chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VOMITING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vomiting was not reported. This report was non-serious.
Shingles outbreak; red rash; itchy rash; painful rash; pain at injection site; redness at injection site; arthralgia; myalgia; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2022, the patient received the 1st dose of Shingrix. On 29th July 2022, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site erythema, arthralgia and myalgia. On 7th August 2022, the patient experienced shingles, red rash, itchy rash and painful rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles, red rash, itchy rash and painful rash were not recovered/not resolved and the outcome of the injection site pain, injection site erythema, arthralgia and myalgia were recovered/resolved.   It was unknown if the reporter considered the shingles, injection site pain, injection site erythema, arthralgia, myalgia, red rash, itchy rash and painful rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comments: The caller was the patient.  The patient received first dose of Shingrix and experienced arthralgia, myalgia, and pain and redness at the injection site the day after receiving dose. The patient had rash that runs from their right side around to their back, near their bra line.  The patient reported that rash was red, itchy, and painful.  The patient was being prescribed Valtrex, for treatment of Shingles.  The patient experienced no Shingles outbreaks prior. The reporter consented to follow up. Additional Supportive Information: 10 days after receiving Shingrix, the patient experienced shingles, red rash, itchy rash and painful rash.
Dizziness, Headache, Fever, FATIGUE, SORENESS TO LEFT ARM,  DISORIENTED, BACK PAIN  Narrative:   Other Relevant History:
Vomiting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
ON 1/15/21 person complained of headache, muscle aches, extreme fatigue, and had fever of 102F x 2 days.
just a little red and swollen/ there is redness underneath the Tape; just a little red and swollen/ her arm is a little swollen; she got the booster yesterday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 22Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, she did not have any side effects when she received the first two doses of Pfizer BioNTech covid vaccine), for Covid-19 immunization; Bnt162b2 (Dose 2, she did not have any side effects when she received the first two doses of Pfizer BioNTech covid vaccine), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "she got the booster yesterday"; ERYTHEMA (non-serious) with onset 23Nov2021, outcome "unknown", described as "just a little red and swollen/ there is redness underneath the Tape"; PERIPHERAL SWELLING (non-serious) with onset 23Nov2021, outcome "unknown", described as "just a little red and swollen/ her arm is a little swollen".   Additional information: It was reported that the patient received booster shot yesterday. and this morning she has noted that her arm is a little swollen and there is redness underneath the Tape. she wants to know if these are normal reactions as she did not have any side effects when she received the first two doses of Pfizer BioNtech covid vaccine. She also asked is that anything to be concerned about. She states she never had any reactions. When patient was directed to physician for additional guidance, she mentioned that she was not worried at all, and she will wait for a couple of days for it to subside and she just wanted to know if these are reported side effects? In the response of the patient's questions, it was reported as in general local side effects such as the redness and swelling of the injection side are considered mild to moderate side effects that are expected to subside within 1-2 days after receiving the dose.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Product temperature excursion issue; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 10-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 10-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
dizzy, faint, fever not high; 24 hrs duration vomiting every 1/2 hr; stomach pains from vomiting; (mom sick @ home today w/sx of chill, cold etc); took compazine for nausea; called MD for tx;
Case previously recorded as MA2009-4286. Initial case report received from a pediatrician via Novartis, on 04 NOV 2009. An 11 month-old male patient was vaccinated with 0.5 ml of FLUVIRIN 2009/2010 (batch no. 100813, expiration date 01 FEB 2010) i.m. on 04 NOV 2009, an off-label indication. No adverse event was reported. Reference no: NA09-007607
pt recv vax 10MAY96 & 13MAY painful lt chest;14MAY vesicular eruptions lt chest culture + varicella;
swelling at injection site, rash at inj. site, whezzing, low grade fever(99, 100) lethargy
Approximate 20 hours after receiving dose #2 of vaccine, presented with symptoms of stroke:  aphasia, unable to process thoughts quickly, unable to write legibly, jarbled speech.  I was working night shift at the hospital.  I was immediately taken to the emergency department.  Placed on monitor, labs drawn, neurochecks, EKG.  Could not identify some simple pictures, could not recall my co-workers name ( worked with her for 25 years).  CT done within 15 minutes of symptoms.  MRI completed.   Episode lasted approximately 45 minutes.
