chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From initial information received on 11/26/2002, it was reported that a 4 month old female infant received second doses of ACTHIB, Lot # UA666AA, intra-muscularly in the left leg, IPOL, Lot # W00632, intra-muscularly in the right leg and TRIPEDIA, Lot # U0582AA, intra-muscularly in the left leg at 9:00 on 11/19/2002.  The patient experienced redness and puffiness at the injection site and inconsolable crying at 11:00 on the day of vaccination.  The patient recovered.  Linked to cases: U2002-01099, U2002-01114, U2002-01115 & U2002-01138.  The case is closed.
Information has been received from a 75 year old female consumer with bone disorder, high blood pressure since 35 years old and a history of back surgery who on an unknown date was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included alendronate sodium (manufacturer unknown), "pain pills" for her back surgery and 3 different types of medication for blood pressure. The consumer stated that on 05-APR-2010 started like a sore throat and broke out with blisters in her mouth. The consumer went to "urgent care" and was given antibiotics (amoxicillin 870 mg) and acyclovir 800 mg for her blisters. Then she went to her ENT (ear, nose and throat) doctor and was given AUGMENTIN-XR 1000/62.5 and rothwells solution mouthwash. The consumer was told by her physician that "if the blisters in her mouth got worse it would obstruct her breathing and would require immediate admission to a hospital". At the time of the report, the consumer had not recovered. The reporting consumer considered blisters in her mouth to be immediately life-threatening. Additional information has been requested.
Dizziness and sweating within 15 minutes of Pfizer Covid 19 vaccination
Wok up in the middle of the night with severe chest pain and shortness of breath. Went to the ER , and was transferred to a cardiologist. Diagnosis is myocarditis/pericarditis.
Began to feel light headed around 11:45 pm followed shortly by achiness that was mild at first and within an hour became very significant. Then, headache started and was quickly very severe.  Accompanied by fever and chills. Slept for 24 hours, woke up for five minutes and slept for another six hours.  Though I felt better within 36 hours, I would not call the side effects mild.  Still feel lightheaded and having difficulty sleeping.
Redness and rash started at injection site two days after vaccine then spread down arm and up neck.  Provider treated with Benedryl 7.5ml.   (On 7/14 patient had a Kinrex vaccine in Right deltoid, last night noticed a slight rash at injection site, today rash seems to be spreading to upper torso and neck, advised to give benadry 7.5ml now and may repeat in 4 hours.  If rash worsens or any signs of SOB or hives she should seek emergent medical care.  Mother to update provider as needed, )
PT REMAINED CONSCIOUS, BECAME PALE AND DIAPHORETIC. NO S/SX OF RESP. DISTRESS, NO CHEST PAIN. Pt remained in sitting position. Pt denied any allergies prior to vaccine, and did not indicate taking any medications.
I started a period on 3/16 that last a week prior to getting my first Moderna shot the morning of Saturday, 3/27, at a scheduled 11 AM appointment, though it was probably closer to 11:30 by the time I received the injection at a local .  The following morning, I had to scramble out of bed at 6:30 AM to run to the bathroom before soaking my sheets with a monster, Stephen King Carrie-worthy period that has been relentless and continued non-stop for 2 weeks, unabated.  I was in contact immediately with my endocrinologist, fearing that my thyroid meds needed to be upped in dosage.  And I was scheduling an appt. with a new gyn as well (won't see this person till June as a new patient) but hey, prior to this, I had no period through much of 2020.  My endocrinologist put me on a daily dosage of medroxyprogesterone to halt the period.  A week later, as of yesterday, 4/10, I was still bleeding heavily.  Today, it is lighter so hopefully, it's coming to an end.   I'd assume my sore arm was the extent of the Moderna side effects but then  came across an article by fluke and happenstance this morning.
Seventeen year old received Moderna Covid-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Seventeen year old received Moderna Covid-19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Seventeen year old received Moderna Covid-19 vaccine). On 05-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Seventeen year old received Moderna Covid-19 vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Received a positive Covid test with symptoms after receiving Moderna vaccine (01Apr2021 1st dose & 30 Apr2021 2nd dose) with a booster (03Nov2021)
By mistake patient was given pediatric dose instead of adult dose of ENGERIX-B. This was not realized until 2/9/2018 when I was looking at patients alert report and saw that the dose was invalid. I left a msg for the pt to return my call to let her know what happened and have her come in to get the correct dose.
