chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: FP4554), in right arm, on 16Apr2021 as dose 2, single (Lot number: 30155BA), in right arm, on 16Oct2021 as dose 3 (booster), single (Lot number: ER8731), in right arm and on 21Apr2022 at 10:30 as dose 4 (booster), single (Lot number: ER8730) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: REMICADE; METHOTREXATE; FOLIC ACID; IRON; VITAMIN D [VITAMIN D NOS]; OMEPRAZOLE; EFEXOR. Past drug history included: Flagyl, reaction(s): "known allergies: Flagyl". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19, Positive again; Negative, notes: Rebound - Got better, Neg test; Positive, notes: Positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid from 05Jul2022 to 09Jul2022 for the treatment of COVID-19. Rebound - Got better, Neg test and week later started coughing and lost of smell/taste -took test and Positive again.  No follow-up attempts are possible. No further information is expected.
Breakthrough case admission after three vaccines  Moderna 3/11/21 Lot# 023M20A;  Moderna 4/11/21 Lot# 018B21A;  Moderna 12/29/21 Lot# 059H21A
Patient presented with flat red rash, approximately 1 1/2 inches in diameter on upper, left arm (tricep area). Patient did not complain of pain, itch, or bump under skin. Approved 3 days after vaccination.
Weak legs after 2nd dose; Terrible headache after 2nd dose; Nausea after 2nd dose; Swelling at injection site after 2nd dose; Slight diarrhea after 2nd dose; Large, hard itchy lump after 2nd dose; Large, hard itchy lump after 2nd dose; Large, hard itchy lump after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Slight diarrhea after 2nd dose), MUSCULAR WEAKNESS (Weak legs after 2nd dose), VACCINATION SITE MASS (Large, hard itchy lump after 2nd dose), VACCINATION SITE INDURATION (Large, hard itchy lump after 2nd dose) and VACCINATION SITE PRURITUS (Large, hard itchy lump after 2nd dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included BENRALIZUMAB (FASENRA) for Asthma.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced DIARRHOEA (Slight diarrhea after 2nd dose), VACCINATION SITE MASS (Large, hard itchy lump after 2nd dose), VACCINATION SITE INDURATION (Large, hard itchy lump after 2nd dose) and VACCINATION SITE PRURITUS (Large, hard itchy lump after 2nd dose). On 24-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site after 2nd dose). On 27-Feb-2021, the patient experienced MUSCULAR WEAKNESS (Weak legs after 2nd dose), HEADACHE (Terrible headache after 2nd dose) and NAUSEA (Nausea after 2nd dose). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Slight diarrhea after 2nd dose), MUSCULAR WEAKNESS (Weak legs after 2nd dose), VACCINATION SITE MASS (Large, hard itchy lump after 2nd dose), VACCINATION SITE INDURATION (Large, hard itchy lump after 2nd dose), VACCINATION SITE PRURITUS (Large, hard itchy lump after 2nd dose), VACCINATION SITE SWELLING (Swelling at injection site after 2nd dose), HEADACHE (Terrible headache after 2nd dose) and NAUSEA (Nausea after 2nd dose) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.