pain and muscular aches, fever, chills, sweats, loss of appetite, fatigue, soreness and saelling at site of injection
Patient developed acute onset of neuropsychiatric symptoms 10 days after vaccine including refusal to eat/drink, hallucinations, vivid dreams, OCD, ticks, difficult dressing and putting on his shoes, ADHD . He was hospitalized for three days. His EEG was normal and so was his MRI brain. He was diagnosed with PANS. There is no was to definitively prove this was from MMR but it is suspicious that this was the cause. There were no other changes in the family or any other stressors . There were no other viral illness or strep infections.
No additional adverse effect reported; on 3/9/2020, patient received a dose of improperly stored PROQUAD that was reconstituted with properly stored MERCK DILUENT; Information has been received from an immunization consultant in charge of vaccine, who was also a healthcare worker, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 09-MAR-2020, the patient received a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (lot # S009756, expiration date 27-SEP-2020; dose and strength were unknown) subcutaneously for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccine was exposed to temperature excursion between 6 to 14 degrees Fahrenheit (11.3 degrees Fahrenheit) for 12 hours and 30 minutes (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. No additional adverse effects were reported.   This is one of four reports received from the same reporter. ; Sender's Comments:  US-009507513-2005USA004443: US-009507513-2005USA004496: US-009507513-2005USA004621:
I fainted while in the bathroom and then again at the ER. Notes from visit said I had 2 syncopal episodes. They cited low blood pressure.
I woke up the morning of January 30, 2021 and it felt like my heart was racing. I checked my vitals with a wrist cuff BP monitor and my pulse was over 100. This lasted for several minutes before going away.  I experinced the same thing at least 2 to 3 more times on separate occasions which prompted me to seek medical attention on Friday, February 5th. I scheduled a visit to see my PCP for 2/9/21 and messaged my oncologist.  My oncologist ordered a STAT echocardiogram. That was not completed until after my PCP office visit.  After the results of the echocardiogram were received I was referred to a cardiolgist.
Severe pain on testicles after the 1st dose on on 7/23/21. Took him to the ER. Ultrasound was performed. and it did not show any abnormality. He took Ibuprofen for pain. Pain lasted for 3 or 4 days.   Testicle pain again after the 2nd shot on 9/30/21. This time the pain was not as severe, but was bothersome. Ibuprofen was given again to ease pain. Pain went away in a day.
Headache, vertigo, tingling in arms, pain both axilla. 3/17/09-records received for EDvisit 3/6/09-C/O headache two epidsodes of syncope and body aches. Numbness in bilateral arms earlier that resolved and now feels weak all over. Subjective fevers. PE: tachycardic at 127, afebrile.Impression: Headache and myalgias status post vaccines, improved.
2 hrs p/shot began vomiting violently; this cont for 6  hrs @ which point had dry heaves then diarrhea began lasting for about 11 hrs; While this was occuring ran a low grade fever, would not eat for about 24 hrs then gradaully recovered;
Initial unsolicited misuse report received from non-healthcare professional (patient's parent) on 27 Oct 2014. A 04-year-old male patient, whose concomitant medications were not reported, had accidentally exposed to an informational FLUZONE ID syringe on 25 Sep 2014. The patient had a reported medical history of sickle cell disease, asthma and anemia. On 25 Sep 2014, the patient punctured his left index finger with the needle from the informational syringe box. Band aid was placed on his finger and reported as resolved. However the outcome of the event was reported as unknown. Documents held by sender: None. Follow up information received from a consumer (patient's parent) on 23-Jun-2015. The patient did not receive any vaccines. It was reported that the syringe box was left on the table which was lower enough such that anyone could have messed with it. The informational box should not have been on the table with the syringe inside. It was not at a secure place. Documents held by sender: none.
