chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 2.5 weeks after my second vaccine, I started to have chest pains; returned with intense palpitations; The palpitations and pain decreased, I had a relatively normal set of data (2% of the time with PVCs)/recently the chest pains returned with intense palpitations; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 44-years-old non pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number FA6780, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 10Jul2021 15:00 (at a age of 44-year-old) as dose 2, single for COVID-19 immunisation. The patient previously took bnt162b2 (BNT162B2, Lot number: EW0181, Expiry: Unknown) via an unspecified route of administration, administered in Left arm on 19Jun2021 at 02:00 PM as dose 1 single, for COVID-19 immunisation. The patient medical history included bee sting allergy, Known allergies was with sulfa from an unknown date and unknown if ongoing. The patient was not positive for COVID-19 prior to vaccination and had been tested post vaccination. Patient did not receive any other vaccines within 4 weeks and other medications 2 weeks include women's daily multi vitamin prior to the COVID vaccine. It was reported that, about 2.5 weeks after her second vaccine, she started to have chest pains. After a week of intermittent chest pain, the pain was concentrated on her left side and she went to the ER where an EKG was done and blood work was done. She just moved when the chest pains were starting and since she didn't have her Holter data, they asked her to do another Holter monitor. In the meantime, the palpitations and pain decreased, she had a relatively normal set of data (2% of the time with PVCs) and felt back to normal for about 2 weeks. Then, recently the chest pains returned with intense palpitations. Patient just had an echo and an MRI done and awaiting results. On an unspecified date in 2021 the patient underwent lab tests and procedures which included blood test: unknown results, echocardiogram: unknown results, electrocardiogram: unknown results, electrocardiogram ambulatory: 15% of the time was with PVCs, after second dose she had a relatively normal set of data (2% of the time with PVCs), magnetic resonance imaging: unknown results on Aug2021, SARs-cov-2 test: negative on 01Aug2021 Nasal Swab, sars-cov-2 test: negative on 07Aug2021 Nasal Swab , sars-cov-2 test: negative on 28Jul2021 Other. No treatment was taken for the events. The outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Incorrect vaccine administered. Pentacel, Hep B, Rota, PCV ordered but Pentacel, HIB, Rota, PCV given so child got 2 doses of HIB and missed a dose of Hep B.
Information has been received from a registered nurse referring to two male boy patients of unknown age. The patients' medical history, concurrent condition and other concomitant medication were not reported. On 03-APR-2018, the two patients were vaccinated with improperly stored VARIVAX (dose, route unknown, lot # N015475 with expiration date 18-MAY-2019) for prophylaxis. The sterile diluent (manufacturer unknown) (unknown lot number and expiration date) used for reconstitution was properly stored. The vaccine was exposed to temperature excursion of -14 degree Celsius to -10 degree Celsius for a time frame of 2 hours. There were no previous temperature excursions. Data logger was involved. No product quality complaint (PQC) was involved in this case. No adverse effects reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA011819: US-009507513-1805USA011820: US-009507513-1805USA011821: US-009507513-1805USA011822: US-009507513-1710USA004084.
She had no issues with the 1st dose in the series.  She did not have any symptoms but acknowledged feeling anxious about the side effects prior to arrival for vaccine. After the 2nd dose, she experienced chest pain, jaw pain, body numbness and tingling, and nausea. She did not have vomiting, shortness of breath, syncope, or headache. She was hypertensive on the cardiac monitor and EKG with T wave inversion in lead III, otherwise unremarkable. Heart rate stable, alert and oriented, cardiopulmonary exam benign. She was sent to the ER for further workup, but did not seem to have any allergic reaction to the vaccine. It is unknown what occurred at ER, as she either went to a separate health system or did not go at all.
pt recv 1dose of varivax 6/15/95 & in 4/98 pt exp ``classic varicella'' w/more than 50 lesions. rpt nurse noted pt was afeb
26mins post vaccination pt reported "pressure" on chest when breathing.  Pt takend to Med facility. Vitals: 11:38 120/82, 80, 16, 100% -- > 11:43 133/76, 67, 99% Pt was anxious today before vaccine.  No swelling of mouth or tongue.  Pt reports feeling better once laying down and removing mask.  Pt stable and released from the vaccination site @12:06 w/ no further complaints.  Gait strong and steady.  NO S/S of distress.