pt recvd 4 doses of DTP & had pos pertussis test; pt started w/coughing 11JUL94; 22JUL94 cough worsening taken to MD 25JUL94 MD felt was bronchitis & part pneumonia; 1AUG94 to MD again blood work that turned out very viral;
Narrative: 55 yo F w/PMH significant for asymptomatic CAD, migraines resolving around menopause, and tobacco use (30+ pack year smoking history). Patient has not been getting medical care in several years and recently re-established care. Patient had recent onset of 5x/week migrainosus headaches following J&J COVID-19 vaccine that seemingly have self-resolved/decreased in 7/2021, aborted with 600mg of Motrin, nausea resolved with dose of prochlorperazine. Patient received the J&J COVID-19 outside the facility either on 4/03/2021 or 4/4/21 (both dates listed in progress notes). Per 6/2/21 general medicine clinic attending progress note, "1. headaches- history of right sided hemiplegic migraines, resulting in n, v, photophobia, phonophobia- Has had them for 30 years. Not sure if she saw a neurologist. Had a CT scan. Getting worse- having them 5 days a week. Last 1 hour of 6 hours. Sleeping doesn't always help. Denies hemiplegia. Started getting these headaches after Covid vaccine. Best treatment in past Chlorproperizine. Is anxioue about Imitrex due to CAD in family. Compazine pills and suppositories. Takes Motrin as well." Primary Care MD discussed that it was extremely unlikely cerebral venous thromboses presentation in patient currently asymptomatic and asymptomatic a few days a week over last few months given Jansen concern. Patient referred to neurology, ordered MRI, and ordered a prescription for prochlorperazine tablets & rectal suppositories for prn use. Smoking cessation consult entered and patient later ordered nicotine gum then bupropion tab by the TeleQuit program. Per 7/7/21 Outpatient Neurology clinic note, "Pt notes that following her June 2nd appointment, she began to feel significantly better with reduced headache frequency in the days that followed. For the subsequent month, she says she experienced approx. 4 headache days, each with headaches that lasted 1-2 hours." Neurology's impression is that, "Headaches appear migrainosus in quality, similarly to previous migraines, but with increased severity, lasting up to 6 hours, likely too long to be cluster headaches. Given abatement with lying down and ibuprofen as well, more likely to be migraine." 6/17/21 MRI demonstrates "significant amount of white matter disease, thought mostly more peripheral than typical of MS. Given smoking history, could represent ischemic disease vs migraine-related." Patient will be followed by outpatient neurology. Patient also noted by neurologist to have a very low vitamin D and Vitamin B12 levels when last checked in 2014. New labs entered, which patient has not yet obtained as of 8/9/21.
This spontaneous report was received from a licensed practical nurse and refers to a 76 year old patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 12-NOV-2010, the patient was vaccinated with the first dose of VAQTA 50/1.0 U/ml (lot #, expiration date, dose and route of administration were not reported). On 19-JUN-2017, the patient was vaccinated with the second dose of VAQTA 50/1.0 U/ml, lot # M009786 (dose and route of administration were not reported), which expired on 26-MAY-2017. There were no adverse effects reported. Additional information has been requested.
arm was sore in the evening; so painful; 1.5 inch scratch where he tried to inject her; questioning if it all got in her and out of the syringe; This is a spontaneous report from a contactable consumer (the patient).  A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included ongoing autoimmune disease.  The patient's concomitant medications were not reported.  On an unspecified date the patient arm was sore in the evening, so painful, 1.5 inch scratch where nurse tried to inject her, questioning if it all got in her and out of the syringe. Caller reported she received the first dose of the Pfizer-BioNTech COVID-19 vaccine. She specified the vaccine was administered through a drive-through and she was sitting on the passenger seat. She explained the "nurse guy was standing outside" and didn't notify her before injecting the vaccine, therefore she "flinched" when she got it. She specified she "probably move" and "he jabbed [her] twice. She added the nurse checked the syringe to see how much of the vaccine was administered and "he thought he got it all out". She explained "he couldn't tell where he had injected" to put the band-aid. She further explained when she took out the band-aid, she noticed "1 inch and 1/4" of what appeared as a "needle scratch". She later described the size of the scratch as "1 inch and 1/2".  She then mentioned her "arm was sore in the evening" and a little bit the next day. She said she called the pharmacist who said her soreness was due to the vaccine and not the needle. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Headache, Fatique, Diarrhea 4-6 times per day, Neck Stiffness and Pain (swollen lymph nodes), Low Grade Fever
Severe fever-like symptoms including chills, full-body muscle aches, moderate nausea
Minor chest pain. I normally walk 4 to 5 miles per day. I have never had chest pain, but I did yesterday. It feels like it's at the top of my heart.
TWO ADVERSE EVENTS 1.  Itchy red bumpy rash appearing on forearm in 3 spots about 2"-3" in size on 1-17-21, still visible, no longer itchy  2.  Red itchy smooth rash 3"x5" around injection site appearing on 1-30-21
Fever 102.5 degrees HR 167 lethargy (L) deltoid warmth/tenderness.
Second adult dose of Hepatitis A vaccine was given 16 days too soon. No adverse events reported.
Tested PCR Covid-19 positive 8/23/21 with onset 8/21/21
Left arm erythematous with calor 3cm. around vaccine site.  Wheel flare (urticaria) face and chest, extremities and lungs cta.
11/19/09 fever, coughing, a little runny nose. Pt w/ w/o asthma - Albuterol PRN.
HEADACHE; CHILLS; LOW GRADE FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced low grade fever. On 09-MAR-2021 10:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 10-MAR-2021, and chills, and low grade fever on MAR-2021. This report was non-serious.
