chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-serious spontaneous case, was initially received on 18-Sep-2017 from other non-health professional (HCP staff), concerning a 76-years-old, elderly, female patient. This is the first case of the 2 cases reported. The patient current condition included: blood clotting, non-specified. Concomitant medication included ASA for an unknown indication. On 08-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (batch no: 00144621A and expiry date: 31-May-2018, dose, route of administration and anatomical location: not reported). On an unspecified date, 8 unopened MDV (multi-dosage vial) and 14 syringes drawn from MDV that reached unknown temperature for unknown amount of time, 1st excursion and patient was administered with that vaccine. It was reported that, the patient did not experience any adverse event after the first excursion of the vaccine administered. At the time of this report, the outcome of the events were not reported. Follow up report received on 21-Sep-2017: New event (no adverse event) was added. It was reported that, the patient did not experience any adverse event after the first excursion of the vaccine administered. The narrative was amended accordingly. Non-significant follow up received on 11-Oct-2017: The age of the patient was changed from 89 to 76 in the narrative. The narrative was amended accordingly. Non-significant case correction received with IRD 18-Sep-2017: Batch number was added in the screen and updated expiry date. The narrative was amended accordingly. Significant case correction received with IRD 21-Sep-2017: The event 'no adverse event' was deleted.
Information has been received from a registered nurse concerning a 15 year old female with a history of dysmenorrhoea and attention deficit/hyperactivity disorder and no drug reactions/allergies who on 24-SEP-2007 was vaccinated with the first 0.5mL dose of GARDASIL (Lot No. 658560/1062U) IM and on 03-DEC-2007 was vaccinated IM with the second dose 0.5 mL dose of GARDASIL (Lot No. 659437/1266U). She has not yet received the third dose. Concomitant therapy included Tdap (unspecified) , influenza virus vaccine (unspecified) and MENACTRA. In October 2007 de patient experienced abdominal pain and fatigue. She was examined with endoscopy and colonoscopy. In October 2007, she was diagnosed with, the possible inflammatory bowel disease. The patient sought medical attention was seen by a physician. At the time of the reporting, the patient had not recovered Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 3:59 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 3:44 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 64.73 for dose administered on 02-Mar-2021 and 64.80 for dose administered on 30-Mar-2021.  No concomitant medications were reported.  Batch number 019B21A administered on 30-Mar-2021 underwent temperature excursion with temperature 33 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 23-Mar-2021 and BUD date for the vial was reported as 22-Apr-2021. Product moved to clinic on 30-Mar-2021.  Batch number 014M20A administered on 02-Mar-2021 underwent temperature excursion with temperature range 27 to 36 degrees Fahrenheit from 09:00 Am to 03:00PM . This vial was moved to fridge on 24-Feb-2021 and BUD date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient received her Hep B vaccination and after minutes, She began to feel dizzy, nauseated  and warmth in her lower back. After another five min PT stated that the warmth was climbing up her spin and the dizziness did not subside. PT was given water and was observed by medical staff while rescue was being called. When rescue arrived she alert and oriented and went with recue to the  Hospital.
Muscle pain traveled to all the joints in left arm. 100° fever 1st night, cold sweats, hot sweats, all around feel like crap for 2 days now.
Patient complained of extreme redness, itching, swelling, injection site fever and pain. She works at a hospital and one of her doctors there said it looked like she had cellulitis at the injection site.
pt states that 45 minutes after 2nd COVID vaccination his body began to break out in full body hives that have evolved and continue to worsen.
