chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seriousness criteria other medically significant (OMIC). From initial information received on 4/27/2006 from a literature report, it was reported that a 7 month old male patient, who as 5 months of age had received budging fontanelle and fever following second dose of diphtheria tetanus pertussis vaccine DTP 2, and second dose of trivalent oral poliovirus vaccine OPV 2, received diphtheria tetanus vaccine DT 3. The manufacturer, route and site of administration were not reported for either vaccine. On day post immunization, the patient was found to have bulging fontanelle and fever. He did not require hospitalization and his physical exam was normal. No CBC or lumbar puncture for CSF was complete. The patient recovered one day after the onset of the adverse events. Reportedly there were no conditions ore exposure EG steroids that could have explained the event of bulging fontanelle. Subsequent followup determined that the patient was normal neurologically and developmentally. The reporter for this case is the same as for cases 200600970 to 200600976, 200600979, and 200600980.
Narrative:  c/o since getting 2nd COVID shot, his legs have been giving out and locking up. Both legs cramp and get stiff. Sx started around April 30th. Pt has not fallen but has difficulty getting OOB and walking d/t pain. "c/o since getting 2nd COVID shot, his legs have been giving out and locking up. Both legs cramp and  get stiff. Sx started around April 30th. Pt has not fallen but has difficulty getting OOB and walking d/t pain. "w/Pain reported as 9 on 0-10 scale Pt indicated above was accurate and he has been having some difficulty walking, left foot a little more difficult to lift than right but both feel weaker than usual. Denies any recent injuries. Has chronic back pain which he says includes upper back and neck areas as well. No UE's weakness. Denies any radiculopathy sx's, incontinence, saddle paresthesias. Assessment and plan: Pt needs urgent eval to r/o spinal stenosis. Sx's are BLE, left greater than right and concern is for cervial stenosis.  Discussed with pt
Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period; 1 Expired Doses Administered - date of administration on 11-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Expired Doses Administered - date of administration on 11-Feb-2022) and PRODUCT STORAGE ERROR (Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 Expired Doses Administered - date of administration on 11-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 Expired Doses Administered - date of administration on 11-Feb-2022) and PRODUCT STORAGE ERROR (Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.
Complaint of soreness in area of IM injection. Some redness and heat as well. Complaint made 3 days after injection.
PT WANTED FLU SHOT. PATIENT RECEIVED SPIKEVAX VACCINE INSTEAD.
After my 1st covid vaccine on 9/19/21 I started my menstrual cycle as usual and when I should have started.  My cycle was on time but clotting was present.  After my 7 day cycle stopped I continued having bad "stomach cramps" that are consistent with a menstrual cycle for a week.  No bleeding noted for that week.  Then I started bleeding again  and clotting is present.  I haven't had any issues with my cycle,  it has been normal and consistent for many years. A change took place after my first covid vaccine.  My cycle is ongoing at the present time.
Had OM w/effusion-not red, not irritable, no fever; t104 24hrs post vax; No obvious source of fever otherwise;
Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). An adult male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date unknown), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient experienced soreness at injection site in Dec2020. Since the vaccination, it was unknown had patient been tested for COVID-19. The outcome of the event was unknown. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Caller reporting an expired dose of VARIVAX was administered to a patient; This spontaneous report has been received from an office manager  concerning a patient of unknown age and gender. The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.       On 04-AUG-2020,  the patient was vaccinated with an expired dose of  varicella virus vaccine live (oka/merck)(VARIVAX) formulation not reported but defaulted to subcutaneous injection,  0.5 ml,  Lot # R018142, expiration date 26-JUN-2020 for prophylaxis (frequency and patient route of administration were not reported).  No additional adverse event details were available.
Patient was seen in office and received her Moderna 2nd dose 1 day too early.
Left arm injection site became quite itchy and red which subsided on its own within 2-3 days. This happened about a week after the vaccine.
This spontaneous report as received from a Licensed Practical Nurse refers to 3 patients of unknown age and gender. Concomitant medication and current conditions were not reported. On 08-DEC-2014, the patients were vaccinated with an improperly stored dose of PEDVAXHIB (dose, route, lot number and expiration date were not reported). Concomitant medications were not provided. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
very tired; low grade fever; with muscle/joint pain; with muscle/joint pain; Light headed- few min after injection and lasted about 25 min.; Metalic taste that lasted a few hours; Pain and small lump at injection site; Pain and small lump at injection site; This is a spontaneous report from a contactable consumer (patient). A non pregnant 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 02Mar2021 20:15 (at the age of 59-years-old) at unknown dose number single for covid-19 immunization. Medical history included cancer, diabetes, hypertension, asthma, high cholesterol, emphazema, arthritis, fibromyalgia, neuropathy and penicillin allergy. The patient previously took diclofenac, celebrex and experienced drug allergy. Concomitant medications included 19 medications of which patient could list only 4. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The most recent covid-19 vaccine was administered at Pharmacy or Drug Store. The patient experienced light headedness few minutes after injection and lasted about 25 min. Patient had metallic taste that lasted a few hours on 02Mar2021. She had pain and small lump at injection site that increased overnight and throughout day on 02Mar2021. She was very tired, had low grade fever with muscle/joint pain on 03Mar2021 morning. No treatment was given for the events. The outcome of the events Light headed and  Metallic taste was recovered on 02Mar2021 while rest of the events were recovering.  No follow-up attempts are possible. No further information is expected.
