chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pancreatic insufficiency; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATIC FAILURE (Pancreatic insufficiency) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCREATIC FAILURE (Pancreatic insufficiency) (seriousness criterion medically significant). At the time of the report, PANCREATIC FAILURE (Pancreatic insufficiency) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications reported.  Patient's gastroenterologist said that the patient developed pancreatic insufficiency after getting a COVID-19 vaccine from  an unknown manufacturer. Company comment:This spontaneous case concerns a patient of unknown age and gender with underlying medical history of severely immunocompromised state, who experienced the unexpected, serious (medically significant) event of Pancreatic failure that occurred on an unspecified date after receiving a dose of COVID-19 vaccine (manufacturer unknown). The clinical course and treatment details were not stated in the case. Patient's underlying medical history of severely immunocompromised state may be considered as a contributory factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. No treatment information reported.   This case was linked to MOD-2022-554674 (Patient Link).; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with underlying medical history of severely immunocompromised state, who experienced the unexpected, serious (medically significant) event of Pancreatic failure that occurred on an unspecified date after receiving a dose of COVID-19 vaccine (manufacturer unknown). The clinical course and treatment details were not stated in the case. Patient's underlying medical history of severely immunocompromised state may be considered as a contributory factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
The site was swollen, red, warm, and hard. It was also painful to the touch.
HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included g6pd carrier. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Started off as not on upper arm the night of immunization, patient then experienced the feeling of "bugs" crawling on the arm. She started taking antihistamine. Tuesday arm was completely red and swollen above the elbow on left arm. She took Benadryl, aspirin and Zyrtec and then went to primary care office and received a steroid shot.  Patient stated that she is missing lymph nodes on that side off body.  Wednesday the arm was improving, not as tight and redness slowly going away.
Pt w/ gradually increasing fatigue, multiple joint pain and swelling, and muscle pain over the following weeks. This is did not subside but increased in April and May, becoming severely painful. Began to self treat pain/swelling with OTC po and topical pain relief of joints/muscles, contemplated ER visit multiple times and finally decided to seek medical care early June. CPK over 900, ESR and CRP also elevated. CPK 2 weeks later 1,256 and pt started losing muscle mass, lost 7 lbs in 3 weeks, is exhausted and in pain. Waiting on Rheum consultation. No family history of ALS or other typical associated diseases w/ these labs.
Patient previously got a dose of Pfizer unknowingly to me, she came in for first dose of Moderna which she got. It was later discovered during billing process that she got Pfizer from an unknown location, time and date. .
ACHE; LITTLE FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex, race and ethnicity.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s vaccination from an unspecified manufacturer (dose number in series: 1) for prophylactic vaccination.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced ache, and little fatigue .(dose number in series: 1)  The patient recovered from ache, and little fatigue on an unspecified date.  On an unspecified date the patient received additional vaccination with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, (Dose Number in Series: 2) 1 total administered, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced ache, and little fatigue. (dose number in series: 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the little fatigue and ache was not reported  This report was non-serious.  This case, involving the same patient is linked to 20211151326.
I had the vaccine on Tuesday around 3ish and then the next day after lunch time, I started to have SOB, ? weird feeling in my chest. I still have symptoms.
Short term: diarrhea. long term: red itchy bumps on top of hands, looks like rash. Aversion to milk now (did not have any issue with it prior to vaccination).
I had a serious adverse reaction of acute appendicitis 11 days after my first dose of the Pfizer vaccine. I had excruciating abdominal pain /vomiting on the morning of 8/23/2021 and went to the emergency room where they did a CT of my abdomen/pelvis with the diagnosis of acute appendicitis. I was admitted to the hospital and had an emergency appendectomy on 8/23/2021. I was out of work for 2 weeks and still don't feel fully recovered from my surgery as I still have discomfort around my surgical site.
DTaP right ant thigh 06/03/02. 06/04/02 erythema noted on the site which spread by 06/05/02 to be 14x15cm red, warm. Possible cellulitis with Keflex.