This case was reported by a physician via sales rep and described the occurrence of periocular swelling in a 18-year-old female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, less than a day after receiving BEXSERO, the patient experienced periocular swelling. The patient was treated with BENADRYL. On an unknown date, the outcome of the periocular swelling was recovered/resolved. It was unknown if the reporter considered the periocular swelling to be related to BEXSERO. Additional details were reported as follows: The patient received vaccine in the morning then later in the day developed isolated swelling around the eyes. After administered of BENADRYL the swelling was resolved with no further issues. No further information was available regarding the report. Field Representative, reported the initial report received from the health care professional was via email with limited information and that she would follow-up with the health care professional for more details regarding health care professional contact information, product information and patient details and she would call back to Medical Information with further details of the event.
Broke out with a terrible case of chicken pox. Missed over the first week and half if school. Ended up with scars from blisters. All children in family was given the Varivax on the same day and all ended up with chicken pox.
Information has been received from a physician concerning a 14 month old pt who on 11/17/2003 was vaccinated with a dose of varicella virus vaccine live. On 02/06/04 the pt experienced a mild case of breakthrough varicella. Unspecified medical attention was sought, but there was no tx and no hospitalization. The pt recovered. No product quality complaint was involved. This is one out of 40 reported. Thirty nine other cases ( WAES 0407USA01446 and 0409USA01855 through 0409USA01876 and 0409USA01878 through 0409USA01893) experienced breakthrough varicella after vacciantion with varicella virus vaccine live. Additional information is not expected.
swollen lymph nodes in arm pits; headache/pressure; fever; fatigue; This is a spontaneous report received from a contactable reporter (Consumer).  An 11-year-old male patient received BNT162b2 (BNT162B2), on 15Jul2022 at 17:15 as dose 3 (booster), single (Lot number: FL8094) at the age of 11 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies: Tree nuts" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (dose number: 2; lot number=FK5618, administration route: Intramuscular, administration time: 05:00 PM, vaccine location=Left arm), administration date: 03Dec2021, when the patient was 10-year-old, for COVID-19 immunization; BNT162b2 (dose number: 1; lot number: FK5618, administration route: Intramuscular, administration time=05:15 PM, vaccine location: Left arm), administration date: 12Nov2021, when the patient was 10-year-old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 16Jul2022 at 07:00, outcome "recovering"; PYREXIA (non-serious) with onset 16Jul2022 at 07:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 16Jul2022 at 07:00, outcome "recovering", described as "headache/pressure"; LYMPHADENOPATHY (non-serious) with onset 16Jul2022 at 07:00, outcome "recovering", described as "swollen lymph nodes in arm pits". The events "swollen lymph nodes in arm pits", "headache/pressure", "fever" and "fatigue" required physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy, headache, pyrexia, fatigue.  Additional information: Patient has not received other vaccine in four weeks and has not received other medications in two weeks. Patient has no Covid prior vaccination, and no Covid test post vaccination.
Nerve pain, tingling.  Felt like bee stings. Started in left quad area and spread through out body.  Still happening but getting better 2 months later.  Also , after second dose experienced extreme brain fog and memory issues.
