chrisvoncsefalvay/vaers-outcomes huggingface dataset:
24 hrs after injection pt had local pain, redness, fever. Also numbness of tongue and lower extremities. No SOB. No anaphylaxis. Symptom lasted 48 hrs. Pt is seen today 10/14/16 Rx ice, ADVIL.
received / first dose on 2018 / never received / second dose due /out of stock.; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The patient did not receive 2nd dose due to out of stock, which led to product supply issue. The patient never received Shingrix second dose. The reporter did not consent to follow up.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 1:45 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 1:45 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 23.67.  Concomitant products were not provided.  On 22-Jun-2021, Excursion time was 08 AM, temperature was 35, total doses given for the day was 36, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 27-May-2021, vial was moved to clinic on 22-Jun-2021. 4 vials were sent to clinic. Vaccine BUD date was 26-Jun-2021 for 8 AM.  On 22-Jun-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 35, 9 AM: 39, 10 AM: 47, 11 AM: 36, 12 AM: 42, 1PM: 43, 2 PM: 43, 3 PM: 43, 4 PM: 43 and 5 PM: not provided.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Rash 2 inches x 2 inches, red spots, itchy, relieved by cold
Child received HEP A #1, HPV #1, and VARIVAX #2 then had syncopal episode seconds later. She did hit her head on exam table and floor but regained consciousness quickly.
I was in the evening services for Yom Kippur Tuesday Oct. 8 when the symptoms began.  Both my hands were shaking uncontrollably, my left shoulder (where I had the shot) became extremely sore as did my back and my neck. It felt like I had pulled a muscle in my neck. I was very cold. When we left services and went outside, my teeth started to chatter uncontrollably and I had trouble talking as a result. All the other symptoms continued. I went to bed soon after we got home around 10 pm.  I checked and my shoulder area around the shot was red, but it was a small area. I used several extra blankets because I had trouble getting warm. I didn't sleep well. The next morning (Wednesday) I woke up with an awful headache, pain in my teeth/gums like a sinus infection, no energy and a little bit of nausea. My husband thought I maybe had a temperature, but I thought I might have been warm from all the extra blankets. I stook acetaminophen (2 tabs). At that time I wasn't cold and my hands didn't tremble. But I felt awful. I only was up for about 90 minutes. My head hurt so much, I just wanted to sleep. I slept for 5 hours. I woke up and took more acetaminophen. I still had a headache and lacked energy but my symptoms were improving. The next day (Thursday), I stayed home from work again because I still felt exhausted and physically worn out from the symptoms.  By Friday I was a little tired but basically better.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on the patient's concomitant medications, pertinent medical history, drug reactions or allergies was reported. On 06-JUN-2017, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB injection, lot # M045653 with expiry date on 03-JUL-2019 (dose and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 12.6 degrees Celsius for 1 hour 45 minutes. There were no previous temperature excursions reported. Data logger was involved in recording the excursion. No adverse effects were reported. Additional information has been requested.
vasovagal syncope after injection. paramedics and md checked out, patient went home with doctor
pain in shoulders expanded into my neck; body aches; joint pain in both shoulders/joint pain; nausea; vomiting; lower back on both side with pain a 5 on a 10 point scale/pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back on both side with pain a 5 on a 10 point scale/pain), NECK PAIN (pain in shoulders expanded into my neck), MYALGIA (body aches), ARTHRALGIA (joint pain in both shoulders/joint pain) and NAUSEA (nausea) in a 37-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57146B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Sep-2022 at 5:00 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 18-Sep-2022, the patient experienced BACK PAIN (lower back on both side with pain a 5 on a 10 point scale/pain), NAUSEA (nausea) and VOMITING (vomiting). On 18-Sep-2022 at 1:30 AM, the patient experienced MYALGIA (body aches) and ARTHRALGIA (joint pain in both shoulders/joint pain). On an unknown date, the patient experienced NECK PAIN (pain in shoulders expanded into my neck). On 18-Sep-2022, NAUSEA (nausea) had resolved. At the time of the report, BACK PAIN (lower back on both side with pain a 5 on a 10 point scale/pain), NECK PAIN (pain in shoulders expanded into my neck), MYALGIA (body aches), ARTHRALGIA (joint pain in both shoulders/joint pain) and VOMITING (vomiting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2022, Pain assessment: 5 on a 10 point scale, ody aches were more severe and about 7 or 8 on a 10 point scale,, joint pain diminished to a 3-4 on a 10 point pain scale and pain continued at a consistent 7/8 out of 10 pain.         No concomitant medications were reported. The patient reported that at 7am (14H), body aches were more severe and about 7 or 8 on a 10 point scale, pain in shoulders expanded into her neck, mild nausea started. By 10am (17H), nausea increased to full vomiting for about 1 hour. Between 11am and 1pm, nausea and pain continued at a consistent 7/8 out of 10 pain rating, then started to subside. She was able to sleep from 1PM to 3 PM.  When she awoke at 3pm the nausea had gone away and the joint pain diminished to a 3-4 on a 10 point pain scale. It was unknown whether the patient experienced any additional symptoms/events. No treatment medications were reported.   Reporter did not allow further contact
This spontaneous report was received from a licensed practical nurse (LPN) referring to a 33 year old patient of an unknown gender. The patient's concurrent conditions, medical history or concomitant medication were not provided. On 31-MAR-2017, the patient was vaccinated with an expired dose of M-M-R II Lot # reported as L009212 and an expiration date of 17-MAR-2017, intramuscular (strength and dose were not provided) for prophylaxis. No adverse reactions were reported. Additional information has been requested.