Wrong vaccines given to Patient - mistakenly was given vaccines meant for sibling who was not in the room
Our son died of ALS right after he turned 16; This spontaneous information has been received from the patient's mother via company representative, concerning a 16-years-old male patient. The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported).  On an unknown date, the patient experienced amyotrophic lateral sclerosis (ALS) and died due to this event.  The causal relationship between amyotrophic lateral sclerosis and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.  Upon internal review, amyotrophic lateral sclerosis was determined to be a medically significant event.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2011USA002096:; Reported Cause(s) of Death: ALS
Tested positive for COVID19 on Saturday; Tested positive for COVID19 on Saturday; Chills; sweats; cold; allergy symptoms; Booster; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 49-year-old male patient received third dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: F73527, Expiration Date: was not reported), via an unspecified route of administration, administered in left arm, on 02Nov2021 at 12:45 (at the age of 49 year), as dose 3 (booster), single for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing, affective disorder (mood disorder) from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, sleep apnoea syndrome from an unknown date and unknown if ongoing, mild asthma from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing. Concomitant medications included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; atenolol (ATENOLOL) taken for an unspecified indication, start and stop date were not reported; lamotrigine (LAMOTRIGINE) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported; colecalciferol (D3) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EM9809, Expiration Date: was not reported), via an unspecified route of administration, administered in left arm, on 09Feb2021 at 13:00 (at the age of 48 year), as dose 1, single for COVID-19 immunization and the patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6205, Expiration Date: was not reported), via an unspecified route of administration, administered in left arm, on 02Mar2021 at 13:00 (at the age of 48 year), as dose 2, single for COVID-19 immunization. The patient received other vaccine in four weeks was not reported. The patient received other medication in two weeks were Lisinopril, Atenolol, Lamotrigine, Wellbutrin, D3. Prior vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was tested for COVID-19. The patient had no known allergies. On 03Nov2021 at 05:00, the patient experienced chills, sweats, cold and allergy symptoms. The adverse event was resulted in emergency room (department or urgent case) visit. The patient stated, she was tested positive for COVID-19 (Nasal Swab, RT-PCR) on 06Nov2021 and though she knows you cannot get the virus as a direct result, she wanted to make you aware in case of any cross-contamination issues may affect others. The patient was not received treatment for the adverse events. The outcome of the COVID-19 positive was unknown. The outcome of the chills, sweats, cold and allergy symptoms was recovering.
continuous muscle pain on the left shoulder/neck area. identical feeling to having a crick in the neck
First: I had the coronavirus infection at the end of December/beginning of January.  Second: I received my First dose of the Pfizer shot on May 24th. Got a fever and body aches for about 24 hours. Thursday June 24th:  T-0: Received PFIZER-BIONTECH COVID-19 VACCINE (Link is to the Pfizer Factsheet)  T-11.5: Began having fever of 100°F and chills. Took a dose of Nyquil.  T-14: Woke up in a daze and was half sleep walking around the room. While walking around in the room I passed out and fell to the floor. Was out for about 10 seconds. My wife woke me. I then passed out a second time and experienced a mild incontinence for about 15 seconds, came out of it and then went to the bathroom. When in the bathroom I passed out on the toilet for about 30 seconds, I experienced incontinence of everything left in me, bowel and bladder, I experienced convulsions and altered state(thousand yard stare). When I came too I began vomiting and had extreme body shakes. Some of this information was relayed to me by my wife obviously.  T-15.3: Arrived at hospital and during check in I had another episode. (15 seconds)  T-25: In hospital bed I had another episode duration unknown, no one saw me go out but I recall regaining consciousness.   T-29: In hospital bed I had another episode duration unknown, no one saw me go out but I recall regaining consciousness. I passed out a total of 6 times.
Patient has bilateral lymphadenopathy prickly of the submandibular lymph nodes as well as the anterior cervical chain. A little bit more prominent on the left side than the right. Patient left anterior cervical chain does extend to the left supraclavicular area.
Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by an HCP and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     It was unknown if patient had ever diagnosed positive with Covid-19.  It was unknown if patient had any acute illness at the time of vaccination or up to one month before. It was unknown if patient had any chronic or long-standing health conditions.     On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 31 years 10 months. No concomitant drug reported. It was reported vaccine administrated beyond use date after the thaw process. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines. No treatment information was provided by the reporter.
Patient called at 6:50 complaining of shortness of breath and cough that had been going on for 15 minutes. Recommended she go to emergency room.
