chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker referring to unspecified number of patients. On unknown dates ranging from 15-JUN-2015 through 07-DEC-2015 the patients were vaccinated with improperly stored PEDVAXHIB (dose and route not reported, lot # L014427, expired date: 09-MAR-2018) (Incorrect product storage). No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
severe urticaria; This case was reported by a physician via call center representative and described the occurrence of urticaria in a 62-year-old female patient who received HBV (Engerix B adult) (batch number bg92z, expiry date 4th July 2022) for prophylaxis.   Previously administered products included Engerix B adult (received 1st and 2nd dose on an unknown date).   On 27th December 2021, the patient received the 3rd dose of Engerix B adult (intramuscular) 1 ml. On 28th December 2021, 1 days after receiving Engerix B adult, the patient experienced urticaria. On an unknown date, the outcome of the urticaria was unknown.   It was unknown if the reporter considered the urticaria to be related to Engerix B adult.  Additional details were provided as follows: The patient received Engerix B adult, at noon, in right deltoid. Following morning after receiving Engerix B adult, the patient developed severe urticaria. The reporter consented to follow up.
Patient was unable to get out of bed for three days, reports being comatose, similar to Guillain Barre reaction.
On the day of the vaccine 12/23/2020- nothing signficant, just a little arm soreness.  2 weeks later when I  woke up,  I notice my hand between my thumb and pointer finger was swollen- it was painful to the touch.  I also noticed a red streak from right arm to elbow. It was a burning sensation.  I took ibuprofen twice a day for a week, then changed to Tylenol 650mg for another week.  I went to see the doctor.  He tested for 2 types of arthritis which came back negative.  He prescribed me Meloxicam (pain) and Buspar (anxiety).  I took meloxicam for 2 weeks and started having severe acid reflux.   I was prescribed Nexium to treat the reflux.  I started to have chest pains and had a whole work up to rule out cardiac issues.  I slowly weaned myself off the medications.  2 weeks later, my left arm was affected with swollen thumb to pointer finger.  Now, I am see an acupuncture and most symptoms have resolved.  The red streak is almost gone and the swelling has decrease by 50%.
Felt sick; Horrible explosive diarrhea; Cannot sleep; Forgetting to take medication; Feels miserable; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ILLNESS (Felt sick), DIARRHEA (Horrible explosive diarrhea), INSOMNIA (Cannot sleep) and MEMORY IMPAIRMENT (Forgetting to take medication) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MORPHINE SULFATE, HYDROXYZINE, LEVOTHYROXINE, VITAMIN D3, MULTIVITAMIN [VITAMINS NOS], OLMESARTAN, DULOXETINE, LAMOTRIGINE, VITAMIN C [ASCORBIC ACID], ROSUVASTATIN, GABAPENTIN and FLUCONAZOLE for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 06-Apr-2021, the patient experienced ILLNESS (Felt sick), DIARRHEA (Horrible explosive diarrhea), INSOMNIA (Cannot sleep), MEMORY IMPAIRMENT (Forgetting to take medication) and FEELING ABNORMAL (Feels miserable). At the time of the report, PAIN IN EXTREMITY (Sore arm), ILLNESS (Felt sick), DIARRHEA (Horrible explosive diarrhea), INSOMNIA (Cannot sleep), MEMORY IMPAIRMENT (Forgetting to take medication) and FEELING ABNORMAL (Feels miserable) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included water and yoghurt.   Most recent FOLLOW-UP information incorporated above includes: On 10-Apr-2021: Follow up information included additional concomitant medication was updated.
severe headache with associated UE paresthesias within 24 hours after receiving second dosage of vaccine.