10/30/08: Shot given in AM almost immed felt tingling and numbness; at approx. 7:30pm, noticed 2 hard knots at inj. site: red and size of nickel. 10/31/08: woke up with large swollen area around inj. site measuring 4-5 inches in diameter, hot. By Monday-most swelling and redness gone
face started burning,swelling,turning red,throat started to close up, approx 30 min after injection.; face started burning,swelling,turning red,throat started to close up, approx 30 min after injection.; face started burning,swelling,turning red,throat started to close up, approx 30 min after injection.; face started burning,swelling,turning red,throat started to close up, approx 30 min after injection.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Right on 08Mar2021 14:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included multiple sclerosis, emphysema, sulfonamide allergy. Patient received other medications within 2 weeks of vaccination. The patient previously took Keflex and experienced drug allergy. The patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Mar2021 at 15:00, the patient experienced face started burning, swelling, turning red, throat started to close up, approx. 30 min after injection. Patient received treatment as Benadryl for the events. The clinical outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Vaccinated while pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccinated while pregnant) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Jan-2018 to an unknown date for Pregnancy.    On 05-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 04-Aug-2021. On 05-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccinated while pregnant). On 05-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccinated while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPOSURE DURING PREGNANCY (Vaccinated while pregnant) to be not applicable.    No concomitant information provided. Treatment included pre-natal vitamins/ once daily; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Intractable nausea vomiting day 2-4 Injection site pain swelling day 2. Injection site Redness, soreness stiffness. Axillary swelling day 4.  Decreased range of motion week 3. Increased pain treated with Tylenol x months. Rest & iced arm. May PCP visit, referral to specialist for shoulder. Steroid injection June. Still have no regained ROM of left arm
Did not develop antibodies against covid-19 virus after vaccination; wondered if Venclexta had caused this to happen; This is a spontaneous report received from a contactable consumer (patient). (Mfr. Control No.: 21K-163-4110551-00). A 77-years-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1, dose 2 and dose 3, all via intramuscular on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunization and venetoclax, orally from Aug2020 to Sep2021, at unspecified dose for an unspecified indication. The patient medical history and concomitant medications were not reported. Spontaneous report by a consumer of an elderly male with an event of non-serious did not develop antibodies against covid-19 virus after vaccination with VENCLEXTA (VENETOCLAX). There was no reported medical history. On an unknown date, the patient experienced did not develop antibodies against covid-19 virus after vaccination. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient completed his Covid-19 vaccines from Pfizer and already received the booster shot too but when he had his biologics, he did not develop antibodies for Covid-19 virus. He wondered if Venclexta had caused this to happen. It was unknown if he was enrolled in a COVID-19 Vaccine Trial. He received COVID-19 Vaccine manufactured by Pfizer.  The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test: negative on an unknown date.  The action taken in response to the events for venetoclax was permanently withdrawn on an unspecified date. The outcome of the events was unknown. The reporter's causality for the events of did not develop antibodies against covid-19 virus after vaccination with VENCLEXTA (VENETOCLAX) was a reasonable possibility.  No follow-up attempts are needed. information about lot/batch number cannot be obtained. No further information is expected.
Initial unsolicited report received from a consumer on 19 October 2015. This case involves a 59-year-old female patient who was vaccinated with a dose of FLUZONE intramuscularly (batch number was unknown, dose, dose in series were not reported) in left deltoid and a dose of TETANUS TOXOID (batch number, dose, dose in series, route and site of administration were not reported) both vaccines on 17 October 2015. Six months ago the patient had history of thyroid ablation and was on medication. Illness at time of vaccination was unknown. The patient had allergies to iodine, nuts, shellfish, fruits, red dye. Concomitant medications were not reported. On 17 October 2015, same day following the vaccination, the patient experienced sleep difficulty. Lab data and corrective treatments were not reported. The patient was not recovered from the event. List of documents held by sender: none.
Approximately 1 month after receiving the Moderna booster, I had an attack of what was diagnosed as sciatica.  Two days later, I had an outbreak of shingles on my left inner thigh.  Over the next few days, the rash ran down my leg.  I was in extreme pain for approximately 6 weeks.  Today I still have some burning  and tingling at the site of the original outbreak.
Patient started with fever on 8/15/21 that persisted for 7 days had a febrile seizure on 8/16/21 seen at Local ER test for respiratory viral panel and negative.  Patient on 8/17/21 had abnormal gait.  refer to Infectious disease and Neurology  Last day of Fever 8/23/21 and on 8/24/21 rash on body noted