chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2/19/03 Step-mom called and stated when PT came home yesterday had itchy rash all over body (had Hep B inject); states they called poison control and was advised to give Benadryl - states child still has itchy rash today - advised to s/u? with P/ and let another medical organization know if they think rash is shot related or not. 2/19/03 Spoke with step mom, states school nurse told her child was better (rash better, no itching) - step-mom states PT also "has a cold" - states school was to call her if any prob's but they haven't called her back (didn't to go MD since she was better) - asked step mom to notify center if any further prob's. 2/20 - Step mom called and said PT was taken to ER last night - rash was on face, neck, all over - state Dx was Hep B reaction, was given prednisone and atarax. She states PT's doing better today - no school x 48 hrs per MD - asked step mom to ask dad to come by the center and sign ROT for hospital records - she said she would.
SICK DUE TO MODERNA BOOOSTER SHOT; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (SICK DUE TO MODERNA BOOOSTER SHOT) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    No Medical History information was reported.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jul-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) Citrate Free, Solution for injection in pre-filled syringe. In 2021, the patient experienced ILLNESS (SICK DUE TO MODERNA BOOOSTER SHOT). At the time of the report, ILLNESS (SICK DUE TO MODERNA BOOOSTER SHOT) had not resolved.            No concomitant medication was reported. In 2021, the patient experienced SICK DUE TO MODERNA BOOOSTER SHOT. It was unknown if patient was enrolled in a COVID 19 Vaccine Trial. No treatment medication was reported.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of SICK DUE TO MODERNA BOOOSTER SHOT was not provided.    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.
Administer expired vaccine to patient, after the manufacture date of expiration 07-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration 07-Apr-2022) in an 80-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration 07-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration 07-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses.  Dates of administration of vaccine were reported as 08-Apr-2021, 12-Apr-2021 and 13-Apr-2021.  The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non-significant information.
Patient described typical injection site discomfort for approximately 3 days post injection. Roughly 1 week after initial resolution of injection site discomfort, pain returned to the middle arm & shoulder joint. Pain has continued for about 3 wks now & numbness & weakness are also occasionally present. Patient reported to pharmacy 12/7/10.
PATIENT STATES THAT HAD SEVERE PAIN, BLEEDING, BRUISING AT INJECTION SITE WITH LIMITED MOTION ABOVE SHOULDER LEVEL
The pt's husband reported that the pt, a 35 year old female, received a Fluzone SV '99-'00 vaccination on 11/99. Thirteen days later, the pt could not see. She was hospitalized and dx'd with DM encephalitis by a neurologist who submitted a VAERS form. The pt's husband states he is filing a lawsuit.
Redness at sight and soreness lasted about 3 days. One month later shortness of breath, rapid heart rate occured, chest tightness.
Sore, aching arm at site of injection only. Soreness reported by patient is "less than before" but still present as of 3/31/17.
This spontaneous report was received from a registered nurse regarding a currently 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unspecified date, the patient was vaccinated with improperly stored doses GARDASIL 9 injection, lot # N007931, expiration date 17-NOV-2019, for prophylaxis (frequency, route and anatomical location were not provided). The vaccine was left under 6°F for 2 hours, below 32°F. There were no previous temperature excursions. No adverse effects reported.
On 2/16/99, the pt reported passing out and losing bladder control. The pt was referred for radiology and neurology. MRI done on 2/23/99 which was normal. On 3/11/99 a consultation with a neurosurgeon. Possibility of a partial seizure. On 3/2/99 and EEG was performed with normal results. On 4/8/99 Cardiology consultation. Failed test. On 5/7/99 a stress echocardiogram performed, results pending.
I came home and felt the pain of the vaccine within 24-48 hours, and within a week I felt that my hand and fingers were numbing. I would say a week after shot that it was consistent. I noticed it wouldn't go away and assumed it was because of the shot on the left side. I called my Doctor and told them what was going on and to come in a couple of days if it isn't better. I went back in May and he said if it didn't go away within a month to visit him again. 3 weeks later the numbness started going away, but it was my whole arm up to the tip of my fingers and especially my index fingers. It was out of the blue too, and I thought resting my arm a certain way would help but it didn't and it would come on sudden and it would be in my shoulder all the way down to arm and index finger. My index finger felt the most numb and I would poke and hit it and wouldn't feel it. My Doctor said I could've gotten the shot in a nerve and he did make note of it and check up on me, but 3 weeks after it started to fade, and eventually went away. My appointment with Doctor was on 05/12/21 and 3 weeks after that it started to fade.