Patient had a seizure in the middle of the night on Sunday. Wife called 911 and patient was transported to ER where he stayed for observation and then prescribed seizure medication. Patient has no history of seizures.
Patient reports feeling lightheaded initially. She expressed that her face and lips were tingling. Her injection site on her left deltoid was red as well as her chest. She was sitting down and drinking water. We asked her to lie down onto a bed. Her head felt foggy she stated. She received one dose of Diphenhydramine 50mg IM one time dose. She has improved after receiving the dose.
06/02/102 Mild Other small, pinpoint size bumps near all injection sites. Mom states that client also has had a bad cold and cough.
This spontaneous report as received from a medical assistant refers to a 11 year old male patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 27-SEP-2017, the patient was vaccinated with improperly stored doses of GARDASIL 9 from lot N015087 expiry date 20-OCT-2019 by intramuscular route for prophylaxis. No adverse events reported. The call was made due to a digital data logger. The vaccine was exposed to a temperature of 50.5 degrees Fahrenheit for a time frame of 1.5 hours. There was no previous temperature excursion involved. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1711USA004678: US-009507513-1711USA004679: US-009507513-1710USA000490: US-009507513-1711USA004676: US-009507513-1711USA004677.
Patient received Hepatitis A and Varicella vaccines 2 days prior to presenting to the ED with respiratory distress and mental status changes.  The patient died 3 days later from influenza B.  There is no indication that the vaccines this patient received or any other vaccine could have had any relationship to the outcome, or is there any reason to believe from the history that anything other than the influenza and the patients underlying medical condition (Congential Heart Disease, Asplenia, CP) were related to the death.  However, we report all incidents of patients with a serious adverse event temporarily related to vaccine administration, whether or not there is a relationship.  6/2/08 Reviewed hospital discharge/death summary for 2/29-3/2/2008, FINAL DX: overwhelming influenza B sepsis & encephalopathy Records reveal patient experienced labored breathing, altered mental status x 1 day; coughing, rhinorrhea & fever x 2 days.  Seen by PCP & dx w/viral illness.  Conditioned worsened & became unresponsive at home. Taken to ER by EMT with oxygen saturation 70's (baseline high 80's).  In ER, noted to have frothy sputum.  Tx w/CPAP & nebs.  Improved & became responsive.  Then after another episode of bradycardia & hypotension, became unreponsive again.  Felt to be having sub-clinical seizures.  Admitted to PICU, intubated & coded several times.  On multiple pressors w/fixed & dilated pupils.  Family requested no further resuscitation efforts.  ME declined case & family declined autopsy.   6/3/08 Reviewed medical records for 2006 & additional medical records for 2008.  Records for 2/15-3/2/2008 reveal patient in usual state of health on day of vaccination.  Seen by PCP 2/29 w/fever 103.3 for 1-2 days; had not received flu shot due to prior facial swelling w/flu vaccine in 2006.  Dx w/viral illness.  Seen in ER later same day for cough, rhinorrhea & fever x 2 days & increased respiratory effort becoming unresponsive.  Admitted to PICU w/influenza w/pneumonia; respiratory failure; & congenital heart disease.  Neuro  & cardio consults done.
Was given 3rd Rotavirus vaccination 5/7/07. Developed abd pain, vomiting, constipation. Needed surgery for small bowel obstruction done in hospital.  10/02/2007 MR received for 2 hospital admissions DOS 6/20-7/02/2007 and 7/06/2007 for DX: Small bowel obstruction and Partial Small Bowel Obstruction.  Child presented on 6/20/2007 with 6 day hx of emesis, vomiting all meals ~ 5 minutes after eating.  One episode of bilious emesis. No diarrhea or fever.  Pt had Exploratory lap, lysis of adhesions, and placement of a central venous line on 6/27/07/.  Discharge on 7/2/07. Pt returned to hospital on 7/6/07 with c/o emesis x 3 days after had been tolerating feeds s/p ex lap.  Txd with NPO, IVF and and NG tube. Records also received from PCP for hospital DOS 7/13-18/2007 and 7/30-8/6/2007 for DX:  Hx of volvulus and small bowel obstruction, hx of small bowel obstruction with post-op ileus and narrowing at the anastomosis and GERD. Small bowel obstruction s/p resection. Infant presented this admission (7/13/07) with persistant projectile vomiting, decreased UO and weight loss.  PE (+) for dehydration.  Discharged home with segmental bowel resection scheduled. Infant presented 7/30/07 after an episode of bright red rectal bleeding on 7/28/07 after constipation. Pt was admitted for another small bowel resection on 7/31/07. Pt remained NPO until 8/4/07 when po fluids were initiated without problems.  D/c after 36 hours of normal feeds.