Swelling. MD told patient she had a small case of shingles which will require antiviral medications.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypertension-Medium
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown gender who on 22-APR-2015, was vaccinated with a dose of GARDASIL (lot # K006960, expiration date: not reported) which was exposed to 47 degrees C for 15 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Within first 30 minutes was experiencing body and face swelling and shortness of breath. Within first 3-4 hours had bad rash on arms, legs, face, neck and chest, fast heartrate, breathing and out of it sensation. I felt like I was having a partial analpylaxis reaction - like throat 1/2 closed but that I would be ok. I took Benadryl and used a Ventolin inhaler. Rash was better by 2nd day.  On 2nd and 3rd day I was having massive headache (felt like pressure from inside all over out to all cranial sutures), severe neck stiffness on rt side, lumbar vertebrate pain, iliosacral and hip pain, felt painful radiating spasms down my left and right legs, also jaw and teeth pain. Taking Naproxen and now ASA.  Very shakey and jittery. Occasionally have lower arm pain and numbness on left side. Also have injection site symptoms but minor compared to above. It's been 1 week and allergic part of rxn is over but concerned with possible neuro and bloodclot possibilties..  On day 2 or 3 I also had problems with my brain with reading comprahension.
The patient was in observation for 5-10 minutes after the vaccine. She reported that she was hot. I asked her if she had any history of anaphylaxis. She said she did to morphine. Her bp was 119/74 with a pulse of 94. She said her nose was starting to get itchy, her ears and scalp were itchy, and her eyes were blurry. She had red blotches all over her neck and chest. She said her throat was tight. She was able to swallow the water she requested. I gave her 50mg of benadryl.  She had no visible signs of being unable to breathe. I explained to her we could call 911. She reported she had no insurance. She said she was on her lunch break at the hospital and wanted to get back. She did walk back across the street unassisted. Clinical observer, followed her over just to verify she made it in the building. She ended up checking herself into the ER instead of returning to her shift.
was burning up; Sore arm; Throbbing headache; I was hot, I was cold; Fever; Chills; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received the second dose of BNT162B2 (BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration, on 07Jan2021, at single dose, for COVID-19 immunization, in the hospital. Medical history included blood pressure high and high cholesterol. The patient reported "I just got my second Pfizer Vaccine (clarified as BioNTech Covid 19 vaccine) yesterday (07Jan2021) and I just wanted to call to report the side effects that I have because they told me you should specially after the second one. And I have had fever, headache, and chills. So, I just wanted to report this". When asked about the event start date, the patient stated, "I went to sleep, I got the shot yesterday morning on early (07Jan2021). And then I was fine except for the sore arm. And then I woke up in the night. I fell asleep fine; I woke up through the midnight and it was burning up. So, I took my temperature. So, I'd say about 3 am (08Jan2021)". When asked if the patient was still experiencing the events, the patient stated, "Little bit because I had also throbbing headache and I was hot, I was cold. I did take Tylenol (treatment) and I did think that it started to help a little bit. Because I did got, my fever has gone down." The outcome of the events was recovering.
