chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered to about 100 patients after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, HBV (Engerix B) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Engerix B, Havrix, Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Engerix B, Havrix, Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-NOV-2022 Reporter's Comment: The medical assistant reported that Bexsero, Boostrix, Engerix-B, Havrix, Infanrix, Kinrix and Pediarix were exposed to 31.00 degree Fahrenheit for 1 minute, not specifying when the excursion took place.  The vaccine were then applied to an approximate 100 patients.  No patients identifiers, vaccination date, lot number or expiration dates were provided at the moment.  The Vaccine Administration Facility waas the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The patients received Bexsero, Boostrix, Engerix-B, Havrix, Infanrix, Kinrix and Pediarix after temperature excursion, which led to incorrect storage of drug.
Janssen COVID-19 Vaccine EUA   Extreme headache Extreme fatigue Nausea  Mild fever
allergic reaction to drug Parents report that she had full-body mild hives for 2-3 days after her 6/1/21 Prevnar 13 vaccine, with no respiratory distress. Will defer future Prevnar for now.
6FEB92 2PM mom states pt had running fever since shots; t104 APAP given; Pt seen by MD dx tonsilitis;
So I basically I had soreness throughout the night after I got the vaccine, at 5:00 in the morning I woke up needing to use the restroom, and when I sat up I got very dizzy so I sat for a little bit  then when I went to get up I passed out completely,  I did not hit my had head on the floor, as I came to I was completely sweaty and dry heaving, and I needed to use the restroom. So for the rest of the entire day, I was unable to sit in a chair without passing out, and I had a telehealth visit with the doctor at about 2:00 in the afternoon, and I was able to sit up a little bit, but I was still in the bed, the symptoms were slightly trying to wear off at that time.  The physician assistant said I was having a vaso-vagal reaction to the vaccine.  They wanted me to go to the hospital, and I declined to go, I did not want to be in a hospital room fainting as the symptoms were slightly fading, I did not want to be alone at that point. I continued to have some weakness for about 3-4 weeks after the injection.
Fatigue, Headache, severe joint pain, fever(100.5-102.5), raised rash.  all reactions present for 34 days.  Rash started on 02/16/2021 and is still present
Redness to upper arm, warm to touch. Pt c/o redness since 19 Nov 10. Pt prescribed KEFLEX for cellulitis on 22 Nov 10.
Patient has previously received Janssen (03/14/2021). When a "1st dose" of Pfizer was administered on 06/16/2021, this was an unnecessary vaccination.
During the 30 minute waiting period the patient absentmindedly started to itch. When asked if this was new the patient reported yes. When asked if she was having difficulty swallowing she reported her throat felt tight. BP 160/88 93 98% on room air at 1105. Cough is dry.  Doctor in to see patient and Claritin 10 mg ordered and given at 1115 The patient O2 sat at 1120 was 98% but still felt she was not getting enough air. O2 at 2 liters applied with good relief of symptoms,  1130 132/80 86. 1200 states throat feels better, is just itchy now.  1205 O2 sat 99% on room air and feeling ready to go home.  Seen by the doctor and precautions given. Will go to family  Members house for monitoring. Pregnancy at 22 weeks, estimated date of delivery 01/04/2022
I could be pregnant, but I am not 100% sure yet. My symptoms the next day after the vaccine I had a lot of fatigue, muscle aches, fever and pain around the vaccine site. The following day I was still not feeling great, so I tried to go out and get groceries. When I got home, I had excruciating pain in my back. The next day the pain had migrated down to my butt so sitting has been really hard. I have been taking pain medicine, but nothing is helping. My acupuncturist said it was a tight muscle in my back that extended to my butt. She tried acupuncture and cupping to help. It helped a little bit but not completely. I have an upcoming follow up with her to see if she can relax my muscle even more. I still can't bend over to pick things up.
A non-serious spontaneous report expired FLUMIST administered to a patient who is older than 49 years was received from a consumer concerning a 64-year-old female. The patient's medical history was not reported. The product expired on 01-Jan-2009. On 30-Oct-2009, the patient received expired FLUMIST. On 04-Nov-2009, the patient was revaccinated with a current FLUMIST. There was no adverse event associated with the vaccination error or expired vaccine used; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
This case was reported by a consumer and described the occurrence of feeling unwell in a female patient who received SHINGRIX. On 15th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced feeling unwell, fatigue, nausea and general body pain. On an unknown date, the outcome of the feeling unwell, fatigue, nausea and general body pain were unknown. It was unknown if the reporter considered the feeling unwell, fatigue, nausea and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had first dose of two shingles vaccine and at the time of reporting still feeling sick, the patient asked how long could she expect to feel sick (tired, nausea, fatigue, body aches).
