chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Decreased appetite Thursday at 4 PM. Woke up Friday and felt sick, started throwing up at 7:15 and did not stop until 8:15. Threw up 17 times within that period.
Developed DM type 1 after AVA. Sx began in a foreign country. May or may not want intervention. Gave states and answered questions. Symptoms: Malaise and fatigue, Symptom, abnormal loss of weight.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Pt was wearing bullet proof vest and jacket as part of security uniform. Pt was ok after receiving vaccine. Roughly 10 minutes after administration, pt became lightheaded and fell out of chair in waiting area. Pt's head hit the floor. Pt stated they did not need EMS, however on-site medical staff recommended pt be seen due to head injury.
Patient had 2nd shot 9/3 . Diagnosed with a fetal demise on 9/22. The last documented fetal heart tones were at 8/12 visit.  Fetus should have been 22 weeks, but was measuring only 16weeks- consistent with a demise a few weeks earlier
Information has been received from an unknown age male patient referring to himself. Information about concurrent condition, concomitant medication and medical history was unknown. In approximately December 2018 (reported as about 1 year ago), the patient received the VARIVAX (strength, dose, frequency, route, lot#, expiration date were not reported) for prophylaxis. In approximately 2018, the patient was unsure if he had received the second dose (inappropriate schedule of product administration).
Left ankle delayed itchy rash.; Then became a very dark red and looks like a bruise one week later.; This is a spontaneous report from a contactable consumer, the patient. A 49-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 left arm on 29Mar2021 at 10:00, as a dose 1 single for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, the patient experienced itchy rash and bruise. 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. The clinical outcome of the events itchy rash and bruise was recovering.  No further information is expected; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Reporter name updated, patient race information added and facility information added
Patient was administered PREVNAR 13 on 10/11/2016, and we administered on 11/11/2016 PNEUMOVAX 23 when we were supposed to administer a year later instead of a month later.
Patient given MODERNA first  dose  on 8/25/2021 (LOT number 024C21A and received Pfizer for the 2nd dose on 9/22/2021.  No symptoms or issues at time of vaccine.
Most of the history is from the wife: Pt left for work around 0400 (she didn't see him) and returned home at 1230.  There was no report from work that the pt was off or acting differently.  Pt thinks his confusion started around noon.  So, the 100% reliable LKWT is when the wife saw him last on the evening of the 13th.  We can presume he wasn't as confused and jumbled in his speech for his workday today.   He felt a bit lost.  When he got home at 1230, the pt was acting off.  He was confused, had trouble with word finding, didn't know some common/easy information.  He had a small headache.  No large or fine motor symptoms, no facial droop or trouble swallowing.   Pt did get some new meds yesterday (flomax, statin, buspar) didn't start taking all of them.
This is in follow-up to report (s) previously submitted on 6/26/2008. Information has been received from a 68 year old female consumer with "severe digestive tract problems," high cholesterol, allergic reaction to antibiotics and "other different types of medications," and a history of shingles in 1965, pancreatitis and removal of melanoma who on Saturday 12-APR-2008 was vaccinated in the arm with "one shot" of 0.65mL of ZOSTERVAX (Oka/Merck). Concomitant therapy included PREVACID, LIPITOR, and PLAVIX. Subsequently, after receiving the vaccine on 12-APR-2008 the patient experienced headache, and the injection site became red, swollen like the size of a baseball and it was hot to touch. The patient stated she still had symptoms and the pain she experienced on the injection arm was the same pain she had when she had shingles before. There was no medical attention sought and there were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested. Information has been received from a 68 year old female with severe digestive tract problems, high cholesterol, allergic reaction to cephalexin, erythermycin, prednisone, MOBIC, ACTENOL and CELEBREX and a history of shingles in 1965, pancreatitis and removal of melanoma who on 12-APR-2008 was vaccinated with a 0.65ml dose of ZOSTAVAX. cocomitant therapy included PREVACID, LIPITOR and PLAVIX. On 15-APR-2008 the patient experienced headache, and the injection site became red, swollen like the size of a baseball and it was hot to touch. The patient stated she still had symptoms and the pain she experienced on the injection arm was the same pain she has when she had shingles before. There was no medical attention sought and there were no lab studies performed. Additional information from the physician indicated that the patient recovered from the events. There was not product quality complaint involved. Additional information is not expected.
Client stated she has a history passing out after vaccinations.  Immediately following vaccination of Pfizer booster to left deltoid, patient had a vasovagal reaction.  Patient was placed in a supine position with legs elevated and supportive care was given by Doctor and clinical staff.  Patient recovered instantly and was monitored for an additional 30 minutes before she left in stable condition, accompanied by her parents.
Severe fatigue, severe lower back pain, chills, fever, headache. Lasting 36 hours.