I received the flu shot on OCT. 23, 2019, about 5pm. About 2 hours after receiving the shoT, I began experiencing a side effecT, which felt 1/2 like a tootheache, and 1/2 like an infection. There was swelling in my face and upper lip. When pressure was applied to my right upper lip, in the area immediately below my right Nostril opening, there was a lot of pain. The pain was throbbing. The pain got worse as time went on, even thought I was taking Advil. On Oct. 25, after continuous pain, I called my Doctors, FNP office, to report the side effecT. The pain was abouT an 8 on a scaled of 1 to 10. The person I spoke with at FNP clinic Advised me to go to an Urgent Care. I did so the same day, Oct. 25. I was evaluated, and prescribed Amox-clav 875 MG tablets for anti-biotic treatment, and Tramadol 50MG tablets for pain. My face was visibly swollen at that time, and especially in my upper right lip area. I Advised the health care person, FNP, that I had no dental problems. I also told him that this was a side effecT. I also reported the side effecT to the FDA.
Issues with swallowing and would always have to swallow; Mouth dry; This is a spontaneous report from a contactable consumer (patient herself). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982; Expiration Date: 20May2021), via an unspecified route of administration, administered in left arm (shoulder) on 22Jan2021 12:00 (age at vaccination: 76 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included ongoing rheumatoid arthritis diagnosed 2 to 3 years ago, Blood pressure high from 1980 and ongoing, blood cholesterol, oropharyngeal discomfort. She stated she already has an issue/problem with her throat, gastrooesophageal reflux disease. She has acid reflux on one side of her throat and the other side has a post nasal drop on the other side. At times she would have to swallow. While sleeping at night she had to swallow a lot. She was up throughout the night. She was scared because she had to keep swallowing. Her mouth was also dry and she had to drink a lot of water, upper-airway cough syndrome. Concomitant medication(s) included losartan 25mg once a day taken for blood pressure abnormal from an unspecified start date and ongoing; amlodipine besilate (NORVASC) 5mg once a day, taken for blood pressure abnormal; hydroxychloroquine phosphate (PLAQUENIL), 200mg once a day taken for rheumatoid arthritis and ongoing; atorvastatin (LIPITOR) 10mg once a day, taken for blood cholesterol from an unspecified start date and ongoing. The patient also takes nasal sprays for nasal congestion. The patient did not have any history of previous immunizations with the Pfizer Vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. On 23Jan2021, the patient experienced issues with swallowing and would always have to swallow, mouth was dry at 6am or 7am and may be she was dehydrated. On an unknown date, the patient's blood pressure measurement was high. At first when she got the vaccine she did not feel anything at all. The whole night she was fine. Then she started to have issues overnight. She is due to take the second shot on Friday. She wanted to know if she should drink more water or something. There was no prior vaccinations within 4 weeks. The patient did not require a visit to emergency room or physician's office. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
L. arm redness and swelling. Advise OTC Claritin, Zyrtec, or Benadryl. Advised to monitor closely.  RTC if any worsening of the symptoms or if no improvement within 2 - 3 days.
nausea and chills for couple days; nausea and chills for couple days; This is a spontaneous report received from Moderna Therapeutics. A male patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea and chills for couple days on an unspecified date. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
5 expired- Doses had been given at that potint; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 expired- Doses had been given at that potint) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.  On 20-Jan-2022 at 10:56 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 20-Jan-2022 at 10:56 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 expired- Doses had been given at that potint). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 expired- Doses had been given at that potint) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported. It was reported that, Moderna vaccine was pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022 printed in red and taped to the boxes. On 26-Jan-2022 staff brought it to attention that it was still in the fridge and expired.~ No treatment information was reported.
paleness, weakness, nausea, faintness upon leaving dr. office and for 15-20 minutes thereafter; fatigued for rest of day
Patient with large local reaction following administration of flu vaccine 2 days ago. No systemic symptoms. Swelling and erythema is spreading distally and not proximally. Advised trial of zyrtec and benadryl at night if needed, but will also start cephalexin for concerns of potential cellulitis. Area of erythema and patchy erythema outlined. Return to clinic if symptoms worsen. Reviewed red flag symptoms indicating need for immediate evaluation. Father and patient voiced understanding.
