chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were administered improperly stored doses of GARDASIL lot # K010574 with expiration date 08-APR-2017 and lot # K014191 with expiration date 10-MAY-2017 (dose and route of administration not reported). The vaccine underwent a temperature excursion of 0.5 degrees Celsius for 2 hours. Digital Data Logger was involved. There was no previous temperature excursions. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Office vaccinated a 6 month old with Fluzone Quad and gave the baby 2 doses of 0.5 mL with no adverse event; Initial information received on 06-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 6 month old who was vaccinated by an office with influenza quadrival a-b vaccine [Fluzone Qiv] and gave the baby 2 doses of 0.5 ml (extra dose administered) (batch number: UT7041JA and expiration date: 30-Jun-2021) via intramuscular route in 1 in right and 1 left unknown administration site for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event extra dose administered (latency: unknown).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: 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 2001/83/ec 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.
This spontaneous report was received from a currently 43 years old male patient who was referring to himself. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On an unknown date, the patient was vaccinated with GARDASIL for prophylaxis, in 0, 2 and 6 months schedule (route of administration, lot number and expiration date was not provided). The patient was 37 years old at the time of the vaccination. No adverse effect was reported.
I received the first dose of Pfizer covid-19 vaccination 4 days prior to my first ever HSV2 outbreak. I had never had an issue before then. The second dose of the vaccine made the outbreak even worse, almost unbearable.
12/2 - Starting at 2am I began having extreme chills that led my body to uncontrollably shaking. That progressed into having hot and cold sweats through the night. The shaking subsided by morning but through Thursday, 12/2 I was cold and had a difficult time staying warm.  My arm was extremely sore. My lymph node in my left arm pit was very swollen. The swelling lasted for several days. It didn't go down until Monday, 12/6.  12/3 - The middle of the night I woke to the bottom of both of my feet being horribly itchy. Nothing seemed to reduce the sensation. It subsided by morning.
T 103 rash all over body, fever 103-reaction to MMR vax, rash cleared up 4 days later
This spontaneous report as received from a registered nurse refers to a 67 year old female patient. The patient has no pertinent medical history and no drug reactions/allergies. On 16-SEP-2013 the patient was vaccinated with a full dose of ZOSTAVAX (lot # J003806, Exp date: 03-JUL-2014), subcutaneously. Concomitant therapies included EVISTA. The patient experienced redness, inflammation, burning, itching (pruritus), erythema and "hot" after receiving ZOSTAVAX (in September 2013). Patient called physician's office on 18-SEP-2013 to report reaction and was  instructed to use cold compress to site, BENADRYL and Hydroxyzine. No lab diagnostics studies performed. Patient was seen by physician in office 19-SEP-2013. VZVIP packet faxed. The outcome of the events was unknown. Additional information has been requested.
102 fever, joint pains, chills, headache, body aches, injection site very painfull.
Swelling in right elbow. Swelling in both knees. Weakness of muscles in right leg.
Spike in blood pressure; blurry vision; burning eyes; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 73-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6206, Expiry date: unknown, at the age of 73-year-old), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. Medical history included rheumatoid arthritis and hypersensitivity (known allergies: yes). It was reported as no covid prior to vaccination and no covid was tested post vaccination. No other vaccine was received in four weeks. Concomitant medications included certolizumab pegol (CIMZIA), levothyroxine sodium (SYNTHROID), cholestyramine and omeprazole (taken for an unspecified indication, start and stop dates were not reported for all medications). The patient experienced spike in blood pressure, blurry vision and burning eyes on 10Mar2021 09:30. The patient underwent lab tests and procedures which included blood pressure measurement showed spike on 10Mar2021. No treatments was received by patient for adverse events. Events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of events was recovered with sequelae (recovered with lasting effects) on an unspecified date.  No follow-up attempts are possible. No further information is expected.