Patient finished receiving vaccines by 1030. Pt. was agitated had to be restrained by parents in order to safely receive vaccinations. Once the patient was done receiving vaccinations they cheered up and appeared as if nothing had happened. The child was asked if they felt fine, and the child said they did feel fine. The child then went into an interview room to schedule a return appointment with a support staff member. After about 5 minutes, the support staff member called me in and said the patient had fainted briefly and fell into her chair. When I arrived in the room, the patient was crying, sitting on the fathers lap with a nose bleed. Immediately I got tissues and had the father pinch the patient's nose and instructed him not to blow it. During this time I performed a brief neurological assessment. I also assessed the child for s/s of an anaphylactic reaction. The child showed no signs and symptoms of neurologic abnormalities nor signs and symptoms of anaphylaxis. No abrasions or bruises were noted on the child. After 2 minutes of pinching the nose, the bleeding stopped completely. Vital signs were then taken. BP: 95/53; HR: 75; Respirations: 20. At this point I took the child on a brief walk down the hallway to assess his gait and it was completely steady. The child stayed for observation for about 30 more minutes. During this time he was playing with toys in our waiting room. The parents were educated that fainting is common after vaccination and other medical procedures that produce a sympathetic response. The parents were also instructed to bring the child to the emergency department immediately if any symptoms returned later in the day. The child left in good condition.
Swelling and erythema on right arm was noted 18 hrs after vaccination (DTaP and IPV). Pt complained of pain but more itchiness on area. Mother claimed she might have had low grade fever but temperature was not taken. Motrin and Tylenol alternatively every 4 hrs were given as well as warm compress. Swelling subsided after 4 days.
This spontaneous report was received from a physician concerning her child - a female of unknown age, who in 2010 was vaccinated with the second dose of VARIVAX (Merck) 0.5 mL (route and lot not reported). No other co-suspects were reported. NO concomitant medications were reported. It has been reported that in 2010 the patient developed chickenpox after receiving the second dose of VARIVAX (Merck). No treatment was given. The outcome of developed chickenpox was reported as recovered/resolved. No laboratory diagnostic studies were performed. The patient did not seek medical attention. Additional information is not expected.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 68 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 27-JAN-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced Herpes Zoster. On an unspecified date, the patient was treated by a physician for Herpes Zoster. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Abnormal tongue movements seizure like symptoms like legs straightened and pt twisting his arms and screaming in pain.
This spontaneous report was received from a registered nurse and refers to an unspecified patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. In 2017, also reported as "27-JUN-2017-12-SEP-2017", patients were vaccinated with VARIVAX lot # N008077 with an expiration date 09-MAR-2019, lot# N015477 with an expiration date 18-MAY-2017 for prophylaxis (doses and routes of administration were not reported). Administered doses of VARIVAX experienced the temperature excursion between 15 and 46 degrees Fahrenheit for 21.5 hours. There was no previous temperature excursion. A digital data logger was involved. This is one of several reports received form this reporter. Sender's Comments: US-009507513-1709USA006189: US-009507513-1709USA007003.
Intermittent hives continuing since 1/9/21 and started 20-25 minutes after administration of vaccine.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PYREXIA (Fever). In March 2021, PYREXIA (Fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was unknown if the patient was enrolled in COVID-19 vaccine trials.  No concomitant product reported by reporter.  No treatment medication reported by reporter.  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.   This case was linked to MOD-2021-620836, MOD-2022-623622 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2022: Significant live follow up (Patient demographics, event information, reporter opinion of causality, suspect drug information, concomitant drug information, laboratory/diagnostic procedures and narrativedescription updated)
Injection site pain, starting approximately 2 hours after receiving shot and continuing for the next 24 hours. Headache starting around 10am the day after receiving the vaccination, continuing for approximately the next 12 hours. Chills and body aches starting around 10am the day after receiving the vaccination, worsening over the next 3 hours, continuing for approximately an additional 10 hours. No pharmaceutical treatment taken. All adverse events were resolved upon waking the following day (approximately 40 hours after vaccine administration).
Complete numbness of arm night off shot; extreme exhaustion and headache day after; headache and nausea daily beginning day 3; appearance/notice of rash on side on day 7; diagnosis of shingles on day 10.