Pregnant when vaccinated,Are you still looking for pregnant women who have been vaccinated; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant when vaccinated,Are you still looking for pregnant women who have been vaccinated) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant when vaccinated,Are you still looking for pregnant women who have been vaccinated). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant when vaccinated,Are you still looking for pregnant women who have been vaccinated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's last cycle was in November.  No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow-up received on 18 Aug 2021 included no new information.
12/15/22 presents to ED for "diarrhea with dehydration". PMHx of "anemia, anxiety, thyroid cancer, chronic back pain, chronic renal failure, diabetes mellitus, hypertension, who underwent lumbar surgery initially on 11/7/2022"
This case was reported by a pharmacist and described a 4-month-old male subject who was inadvertently vaccinated with a dose of diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) sooner than recommended. On 14 February 2006 the subject received 1st dose of Pediarix. On 14 February 2006, the subject then inadvertently received the 2nd dose of Pediarix. This resulted in the subject receiving more than the recommended daily dose of poliovirus vaccine. The recommended interval between the 1st and 2nd doses of Pediarix is 6 to 8 weeks. On the evening of 14 February 2006, the subject experienced a " low grade" fever and fussiness. The fever and fussiness resolved on 15 February 2006. The pharmacist considered the events to possibly be related to vaccination with Pediarix.
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 15-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 05-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in left thigh, lot #U031544, expiration date: 23-JUN-2024, administered intramuscularly for prophylaxis (strength was not provided). and with the third dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot #W012143, expiration date: 09-NOV-2023, administered orally for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933: US-009507513-2301USA009943: US-009507513-2302USA000456: US-009507513-2302USA000412: US-009507513-2302USA000403: US-009507513-2302USA001303: US-009507513-2302USA000949:
Patient stated that she began "feeling funny" about 5 minutes after I administered the Shingrix vaccination.She said she had a similar feeling when in the hospital and having a reaction to a medication. She stated that she felt like it was "hard to swallow." At that point I requested EMS be contacted and the patient agreed. Blood pressure was checked and it was 152/39. Pulse 126. I asked if she felt like her throat might be swelling and she said yes. An epipen was brought to me which I quickly inspected to verify the dose. A single dose of epinephrine 0.3 mg was administered into the right vastus lateralis at 3:40 pm. Blood pressue was checked again a few minutes later. This time the reading was 121/89, pulse 118. Patient said she felt a little better. Patient remained conscious the entire time and could talk to us. No swelling of face observed. No skin reactions observed. EMS arrived and took over. Patient was treated and released this evening from a local hospital.
Late day 7, a red area developed at the injection site, similar to an insect bite. Very itchy.
I broke out in hives all over my body and they lasted over a month , the doctor said tthey could have come from the vaccine or somewhere else and no way to really tell. I took Zyrtec for over a month and the hives stopped.
Redness around the site of varicella vaccine. Generalized but scant red papular rash. (All blanching). No purpura.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old male patient of an unspecified race received TRUMENBA at single dose and MENACTRA, both doses were given in separate locations on the same unknown date. Within 24 hours patient had flu like symptoms, chills, nausea and fever. Patient return to the office the next day where resulted positive for the flu. Patient was given Oseltamivir (TAMIFLU).
Pt states three days after the shot she started experiencing sharp pain in her arms, elbows and knees.  The pain progressed and her extremities became tingly.  The pain moved to her face and her Neurologist did a MRI that was negative.  They also did an EMG that was positive for muscle and nerve damage.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown demographics. On unspecified dates, the patients were vaccinated with M-M-R II (dose, frequency unknown). No concomitant medication was reported. The healthcare worker reported that the vaccines were reconstituted with less than the recommended amount of diluent. No adverse effects were reported. No product quality complaint was reported. The outcome of events was unknown. This case is related with 1407USA008555, 1407USA008556, 1407USA007501, 1407USA008558 and 1407USA008559 via same reporter link. Additional information has been requested.