more emotional; outspoken; This spontaneous case was reported by a consumer and describes the occurrence of EMOTIONAL DISTRESS (more emotional) and LOGORRHOEA (outspoken) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 058E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced EMOTIONAL DISTRESS (more emotional) and LOGORRHOEA (outspoken). At the time of the report, EMOTIONAL DISTRESS (more emotional) and LOGORRHOEA (outspoken) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provided   This case was linked to MOD-2021-321099 (Patient Link).
back pain; sciatica; leg pain; This is a spontaneous report based on the information received by Pfizer from (Company name withheld) Pharmaceuticals, LLC .  A contactable 83-year-old female consumer reported that: On 25Jan2021, (Company name withheld), was contacted via phone by a currently 83-year-old female consumer (initials: [Initials withheld], DOB: [Date of birth withheld]), regarding adverse events she experienced while taking (Company name withheld) NP Thyroid 120 mg tablets. On 26Jan2021, (Company name withheld) Medical Information contacted the consumer via phone, and she provided the following additional information. Her medical history is significant for hypothyroidism, arrhythmia, hemithyroidectomy (2006), Hashimoto's thyroiditis, goiter, thyroid nodule. atrial fibrillation, systemic lupus erythematosus. pain in arm related to lupus, cardiac pacemaker insertion (2007, 2014), physical therapy (2017), rheumatoid arthritis, and viral infection (Sep2019). She denies taking any concomitant medications for arrhythmia or atrial fibrillation. stating that in the past, those medications (unspecified) made her "sick". She takes no concomitant medications, but she takes the following supplements (therapy dates: UNK to ongoing): Trace minerals from Salt Lake, liquid magnesium once daily, vitamin C, vitamin B, and frankincense. She has known drug allergies to ibuprofen, Tylenol, unspecified antibiotics which caused her to "feel worse". and she claimed to be allergic to many unspecified medications (reactions: UNK). On an unknown date, she received a pneumonia vaccination that caused back pain, sciatica, and leg pain. On an unknown date, "years ago", she began therapy with Nature Thyroid. I grain 2 days a week; and 1 and one-quarter grain 5 days a week. On an unknown date. she began to experience "felt exhausted all the time" and "steeping all day long" On 07Oct2020, she was switched to Armour Thyroid 120 mg tablets. one tablet by mouth once daily for hypothyroidism. However. on 07Oct2020. her pharmacy substituted NP Thyroid 120 mg tablets for Armor Thyroid 120 mg tablets. and on 07Oct2020, she began therapy with NP Thyroid 120 mg tablets. one tablet by mouth once daily for hypothyroidism. On an unknown date in Oct2020, she began to experience feeling exhausted all the time (Fatigue) and sleeping "all the time" (Somnolence). On approximately 07Jan202 1. she discovered her Armour Thyroid 120 mg tablets have been substituted with NP Thyroid 120 mg tablets. She is scheduled to see her physician in early Feb2021. On 28Jan2021. she contacted (Company name withheld) once more via phone and included that she now believes NP Thyroid is causing her heart to beat harder (Palpitations) and heart to beat irregularly (Heart rate irregular). She was advised to contact her physician. No relevant laboratory data or treatment was reported. At the time of this report. she continues to take (Company name withheld) NP Thyroid 120 mg tablets and her adverse events remain ongoing. No additional information was provided.  No follow-up attempts are possible. No further information is expected.
