chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received / first dose / roughly a year ago! When COVID hit/ missed their second dose; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of shingrix received roughly a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: The age at vaccination was not applicable to this report. The age group was not reported but captured as an adult as per vaccine indication. The pharmacist reported that the patient had not received the second dose of Shingrix due to Covid-19. HCP declined to provide date of birth and did not have any additional vaccine information as she was not at work. The reporter consented to follow up. The case is linked with US2021075986, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021075986:same reporter
The pt experienced convulsions, crying, high pitched screaming, ear infections, and ER visits. Treated with antibiotics.
Starting on  Saturday, 2/6/2020, four days after vaccine, elevated heart rate, 160 bpm and low blood sugar.  Before the vaccine, there was no problem with my heart rate.  Now, I am taking Labeatol 4 times a day to keep rate at least at 90.  This vaccine has doubled my heart rate.  It was 70 before the vaccine.  Now if I do not take my Labetalol, it goes up to 140.  Because my body is working so hard with that heart rate, it is making my sugar low.  So now I'm taking less insulin and this whole situation is getting confusing on how to handle this long term, adverse reaction to the Pfizer vaccine.
Seen in ER 6/21/13 with ~1 wk h/o rash and balance being off in the evenings and "tremor" in her hands. She did have increased falls but no apparent injuries.  ER physician described "fairly new and healing discrete maculopapular rashes with a raised center on an erythematous base...no significant crusting or purulent sores...neurologically intact and in fact quite playful and active...appeared to have good balance while walking with minimal assist."
On the 26 and 27, it was fatigue, malaise, and headache. On the 26th in the evening, I could feel skipped beats of my heart heart palpitations. The headache started on the 26th and it lasted through the 31st and it worsened in intensity. Noted on the 31st: Blood Pressure was elevated to 161 over 110 I've never had a history of hypertension before. I called my Dr and she started me on medication Metoprolol XL 25 mg on February 1st or 2nd. The medication would work for a little while (a few hours) and then it would spike back up and so I saw a Cardiologist. High blood pressure and palpitations and headache lasted three weeks and then it all stopped and so I'm blood pressure medication and I no longer have any of these symptoms. 12/17/2020 I did have heart palpitations on day 5 and that stopped approximately 7 days later.
Child had ER visit 12/26/03, diagnosed with pneumonia, antibiotic prescribed. A routine blood culture obtained at ER visit. On 1/8/04, child had follow-up visit. Had recovered. On review of lab, doctor found blood was positive strep pneumoniae resort and called the immunization program.
12 hrs after first and second vaccines: injection site pain, fever 100F, sweating, body aches, joint pain, headache, malaise. First vaccine side effects lasted 1-2 days. Just had second vaccine yesterday, symptoms have not resolved yet
experienced soreness in her arm; experienced being achy like she was having the flu; experienced being achy like she was having the flu; fever; palpitation; shortness of breath; nausea; her eyes were burning; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at 8AM at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not feel anything until 5PM. At 5PM, she experienced soreness in her arm until the next day at 6:30PM or 7PM. At this time, she also experienced being achy like she was having the flu. In addition to that, she also experienced having fever, palpitation, shortness of breath, nausea, and her eyes were burning. That night, she took 2 paracetamol (TYLENOL) and got up fine. Outcome of all events was recovered on unspecified date.   Information on the lot/batch number has been requested.
A rash appeared at injection site. Rash still present on 08-21-12. Mom to monitor for changes.
36 hours after vaccination had edematous hands and feet with apparent arthralgia, involving affected appendages. Treated with ibuprofen with relief. 24 hours later generalized itch relieved with benadryl.
On 6-4-07 at 10:00 a.m. patient received two month vaccines.  Went home and at 8:00 that evening pt. had severe apnic events with color changes which required hospitalization including septic workup.  As of 6-6-07 pt. still in hospital. All cultures negative and patient improving.  Plan probable discharge in the next couple of day.  6/12/07 Received hospital medical records which reveal patient experienced pauses in breathing w/accompanying pallor, lethargy.  Brought to ER where O2sats were 100% on RA w/exam WNL but was admitted for observation as patient had only been d/c from NICU 5 days prior to readmission. Admitted 6/4-6/7/07.  Family instructed to not give pertussis to patient again but all other family members were to have pertussis vax or booster. FINAL DX: apnea, O2 desats & bradycardic events; GERD resolved; sepsis ruled out.  7/17/07 Received pcp vax record & office notes which confirms RO dose & lot number as reported.  Office note indicates patient doing well on day of vax.