Patient given vaccine without dilution of vial, thus receiving six times the normal dose. Patient notified immediately upon realization at the pharmacy (30-60 minutes post injection). Patient monitored with phone calls throughout the weekend. Pt reported feeling fine, nothing atypical from normal second dose symptoms.  Polices, procedures, and re-education implemented to prevent for future vaccines.
This case was reported by a consumer via call center representative and described the occurrence of rash in a 76-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (has shingles 3 times previously with most recent episode occurred 1 year before reporting). On 19th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th February 2019, less than a day after receiving SHINGRIX, the patient experienced rash, vesicular rash and muscle pain. On 20th February 2019, the patient experienced insomnia. On an unknown date, the outcome of the rash, vesicular rash and insomnia were not recovered/not resolved and the outcome of the muscle pain was recovered/resolved. It was unknown if the reporter considered the rash, vesicular rash, muscle pain and insomnia to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she received SHINGRIX and that evening she got undressed and saw a rash on her arm and there was one spot with two separate bubbles on it that have faded at the time of reporting. She also experienced pain in her muscle which went away after a few days. The night of her injection, she could sleep that night, however, she has experienced insomnia for the past two weeks at the time of reporting. The patient has a history of shingles three times previously with her most recent episode occurring a year ago. The patient claims that her pharmacist already reported this information to GlaxoSmithKline. The reporter gave consent to follow up.
Irritable - fever 101 x 2 days - 5/23/11- rash face - red papules head - trunk few on extremities.
Loss of bladder control, dizziness, mild fever, disorientation, loss of appetite, constantly fatigued, uncontrolled shaking, chills, loss of muscle control. Per follow up report received on 06/01/2005:  Patient was hospitalized for 5 days and had to continue antibiotic another 10 days.  Patient also developed urosepsis, but did recoverd. Information from discharge summary states constipation, bacterial infection, urinary tract infection. msv. Information from medical records states hypovolemia, hypokalemia
Next morning awoke with severe Vertigo with nausea with vomiting and went to the doctor and he referred to the physical the Epley maneuver to assist with Vertigo . End of the day on 03/07/2021.    03/11/2021  husband performed the assistance. Physical therapist was able to perform the Epley maneuver and correct the vertigo.  Hold Vertigo with about a week with Vertigo.  In resolved occasional dizziness.
1ST INJECT OF ENGERIX-B IN THIRD DOSE IN IMMUN SERIES GIVEN 26-DEC-89. FOUND TO BE NON-RESPONDER. RECVD SUBSEQUENT DOSE ON 3-7-90 AND 4-6-90 AND HAS NO ANTIBODIES.
Yes he had seizures after every booster shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 2, single, Lot Number: EN6205, Anatomical location: Arm), administration date: 26Feb2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "petit mal seizures"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE , Lot Number: FH8028, Anatomical location: Arm), administration date: 11Nov2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "Yes he had seizures after every booster shot"; Bnt162b2 (Dose:1, single, Lot Number: EM9809, Anatomical location: arm left, Time the vaccination was given: Morning), for COVID-19 immunization, reaction(s): "Petite mal seizures starting sometime shortly after 1st COVID  Petit mal epilepsy"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Lot: GL2092  , Anatomical location: Arm), administration date: 2023, when the patient was 74 years old, for COVID-19 immunization, reaction(s): "Yes he had seizures after every booster shot". The following information was reported: SEIZURE (medically significant) with onset 2023, outcome "unknown", described as "Yes he had seizures after every booster shot". She stated that her husband took the 1st dose, 2nd dose and three boosters. She also confirmed that the seizures started after the 1st dose and continued after at random times and then after the 1st booster dose he had one the next day. He had never had any seizures of any kind before the series of shots. The reason I believe it was the "Vaccine" is because each time he has gotten a booster, he would have at least 1 episode even though he has been taking XCOPRI 300's daily. Reporter stated- Yes he had seizures after every booster shot. They started with the initial shot. So the next day after each booster he would get a seizure- around 4 pm. Then the following morning- around 4am and he had another seizure. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300127998 same patient/drug/AE, different dose number;
10yo patient was given a 3rd Pfizer COVID primary vaccine dose for 5-11yo on 10/19/22 (lot # FT1551). Patient is not immunocompromised and does not fall under the guidelines to receive 3 primary doses. First 2 doses of Pfizer COVID primary vaccines for 5-11yo given on 12/1/21 (lot # FK5127) and 12/24/21 (lot # FL0007). Patient received 3rd dose on 10/19/22 using the primary Pfizer COVID vaccine. Patient should've received the peds (5-11yo) Pfizer COVID bivalent booster vaccine. There is no adverse event, this is reported as a COVID vaccine administration error.