A 39 year old pharmacist reported that she received an influenza vaccine on 11/30/00 and subsequently developed premature ventricular contractions. On 12/11/00 she was seen by the physician. An electrocardiogram was reportedly positive for premature ventricular contractions. The reporter noted that she did not have any other symptoms or has not experienced premature ventricular contractions prior to this. The event is considered medically important.
terrible brain fog; Loss of short term memory.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included protein s deficiency, factor v leiden mutation, mthfr gene mutation, migraine and deep vein thrombosis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included apixaban (ELIQUIS) and fremanezumab vfrm (AJOVY) from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced terrible brain fog and loss of short-term memory. No therapeutic measures were taken as a result of the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome for the events confused and short-term memory loss were not recovered at the time of the report.  No follow-up attempts are needed; information about lot number cannot be obtained.
pt had morning feeding milk 830AM & vomited;pt given thawed milk but vomited again;pt given sterilized water w/o success- MD called who recommended pedialyte q 15 mins x 6hr;pt refused pedialyte;pt stop breathing en-route to ER
Sudden onset of diarrhea without any other diagnosis for five weeks at this time. No hx GI issues. Work up neg to date. Colonoscopy scheduled in one week.
Swelling, redness, hot, given Keflex 25 mg PO tid x 10d
Rash (within 48 hrs of vaccine administration) to Rt anticubital area. Reports red, raised rash blistery like at first, now dry, red, raised. Slight itch. Applied CALAMINE lotion & cortisone salve x 1 mo.
Sore arm for day and a half; onset of chills, body aches, low grade fever.; onset of chills, body aches, low grade fever.; onset of chills, body aches, low grade fever.; This is a spontaneous report from a contactable nurse (patient).  A 50-year-old male patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL0142), via an unspecified route of administration on the right arm on 31Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital.  There were no concomitant medications.  It was reported that the patient was the patient diagnosed with COVID-19 prior to vaccination on 12Dec2020 (pending clarification). On 31Dec2020 22:00 (approximately 14 hours after vaccination), the patient had a sore arm for day and a half and onset of chills, body aches, low grade fever were noted. It was mentioned that the symptoms were treated with acetaminophen (TYLENOL) and ibuprofen. The patient was not tested for COVID-19 since the vaccination. The patient recovered from sore arm  on 02Jan2021 10:00 (day and a half) and from the remaining events on 01Jan2021 14:00 (lasted for approx. 16 hours off/on).
My daughter received 4 year old vaccinations (Dtap, Polio, MMR, Varicella).  She was fine for about 5 minutes post vaccinations.  Then, she stated her head and stomach hurt.  I asked her dad to go ahead and take her to car.  She then got very pale.  He picked her up, but she vomited and proceeded to pass out.  After 20 minutes, she finally came back to normal.  We had to continuously call her name to wake her.  The doctor came back in the room.  She asked the nurses could one of the vaccinations possibly have one of her allergens, and they stated no.  Her blood glucose was tested, and it was completely normal.  I do feel like she had a strong allergic reaction to these vaccinations.