Started cycle on 9/6/2021 and cycle was completely gone 9/07/2021.  Still had menstrual cramps but nothing more.
Starting 12/03/2022, I had a mild cough and slight congestion. The next day, 12/04/2022, I had a low grade fever, coughing slightly and had some mild congestion. Also, I was slightly achy. I got it from my husband who tested positive for COVID-19 on 12/03/2022. I tested myself for COVID-19 at home twice that day and both were negative. The following day, 12/05/2022, I tested myself for COVID-19 and it was positive. I called the pharmacy telehealth that day to get PAXLOVID. I got the PAXLOVID and started taking it. I finished taking those and I am feeling pretty good. I still have lingering congestion and lingering fatigue but otherwise feel pretty good. Once I started taking the PAXLOVID, I started to feel better pretty quickly (within 24 hours I had no fever and my cough was markedly better).
Approximately  14 hours after receiving the vaccine, I woke up feeling very nauseated, I became diaphoretic and vomited.  I did feel better after vomiting.  I had a mild headache, some muscle aches and fatigue as well.  I still have mild headache, but it is still <24 hr. post vaccination.
Pt noticed elevated blood pressure readings at home up to 190s systolic 3 days after vaccination. Also reporting left shoulder and neck pain  which also began 3 days after vaccination.
Pt got an "infection" that she was given a Z-pack for. As far as I could tell, it just looked bruised, a little swollen and red.
8/13/2021 hospital with COVID breakthrough.  Patient states he has been having chest congestion x 1 week. He has been treated with Azithromycin prescribed by his PCP. While at home he started to having fevers 103.0 and chills when he reported to the emergency room.  Diagnosed with: sepsis from COVID-19, fever from COVID Note: previously vaccinated with Moderna COVID-19 vaccine on: First Dose: 01/08/21 Lot Number 011J20A; Second Dose: 02/01/21 Lot Number D28L20A. Discharged 8/16/2021
Information has been received from a physician reporting on herself who "years ago when in medical school", was vaccinated with three-dose series of RECOMBIVAX HB (dose, route and lot # not reported). The physician noted that she did not develop antibodies to her three-dose series of RECOMBIVAX HB (manufacturer unknown). The physician sought unspecified medical attention. No treatment was given for the adverse event. At the time of reporting, the patient's status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Received Imm 9/17/16 11 AM and at 3 PM same day c/o HA. Dizziness, chills, fever. Symptoms continued thru 9/20/16. Seen at clinic on 9/19/16 and OV on 9/21/16 - resolved.
Pain, red, swelling around injection site. Seem to have spread from injection site. Been about a week since injection.
titers for MMR, duphtheria and pneumococcal IgG were undetectable despite prior vaccinations; Literature report:   This report has been received from the authors in a published article, tittle as stated above, concerning a 59-year-old female patient with history of stage 4 follicular lymphoma, treated with 6 cycles of rituximab and bendamustine followed by rituximab maintenance was observed by her PCP to have recurrent and refractory bacterial infections (including sinusitis, conjunctivitis, and a pneumonia) starting more than a year after completing treatment for the patient's cancer.   On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), Pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown) and diphtheria (doses, frequencies, routes, lot numbers and expiration dates were not provided) for prophylaxis.   On an unknown date, at 18 months post-treatment with rituximab, an immunofixation panel revealed undetectable IgA and IgM and IgG 356 (700-1600). The patient was referred to an immunologist. Assessment for immunoglobulin functionality revealed low IgG subclass 1 levels. The patient's titers for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown) and diphtheria were undetectable despite prior vaccinations (antibody test negative).  The outcome of antibody test negative was unknown. The reporter considered antibody test negative to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown) and diphtheria.  A copy of the published article is attached as further documentation of the patient's experience.
The morning following the vaccination I woke with burning pain in my shoulder region. Then became progressively worse over the next week. By the third day I was experiencing significant weakness in the involved extremity, which prevented me from working. Pain lasted 3-4 weeks. Frank muscle atrophy was apparent by week 4. Following evaluation by two neurologists I was diagnosed with brachial neuritis. This was confirmed by EMG. Treatment has included a course of steroids the first two weeks and Physical Therapy, which I continue to do daily. My ability to perform the tasks essential to my job (I am an Anesthesiologist) has been severely impaired. I have been doing very limited work on small/light patients since the acute pain phase resolved. My ability to perform daily activities is impaired. My ability to participate in my usual recreation activities remains severely impaired.