Mom and Grandmother reported pt vomited 2 oz of formula at 1 pm (9/19/06) few hours after vaccines. Baby became fussy and crying a lot. Vomited 4x no fever.
very bad neck cramps; gave headache; blurry vision now; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: box-18) via an unspecified route of administration in the arm left on 29Mar2021 at 09:00  (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have allergies to medications, food, or other products. Concomitant medications included levocetirizine dihydrochloride (XYZAL) and fluticasone propionate(FLONASE) on unknown date and for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was reported as unknown if the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 01:00 PM the patient experienced very bad neck cramps, had headache and blurry vision. It was unknown if the patient took any treatment for the reported adverse events. The event resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the events was unknown at the time of report.   No follow-up attempts are needed. No further information is expected.
After receiving flu vaccine (R) shoulder and arm swelled became red and warm. BENADRYL & ibuprofen given and helped.
patient should have received second dose of twinrix.  Received the Hep B instead, pediatric dose.  He did not have any adverse effects, except the immunization was not protective to the patient, and he will need to be immunized with correct vaccine. Has been reported to the state.
After administered the vaccines, patent was advised to wait for 15 to 20 minutes. And the other patient signal that Pt was experiencing reaction. She was initially not responding when called her name. But later she started responding slightly. It seems as if she was sleeping with her eyes closed
Patient received his J&J vaccine for COVID-19 on 03/10/2021.  On 3/17, he was at the grocery store when he felt a sting on his left lateral ankle. When he pulled up his pant leg, he saw the small little red spots that were exquisitely tender. He went immediately to his primary care physician's office, where he was prescribed Bactrim for suspected cellulitis. The rash steadily worsened with extension up his left leg and onto his right leg and blistering of some of the lesions most markedly in his groin. Pain associated with the rash increased and remained most severe on the lateral aspect of the left ankle. He presented back to his primary care physician's office on 3/19, where he was given methylprednisolone 80 milligrams IV, discharged with a prescription for prednisone 60 milligrams daily for the next few days. Pain worsened the morning of 3/20/21 to the point that he was unable to bear much weight on the left leg prompting his presentation to the emergency department.
A lump that was the shape of 1/2 of a tennis ball formed at the injection site. It was covered with a red rash and it hurt. It lasted about 2 weeks.
Fever of 103. Macular rash on face and chest. No rash or induration at immunization site.
Woke up 1 week after my 1st shot, both arms were numb and tingling in my right 4 fingers.  Neck pain, felt like I slept on it wrong.  Headache and fatigue all day.  Around 5pm, left arm at injection site was extremely sensitive, warm and red.  My entire upper arm and 1/2 of my lower arm felt as if it was burnt.  No fever.  I took tylenol and benadryl, and went to bed.  Next morning fingers were still tingling and my right thumb area under my fingernail feels like I burnt it on something.  Even today, 1 month later, my thumb still feels burnt and tingling in the very tips of my right 3 fingers.
Swelling and pain at the injection site; Swelling and pain at the injection site; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in arm left on 08Feb2021 at 14:15 (at the age of 31-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swelling and pain at the injection site on 08Feb2021. Treatment was not received for the events. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected.
Facial swelling and redness, Mom noticed 5-10 minutes after receiving flu vaccine. Monitored in office by RN and MD until resolved. Resolved on it's own without intervention.
The vaccine was given high up on my left arm approximately 1" below the top of my shoulder. I had an unusual sensation as the shot was going in like a filling up sensation. Then in the afternoon of that same day I could not lift my left arm.  It was very pain full.  I have had vaccines before but never had this type of reaction. When in the morning I could lift my arms. Now I can not. I could not sleep because of the pain in my arm so I took advil. I called the doctor's office the next morning to report my conditions. That I was in pain and more importantly could not lift my arm. They got back  to me at 5:00 and said to ice the area, take ibuprofen and if it got worse to go to urgent care. Contact them on Monday if nothing has changed.
Body aches that lasted 24 hours.  Daily migraines since 2nd vaccine that require prescription medication.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster.  In 2014, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Patient remained in observation after receiving first dose of COVID vaccine for bilateral eye pressure and blurry vision, symptoms self resolved with rest and fluids, patient instructed to see ophthalmologist/optometrist for routine eye exam or if symptoms return, released from observation
day after vaccine: rash on face, neck;                            headache, woozy;                            redness at injection site
signs of tremors & weakness which persists since vax given in 1994;pt believes has GBS & says MD can not r/o;has appointment w/neuro next month MAR96;needs walker to ambulate;has had several bouts of depression & has attempted suicide
Ache in upper right arm. SEVERE ache in right fingers. Tylenol and ice pack for 3 days slowly reduced symtoms and they are totally gone now.
Patient states she felt sedated and half of the face was sedated and heavy and loss of sensation.
Blisters appeared all over hands and feet about 12 hours after first dose of Covid-19 injection.
Pt seen today with maculopapular lesions over trunk, neck, legs, same with wheals/blisters - rash is pruritic- I feel she has varicella// Treated with Benadryl Oatmeal baths.