terrible joint pain; muscle aches; headaches; naseaua; terrible fatigus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6201) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "headaches"; MYALGIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "muscle aches"; NAUSEA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "naseaua"; FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "terrible fatigus"; ARTHRALGIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "terrible joint pain".  Additional information: Within hours, Patient had terrible joint pain and muscle aches in all parts of my body at various times. She also had headaches, nausea and terrible fatigue. The reaction after the first lasted about 2 weeks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300258808 same reporter/patient/product, different dose/event;US-PFIZER INC-202300258807 same reporter/patient/product, different dose/event;US-PFIZER INC-202300258809 same reporter/patient/product, different dose/event;
Venous thromboembolism; This literature-non-study case was reported in a literature article and describes the occurrence of EMBOLISM VENOUS (Venous thromboembolism) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.        No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EMBOLISM VENOUS (Venous thromboembolism) (seriousness criterion medically significant). At the time of the report, EMBOLISM VENOUS (Venous thromboembolism) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported. This case refers to a patient of unknown age and gender who experienced the Venous thromboembolism after first dose of mRNA-1273 vaccine.   This study described simultaneous vaccination (SV) with primary series COVID-19 vaccines and assess 23 pre-specified health outcomes following SV among persons aged greater than or equal to 5 years in the Vaccine Safety Datalink (VSD). from December 11, 2020-May 21, 2022. Analyses assessed frequency of SV.   Rate ratios (RRs) were estimated by Poisson regression when the number of outcomes was greater than or equal to 5 across both doses, comparing outcome rates between COVID-19 vaccinees receiving SV and COVID-19 vaccinees receiving no SV in the 1-21 days following COVID-19 vaccine dose 1 and 1-42 days following dose 2 by SV type received.  The most frequent simultaneous vaccines were influenza, HPV, Tdap, and meningococcal. Outcomes following SV with COVID-19 vaccines were rare (total of 56 outcomes observed after dose 1 and dose 2). Overall rate of outcomes among COVID-19 vaccinees who received SV was not statistically significantly different than the rate among those who did not receive SV.  The most frequent simultaneous vaccines were influenza, HPV, Tdap, and meningococcal. Outcomes following SV with COVID-19 vaccines were rare (total of 56 outcomes observed after dose 1 and dose 2). Overall rate of outcomes among COVID-19 vaccines who received SV was not statistically significantly different than the rate among those who did not receive SV.   This case was linked to US-MODERNATX, INC.-MOD-2023-731103 (Linked Report).  Company Comment: This is a literature non-study case concerning a patient of unknown age and gender, with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of embolism venous. The event on an unknown date after a dose of mRNA-1273 vaccine (dose number and date of administration were not provided). Clinical course, supportive diagnostic procedures, vaccine received in the context of simultaneous vaccination, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731103:Master case
Kidney stones; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney stones) in a 62-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) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 01-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NEPHROLITHIASIS (Kidney stones) (seriousness criterion medically significant). In 2021, NEPHROLITHIASIS (Kidney stones) had resolved.            The patient had seven kidney stones in right kidney. She had first surgery in Sep-2021 and second surgery in Oct-2021 and had not seen physician since to speak about findings.  No Concomitant medications were reported. No treatment medications were reported.  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.  Company comment.  This spontaneous case concerns a 62  year  old female patient, with no relevant medical history, who received two doses of mRNA  1273 vaccine, and experienced the serious medically significant unexpected event of nephrolithiasis. Onset date of the event was not provided; hence latency and temporal association cannot be properly assessed. The report mentioned the patient had seven kidney stones in her right kidney. Approximately 5 months after the second dose of mRNA  1273 she had a first surgery, and 6 months since vaccination a second surgery. The event was recovered. No further clinical information was available for medical reviewing. Co-suspect product included Adalimumab. The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62  year  old female patient, with no relevant medical history, who received two doses of mRNA  1273 vaccine, and experienced the serious medically significant unexpected event of nephrolithiasis. Onset date of the event was not provided; hence latency and temporal association cannot be properly assessed. The report mentioned the patient had seven kidney stones in her right kidney. Approximately 5 months after the second dose of mRNA  1273 she had a first surgery, and 6 months since vaccination a second surgery. The event was recovered. No further clinical information was available for medical reviewing. Co-suspect product included Adalimumab. The benefit risk relationship of mRNA-1273 is not affected by this report.
Approximately 3.5 hours after the shot I suddenly felt a surge of pain from my right arm up my neck - numbness in neck on both sides and top of head.  Dizziness and blurred vision - extremely blurry.  Trouble breathing - throat getting tight.  Called Publix to find out if these were normal side effects - they told me to go to the emergency room.  I immediately drove to the emergency room - hospital is about 1.5 miles from home.  Once there, I had trouble breathing and went outside for fresh air.  I was sitting down.  I stood up when they called my name and my left leg locked up and I could barely move.  This was probably one hour later (3:45 pm). Blood pressure was taken and it was 164 - my heart was racing - I felt like I had ingested a severe dose of caffeine.
In the morning following the shot, she could not get out of the bed without assistance.  She was very weak and could not stand by herself.   She did not want to eat very much.  Then by lunchtime, she was running a fever of 102.5 fever for many hours.  We put her to bed.  On Sunday morning she was much better with a better appetite and no fever.  She also had normal amount of energy.   She had a rash on her arm that received the shot and it ran from her spot of injection to her elbow.  It was hot with the rash for about 5 days.