5 days following receipt of AVA#2 & HEPB#2, SM developed discomfort in right axilla with small lump & facial warmth - he was afebrile; on day 6 post-vaccination, he developed mildly pruritic eruptions which appeared like "red pinpoint dots" spreading from right anterior axillary line across anterior upper chest, lower right neck, to left axilla (PCM described as papular rash- no photos taken); SM took 2 doses of Zytec on 11/20 & 11/21, rash lasted total 3 days. No systemic symptoms, underlying past medical history, prior drug or vaccine allergies. SM was well 2 weeks prior & day of vaccinations. On 10/8/2008 SM received AVA #1, HEPB #1, Tdap, typhoid, & Influenza IM w/o reactions.
4-5 days after admin. of vaccine, I experienced pain from bottom of left deltoid to behind left ear all the way up the side of my neck. Pain lasted x1 wk. Missed 1 day of work.
He was itching behind both ears and now it is in the crack of his butt and on his butt cheeks; It is big, welty, and red; It is big, welty, and red; Rash was reported as worsened.; Rash; This is a spontaneous report from a contactable consumer or other non hcp. A 79-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, lot #: EL3302), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 (Batch/Lot Number: EL3302) as SINGLE DOSE for covid-19 immunisation. Medical history included gingival disorder from an unknown date and unknown if ongoing. Concomitant medications included doxycycline hyclate (DOXYCYCLINE HYCLATE), chlorhexidine gluconate (CHLORHEXIDINE GLUCONATE) taken for gingival disorder from 21Jan2021 to 06Feb2021. On 06Feb2021, the patient experienced rash, on an unspecified date he was itching behind both ears and now it is in the crack of his butt and on his butt cheeks, it is big, welty, and red, rash was reported as worsened. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of he was itching behind both ears and now it is in the crack of his butt and on his butt cheeks (pruritus). The outcome of the events was not recovered. The outcome of the event rash was reported as worsened was unknown.
Early facial flushing, then neck and chest itching, follow by burning, inflamed skin. Immediately took OTC extra-strength Benadryl. Two does before bed.  Woke up my entire core was covered, front and back with prickly, itchy, sun-burn type rash. Paged my PCP Sunday morning @ 8am.  PCP called in prescription for Prednisone 20mg (2x daily) for 5 days, along with Hydroxyzine 25mg (3x daily).
Dose administered to adult patient from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vials instead of bivalent vaccine).    No relevant concomitant medications were reported. On 8 Oct 2022, 9 Oct 2022 and 10 Oct 2022 vaccine was administered. Reporter was not aware of any AEs after the vaccines were given. No treatment medication reported.   This case refers to patient- 1 out of 26 patients.
Immediately following the injection, my daughter began exhibiting seizure like symptoms. For several seconds, she was convulsing and her eye movement was erratic. Her blood pressure dropped and she was sweating.
On the seventh day after receiving the first vaccination I started to feel itchy all over my body and I developed many hives all over my body. This itchiness turned into urticaria.
Patient was administered dose from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered dose from an expired vial) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered dose from an expired vial). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Patient was administered dose from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.  The reporter later realized that the vial from where the vaccine was administered was found to be expired after administration.  The vial had not undergone through a temperature excursion and was initially stored in the refrigerator on 03-Jan-2022 and kept in freezer since arrival until the day of use.   This case was linked to MOD-2022-438672, MOD-2022-438670, MOD-2022-438657, MOD-2022-438669, MOD-2022-438671, MOD-2022-438674, MOD-2022-438675, MOD-2022-438676, MOD-2022-438677 (Patient Link).
Information has been received from a nurse referring to a patient of unknown age and gender. On 14-JUL-2017 the patient was vaccinated with the first dose of GARDASIL 9 (lot#, expiration date, dosage and route unspecified) and second dose of GARDASIL 9 (lot # N000326, expiration date of N000326; dosage and route unspecified) on 24-AUG-2017 for prophylaxis (inappropriate schedule of drug administration). No adverse effects were reported. The patient had not received a third dose of GARDASIL 9 at the time of the report.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L028666, expiry date: 04-NOV-2016; dose and route were not reported). There were no adverse effect reported after improperly stored vaccine was given to the patients. This is one of two reports received from the same reporter. Additional information has been requested.
Narrative:  Pt was a 91 YO male with PMH of vasculer dementia, HTN, HDL, SSS s/p pacer, and urinary incontinence referred to hospice for dementia; pt ultimately refused hospice care. Pt's family feels that his decline accelerated after receiving 2nd COVID vaccine. This assertion was not corroborated by provider in chart. Pt's family also stated their belief that his refusal to leave bed was symptomatic of depression & grief.