soreness; diarrhea; fever(between 101-103 F); vomiting; chills; headache; swollen lymph nodes; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (soreness), DIARRHOEA (diarrhea), PYREXIA (fever(between 101-103 F)), VOMITING (vomiting) and CHILLS (chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN (soreness), DIARRHOEA (diarrhea), PYREXIA (fever(between 101-103 F)), VOMITING (vomiting), CHILLS (chills), HEADACHE (headache) and LYMPHADENOPATHY (swollen lymph nodes). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (soreness), DIARRHOEA (diarrhea), PYREXIA (fever(between 101-103 F)), VOMITING (vomiting), CHILLS (chills), HEADACHE (headache) and LYMPHADENOPATHY (swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-011004 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: Valid case (patient identifier provided) On 11-Mar-2021: No specific follow-up information recorded.; Sender's Comments:  MOD-2021-011004:Same reporter/Different patient
Vertigo, dizzy, nausea, more than 24 hours  The above occurred 7 days after my vaccine
given after manufacturer's expiration date, but stability data supports use of product through 10/19/22
18 y/o male reported having blurry vision approx.. 5 minutes after having his 1st dose vaccine. Pt walked to 15 waiting area prior to felling ill. Pt was siting down and had a syncopal episode lasting 20 seconds. Pt was Pale and cool to the touch. After he gained consciousness pt. stated he felt pins and needles to his legs arms hands and lower back. Pt felt better after gaining consciousness. 911 was called R22 arrived on the scene did an evaluation and obtained a pt. refusal as pt. did not want to go to the hospital.
The patient reported having a very red rash with some swelling around vaccine area. She went to her doctor about it. Her doctor prescribed her an antibiotic to treat what the patient said was cellulitis.  The patient got a follow up call from the pharmacist on 10/5/22 to see how she is doing.
Initial report received from medical assistant on 27 Apr 2010: This patient with an unknown medical history received expired FLUVIRIN (batch no 102046P1, expiry date- 31 Mar 2010) 0.5 ml, intramuscularly on 26 Apr 2010. The patient did not experienced any adverse event.
5 1/2 cm diam. area extending from lower 1/3 of (L) deltoid down 5/2cm, tender, mildly indurated, small puncture site in center of lower third  of deltoid.
Resident received both doses of the Pfizer vaccine on 12/17/20 and 1/5/21.  She tested positive for Covid-19 on 2/1/21.
Client assessed. Paramedics on site took client vitals. Client observed for a total of 25 minutes and D/C'd home AMA.
Vaccine administered after 30-day use by date or after manufacture date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 30-day use by date or after manufacture date of expiry) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     It was reported that the patient did not have any acute illness at the time of vaccination and up to one month before. The patient had never been diagnosed with/ tested positive for COVID-19. The patient had no chronic or long-standing health conditions. On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 30-day use by date or after manufacture date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 30-day use by date or after manufacture date of expiry) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no concomitant medications taken at time of vaccination and or at the time of the adverse event. It was reported that, 28 doses were administered after 30-day use by date or after manufacture date of expiry. The expiry date for the vaccine was given as 18-Mar-2022. The date of vial initially stored in refrigerator was unknown and vials were transferred from another store.  The vial did not undergo any temperature excursion.  Stability study was requested and the results showed full activity against COVID-19. No information on treatment medications was reported.
Local reaction with 10x5 induration/swelling, redness after DTAP in Rt thigh, mild tenderness. Going to avoid DTAP con try Tetanus using Motrin.
Very bad arthritic flare ups.  Total of 4 since 12/21 /2021.  Upper back, could not breathe in or out without excruciating pain.  Lower back, could not walk for 1 hour after getting up in the morning, screaming with pain.  Pulled muscle in left side for over compensating when I couldn?t walk.  Almost healed then it popped again, I am still in pain.  Finger joints stabbing pains.  Lots of muscle aches and flare ups.  My dupuytren?s has worsened too  since having vaccine.
Rash, red, swollen, warm to touch 24-48 hours after vaccine given.