No adverse reaction reported. Pt administered Hepatitis A in error-too early. Lot number for Hepatitis A given-M033611.
Received 1st dose of COVID-19 Moderna vaccine 08/28/21 aprox. time 11:20 AM, right arm. Onset of reactions occurred within first 1-4 hours after injection: numbing/tingling of left side of face, eye, neck, back of head and bottom lip, dizziness, headache, brain fog (unable to make out words or focus), blurry vision, weak. This continued for first 3-4 days after injection, started to subside a little but lingering for first 2 weeks after injection. Drank water, rested for the weekend and spoke with nurse doctors office over the phone on Monday 08/30/21. Scheduled telehealth appt to speak with doctor on 09/10/21. Informed doctor of reactions still lingering at time of doctors appt.
He had diarrhea beginning January 2nd. It was 6-8 times for the first 2 weeks. Then 4 to 6 times the 3rd week. He saw the doctor towards the end of the 3rd week. He saw the doctor on the 20th, and he was down to 4 times a day. The doctor advised me not to treat it and to allow it to phase out. He also had a runny nose and minor cough from the 14th-19th. He went back to the doctor, and she also advised me to allow this to phase out as well. His diarrhea stopped after 23rd and the cough and runny nose subsided as well.
A non-serious, spontaneous report of headaches and vomiting has been received from a nurse concerning a 22-year-old female patient, subsequent to receiving FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 15-Oct-2009. On 15-Oct-2009, the patient developed a headache that lasted for two days and vomiting. Approximately one and a half weeks later, the patient experienced similar headaches and vomiting. The events of headaches and vomiting are ongoing.
administered first dose in 2018 and physician do not have record of second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient administered first dose in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: administered first dose in 2018 and physician do not have record of second dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-OCT-2023 The reporter was calling on behalf of her elderly mother. The reporter could not find verification that mother received her 2nd dose of Shingrix. Pharmacy that administered first dose in 2018 and physician did not have record of second dose. No further information was available. The reporter did not consent to follow-up. The reporter was not in agreement with filing a safety report about her mother's experience with the vaccine. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2019187002:Same reporter
Fever , headache , itchy everywhere! Hives, dizzy,  cough, stomach cramps, rash all lasted 12 hours and started 2 days after injection .   After that I became allergic to medication that I was never allergic to before  All injection I had weird symptoms 2-3 days after shot however, the first 2 shots were not bad just headache and stiff muscles
Vaccine administered to incorrect patient. Intended patient did later receive vaccine, and this patient was found to be candidate for the vaccine regardless of error.
Information has been received from a mother concerning her 22 month old son with allergy to corn, turkey, soy, dairy, sesame, eggs, chicken, watermelon, tree nuts, peanuts, onions, garlic, shellfish and fish and a history of immunocompromised who in approximately December 2007, was vaccinated with a dose of MMR II, (dose, route and lot number not reported). On an unknown date, the patient developed a high fever with spots over his body, accompanied by vomiting ("through up for days"). The mother reported that her son lost his speech and developed autism after vaccination with the MMR II and had not completely recovered at the time of the report. The patient sought medical attention, contacted the physician. Lost speech was considered to be an other important medical event. The patient also had a history of stopped breathing and respiratory infection while on therapy with influenza virus split virion 3V vaccine inactivated, (WAES # 1202USA00716). No further information is available.
Patient called to state that the day following the immunization, she had muscle weakness and numbness that began in bilateral feet and legs and ascended to her hands and arms. She has since gone to her regular physician and a neurologist. The neurologist stated it was unlikely Guillain-Barre syndrome, but was advised to contact pharmacy to discuss reaction with pharmacy.
