chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 5 year old male with allergic rhinitis who in August 2002, was vaccinated with the first dose of hepatitis B vaccine recombinant (yeast).  The pt was vaccinated with the second dose (Lot # 643683/0705M) in the left deltoid on 10/29/02.  there was no concomitant medication.  There was no illness at the time of vaccinations.  The physician reported that, according to the pt's parents, the pt subsequently developed behavioral changes after the first and second doses of the vaccine.  The pt was noted to be more hyperactive and had more temper tantrums.  During school, the pt would not pay attention to the teacher and would often pull the hair of his classmates.  Unspecified medical attention was sought.  On 05/14/03 it was reported that these symptoms are "much improved now".  No product quality complaint was noted.  No further information is expected.
covid 19 vaccine was administered to pt in r deltoid. approximately, 5 minutes after administration. pt began to complain of itchiness, light headedness, and "throat feeling scratchy". pt was then administered 50mg of Benadryl odt. pt then stated that she takes hydroxyzine for body itchiness and that she was out of her medications. vaccine crew monitored pt for approx. 30 minutes after administration of vaccine.
Red, painful, itchy patch spreading larger each day since injection. Started a couple inches below injection point, has spread more than half way down and now around the front of my arm.
Body itching; Tenderness at site of injection; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Body itching), INJECTION SITE PAIN (Tenderness at site of injection) and NAUSEA (Nausea) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (Body itching), INJECTION SITE PAIN (Tenderness at site of injection) and NAUSEA (Nausea). On 24-Feb-2021, PRURITUS (Body itching) and NAUSEA (Nausea) had resolved and INJECTION SITE PAIN (Tenderness at site of injection) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Added outcome of the events
Body and joint aches Previously taken Acetaminophen, Naproxin, currently taking  MethylPredniSolone dose pack
Night after I got shot. Woke up around 2 am. Threw up and sick to my stomach. Was dizzy which lasted for about six weeks. Don't know if I had a adverse effect. But now afraid to get flu shot this year.
Pfizer-BioNTech COVID-19 Vaccine EUA Experienced dizziness, nausea and extreme imbalance since the first dose that has not resolved and led to me passing out and needing two separate trips to the ER.
1 week post vaccination - patient, not responding to albuterol HFA, called 911, he passed out, was unresponsive, pronounced dead.
Allergic reaction consisting of rash (non-urticarial). Post Prevnar, had maculo-papular rash occurring less than 24 hours. Treated with hydroxyzine.
No signs or symptoms reported; Excursions occured; This spontaneous report was received from an administrator referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 15-APR-2021, the patient was vaccinated with an improperly stored dose of yeast)(GARDASIL 9) prefilled syringe, dose and frequency reported as 1 time dose with lot # T026168 (expiration date: 04-DEC-2022) or 1691180 (expiration date: 15-NOV-2022) for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of  49 and 48 degrees Fahrenheit on 09-APR-2021 and on 23-APR-2021 respectively  for 1 hours/ 15minutes. It was not recorded by a data logger and not previous temperature excursion was reported. No signs or symptoms reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
patient returned to pharmacy 11 days after immunization to report that he is still experiencing arm soreness/pain upon moving arm
Redness and warmth surrounding injection site, very large-diameter 26 inch no pus no pain (+) itchy/Adverse local reaction
Pt recvd 2 Engerix-B injects 4JUN91 & 2JUL91; pt devel Hep B w/jaundice & vomiting; ER tx required; 17AUG91 recvd Phenergan for nausea & vomiting;
Patient states that the evening after receiving SHINGRIX (5/4/18) she experienced a red, puffy raised area at the injection site on her left arm, about 3/4 the size of a hand print, as well as tenderness at the injection site. She reported the reaction on Monday, 5/7, and stated that the swelling, redness, and tenderness had subsided.
Fever of 102.0 (reported via patient). Left arm pain/shoulder pain. Mild nausea (intermittent).