Death after my mom took the booster shot; Stomach pain; Vomiting; Death after my mom took the booster shot; not feeling well; This is a spontaneous report received from a contactable reporter.  A 79-year-old female patient received bnt162b2, administered in arm, administration date 10Nov2021 (Lot number: FG3527) at the age of 79 years as dose number unknown, single for covid-19 immunisation. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose number unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (death) with onset 10Nov2021, outcome fatal, DEATH (death) with onset 13Nov2021, outcome fatal and all described as Death after my mom took the booster shot; ABDOMINAL PAIN UPPER (death) with onset 11Nov2021, outcome fatal, described as Stomach pain; MALAISE (death) with onset 10Nov2021, outcome fatal, described as not feeling well; VOMITING (death) with onset 11Nov2021, outcome fatal, described as Vomiting. The patient date of death was 13Nov2021. The reported cause of death was Death after my mom took the booster shot. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death after my mom took the booster shot
Breakthrough case after three vaccines Pfizer 3/15/21 Lot# En6207;  Pfizer 4/6/21 Lot# Er8733;  Pfizer 12/8/21 Lot# FH8028
Pt states that on her left arm where the pneumonia shot was given she had large swelling, felt sick, and had a fever. She also bled where the injection was given which she states she doesn't normally bleed from a shot. She went to Urgent care on Wednesday 11/4/20 where she was diagnosed with cellulitis on the left arm and was put on doxycycline. The PA told the patient that the injection was given too low. Pt states she did not have any issues with her right arm.
I experienced significant fatigue, sore arm worse than the first shot, nausea, metallic taste in mouth. from 7:00 to midnight.
After 1st dose of Pfizer Covid vaccine Received on 2/25/2, 20 mins later noted mosquito bite size hive on upper extremities. 6 hours later hives appeared on all extremities but not face or body truck. No airway and facial involvement. Pt states hives are not painful but pruritic. Also has some numbness and tingling. As of today 3/2/2021, all hives resolved. Finished prednisone course today. Taking Benadryl along with prednisone.
PT RECEIVED HER FIRST PFIZER COVID VACCINE DOSE ON 05/05/2021@2:08PM.  PATIENT'S ARM WAS SORE THAT EVENING AND THE NEXT DAY (SHE DESCRIBES IT AS THE TYPE OF SORENESS THAT YOU GET AFTER THE VACCINE). 6 DAYS LATER (AROUND 05/11/2021) SHE STARTED TO HAVE PAIN IN HER SHOULDER BLADER, RIGHT SIDE OF NECK AND BACK OF RIGHT ARM WHERE SHE RECEIVED HER DOSE.   SHE HAS SEEN  A CHIROPRACTOR  (RECOMMENDED SHE SEE A MASSAGE THERAPIST BECAUSE THE SHOULDER AREA WAS STIFF) AND MASSAGE THERAPIST SINCE AND TODAY AFTER RESEARCHING ONLINE SHE CONTACTED THE PHARMACY BECAUSE HER SYMPTOMS MATCH THAT OF SIRVA.  PATIENT HAS TAKEN ADVIL BUT WITH NO RELIEF.
Nausea, vomiting, dizzy, headache, some arm swelling, tenderness, ? amt of swelling, right arm.
Sudden abdominal pain 12 hours after vaccination and vomiting.; Sudden abdominal pain 12 hours after vaccination and vomiting; This is a spontaneous report from a non-contactable consumer(patient).  A 26-year-old female patient received first dose BNT162B2, via an unspecified route of administration at left arm on 11Jan2021 14:30 at single dose for COVID-19 immunization . Patient had other medications in two weeks. There was no other vaccine in four weeks. The patient medical history was not reported. There was no covid prior vaccination, no covid tested post vaccination, no Known allergies. The patient experienced sudden abdominal pain 12 hours after vaccination and vomiting on 12Jan2021 03:00 with outcome of recovering. There was no treatment received.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Arm pain, large, red, itchy rash in area of the vaccination.  Swollen supraclavicular lymph node on right side.
L deltoid erythremia 9.5 x 3.5 cm. Dx' d cellulitis and given antibiotics  (ANCEF) by Dr. Denies any previous reactions.
Pfizer-bioNtech COVID-19Vaccine EUA Approximately 2-3 hours after the vaccine was administered, I noted tingling and a "tight" feeling on the right side of my face.  I have had bells palsy before and if felt the exact same way.  I noted drooping of the right side of my mouth, stabbing pain in my right ear.  This lasted for 24 hours, currently, slight numbness remains at corner of right side of mouth and occasional stabbing pain right ear.
I received my first covid vaccine 03/18/2021 Lot #047A21A. After that vaccine I had headaches and a flushed face and was very tired. I an not a headache person so this is new to me. This continues. I received my second covid vaccine 04/19/2021. Since that vaccine, I have had continued headaches, am tired and have had brain fog.  Trouble concentrating and focusing.  I even had to see a neurologist.  These symptoms continue as well. I was just diagnosed with a DVT 06/23/2021. This all is new to me and I believe are all related to my covid vaccines.
Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced welts at the injection site that lasted for about a month. The patient's outcome was not reported. Additional information has been requested.
Deceloped a rash.  Kept taking Lortadine and it went away
LIGHTHEADED/DIZZY; WEAK; NAUSEOUS; 102.7 FEVER; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: UNKNOWN) dose was not reported, administered on 30-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-DEC-2021, the patient experienced lightheaded/dizzy, weak, nauseous, and 102.7 fever. Laboratory data included: Body temperature (NR: not provided) 102.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 102.7 fever, lightheaded/dizzy, weak, and nauseous. This report was non-serious.
This spontaneous report as received from registered nurse refers to unspecified number of patients. No information regarding current condition, medical history or drug allergies were reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB (strength, dose unit, lot number and frequency unknown) for routine vaccination. No concomitant therapy was reported. No adverse effect was reported. The outcome of event was unknown. No further adverse event information was provided. This is one of several reports received from the same source. Additional information has been requested.
Evening of receiving TDAP, PT's (R) arm swelled, became hard, painful -hives on arm, up neck to face for 24 hrs. No problems breathing or other symptoms.
must have fainted; severe nausea; This is a spontaneous report from a contactable consumer.  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered on right arm on 25Mar2021 14:00 (Batch/Lot Number: EW6204) at single dose (at the age of 55 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included estradiol, progesterone, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) and spironolactone, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, on 04Mar2021 (Lot number: EN6198), 02:00 PM on the right arm. The patient stated on 26Mar2021, "woke up with severe nausea, went to restroom, must have fainted, because I came to with my face on the register vent". The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
This report describes the occurrence of dehydration in a pt who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) for prophylaxis. This report was rec'd from the pt's spouse and has not been verified by a physician or other health care professional. The pt reportedly had no relevant medical history, concurrent medical conditions, or concurrent medications. She rec'd injections of Twinrix on 8/28/02 and 10/9/02 (lot#HAB222A6). She then traveled to China and returned on 10/14/02. On 11/15/02, the pt experienced all symptoms of hepatitis A including fever primarily at night, dehydration, nausea, and lack of appetite. She was seen by her physician who reportedly made the determination that the pt was experiencing symptoms similar to hepatitis A based upon a low white blood cell count. Recent serology was positive for both hepatitis A and B antibodies. The events had improved by 11/26/02.
TOOK UNREFRIGERATED DOSES; This spontaneous case report (PVX2019-1973) was received from a pharmacist on 30-Jul-2019. It described a 49-year-old adult female consumer who "took unrefrigerated doses" (PT: Product storage error), while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The Vivotif was dispensed on 26-Apr-2019 and was left out at room temperature. The consumer completed the full course with unrefrigerated doses of Vivotif taking doses on 22-Jul-2019, 24-Jul-2019, 26-Jul-2019, and 28-Jul-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Fatigue; Headache; body aches; swelling and pain in the arm; sore feet,sore hands and pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling and pain in the arm), PAIN IN EXTREMITY (sore feet,sore hands and pain in the arm), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (body aches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced PERIPHERAL SWELLING (swelling and pain in the arm), PAIN IN EXTREMITY (sore feet,sore hands and pain in the arm), HEADACHE (Headache) and MYALGIA (body aches). On 20-May-2021, the patient experienced FATIGUE (Fatigue). The patient was treated with IBUPROFEN ongoing since an unknown date for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (swelling and pain in the arm), PAIN IN EXTREMITY (sore feet,sore hands and pain in the arm), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-155192 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up received on 01-JUL-2021.Patient updated event outcome from unknown to recovered.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-155192:
Around 3 hours after the shot I started shaking all over. Got light headed, weak and woozy. Started going in and out of consciousness. Had to call my husband to help me get to a chair. Then he helped me get to bed so I could lay down all the while passing out. Once got laying down, things eased up unless I tried to get up again. The next day my head felt very out of it and my eyes would get blacked out for just seconds. On the second day after shot, I started feeling back to myself.