Information has been received from a RN concerning a 15 year old female patient who on approximately 16-MAR-2009 was vaccinated with the first dose of GARDASIL. It was reported that the patient has been having acute anxiety since. The patient sought unspecified medical attention. It was reported that the patient had not recovered at the time of the report. Additional information has been requested.
Severe shortness of breath with BP drop with small exertion. I am not out of shape.
Expiration of vaccine was 10/28/2021.  vaccine administered on 11/5/2021.  patient's PCP (Dr. was notified.   contacted patient on 11/10/2021, as per pt's mom pt has had no signs or symptoms of adverse reactions.
Pt had 2 episodes of seizure like activity after receiving his 2 month and 4 month vaccinations. Seizures lasted less than one minute, starting with one leg and involving entire body. Mother reported at 4 months check up.
I received 3 Pfizer vaccinations for COVID-19 in total. The first two were the original vaccines and the 3rd was a booster.  I had no symptoms following the first vaccine. Following the second vaccine, I had myalgias in the left arm where I had the vaccine administered and this lasted for about a day. Following receipt of the third vaccine, a day after administration, I had an enlarged axillary lymph node on my left axilla, then I developed diffuse, full-body myalgias that lasted for several days, and finally, I had scintillating scotoma (without a migraine) that obscured my entire field of vision and lasted for about 30 minutes. Since then, any time I am exposed to COVID, I have had similar episodes of myalgias in the left arm and scintillating scotoma. The scintillating scotoma occurs sporadically about once every 4-5 months and lasts for 20-40 minutes. The myalgias last for an entire day.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cystic fibrosis" (unspecified if ongoing). Concomitant medication(s) included: ZENPEP, start date: 01Oct2016, stop date: 02Aug2023; TRIKAFTA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The event "treatment of covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: testing positive for Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: After testing positive for Covid-19 for the first time since the pandemic began, the patient reached out to his doctor on 18Jul2023 for guidance on treatment options and he recommended a 5 day course of Paxlovid. The patient had other medication in 2 weeks. The patient was also taking 14 medications routinely. His Trikafta prescription was modified while taking the Paxlovid based on his doctor's instructions. The patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Temperature excursion; no adverse event; Temperature excursion occurred on 29-Nov-2022 and administered to the patient on 05-Dec-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29-Nov-2022 and administered to the patient on 05-Dec-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29-Nov-2022 and administered to the patient on 05-Dec-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29-Nov-2022 and administered to the patient on 05-Dec-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29-Nov-2022 and administered to the patient on 05-Dec-2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion).    No concomitant medications were reported.  On 29-Nov-2022, temperature excursion occurred, and a dose was administered to the patient on 05-Dec-2022. No further information was provided.  No treatment medications were reported.  This case contains information for the first of two patients received vaccine on 05-Dec-2022 as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-688123 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-688123:patient 2 case out of two patients received vaccine on 05-Dec-2022
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 16-DEC-2014, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 12. The lowest recorded temperatures was 32. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
ANGIOEDEMA, GIVEN EPINEPRINE, BENADRYL AND PEPCID. IMPROVED OVER 3 HOURS
received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HAV (Havrix) (batch number E9G4E, expiry date 29th December 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th January 2022, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 24th January 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter reported that a patient received an expired dose of Havrix, which led to expired vaccine used. The reporter gave consent to follow up.
3-4 days following smallpox vaccine developed headache, neck pain, marked fatigue and body aches. These symptoms persisted over the next two weeks along with trouble concentrating and some dizziness.
as of this report, it is day 9 and I still have sore muscles in my arm where shot was given. midway between shoulder and elbow, when using the arm. It gets worse overnight. calms some after rising.
feeling nauseous from the first dose of vaccine; shoulder hurting; This is a spontaneous report from a contactable consumer (patient).  A 58-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK9231), via an unspecified route of administration on 20Jan2021 at 12:30 on the left arm at a single dose for COVID-19 immunization.  The patient had no medical history.  There were no concomitant medications.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she was feeling nauseous from the first dose of the vaccine. She called to find out how long she will be nauseous because this is the second day. The patient stated that she started feeling nauseous about 15 minutes after. The only other symptom is her shoulder hurting since an unspecified date in Jan2021. The patient added that she still feels nauseous. The outcome of the event feeling nauseous from the first dose of vaccine was not recovered while the outcome of the event shoulder hurting was unknown. The case was reported as non-serious.
