seizure medications. MRI/MRV - negative; Video EEG - negative.  4/29/08 Reviewed hospital medical records for 1/10-1/12/2008. FINAL DX: likely pertussis encephalopathy; recurrent seizures. Records reveal patient experienced nasal congestion x 2-3 days, received vaccines, developed fever, irritability, generalized tonic-clonic seizure lasting 3-4 min.  Seen in outlying ER & continued to have seizures w/eyes rolling back, frothing at mouth, desaturations & tachycardia despite medications.  Total of approx 15-17 seizures.  Temp in ER 101.2.  Transferred to higher level of care.  Peds ICU.  Tx w/antiseizure meds & precautionary antivirals initially then d/c'd.    Neuro consult done.  Continued to have brief seizures w/perioral cyanosis.  Progressed w/fewer & shorter seizures.  D/C to home on antiseizure med.  F/U phone call by MD on 1/13/2008 parent stated continued to seize approx every hour for approx 90 secs w/brief cyanosis.  Parents refused readmission, meds were changed & were to f/u w/neuro on 1/14.
Flu vaccination on 10/23/2014 and approximately 7 days later began experiencing tingling/burning thru body. Currently still dealing more with tingling/burning mainly in upper body.
Stroke; This is a spontaneous report from a contactable pharmacist. A 48-year-old female patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 48-year-old, intramuscular, administered in right arm on 24Mar2021 13:00 (Lot Number: EL9262) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was previously vaccinated with the first dose of BNT162B2 (lot number: EN6202) at the age of 48-year-old, on 03Mar2021 at 12:00 PM intramuscularly administered as the left arm for COVID-19 immunization. The patient experienced stroke on 25Mar2021 15:00. The event resulted in emergency room visit and the patient was hospitalized on an unspecified date for 6 days. It was unknown if treatment was given. The event was also reported as life-threatening and disabling/incapacitating. The outcome of the event not recovered.; Sender's Comments: A causal relationship between the event stroke and suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) is possible based on the information provided, drug profile and a temporal association in this 48-year-old female patient. This case will be reassessed should additional information become 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 RAs, Ethics Committees, and Investigators, as appropriate.
her friend has been freezing since receiving her second COVID-19 Vaccine dose/cold; stated her friend experienced terrible chills after receiving her second COVID-19 Vaccine dose; This is a spontaneous report from a contactable consumer reported for a female patient (friend).  A female patient of unspecified age received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number& Expiry date not reported) via unspecified route of administration on 03Feb2021 as single dose for COVID-19 Immunization. Patient medical history and concomitant medications not reported. Historical vaccine included, Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number& Expiry date not reported) via unspecified route of administration on Jan2021 as single dose for COVID-19 Immunization. On 03Feb2021, Patient had been freezing and experienced terrible chills since receiving her second COVID-19 Vaccine dose. The patient reported freezing since receiving their second COVID-19 Vaccine dose. The reporter reported that her friend experienced terrible chills and cold, but no nausea. Patient underwent lab test and procedures include weight about 160-165 lbs. The reporter stated that she lost a lot of weight recently. The outcome of events were unknown.  Information about lot/batch number has been requested.  Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
the day following vax pt described react event size of silver dollar getting redness slightly itchy & tender  & heavy, but not painful, on left arm inject site.
Patient came to ED with complaints of shortness of breath, nausea, and loss of taste.  Patient was admitted to hospital for Covid pneumonia and treated with remdesivir.
I missed a period and my periods have been very inconsitent and very very headvy since then. Prior to the shot i had a very very regular period and not heavy at all.
After the shot I had a sore arm, constant chronic headache, fatigue, head aches, muscle aches. Several weeks after, in 03/07/2021 I started to have total loss of hearing in my left ear, and ringing in both ears. I went to the ER. After going to another ear doctor I have 40 % loss of hearing in my left ear and ringing in both. I have acid reflux and I could not eat anything because I would throw up. They did an upper GI and turns out I have a small  hernia and they gave me Pantoprazole. I go back to the stomach doctor this month and to the ear doctor on October. I still have no taste or smell since 11/19/2021.
Soreness of arm near injection site started 3/21 Noticed scab like thing on arm (large  1 cm square and 4 small specks) 3/21 3/23 started to feel warm 3/24 welp started to appear about 2 inches wide Arm injection area remains sore 3/24
Pt. states he has never had a shot "hurt as bad as PREVNAR" that he got on 6/26/18 other than a gamma globulin shot. He states there is no redness or swelling that he can see. He states it is so painful that it goes up into his shoulder and down to his elbow and is even tender to touch." Reviewed literature regarding PREVNAR related adverse events. Noted pain at the injection site has been reported in the literature as a common adverse event (51% to 96.7%) and usually resolves on its own. However, severe pain at the injection site is rare (0.3%). If patient continues to experience pain greater than 1-2 weeks after injection, would recommend patient make appointment with PCP to evaluate severity of reaction.
Significant urticaria particularly near eyes and mouth. No resp. distress nor tachypnea. 25mg Benadryl given po. Symptoms completely resolved within 45min period of time. Throughout vials were stable.
HA, eye red with matting, increased BP, hoarseness tight chest with wheezing - lasted about 5 hours.
redness at injection site; blister at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax.   On 19th November 2019, the patient received the 1st dose of Shingrix. On 20th November 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema and injection site blisters. Shingrix was continued with no change. On an unknown date, the outcome of the injection site erythema and injection site blisters were recovering/resolving.   It was unknown if the reporter considered the injection site erythema and injection site blisters to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient noticed redness at the injection site and started applying a cold compress to the site.  The patient stated that, she later noticed a blister at the injection site as well. The reporter did not consented to follow up. The patient declined to provide address, date of birth, or healthcare professional information.
Client states that after receiving Moderna Dose 2 client experienced chest pain three days after vaccination. Pain level 5/10 that lasted for 7 days along with congestion and back pain. Client didn't seek emergency care or Dr visit. A medical consult was submitted Approval was received from MD. Client was vaccinated with Pfizer Booster.
her sister's lymph nodes were swollen for weeks; This is a spontaneous report from a contactable consumer (patient's sister). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as unknown dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's lymph nodes were swollen for weeks on an unspecified date. The outcome of the event was unknown at the time of report.   Information on lot/batch number has been requested.
Unknown vaccine date. Patient received moderna vaccination x 2.  as had two Moderna vaccination and not due for a booster yet, who comes into the emergency room with 24-hour history of nausea, vomiting, no abdominal pain, and had a temperature of 102.  The patient's symptoms are on for last 24 to 48 hours.  She had O2 saturations of 99% on room air.     Per H&P
15SEP97 PM pt c/o soreness in lt arm;sl temp MOC gave APAP;itched may have been scratching it;size of small orange;16SEP97 AM some swelling & redness-ice packs applied;17SEP97 AM more swelling & redness w/brown center & head blisters;