Per pt she noted decreased hearing (R) ear 48 hours after 2nd MMR vaccination. She says she was seen by ENT and given oral steroids. She was told that it may be related to the vaccination. She has follow up with ENT.
general malaise, excessive salivation, facial parathesia radiating to upper extremities, disturbance of equilibrium;
My daughter started crying and screaming uncontrollably for over 5 hours. She would not calm down even when we were holding her or when nursing.
the vaccine triggered an AFib 18 hours after the 1st shot; sore arm for a couple of days after 1st dose; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (the vaccine triggered an AFib 18 hours after the 1st shot) and PAIN IN EXTREMITY (sore arm for a couple of days after 1st dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm for a couple of days after 1st dose). On 16-Apr-2021 at 8:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ATRIAL FIBRILLATION (the vaccine triggered an AFib 18 hours after the 1st shot). At the time of the report, ATRIAL FIBRILLATION (the vaccine triggered an AFib 18 hours after the 1st shot) had resolved and PAIN IN EXTREMITY (sore arm for a couple of days after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications included Diltiazem.  Company Comment Based on current available information and the temporal relationship between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal relationship between product use and the start date of the events a causal relationship cannot be excluded.
Patient arm swelled the following day after shingle shot (ZOSTAVAX). It was red/hot  and swollen and raised. She took BENADRYL that night. Went to dr next day. They gave her cephalexin and pain meds for infection.
10:00am Patient returned from walking to car post-vaccination, stating that her mouth began to feel numb and she felt a bit lightheaded. Patient brought to back area to semi-reclining chair, BP 128/77, 72HRT. States she ate breakfast, felt a bit anxious. Allergic to amoxicillin which causes rash and vomiting. Takes only prenatal vits; denies any medical condition. Numb lips, mouth, tongue, breathing fine according to patient. 10:17am Numbness spread to hands, nose, upper face, dull headache; states her breathing is fine, feels lump in back of throat however. Given 25mg liquid Benadryl oral, tolerated well. BP 116/69, HRT 67, 10:35am symptoms improving, denies feeling lightheaded, stood for 1 minute, stated she felt fine, patient discharged to self, ambulatory, husband aware and at home.
7 days p/vax pt had tingling rt hand little finger, numbness on underside of arm, dizziness & nausea & weakness in legs w/paleness & clamminess;went to ER & blood work done then lt side (arm & leg) began quivering;dizzy, clammy w/tingling;
High fever for 6 days following, vomiting after eating for over 3 weeks.
Information has been received from a physician concerning a 2 month old male with gastroesophageal reflux disease who in approximately November 2007, was vaccinated PO with his first dose of Rotateq. In approximately November 2007 about 3 to 4 hours after vaccination, the patient experienced "relentless crying and abdominal distention." The patient was hospitalized for 2 days and tests showed it was not intussusception. Other lab diagnostic studies performed were unknown. The outcome was unknown. It was also noted that the reporting physician was not the patient's primary care provider and did not administer Rotateq to the patient. There was no product quality complaint. The physician considered relentless crying and abdominal distention to be disabling. No further information is available.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm (pain in arm)) and ABDOMINAL PAIN (abdominal pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product OBETICHOLIC ACID (OCALIVA) for Primary biliary cirrhosis. Previously administered products included for an unreported indication: PENICILLIN NOS since an unknown date. Concurrent medical conditions included Primary biliary cholangitis and Penicillin allergy. Concomitant products included IBUPROFEN for an unknown indication. In 2018, the patient started OBETICHOLIC ACID (OCALIVA) (Oral) 5 mg once a day. On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm (pain in arm)) and ABDOMINAL PAIN (abdominal pain). In April 2021, PAIN IN EXTREMITY (sore arm (pain in arm)) had resolved. At the time of the report, ABDOMINAL PAIN (abdominal pain) had not resolved. No treatment information provided. Action taken with mRNA-1273 in response to the events was not applicable.
Inadvertent administration of Vaxelis and Rotateq after TE/ 65.2F for 9 Hours 45 Minutes; 32.4F for 42 Hours 45 Minutes;; This non-serious spontaneous safety report, with reference number, was received by a partner on 19-JUL-2023 and forwarded to agency on the same day, from a non-HCP. Additional information was received by a partner on 19-JUL-2023 and forwarded to agency on 20-JUL-2023 by a HCP.  The causal relationship between Vaxelis and the reported event "Inadvertent administration of Vaxelis and Rotateq after TE/ 65.2F for 9 Hours 45 Minutes; 32.4F for 42 Hours 45 Minutes" was assessed as not applicable due to the nature of the event.  Further information is expected
Patient's mom lied to us that her daughter is 12 years old and didn't not show us any proof of date of birth. So I gave Pfizer COVID vaccine to the patient. Then we found out that patient was only 11 years old. Called mother back to confirm little girl's age and the mother said 11 years old.  Patient did not have any adverse reaction from the vaccine.