This is spontaneous case, initially received from other health professional on 16-Oct-2018, concerning a 54-year-old, adult, female patient. The patient reported that she was allergic to sulfa drugs which caused hives with nausea and vomiting. The patient's concomitant medication included zolpidem, Sertraline and omeprazole for unknown indications. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252672, expiry date: 30-Jun-2019]. On the same day of vaccination (in the afternoon, approximately 7 hours, as reported), the patient experienced hives with itching all over. The patient took BENADRYL but was not effective in controlling the itch. On 10-Oct-2018, in the morning, the patient was treated with 8 mg DECADRON. At 5 PM, an additional 8 mg of DECADRON was given along with 6 mg CELESTONE in evening and oral ATARAX to control itch. No edema and anaphylactic symptoms were noted. The post vaccination symptoms lasted for 2-3 days (as reported). On an unspecified date, the patient had intermittent times when she seemed to itch all over just momentarily but subsided without medication. It was reported that, the patient did not have any symptoms in the past 2-3 weeks (as reported). On an unspecified date in Oct-2018, the patient had recovered from the events. The reporter assessed the events as non-serious. Follow-up report received from other health professional on 27-Nov-2018: The patient initials were updated and date of birth was updated in the patient tab. Route of administration, anatomical location, batch number and expiry date were updated in the product tab. The outcome of the events was updated from 'not reported' to 'resolved' with stop date as Oct-2018 in the event tab. The narrative was amended accordingly.
After arising early to take daughter to airport, first noted symptom was a painful headache with pain centered in head above the forehead. this was also noted after the second Moderna dose 03/09/2021. Next symptom was nausea which resulted in emesis. One short burst which resulted in a small amount of bile tasting fluid. Nausea abated after emesis. Took 1 650mg tab of Tylenol for headache which attenuated but did not completely relieve pain. Also note was a neuralgia similar as the initial symptoms of influenza. Neuralgia increased during the evening. After driving daughter to airport returned home at 07:30. Both my wife and myself retired & slept in for most of the day. I did not eat but did drink ample amount of water to avoid dehydration. During the evening from 19:00 on and through the night it was noted that I had a low-grade fever and was also very diaphoretic. Diaphoresis was extreme to the point of changing night clothes 3 times and changing bedding. Today headache has abated Minor neuralgia, but still have a low-grade fever and I am still diaphoretic. Was also able to consume food with no ill effects noted.
Amenorrhea and Premature Ovarian Failure, 4 years later. I was on birth control for those 4 years so those would have masked the symptoms (amenorrhea) had I developed POF before it was diagnosed in 2018.
25Oct90 pt vax hepta B; 26Oct90 exp dizziness, n/v/d, which resolved in 48hrs.
6/14/13 patient came in pharmacy to report he stated noticing red rashes on shoulder, lower neck after receiving shingles vaccine (administered 3/12/13). Pt also stated he developed shingles in last week and was prescribed valacyclovir tablets on 6/13/13. Pt was informed shingles vaccine only decreases these evenly of the diseases.
Metallic taste in mouth (though I was still able to taste food normally); Arm pain where I received the injection; This is a spontaneous report from a contactable Other Health Professional, the patient.  A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3247), via an unspecified route of administration on 23Feb2021 at 13:45 (at the age of 37-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included asthma. The patient has no allergies to medications, food or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The vaccine was administered at a workplace clinic. Concomitant medication was reported as "No." The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021 the patient experienced arm pain where he received the injection and experienced a metallic taste in his mouth. He specified that he was still able to taste food normally. As treatment for the event vaccination site pain, the patient applied ice to his arm (reported as "iced my arm"). The clinical outcomes of the events vaccination site pain and metallic taste in mouth were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
SEIZURES; This spontaneous report received from a patient via a company representative via social media concerned a 65 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had seizures in 65 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced seizures. As per reporter, "covi vaccine caused me seizures l never had seizures in 65 years But after covi vaccine l had 4 " The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizures was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220863804- Covid-19 vaccine ad26.cov2.s- Seizures. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
I noticed twitching of left eye 2 days after the 3rd injection then I developed numbness around mouth a couple of days after that. Then the next morning on the 18th it seemed that my left eye lid was drooping. On the morning of the 19th I had noticeable  facial drooping on the left side of my face.  Due to the similarity of stoke symptoms I sought medical treatment at the emergency room. After evaluation and testing I was diagnosis with Bells Palsy.