Breakthrough case admission after 3 vaccines Moderna 3/4/21 Lot# 030A21A;  MOderna 4/1/21 Lot# 008B21-2A;  Moderna 11/9/21 Lot# 051F21A
Feeling funny/ feeling miserable/ not feeling myself/ had a strong reaction to the booster dose; Stomach issues; Don't have a lot of energy; Slept all day; Head aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Feeling funny/ feeling miserable/ not feeling myself/ had a strong reaction to the booster dose), ABDOMINAL DISCOMFORT (Stomach issues), ASTHENIA (Don't have a lot of energy), SOMNOLENCE (Slept all day) and HEADACHE (Head aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A or 012F21A, 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Feeling funny/ feeling miserable/ not feeling myself/ had a strong reaction to the booster dose), ABDOMINAL DISCOMFORT (Stomach issues), ASTHENIA (Don't have a lot of energy), SOMNOLENCE (Slept all day), HEADACHE (Head aches) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Feeling funny/ feeling miserable/ not feeling myself/ had a strong reaction to the booster dose), ABDOMINAL DISCOMFORT (Stomach issues), ASTHENIA (Don't have a lot of energy), SOMNOLENCE (Slept all day), HEADACHE (Head aches) and CHILLS (Chills) was resolving.      Concomitant medications include one day pill daily for asthma.  Patient reported that she had a stronger reaction to booster dose than with the second dose. She stated that the symptoms started three or four hours after the booster dose.   This case was linked to MOD-2021-362994, MOD-2021-363397, MOD-2021-363444 (Patient Link).
Information has been received from a physician concerning an 18 month old male with no medical history or allergies who on 06-JUL-2007 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 654525/1041F). Concomitant therapy included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On 06-JUL-2007, after vaccination the patient developed redness and a welt like area at injection site. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested.
Contracted Covid-19 at the end of January 2023. Symptoms were sinus congestion, cough, headache, chills. Had telehealth meeting with doctor's office, prescribed five-day course of Paxlovid. Also isolated upstairs. My wife did not contract Covid. Felt better for a while after I finished the medication but then got a rebound case of Covid about two weeks later. I did not consult my doctor or take medication after the second positive test. I felt better after about four days.
I had digestive issues, frequent stools several times a day that lasted almost two weeks. It wasn?t really diarrhea, just frequent.    I took OTC Imodium most days which helped in the short term but it kept reoccurring.
I63.9 - Stroke (cerebrum) (HCC) I63.9 - Cerebral infarction, unspecified
I was on a cruise ship. Everyone was vaccinated. Five present was in isolation due to COVID-19. I developed a scratchy throat then took a COVID-19 test that was positive. I also received a positive PCR COVID-19 test. I was put in isolation. Two days later, I got really tired with fatigue, with a headache and achy that lasted two days. I also had a dry cough and lost my sense of smell. I was still positive on day 10 which was the protocol to get out. I went home and then on day 15, I finally tested negative. I did see nurses that on the ship that took care of me and was under supervision of a doctor.
Left upper leg bruising and swelling-hot and tender to touch-Friday 6-29-07-seen at ER. much improved on 7/2/07 in office-6" x 15" area slightly red, moderately tender and moderately inflamed. Duricef 500 mg daily x 10 days
Headache, Fever, NauseaVomiting, Chills, and Body aches, back pain Narrative:
Information has been received from a physician concerning a 12 month old female with no pertinent medical history and no drug reactions/allergies, who on 16-MAR-2008 was vaccinated SC with a 0.5 mL dose of VARIVAX  (Oka/Merck) (lot number: /1493U). There was no concomitant medication. On 26-MAR-2008 the patient had 3 "dots" that were located on the thigh, lower abdomen and in the head. The "dots" are dry. The physician mentioned the patient also had a diaper rash. No further information was available. There was no laboratory diagnostic studies performed. Unspecified medical attention was sought; the patient was seen in office on 27-MAR-2008. The outcome was reported as not recovered. There was no product quality complaint. follow-up information received on 13-MAY-2008 The physician did not remember the name of the patient; he was covering for another physician. The physician did not believe it was chicken pox rash This is one report of several from the same source. Additional information is not expected.