Severe itching on toes; Severe itching on feet; Toes are swollen; Toes are still blistering; Toes are red; spot on the left side of back near kidney; (spot) hard; (spot) swollen; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Toes are still blistering), INDURATION ((spot) hard), PRURITUS (Severe itching on toes), PRURITUS (Severe itching on feet) and SWELLING (Toes are swollen) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE, PROPRANOLOL, MAGNESIUM and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced INDURATION ((spot) hard), SWELLING ((spot) swollen) and SWELLING (spot on the left side of back near kidney). On 02-Mar-2021, the patient experienced BLISTER (Toes are still blistering), PRURITUS (Severe itching on toes), PRURITUS (Severe itching on feet), SWELLING (Toes are swollen) and ERYTHEMA (Toes are red). At the time of the report, BLISTER (Toes are still blistering), INDURATION ((spot) hard), PRURITUS (Severe itching on toes), PRURITUS (Severe itching on feet), SWELLING (Toes are swollen), SWELLING ((spot) swollen), ERYTHEMA (Toes are red) and SWELLING (spot on the left side of back near kidney) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was not reported
NUMBNESS AND TINGLING ON THE BOTTOM OF THE FOOT (ALL LEFT FOOT) ALL THE TIME NOW; 2ND TOE (LEFT FOOT) HAS BEEN DISCOLORED WITH A RING AROUND IT; SWELLING AND HURTING KNOT ON TOP OF FOOT (LEFT FOOT), KNOT ON 3RD TOE, KNOTS ON CALF, THIGH (ALL LEFT SIDE)/ KNOT ON RIGHT ARM; MUSCLE CRAMPS IN CALF; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no history of known allergies and drug abuse and illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced muscle cramps in calf. On 25-MAR-2021, the subject experienced swelling and hurting knot on top of foot (left foot), knot on 3rd toe, knots on calf, thigh (all left side) / knot on right arm. On an unspecified date, the subject experienced numbness and tingling on the bottom of the foot (all left foot) all the time now, and 2nd toe (left foot) has been discolored with a ring around it. Treatment medications (dates unspecified) included: acetylsalicylic acid, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling and hurting knot on top of foot (left foot), knot on 3rd toe, knots on calf, thigh (all left side)/ knot on right arm, numbness and tingling on the bottom of the foot (all left foot) all the time now, and 2nd toe (left foot) has been discolored with a ring around it, and the outcome of muscle cramps in calf was not reported. This report was non-serious.
This initial spontaneous report was received on 23-OCT-2017 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 18-DEC2010, at a pharmacy, the patient was inoculated (by an unspecified healthcare professional) with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 21-SEP-2016, she was treated (by an unspecified healthcare professional) at a clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The female patient was prescribed Famciclovir (as reported) and KENALOG CREAM for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Patient experienced redness, swelling, itchiness at the site of injection. She felt cramping in her arm. Patient iced her arm and has since feeling better
Patient initially vaccinated against COVID with J&J (date unknown) and boosted with Moderna in 11/2021 was admitted with COVID-19, developing ARDS. While admitted, had new onset afib with RVR and AKI. PMH: COPD, CHF, h/o heroin use (on methadone). She died on 12/21/21 with a primary diagnosis of ARDS due to COVID-19 pneumonia.   Patient admitted 12/11 with COVID pneumonia.  Treated with steroids, remdesivir with worsening oxygen requirements that necessitated transfer to ICU on 12/18 for HHF NC.  Tocilizumab ordered.  Patient with Afib w RVR. She developed progressive hypoxia despite maximal therapy with HHF NC.   Patient was DNR/DNI and multiple conversations occurred around goals.  She received as needed morphine
faint erythema stemming from the medial rt elbow over the lateral biceps area;no streaking axilla tenderness w/o palpable adenopathy;eve of inj had low grade fever & pain @ site;
Medication error. Pt was given Moderna, instead of approved COVID-19 vaccine, Pfizer.
16 year old received Moderna as 1st dose. 2nd dose Moderna was administered according to CDC guidelines - off label use unauthorized age.  Medical Director signed off on Moderna administration.
This case was reported by a healthcare professional and described the occurrence of floppy in a 6-month-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline), ENGERIX B, IPV and Rotavirus vaccine (Non-GSK). On 13 October 2008 the subject received 3rd dose of INFANRIX (.5 ml, unknown, left thigh), unspecified dose of ENGERIX B (unknown, left thigh), unspecified dose of IPV (unknown), unspecified dose of Rotavirus vaccine (unknown). On 13 October 2008, five minutes after vaccination with ENGERIX B, INFANRIX, IPV and Rotavirus vaccine, the subject experienced floppy, flushing and injection site redness. The physician is an allergist and is seeking components for testing of an infant subject that received INFANRIX and ENGERIX B vaccine on 13 October 2008. The subject became floppy and flushed about five minutes after the vaccinations. The subject also experienced redness around the IPV injection site. The subject was observed for a period of time in the physician's office and symptoms were completely resolved after 20 minutes. The physician was not certain if the subject reacted to the INFANRIX, IPV or ENGERIX B vaccination. The brands of the two previous DTaP vaccinations were unknown, but the subject did not have a reaction to them. On 13 October 2008, after 20 minutes the events were resolved. The healthcare professional considered the events were possibly related to vaccination with INFANRIX, ENGERIX B, IPV and Rotavirus vaccine.
Severe swelling and hardening at injection site immediately following injection. The hard lump swelled to 1.5 inches wide and lasted for three days.