Heart attack; a little bit of a sore arm after the first dose; This is a spontaneous report from a contactable pharmacist. An 87-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3302; Expiration Date: Jul2021), via an unspecified route of administration on 27Jan2021 as single dose for COVID-19 immunisation. Medical history included ongoing cancer, ongoing chronic obstructive pulmonary disease (COPD), and diabetes. The patient's concomitant medications were not reported. In Feb2021, the patient experienced heart attack. On an unspecified date, the patient experienced a little bit of a sore arm after the first dose. The patient stated the sore arm was mild. The patient was hospitalized due to heart attach on an unspecified date. The reporter wanted to know if the patient needed to restart the vaccine series. The patient had no prior Vaccinations (within 4 weeks) and no events following prior vaccinations. Patient was not overweight and probably 5'8" or 5'9". The reporter guessed the patient was around 160 pounds. Patient's vital signs were stable on 13Apr2021. The patient received second dose on 13Apr2021, 11:50, right arm. The reporter confirmed that the heart attack occurred before the second dose. Outcome of events was unknown.; Sender's Comments: The event myocardial infarction is likely due to an intercurrent condition given the patient's ongpoing medical history and age and not related to BNT162B2.
fatigue, chills, and headache lasing approximately 36 hours; rash near injection site - rash is red, hot to the touch, and approximately 3" in diameter still present on 4/3/2021
injection site was a red, warm, itchy, and a little bit elevated; red area was almost a perfect circle and a couple of inches in diameter; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (injection site was a red, warm, itchy, and a little bit elevated) and INJECTION SITE SWELLING (red area was almost a perfect circle and a couple of inches in diameter) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site was a red, warm, itchy, and a little bit elevated) and INJECTION SITE SWELLING (red area was almost a perfect circle and a couple of inches in diameter). At the time of the report, INJECTION SITE ERYTHEMA (injection site was a red, warm, itchy, and a little bit elevated) and INJECTION SITE SWELLING (red area was almost a perfect circle and a couple of inches in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INJECTION SITE ERYTHEMA (injection site was a red, warm, itchy, and a little bit elevated) and INJECTION SITE SWELLING (red area was almost a perfect circle and a couple of inches in diameter) to be possibly related.    No relevant concomitant medications were reported.  She took Benadryl for 3-4 days along with cortisone cream.
Fever (101.6) x 10hrs, severe headache at base of neck, x 10hrs,  chills x 10hrs, rapid heart rate (100+ bpm) x 10hrs.  Lingering mild headache at base of neck x 1 week.
Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a six months old female patient who was vaccinated with a 0.5 ml dose of DAPTACEL (lot C5519BA and Exp. Date: 12-Sep-2020) via unknown route in the left thigh on an unspecified date, instead of intended 3rd dose of ADACEL. The patient's medical history was not reported. Concomitant medications included INFLUENZA; POLIO VACCINE; ROTAVIRUS VACCINE; HEPATITIS B VACCINE and PNEUMOCOCCAL VACCINE for Immunisation. It was an actual medication error due to wrong vaccine administered. No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC 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. List of documents held by sender: none.
Child awoke this morning with 50 cent-sized red area on back of left arm. Mother has applied cool compresses and given Motrin and problem has improved. Instructed to continue with cool compresses and Motrin. Go to pt's MD or ER if worsens over weekend. On 3/20/00, talked to mom and problems were resolved.
Pt. receieved J&J Covid Vaccine on 03/12/21. Pt. did not report J&J Vaccine to Vaccine administrator/staff/COVID-19 Screening Form. CAIR NUMBER # 42655957
suspected vaccination failure/had the shot but still got Shingles; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received Shingles vaccine and experienced shingles and could have a lighter case having it but he/she would not have wanted them any worse either. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as not contact details available.
she had a full case of chicken pox (approx 200 pox), May 2003
after few days of the second dose ,I start to feel for moments out of balance and discomfort in head , not pain , I visit an oftamologist because I thought I was my vision ,but nothing overhang is normal. 2 weeks ago the feels is more often almost the most of the day. is not dizzy is vertigo ,yesterday I when I was sit in bath I saw the door move. the discomfort is in any time of the day.