On 6/3/99, the pt developed a fever of 102 to 103 and vomiting. On 6/6/99 he developed a rash of small, red bumps all over his body and of larger diameter on his legs. On 6/17/99, the pt was seen by a dermatologist and dx with erythema multiforme. He was treated with Elocon. On an unspecified date the pt recovered. The pt's mother reported that since receiving the vax, her son's rash comes back, usually accompanied by a light fever, every time he has a little bit of egg such as in baked goods.
Patient presented to the pharmacy asking to review immunization history with the help of immunization registry. The registry showed the patient as getting Zostavax, no history of Shingrix. Patient was asked if he received Shingrix in the past, he said he has not and asked to get it done that day. We administered 1 dose. Patient came back a few hours later showing us that he did actually get it, from the hospital. The hospital does not report to the state agency, and because the patient forgot they got it it was administered to him a 3rd time. The first two doses were given in 2021.
Patient received a booster dose (3rd) of the Pfizer vaccine on 10/7/21 when she previously received 2 doses of Moderna on 2/11 and 3/11/21. Patient is not considered immunocompromised.
This case was considered medically important (OMIC). A nurse reported that a 15 month old male received his 1st dose of Prevnar on 08/28/2002 at the age of 2 months. Concomitant therapy included ActHIB. Relevant medical history was not reported. Indication for Prevnar was immunization. Product was administered on 8/28/02. dose regimen was 0.5mL (IM). Concomitant therapy included Act-Hib. On 8/30/02, 2 days post immunization, according to his mother, the child experienced seizure-like activity, characterized by an arching of the back with stiffness and tongue thrusting. It is unknown how long this activity lasted, but it did resolve. The patient had the remaining full series of Prevnar with no reactions to it or any other vaccine. No additional information was available at the time of this report. A 15-day follow up report received 12/29/2003 adds: The physician reported that (at time of vax) the infant had no evidence of neurologic problems and that no lab tests were performed. The infant was sent home without further problems. The infant had the remaining full series of Prevnar with no reactions to it or any other vaccine. A copy of this report has been forwarded to manufacturer of Act-Hib.
pt received second Moderna does on 5-20-21; lot 002C21A IM Pt has since developed Covid on 7-1-21
still break out with them/suspected vaccination failure; still break out with them; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional Information: GSK Receipt Date: 26-Mar-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter stated, it did not matter if you get the two-part shot, the patient still broke out with shingles. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible, as no contact details were available. This case had been linked to US2022AMR056645, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR056645:Same reporter
Patient in today for assessment. Noted a small area approximately 1/2 inch by 1/2 inch on posterior left arm. Area is slightly reddened with a small amount of old purple bruising noted. Patient reports area is no longer tender to touch. Also has a 5-6 unraised  red spots the size of a pencil eraser that she has been scratching. and has scratching the skin of the top of them . Patient reported that areas were never fluid filled. Patient reported that she has had some headaches post vaccine that have been relieved with ibuprofen but besides that she has not ran any fever or had any other problems. Advised patient to not scratch the areas anymore and to avoid contact with any immunocompromised individuals or unvaccinated small children
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age (gender not reported). On 01-NOV-2013 the patient was vaccinated with a dose of GARDASIL (lot # J008423, exp. date 21-JAN-2016) (route and dose not reported) which was exposed to a low temperature of 29F for a total of 11 hours from 30-OCT-2013 until 07-NOV-2013. These excursions were not supported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
appendicitis/had his appendix removed; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 25Jan2021 (lot number: EL3249) at the age of 35 years old, as single dose for COVID-19 immunisation. Medical history reported as none. The patient has no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. No other vaccines received in four weeks. No other medications taken in two weeks. On unspecified date, after first vaccination, the patient had appendicitis and had his appendix removed. The event resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab): negative. The patient was given dose 2 of BNT162b2 on 15Feb2021 (lot number: EL9267), administered in left arm. Outcome of the event appendicitis was recovered with sequelae.
Pt was shaking, having a seizure with eyes rolled back but no fever. He was making a slight "clicking" sound with his mouth. Duration unknown exactly. After parent noticed behavior, it lasted a minute or so. Doctor was called.