Induration on right thigh, mild cellulitis 2 days post vaccination. Treated with Benadryl, warm packs, and Keflex. 1/3/07 Mom reported redness gone, still slight tender.
Fever/chills, Severe headache, nausea, catatonic for 72hrs
Information has been received from a consumer concerning someone she known was vaccinated with a dose of GARDASIL (dose, route, and lot# not reported). On unknown date, the patient had tested positive for GARDASIL despite receiving GARDASIL. At the time of the report, the patient's outcome was unknown. No further information is available. No further information is available.
fever, chills, muscle aches,  for 3 days, rash and bruising at site - still feel  weak one week later
According to the hospital records, pt was due for 3rd covid booster, Mother asked twice about the vaccine card and which point she did not have it on her at that time but was here for the booster. Private administered what she thought was the 3rd booster as it has been 6 months since her last Covid vaccine was given on 02/03/2022. The patient and her family were advised to wait 15 minutes and notify staff in case of a reaction.  While waiting, the mother gave a vaccine card to update and at that time, the Nursing staff noticed that she had received a vaccine from an outside facility on 06/18/2021. Staff notified of miscommunication between family and nursing staff, Provider Dr. was informed about the incident and had review dates given for the patient. All vaccines were given in time allotted.  The family monitored for the recommended time and left with no reaction.
Information has been received from a registered nurse via a company representative concerning a female patient who on 17-APR-2007, was vaccinated with a dose of Pneumovax 23 (Lot #656222/0381U). On approximately 17-APR-2007 the patient developed erythema. It was reported that the pateint was treated with hydrocortisone. At the time of the report, it was unknown if the patient recovered from erythema. Additional information has been requested.
Primary dose back in March of 2022 and She is requesting to get the second dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Primary dose back in March of 2022 and She is requesting to get the second dose) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Primary dose back in March of 2022 and She is requesting to get the second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Primary dose back in March of 2022 and She is requesting to get the second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Primary dose back in March of 2022 and She is requesting to get the second dose).    No concomitant medications were provided. No treatment medication was provided.   Reporter did not allow further contact
Pt is a 38 y/o female who came in for J&J booster after anaphylaxis reaction post Moderna vaccination and has her epi pen readily available. Upon vaccination, pt developed SOB and audible expiratory wheezing. Pt was assisted with personal epi of .3mg IM via auto-injector and used personal rescue inhaler. Pt was then taken into ER where left under ER supervision.
Fever, nausea, joint pain, headache, strong tinnitus, dizziness. Treated with Tylenol for pain, Dramamine for nausea/dizziness. No relief from tinnitus. ENT and family doctor say there's nothing that can be done because it was caused by the vaccine.
Information was received from a pharmacist regarding a 67 year old female patient. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On 10-JUL-2017 the patient was vaccinated with ZOSTAVAX lot # N010494, expiration date 16-MAR-2018, 0.65 ml once to prevent  herpes zoster. STERILE DILUENT lot number was MO26304 and expiration date 13-MAR-2019. It was reported that the patient experienced redness at the injection site and that the injection site "hurts on contact with anything" on 12-JUL-2017. The patient saw the pharmacist and also her physician. The pharmacist contacted the patient on 12-JUL-2017 and the patient replied that she was okay. The pharmacist planned to contact the patient on 14-JUL-2017. The outcome of the events was unknown. Causality assessment was not provided. Additional information has been requested.
PATIENT CAME IN TODAY C/O RIGHT ARM PAIN AND REDNESS. PNEUMOVAX 23 WAS GIVEN ON THAT ARM. I TOLD PATIENT THAT I HAVE SEEN, THOUGH RARE, THIS REACTION BEFORE WITH PNEUMOVAX. SHE MAY TAKE SOME TYLENOL IF NECESSARY. RECOMMENDED PATIENT TO SEEK MEDICAL HELP IF SHE FEELS SYMPTOMS WORSENING. THERE WAS NO REPORT OF DIFFICULTY BREATHING, OR ANYTHING LIFE THREATENING (SWOLLEN THROAT, LIPS, ETC.).
Pt vacc. w/Engerix-B developed arthritis flare-up, problems walking, problems moving arms & legs.