HEADACHES DIZZY FEELS FAINT UPON EXERCTION HAPPENS MID MORNING.
Severe diarrhea, Pain all over body, sore throat, cough, fever/chills, lost of appetite, Headache, overall fatigue and felt awful. All over pain, fever  and diarrhea lasted 3 days. Loss of appetite lasted about 9 months. I lost 25 lbs. Did not lose sense of taste or smell, but all food smelled rancid. Could not eat very much. Headache lasted about 4 months. I still feel awful and still experience fatigue. Now I am hurting all over my body again like I did in the beginning. I have never completely gotten over sore throat or cough. This may be allergies now.  My appetite is still not good. Food does not smell good.. Foods I enjoyed, I can no longer tolerate. Haven't lost any more weight since about February of 2022.
shortness of breath; cough; sneezing; Headache; This is a spontaneous report from a contactable consumer (patient) reported that a 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced shortness of breath, cough, sneezing, and headache. The patient also mentioned that he had to go to the emergency room. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Pfizer-BioNTech COVID- 19 Vaccine EUA Patient inadvertently received an injection of 0.6 ml (60 mcg) of vaccine.
Incident occurred from possible inviable dose being administered to patient. We tried to reach the patient 3 times but no answer.
I think the rash started the night of the vaccination (Monday) and then progressively got worse (today is Thursday).  The rash is on my face (cheek area); my face is flushed and slightly itchy.  I'm applying ice and I just took a benedryl, hoping to stop it from getting worse.  I called my doctor and she said this reaction could definitely be from the vaccine.
Patient called our office on 1/5/03. Patient complained of rash that started on 1/4/03. Pat had flu vaccine on 1/3/03. Patient complained of pruritis and rash. Patient to take Benadryl. Patient denies other symptoms. Afebrile, no SOB.
Reports that she had a flu shot 2 weeks ago 10/5/2020. Reports that she noticed a pressure, when she got the shot, but didn't think much of it, until it has just persisted. Upper left shoulder where the shot was injected his sore, the pain radiates around her medial upper arm and under her armpit. She does take care of her grandson who is 17 months old, and she has been busy with him. Has not been resting. Has been taking Tylenol, but no ibuprofen. No flu-like symptoms.  Left arm pain   Continue ibuprofen tablet, 200 mg, 4 tab(s), orally, every 8 hours Clinical Notes: suspect due to muscle and/or nerve irritation s/p flu shot. recommend treating with ibu TID x 1 week. advised to rest and ice so as not to cont. to aggravate it.
This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) 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 patient experienced initially took the Janssen and Janssen vaccine and had severe allergies. The action taken with covid-19 vaccine was not applicable. The outcome of initially took the Janssen and Janssen vaccine and had severe allergies was not reported. This report was non-serious.
Moderna COVID-19 vaccine EUA  9pm: began feeling cold, a little out of it, like an illness was coming on 11pm - 11am: chills and sweats throughout the night, possibly had a fever but didn?t take my temperature. Very restless sleep 11am (2/7) - 9pm: alight body aches and headache throughout the day. Much better than the night before but not 100%.  7am (2/8): headache, but no body aches or other symptoms
2 days after the pneumonia/flu shots patient complained of severe continued body aches and chills. At times has severe pain in the spot where the pneumonia shot was given. He continues to have chills and body aches. Has been to ER and they did blood work and a good exam and sent him home. Has a pneumonia shot about 18 years ago. Went to ER.
myocarditis; chest pains; tachycardia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001244 (Novavax).  A 67-year-old female patient received bnt162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "chest pains"; MYOCARDITIS (medically significant) with onset 2021, outcome "unknown"; TACHYCARDIA (non-serious) with onset 2021, outcome "unknown". Clinical course: Patient started treatment with Pfizer BioNTech COVID-19 vaccine dose 1 on 13Mar2021, and dose 2 on 16Aug2021 for COVID-19 immunisation. After the 1st dose, on unreported dates, the patient had chest pains for 9 months, tachycardia, and myocarditis.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300327879 same patient, different dose/event;
Itchy rash around the site of the injection appeared the morning of the third day after my injection. I also lost my balance in the middle of the night the first night after the injection but I have no idea if that was side effect to the vaccine or something else.
Large red and swollen area measuring 6 in x 4 in wide, with induration. Warm to touch.
COVID-19 infection; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint (PQC) 90000210009. This case, from the same reporter is linked to 20220104644.
I had my annual work physical and failed my EKG test. I have been getting the same physical for work for 27 years and have never failed my EKG test.
Redness approx. 3 in in diameter over deltoid are right arm. Denies fever, itching.
Patient had possible seizure. Patient had fever, eyes rolled back and then passed out for >30 seconds.  Patient then had some dyspnea and a croupy cough.