approx 15-20 minutes after vaccine and pt had left exam room-notified that pt. had "collapsed down the hallway" and that emergency had been called. reported he had used restroom- and was hurrying down the hall and had fallen face first after stumbliing
A nurse (name unknown) had a cut on her finger from the broken syringe; A nurse (name unknown) had a cut on her finger from the broken syringe; had a cut on her finger from the broken syringe; This spontaneous report was received from a consumer referring to a female nurse of unknown age. Information about her pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 21-APR-2023, it was noticed during opening the box to take the syringe out that the 2 syringes of hepatitis A vaccine, inactivated (VAQTA) (formulation prefilled syringe, lot # X004813, expiration date 28-JUL-2024) from VAQTA INJ 25U/0.5ML PED PF SYR CARTON OF 1000006409502 were broken (syringe broken). On that day, the nurse cut her finger from the broken syringe (laceration of finger, injury associated with device). It was reported that the syringe was broken into 2 or more pieces from the bottom of the syringe (ring). There was not liquid or dried residue in the tray. The outcome of the events was unknown. Action taken with suspect vaccine was not applicable.   The causal relationship between events and suspect vaccine was not provided.
Case number PHEH2014US026132, is an initial spontaneous report received from a pharmacist on 30 Dec 2014. This report refers to a patient of unknown identifiers. The patient's medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUVIRIN (batch number: unknown) intravenously on 30 Dec 2015. No adverse events reported after the maladministration. No further information available at this time.
pt brought to ED with anemia and acute renal failure; positive test for COVID in ED; admitted; O2 sats dropped suddenly and pt was intubated; eventually was weaned from the vent; pt suffered a MI and went into heart failure; pt experienced ICU psychosis; O2 sats worsened and pt passed away in the hospital
Information has been received from a registered nurse concerning a 5 month old male who was vaccinated a first and second dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) on 20 June 2006 and 25 September 2006 (lot # 654970/0777F), respectively.  No problems were reported.  It was unknown if medical attention was sought.  There was no product quality complaint involved.   Additional information has been requested.
Two weeks after tetanus vaccine started to develop contractures of the muscles of her face including the forehead, around the mouth and the jaw.  No systemic symptoms.  Contractures have continued for three months and does not seem to be resolving.  02/12/2007  MR received from Infectious Disease MD for c/o facial muscle spasms that began 2 weeks following multiple vax.    Pt. received multiple vax. in preparation for a trip to Africa.  No local reactions to vax. noted.  While in Africa pt. began noticing spontaneous contractions of the muscles of her forehead, which were also painful.  This progressed to the muscles of the eyes, face, and tongue.  The symptoms are bilateral. Spasms around the eyes, dry eyes, frontal headaches, night sweats, insomnia, leg cramps, and  occasional neck cramps have also been noted.   PE: WNL except for spasm of the muscles of the face which cause the forehead to wrinkle and the muscles around the mouth to contract making the mouth into an O shape. Assessment:  Muscle contractions of the face possibly due to the tetanus toxoid immunization. Doubt Myasthenia Gravis. F/U Exam  2 weeks later which notes that the frequency and severity of the spasms seem to be increasing. Assessment: Muscle spasms of the face and neck possibly due to tetanus immunization.  Pt. has been evaluated by a neurologist, records requested.   03/21/2007 TC to reporter to clarify neurologist. . Reporter stated that he saw the patient this week and she reports that symptoms have worsened. He now feels that because of this, the vaccine as cause is less likely. He reports that neuro tests have all been (-).  03/26/2007 MR received from Neuro. consult. Initial visit 1/23/07 for c/o facial twitching, dry mouth, jaw tightness. PE:  WNL.  Symptoms not occuring at that time. Assessment:  Cervical facial dystonia, etiology uncertain. F/U 1/30/2007 for cervical/facial dystonia and/or dyskenesia. PE: Facial movements noted that were asymetric, some grimacing.  They originally began near they eyelids and upper face, now spreading caudally to below the clavicles. They can be partially supressed.  Summary:  Dystonia vs. tic disorder.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates, between January, 2016 and March, 2017, these patients were vaccinated with improperly stored doses of PEDVAXHIB for prophylaxis (strength, dosing details, anatomical location, lot# and expiration date were unknown). No adverse effects were reported. Time frame of temperature excursion was from January, 2016 until March, 2017 (exact hours not provided). There were no previous temperature excursions. A data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1704USA000110: US-009507513-1704USA000111: US-009507513-1704USA000068.