Massive stroke; A spontaneous report was received from a consumer (patient's daughter), concerning an 85-year-old female patient, who received Moderna COVID-19 vaccine and death occurred in two days.  The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies. She states that her mother was physically and mentally healthy before vaccination.   On 29-JAN-2021, prior to the onset of events, the patient received her first of two planned doses of covid-19 vaccine for the prophylaxis of Covid-19 infection. There were no complaints on any side effects from the patient for 6 hours after vaccination. Next day, she was found unresponsive on her bed by her neighbor after they were sent to check on her by her daughter. Her heart was beating, and she was breathing at that time, but did not have consciousness. According to her daughter, the patient had a massive stroke in her sleep sometime between 8:pm on 29-JAN-2021 and 9:30 am on 30-JAN-2021. Her life saving measures were taken out at 1:15 am on 31-JAN-2021 and she died approximately at 1:45am.  No information available on hospitalization and treatment received with this event. It is not known whether autopsy was done.  Action taken with 2nd dose of Moderna Covid-19 vaccine was not applicable.  The outcome of the event stroke is fatal.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of stoke, a causal relationship cannot be excluded. Patient's elderly age is considered a risk factor.; Reported Cause(s) of Death: Massive stroke
Patient completed COVID vaccine 3rd dose on 1/21/22. 10 days after that, she developed a pain in left arm at injection site that travelled to left armpit and left breast. Pain has fluctuated between 7-10/10. She has had limited ROM of left shoulder due to the pain. Ibuprofen 800 mg has not helped. A diagnostic mammogram and Ultrasound was ordered. Results are pending.
pt devel muscles aches, malaise & a fever of 101, duration almost a wk;nurse feels as though vaccine related;
Information has been received from a physician concerning an 18 month old male with a history of eczema and no allergies, who on 23Nov04 was vaccinated with a 0.5ml dose in the right lower thigh of varicella virus vaccine live (Lot0345p). There were no concomitant medications. Last night, on 14Jun05 the pt presented with possible breakthrough varicella rash which the physician felt was worsened by the child's history of eczema. The physician thought it was eczema herpeticum. It was reported that the physician obtained a scraping of the lesion. The pt began on acyclovir yesterday. Follow up information from a physician indicated that on 12Jun05 the pt experienced hundreds of vesicles then excoriations and undilated ulcerations that were distributed on his face, elbows and knees in an eczematous distribution. It was reported that the pt also experienced a maximum temp of 100, fussiness, and eczema herpeticum. It was noted that a rash did not occur at the site of injection post vaccination, and that the pt did not have a recent exposure to chickenpox or shingles. The specimen arrived in the lab on 15Jun05 and VZV DNA was not amplified, B globin DNA was amplified and the interpretation was that it was an adequate specimen but no VZV was identified negative. The pt's status was reported as recovered. Additional information has been requested.
I had my vaccination 03/10/2022. On 06/30/2022 I started to experience body aches. I did an at home COVID-19 test early on 07/01/2022 and it was positive.  I then started to have sniffles and 103 temperature with a mild cough on 07/01/2022. I started the Plaxovid on 07/02/2022 I had mild cough and sniffles with a sustained low grade fever for five to seven days. I haven't fully recovered as it has been slow.
This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020). Concomitant products included Aspirin, Calcium, CRESTOR, Probiotics, ZOLOFT and Multivitamin. On 9th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site rash. On an unknown date, the outcome of the injection site erythema and injection site rash were unknown. The reporter considered the injection site erythema and injection site rash to be related to SHINGRIX. Additional information was reported as follows: The physician reported that, her patient received SHINGRIX on Monday. The patient came back to the office on the date of reporting, and presented erythematous patch below the injection site, that was 3 to 4 centimeters in size. The caller categorized the event as rash.
Had the first shot on 02-02-2021 Arm was slightly red and itchy Diarrhea started 4 days later on 02-04-2021 Diarrhea has continued unabated through 04-09-2021 at which time it started to let up. I still have diarrhea but to a milder extent, only going twice a day with somewhat formed stool.
This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 in total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  Patient was not having any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). Patient received non-company suspect vaccine included: tozinameran (Pfizer vaccine) (Dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported), dose, start therapy date were not reported for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2).  On an unspecified date, the patient experienced rash for 2 months following vaccination with tozinameran (Pfizer vaccine) (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash for 2 months after a pfizer booster, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Developed cold, cough, vomiting after Influenza vaccination, requiring hospitalization for Pneumonia.  1/26/2009 MR received for DOS 12/15/2008-1/xx/2009. No D/C Summary sent since pt still hospitalized. DX: Pneumonia. S/P Respiratory Failure with intubation.  Pt presented with worsening fever, SOB and cough x 2 days. PE (+) for dry mucous membranes,nasal flaring, retractions and grunting. O2 sat 88% on RA. Started on O2 NC then later intubated for further respiratory decline. May require tracheostomy. TX abx. Still hospitalized.
the other two doses were given somewhere else and can't confirm if they were intramuscular injections or not.; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (the other two doses were given somewhere else and can't confirm if they were intramuscular injections or not.) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (the other two doses were given somewhere else and can't confirm if they were intramuscular injections or not.). On 28-Jan-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (the other two doses were given somewhere else and can't confirm if they were intramuscular injections or not.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter.  No treatment medications provided by the reporter.   This case was linked to MOD-2021-365085, MOD-2021-364970 (Patient Link).