Pt received Pediarix, Hib and Prevnar at 10:30 am. Atabout 2 pm was fussy with low grade temp to 100. Went to sleep at 11 pm. At about 2 am, mom tried to wake up the baby for his usual feeding and found him to be hyporesponsive and difficult to arouse. She picked him up and the baby was hypotonic. After about 15- 20 minutes of stimulation, she was able to arouse him enough to take the feeding. At 6 am he was still very drowsy. Was seen by me at 11 am on 6/02/05 in the clinic at which time he was his normal self.
This spontaneous report was received from a healthcare worker concerning a 5 year old patient. Medical history and concurrent conditions were not reported. The healthcare worker reported that patient was vaccinated with the first dose on 15-JUN-2004 and the second dose on 27-JUN-2008, of M-M-R II (dose, dose number, lot number, expiration date and route were not reported). The patient has not reported or demonstrated any adverse effects. Co-suspect and concomitant therapies were not reported. Additional information has been requested.
Left arm flushed, swelled and itched, with hive-like bumps around the injection area after 1 week from date of vaccine injection. After 2-3 days, the left arm swelling around the injection site is still a bit red and swollen but the itch has gone done. However, I then broke out in hives! Currently taking Zyrtec to see if the hives go away - bumps all over arms, legs, back - itchy! Hives has been happening for 1-2 days so far.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 65 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 19-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular, Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 37 years old female patient who was exposed to vaccine FLUZONE QUADRIVALENT in context of FLUZONE QUADRIVALENT was administered to a pregnant patient with her permission. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported FLUZONE QUADRIVALENT was administered to a pregnant patient with her permission occurred at unknown gestation period. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT6310LA and expiration date 30-Jun-2019) via unknown route in the left deltoid. It was not reported that the patient had no adverse event. (Other relevant tests included No lab data.) Final diagnosis was FLUZONE QUADRIVALENT was administered to a pregnant patient with her permission. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for FLUZONE QUADRIVALENT was administered to a pregnant patient with her permission. Additionally, at time of reporting, the outcome of the pregnancy is unknown. List of documents held by sender: none.
Pt previously healthy. Six days after 6 mo WCC and vaccines x 3 (hep B, DTaP, HIB), pt presented with vomiting and jaundice. Transferred to hospital on 12/20/02. Developed fulminant liver failure of unknown etiology and died 1/22/03. Principal diagnosis: idiopathic liver failure. Secondary diagnoses: hypoglycemia. Coagulopathy. Citrobacter freundii bacteremia and line infection. Multiorgan system failure.
28 January 2021  To : Vaccine Adverse Event Reporting SystemO  Im am writing to report a possible adverse reaction . On Wednesday, January 20, 2021, at 9:22 AM, I received my first dose vaccination of Pfizer COVID-19 Lot# EL3247 at the Health Clinic Site.  At approximately 4 PM that afternoon I experienced the first of a number of episodes of watery, gassy, non - bloody diarrhea which was heralded by great urgency but was accompanied by neither  fever, abdominal pain , nor any other systemic signs or symptoms.  There was no anosmia, headache, nor respiratory difficulty.  I continued to feel clinically well and I had no change of my daily activities.  I experienced no change of appetite.  I experienced two or three such urgent episodes daily for the next eight days. At no time during that week did I have a formed stool.  I cannot recall the last prior episode of watery . gassy diarrhea since it is not an experience which I have experience for, likely, decades.  During the 7-8 day period, my wife and I ate exactly the same foods. My wife experienced no diarrhea, cramping of frequent stooling. She reports that all of her stools have been normal. After three or four days, I spoke with several internists who suggested that I obtain a   SARS-CO-V-2 NAT, NP Swab test. Since I had been symptomatic for a number of days. I self quarantined and moved out of my wife?s and my bedroom. During all that time I wore a face mask and increased the frequency and duration of hand washing. NO SARS-CoV-2 RNA was detected by PCR.  It is now 48 hours since my last watery, gassy stool. I have just passed a normal appearing, non -melanotic, formed stool.  Sincerely,  Patient