Bruising at site of injection.  Increased redness, edema, induration upper arm.
I broke out in red, hot, itchy patches,  headache , chills and sweats 8 hours later.  I called my doctors  office and took two benedryl  ultratabs each.   The next day, the red skin was gone, bno more itching.  The next day injection site pain, muscle aches and headache.     Still had headache and backache Monday,  which was two days later.
Sudden light headedness, room spinning, increased heart rate,  slight ringing in the ears. Weakness. Lasted about 15 minutes. Felt mildly lightheaded, and had loss of energy symptoms for about 12 hours. Felt good for about 1hour after that then a second episode happened about 10pm. The second episode was about half as severe as the first and only lasted about a minute or two. Woke up this morning 02/01/2021 feeling fairly normal.
No adverse event; Maternal exposure during breast feeding; This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.  On 19-Jan-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Jan-2023, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 19-Jan-2023, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding).    No concomitant and treatment medications were reported.   Reporter did not allow further contact
After the second shot, her hair started to fall out; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (After the second shot, her hair started to fall out) in a 78-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 040B21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (After the second shot, her hair started to fall out). At the time of the report, ALOPECIA (After the second shot, her hair started to fall out) outcome was unknown.            The patient weight reported as 192. The patient had no past medical history. Patient did not disclose medication, concomitant drugs were not reported. Patient did not receive treatment.
Bad headache, upset stomach, horrible itching all over, fever for 5 days, hard lump, swelling, heat and rash at injection site lasting over 5 days so far. Today blistering and bright red ring around upper arm.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/few people vaccinated with a vaccine beyond usage date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul-2022 after 30 days) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. In July 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/few people vaccinated with a vaccine beyond usage date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul-2022 after 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/few people vaccinated with a vaccine beyond usage date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul-2022 after 30 days) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. This case contains information of the three patient out of 12 patients who received the vaccine on Jul-2022 as described by the reporter. No concomitant medication was reported. Number of patients who received the vaccine beyond usage date were 12 patients. Number of doses/vials that were affected were 3 vials and 12 doses. The vial was initially stored in the refrigerator on 13-Jun-2022. The number of patients who received the vaccine on 16-Jul-2022 was 3, the number of patients who received the vaccine on 23-Jul-2022 was 5 and the number of patients who received the vaccine on 24-Jul-2022 was 4. The vial did not undergo any temperature excursion. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2022: Follow Up received contains reporter details and narrative updated.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. From 13-FEB-2014 to 14-MAR-2014, doses of ROTATEQ injection (lot #, expiry date, dose, route and indication unknown) that were exposed to temperatures outside of the prescribing information, might have been administered to the unspecified number of patients. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Woke up the morning of 10/1 with dizziness, unable to walk straight without bracing against the wall.  Severity improved within minutes but symptoms persisted to a milder extent in which he felt it more difficult to walk straight over the next 48 hours.  Slow improvement but persisting at the time of visit on 10/3/23.
PT was given a second dose of a one time dose vaccine, Janssen COVID vaccine.  No signs/or symptoms of difficulty or none reported at this time.
14FEB90, 14MAR90, 07SEP90, pt vax w/hepta B; titers indicated non-responder.  Pt recd booster vax from different lot# 12NOV90.  Titer to be done Dec90.
Pt recved vax in OCT91 & following vax pt exp a funny feeling in head;
2"x2 1/2" swelling, redness and hot to touch area over LT upper arm.
Arm tenderness.  Armpit area tender and feels swollen for 2 days now.  Headache for 2 days now.