Patient urticaria around face, neck occurred same day as Anthrax injection. Patient also  received Hep A.
Itchy rash on upper body and face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 50-year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Nov2021 20:45 (Lot number: FE3590) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pcos" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Tree nuts" (unspecified if ongoing); "soy" (unspecified if ongoing); "fish" (unspecified if ongoing); "shellfish" (unspecified if ongoing); "penicillin" (unspecified if ongoing); "sulfa drugs" (unspecified if ongoing); "Known allergies: peanuts" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC; METOPROLOL. Past drug history included: Erythromycin, reaction(s): "Known allergies: erythromycin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8730, Location of injection: Arm Left, Vaccine Administration Time: 16:30 PM), administration date: 26Mar2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ENC6202, Location of injection: Arm Left, Vaccine Administration Time: 14:30 PM), administration date: 25Feb2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: RASH PRURITIC (non-serious) with onset 05Nov2021 21:00, outcome "not recovered", described as "Itchy rash on upper body and face". Therapeutic measures were not taken as a result of rash pruritic.  Additional information: Patient did not receive any other vaccine within 4 weeks. Patient was not tested to covid-19 prior to vaccine and not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2014US010626 is an initial spontaneous report from a pharmacist received on 22 may 2014. This report refers to a patient of an unknown age and gender. The patient was vaccinated with FLUVIRIN (batch number: unknown) on 21 May 2014 or 22 May 2014 which was expired. No adverse reaction was reported following this medication error.
Information has been received from a medical assistant concerning a female (age not reported) with a history of migraines who was vaccinated with a dose of Gardasil.  The medical assistant reported that 48 to 72 hours after vaccination was administered, the patient experienced migraine.  The patient sought unspecified medical attention.  The patient's status was not reported.  There was no product quality complaint involved.  Additional information has been requested. This is in follow-up to report (s) previously sumbmitted on 6/14/2007. Additional information is not expected.
Was working on a shower door and i got dizzy, called my wife (She's a RN) because i didn't feel good.  She came in and said it looked like i had a stroke.  She called 911 and i was taken to ER
Patient reported as experiencing some vertigo prior to vaccination.  Approximately 10 minutes post-vaccine, patient experienced a witnessed tonic-clonic like reaction.  Vitals:  150/90, pulse 120, SaO2: 95%.  Patient was postictal approximately 10 minutes post onset.    No meds given.  EMS notified.  Transferred to the hospital.
Severe headache within 2 hour of vaccine.  Extremely fatigued,  headache, muscle ache and soreness at injection site lasted 4 days.  Treated with tylenol and ice packs.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset Jan2022, outcome "unknown", described as "I caught Covid in January"; DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", described as "I have received all 3 Pfizer vaccine shots. After every shot, I do get a rash. I caught Covid in January"; RASH (non-serious) with onset 2022, outcome "unknown", described as "After every shot, I do get a rash"; VIRAL RASH (non-serious), RASH PRURITIC (non-serious) all with onset 2022, outcome "not recovered" and all described as "I developed serious viral rashes all over my face, neck, and arms. The itchy viral rash is appearing on my face, neck and now the trunk of my body"; INFLAMMATION (non-serious) with onset 2022, outcome "unknown". Therapeutic measures were taken as a result of suspected Covid-19, rash, viral rash, inflammation, rash pruritic. Clinical information I took prednisone just 10 days ago and it suppressed the inflammation. I stopped taking it for two days and the itchy viral rash is appearing on my face, neck and now the trunk of my body. Have you seen this before I do not know what to do. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.