Information has been received from a health professional concerning a 16 year old female with an allergy to penicillin who on 19-SEP-2007 @ 15:00 was vaccinated subcutaneously into the right arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 658197/0853U). Concomitant vaccine therapy that same day included a first dose of Gardasil for the treatment of prophylaxis administered into the left arm (Lot # 658488/0930U) and a first dose of Menactra administered into the right arm (Lot # U2386BA). On an unknown date the patient developed a mildly warm, swollen right tricep area. There was no illness at the time of vaccination. There were no diagnostic tests performed. The patient recovered on an unspecified date. Additional information has been requested.
skin reaction in a triangular shape down from the injection point.  red and hot, not itchy.  started about a week or so after the shot, but became very visible today, 12 days after the shot.  appears to be the reported moderna side effect of skin reaction at the injection site.  I feel otherwise fine
I got Acute Pancreatitis on April 3rd, 2021. I was hospitalized and eventually diagnosed with Acute Pancreatitis  after my lipase levels were at 314U/L. They couldn't find anything else wrong with me or what might have caused it. I read the following article and it appears their is some emerging data linking the COVID_19 vaccine and Acute Pancreatitis. I can't speak to the validity of these findings, but felt it was worth reporting.
pt stated that  went to bed w/ a sore are the night after receiving the covid vax.  She woke up the next day w/ unbearable pain all over her body, body aches, joint pain, head ache, back ache.  She felt like she had fever but she said it was only 99.  Her left arm was swollen, red  and hot around the injection site.   Pt states she still has shaky, achy legs and swelling in left arm. Pt called her PCP and left message for them to give her a CB.
Mom reported at 1:50 AM that patient woke up crying with difficulty breathing. Mom gave BENADRYL and prepped to go to ER but didn't go because patient symptoms decreased before leaving house. Spoke to mom at 9:11 AM following day (9/22/17) and patient is okay with no problems.
flu & pneumoccal vaccine given on 10/24 at 2pm. Patient experiencing flu like symptoms on Wednesday (febrile, chills, sweats). Patient woke up Thursday with temp 101F and redness , increased swelling on arm-pain 7/10. Area 10x12cm, general malaise, feeling slightly better Friday. Afebrile.
The patient has not had an adverse event. The vaccine was expired by 2 days. Wanted to report that there was a medication error due to the expiration of the vaccine.
Pt reported joint pain all over & fever for 2 days, tired for several days, and rxn on arm still present - redness, swelling, and warmth.
Vaccines given about 9 am. Father called at 10:24 and stated pt eyes were swollen (L) about 3/4 way and R about 1/2 way. RTC Asap Tx with BENADRYL.
This spontaneous report as received from a pharmacist refers to a 68 year old male patient. There were no pertinent medical history and concomitant medications. The patient was not allergic to any drugs. On 21-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 (dosing details were not reported) (lot # N000508, expiry date: 19-OCT-2018) for prophylaxis. On 22-AUG-2017, the patient visited the pharmacy and stated that he was experiencing redness and warmth on his left arm located under his arm down to his elbow". Patient did "feel a little discomfort" (erythema, discomfort and feeling of warmth). The patient had undergone treatment for the events. The outcome of the events was reported as not recovered/not resolved. The reporter did not provide the causality assessment between the events and the suspect therapy. There was no product quality complaint involved.
redness on injection site; swelling on injection site / huge knot; Injection site knot; neck swelling; neck pain; neck stiffness; This case was reported by a nurse and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis.   Previously administered products included Keflex, Naproxen and Simvastatin.   On 8th March 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 8th March 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site lump, neck swelling, neck pain and stiff neck. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site lump, neck swelling, neck pain and stiff neck were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site lump, neck swelling, neck pain and stiff neck to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right deltoid. The patient experienced redness, swelling on injection site. After vaccine the patient reported a huge knot and redness neck stiffness. The patient complained of neck swelling and pain
Vaccinated arm became swollen, area of redness and swelling included chest and back muscles and continued down arm to elbow.
This case was reported by a physician via call center representative and described the occurrence of fever in a 16-year-old male patient who received BEXSERO (batch number 166901A, expiry date 30th November 2018) for prophylaxis. Co-suspect products included MENVEO (batch number M17038, expiry date 31st March 2019) for prophylaxis. On 13th June 2018, the patient received BEXSERO (intramuscular) .5 ml and MENVEO (intramuscular) .5 ml. In June 2018, less than a week after receiving BEXSERO and MENVEO, the patient experienced fever, pain in arm, nausea, pain and headache. On an unknown date, the outcome of the fever, pain in arm, nausea, pain and headache were not recovered/not resolved. The reporter considered the fever, pain in arm, nausea, pain and headache to be related to BEXSERO and MENVEO. Additional details were provided as follows: The patient received MENVEO and BEXSERO in the reporting physician's office a day before the reporting date. The patient complained about achiness, headache, nausea, mild fever and soreness on his arm. This case has been linked to case US2018107284, reported by the same reporter.