After 1st shot 1/21/21 taste changed  Everything bitter Had Covid test 2/7/21  Not detected 2nd shot 2/17/21  still taste is off  everything bitter
pruritus, felt warm Narrative:  Patient experienced mild reaction: c/o headache 5/10, itchiness in his head, neck, and upper back/front chest and felt warm at approximately 10:15 a.m. Observed et. for 30+ min. until symptoms lessened as reported by patient. VS: T-96.4, P-98, R-20 RA B/P-142/86, O2 Sat. 96%, LA B/P-123/69, P-100, & O2 Sat. 97%, weight-225 lb. No medication used for treatment. Patient stated, "I'm alright to go now," "I think my symptoms has lessened," "I will just take my time to go to my car." Discussed with patient to call for help if symptoms worsened such as shortness and or constriction from breathing, dizziness/light-headedness, or any life threatening situation.
Nausea, night sweats x 6 days  Ongoing sore, hard arm at injection site, on day 9 now
High fever after vaccines for 2 days-given TYLENOL , bleeding rash/eczema 1.5 week after shots-warm baths with baking soda.
The same day of vaccinations, child had low-grade temperature, was clingy and fussy X 8days or more. On 10/24/00 at 18:00, left eyelid pink and slightly puffy. On 10/25/00, pt was seen by doctor (eyelid swollen and pink) "cellulitis" and started on Augmentin. Also, same day, was dx'd with "eczema" and switched to dove soap, eucerum cream, hydrocortisone. That night left temple and cheek area was swollen, slightly too. On 10/27/00 AM, had a rash on torso and back which was itchy, tiny raised, red bumps. Treatment is to continue Augmentin for cellulitis and continue hydrocortisone and start on Benadryl Elixir. At 22:00, that night, had severe hives and some swelling in both feet and some hives and minimal swelling in hands. Discontinue Augmentin X 24 hours and call pediatrician before resuming, but continue hydrocortisone and Benadryl. On 10/29/00, called on-call doctor and discontinued Augmentin and started Ceftin. On 10/30/00, hives dissipating. On 10/31/00, only 14 hives left on feet and 2 on hand. No swelling. Questionable cellulitis Hib related; angioedema or just viral or bacterial related.
According to the VAERS form, MMR was given via intramuscular route but recommended to be given subcutaneously. She went to the doctor on 12/07/2018 for fever, chills, rash, lymphadenopathy of left axilla.
* days after getting my first Moderna shot, I woke up with a swollen left arm at the injection site.  It was hot and I couldn't lift my arm above my chest.  By the end of the day, I had a SEVERE welted rash ALL over my body.  You could feel it though my clothing.  The rash proceeded to spread and it hot and itchy beyond anything able to describe.  You just can't itch it deep enough.  I took Benadryl but it did nothing.  We called my dermatologist who suggested Zyrtec and Cortisone cream for the rash.  It helped alleviate the initial, itch for a little bit,  but it was still welted and hot and spreading.  I have tried other creams, and was given a prescription of prednisone.   The rash has mostly subsided but the UNCONTRLLABLE itch is still there.  It's a deep itch that you can't seem to get to. Unable to sleep because of the itching, and discomfort has been a huge issue for me.   My question is, how long is this expected to last,  is there anything else I should be doing or doing different, and  should I proceed with the second shot???
Pt recvd 1st dose of Hep B vax in MAY91; a few days following vax pt devel fever over the next 5 months, exp intermittent fevers ranging from 99 to 100.5; dx w/tuboovarian abscess; MD felt fever was not assoc w/vax;
Received Covid vaccine in am.  Last seen by family at 17:30 pm and observed to be well. About an hour later he collapsed, unresponsive.   A 911 call was initiated at 18:29.  Paramedics arrived to find the patient in cardiac arrest.  CPR/ACLS was initiated, but resuscitation was unsuccessful.  Pt. was transported to MC where he was pronounced dead at 19:32.  There was no sing of an injection site reaction, nor of allergic reaction..
6 days after second injection - full body rash with hives and itch. 2 ED visits. Dermatology consult - treated with Prednisone and Zyrtec. In day 4 patient appears to be improving - steroids and antihistamines prescribed for additional week.