Throat irritation Narrative:  Patient complained of a "scratchy throat" and mentioned that he had a similar reaction with his first dose. Patient was evaluated and showed no signs of difficulty breathing and no swelling in the face, lips, or tongue. He denied shortness of breath and itching. Denied post nasal drip. He reported feeling better immediately after assessment.
2nd dose was 6 months after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was 6 months after the 1st dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Prostate cancer (Stage 4 prostate cancer 11 years ago) and Bypass surgery (11 Years ago). Concomitant products included ATORVASTATIN CALCIUM (AVASTATIN) for Heart disease, unspecified, METOPROLOL for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was 6 months after the 1st dose). In August 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was 6 months after the 1st dose) had resolved.            Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-370201 (Patient Link).
Diarrhea; stomach cramps; low-grade fever; Headache; Felt minor aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (stomach cramps), PYREXIA (low-grade fever), PAIN (Felt minor aches and pains) and HEADACHE (Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (stomach cramps), PYREXIA (low-grade fever) and PAIN (Felt minor aches and pains). At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (stomach cramps) and PYREXIA (low-grade fever) outcome was unknown and PAIN (Felt minor aches and pains) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received its 30-days Exp date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 49-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 12-Feb-2022 at 5:37 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Feb-2022 at 5:37 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported dose number as additional  which was administered on 12 FEB 2022 at 5:37:51 PM.  No treatment medications were reported.
Approximately 1cm diameter hive appeared 2 days after the injection about 2cm below the injection site.  The hive would disappear in the morning and come back in the evening for a couple of days.
Left arm where ProQuad was given with swelling, 4x5cm redness and warm to touch. Dx with shot reaction vs early cellulitis. Treated with 7 days Augmentin and ibuprofen.
Incorrect Product Storage; patient was given PNEUMOVAX 23 that was recalled; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not reported.  On 15-OCT-2020, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe (dose 0.5 ml, lot number S036495, expiration date reported and established as 13-SEP-2021, strength, route was not reported) as prophylaxis that was recalled (Recalled product administered) (Product storage error). The recall was related to improperly stored vaccines resulting in a temperature excursion. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; serialnumber: UNKNOWN; catalognumber: UNKNOWN; udinumber: UNKNOWN; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
After receiving the Moderna vaccine, she starts having a fast heartbeat (pulse 155/mins), and she still has this fast heartbeat for 30 mins. She called her PCP, and she wanted to go to the hospital to check her heart.
placed in refrigerator after the expire date; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (placed in refrigerator after the expire date) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (placed in refrigerator after the expire date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (placed in refrigerator after the expire date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. There was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. Date place in refrigerator was 26-Oct-2021. Patient did not experience temperature excursion and any adverse event   No treatment medication was provided by reporter.
The night on the day I received the shot, I developed a headache and mild body aches. The night from 5/13 to 5/14, the body aches because so severe I could not sleep. I had some chest pains that felt sharp through my heart/mid-left side of my chest. The chest/heart pains last the very early morning of 5/14 through the rest of the day. The headache that started 5/13 continued to get worse and became extreme on 5/15. All that was used during these few days was Tylenol, heating pads, and ice packs.
First one muscle aches. Second one chills, extreme body aches, muscle aches, nausea, head ache, low fever.
vaccine received 12:05pm at about 12:20 patient stated hands were tingling/itching.  at 12:30 patient stated lips were tingling/hands were about the same. I gave patient 25mg of benadryl liquid at 12:35. I asked patient to wait another 15 minutes to monitor. at 12:55 patient stated she felt much better. she stated that she felt good enough to go home, and that she and her husband would monitor and if she had any worsening of symptoms, she would seek medical care.
Pt recvd 3 doses of Engerix-B JUL90, AUG90, & JAN91 & did not achieve protective antibody titers;
20NOV91 began vomiting @ 130AM x 2 refused to eat through the day; no audible bowel sounds @ 715PM & c/o abd tenderness & admitted to Hosp 20NOV; bowel resection completed due to volvolus of bowel;
Same as described on "possible side effects" list with brochure.  Nausea, fever, cycle between chills/shivering then feeling hot every 20-30 minutes, muscle ache, headache. Note:  This was my second round of the vaccine (first was previous June 16, 2019).  I do not recall any adverse symptoms with my first injection of the vaccine.