Nausea for 48 hours, starting a few hours after the vaccination Numbness in left hand and soreness in left arm for over a week, starting about 24 hours following the vaccination
still got sick; Initial information was received on 18-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional (Patient)  This case involves an unknown age/gender patient who still got sick after being vaccinated with INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, route, administration site, formulation, expiry date: Unknown).  On an unknown date the patient developed a non-serious still got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (still got sick).  Outcome: Unknown for the event still got sick.
11cm X 16cm erythematous area at right thigh that is warm to touch. Circumference of right thigh is 28.5cm. Circumference of left thigh is 25.5cm. No fever, no limp and complains of no pain.
During a mass vaccination clinic, client was administered one dose of Janssen COVID19 vaccine IM.  Pt was under age 18 at time of vaccination, Janssen EUA and our standing orders for Janssen vaccine state patients must be 18 or older to receive this vaccine.
Pediarix vaccine (Diphtheria, tetanus toxoids, acellular pertussis, recombinant hepatitis B, and inactivated poliovirus vaccine (DTaP-HepB-IPV)) was administered instead of Infanrix vaccine (Diphtheria, tetanus toxoids, and acellular pertussis vaccine (DTaP and Tdap)) on 3/11/21. Infanrix is what was ordered. Vaccine administered intramuscular to left thigh.
This spontaneous report as received from a pharmacist refers to a 68 years old female patient with hypertension, hypercholesterolemia and sulfa drugs allergy. On 16-JAN-2013, the patient was administered a 0.65 ml dose live ZOSTAVAX (subcutaneous injection) (lot# not reported). No other co-suspects were reported. Concomitant medications included lovastatin, EVISTA, zolpidem tartrate, diltiazem hydrochloride and hydrochlorothiazide (manufacturer unknown). Immediately after vaccination the patient developed redness at injection site. On the second day after the vaccination the redness became warm, itchy and a non-vesicular rash developed with discomfort. The patient still has a very light rash as of 22-JAN-2013, although she stated she is not in as much discomfort as she had been. The patient was not treated. The relatedness of the event with live ZOSTAVAX was not provided. Additional information has been requested.
Left sudden sensorineural hearing loss (moderate to moderately severe) with onset on May 20, 2021. Hearing loss and tinnitus identified. Presentation to my office on July 22, 2021 confirmed hearing loss. High dose prednisone given. Treatment response still pending. Intratympanic dexamethasone may be given.
No other issues or concerns noted; a patient was given expired dose of MMRII; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 15-NOV-2021, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) expiration date 14-NOV-2021, for prophylaxis (dose, lot #, route and site of administration were not reported). No additional adverse event was provided.
At point of injection at 315 pm patient tensed up left arm and pulled arm back. Patient described immediately that injection hurt. Called patient around 730 pm to check on patient and how she was feeling. Patient described arm pain. Described to patient to massage area, take ibuprofen 200 mg every 8 hours to help with pain. Also to ice area of soreness for 20 minutes and apply heat for 20 minutes. Patient called pharmacy 4/12/2018 at 846 am describing excruciating pain did not follow pharmacist advice however did take hydromorphone 4 mg to help with pain. Patient described arm could not be lifted and is hard to the touch.
The first day I just had a sore throat. The second day I had cold like symptoms - runny nose, chills, achy and like I had a real bad cold. Then Tuesday morning I had a at home COVID-19 test and it was positive. I had no energy to do anything and couldn't sleep. Severity was like a really bad cold. I suspected it was COVID-19 because I was on an airplane and in the airport without a mask. Now I'm isolating. I called my Doctor and I wasn't anywhere near my home and that afternoon they told me they had antivirals but it was hard to find and I should take vitamin D, C and Zinc. Once I got home I went and got the antiviral prescription 2x day for 5 days.
This spontaneous report was received from a register nurse, refers to an unspecified number of patients, of unknown age and gender. medical history and concurrent conditions were not reported. The register nurse informed nurse informed that on an unknown date the patients received improperly stored, ROTATEQ, oral (strength, dosage, lot# and expiration date were not reported). No adverse were reported. This is one of several reports received from the same reporter. Additional information has been requested.
On day 8 after receiving the vaccine, the patient woke up to her arm itching, with a small, red, raised area where she had been vaccinated.   On the 9th day, January 14, 2021, the area was still itchy, red, hard, no pain, warm to touch and much larger than  the prior day.   Patient was previously diagnosed with COVID-19 and it was lab confirmed.   Patient notified Public Health Nursing
This is a spontaneous report from a contactable consumer (patient's mother). A male patient of an unspecified age received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the physician who administered the vaccine had troubles administering the product; like it was stuck on the syringe because the physician had to change the needle at least twice. After that (which was the first dose administration), the patient experienced muscle weakness, muscle soreness, fatigue, and a heavy head on an unspecified date. The outcome of the events was unknown. Follow-up activities are possible and information on the batch number has been requested.
Swelling to (R) lower leg/foot, high temp, antibiotic Thursday - overnight at hospital - Friday ER visit.
Chills; Achy; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and MYALGIA (Achy) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced CHILLS (Chills) and MYALGIA (Achy). On 07-Feb-2021, CHILLS (Chills) and MYALGIA (Achy) 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.
My daughter had a fever following the vaccine. She took Tylenol. The next several days she was tired but did not have a fever. She presented with a fever and stomach pain on July 18. She had vomiting so we took her to urgent care. They gave her anti nausea meds and said to go to another clinic to get blood tests if she didn?t start to feel better. We took her to get her blood checked on July 28 because she was still sick. Her WBC was incredibly high. We were sent to ER where they confirmed leukemia. We then took a life flight to hospital the same day, where they confirmed T-cell acute lymphoblastic leukemia. She began chemo therapy the following day, July 29.
Extreme fever,body aches, chills and rash. Could not use the left arm the shot was given in too sore then rash spread around and down arm. Angry red and increased itching has continued and as of today is still badly sore and itchy.
No adverse event; Call transferred from MNSC. Nurse calling to report adverse event on expired dose of GARDASIL 9 was accidentally administered to a patient. Permission to contact HCP was unspecified. No other information provided. No additional AE/PQC reported.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 11-JAN-2023, the patient was accidentally vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, 1 dose, lot #T025367, administered for prophylaxis (strength, and route of administration were not provided). The vaccine expired on 18-NOV-2022.  No adverse events were reported.
patient is 64 years old. he received a gardasil 9 vaccine, but it is not indicated for his age. patient is now aware and will not receive any more doses in this series.
Pt. had acute onset of severe vomiting and dizziness.  Lasted into next day.  Also began to have leg pain & perceived weakness, tingling.  The leg symptoms lasted >/wk.  Pt totally normal on 4/8/09
Tiredness; Cold; Pain; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), PAIN (Pain), DIZZINESS (Dizziness) and FATIGUE (Tiredness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In April 2021, the patient experienced FATIGUE (Tiredness). In 2021, the patient experienced NASOPHARYNGITIS (Cold), PAIN (Pain) and DIZZINESS (Dizziness). In 2021, FATIGUE (Tiredness) had resolved. At the time of the report, NASOPHARYNGITIS (Cold) was resolving, PAIN (Pain) had not resolved and DIZZINESS (Dizziness) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Systemic: Lymph Node Swelling-Mild, Additional Details: Patient presented with swelling above left shoulder.  Said it hurt "a little" she presses it.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Between July 2014 and August 2014, the unspecified number of patients were vaccinated with doses of VARIVAX (Merck) (dose, lot number, expiration date were not reported) that were improperly stored. No adverse effects were reported. Additional information has been requested.
10:pm Strong Chills, 1:00 Chills then vomiting, no fever until 9:30 am, says he aches all over. I have been giving him liquids and tylenol. In Feb. 2021 he had Covid 19 and was in the hospital for close to a month. He still has re-percussions from that, his balance and gets tired easily.