chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no known adverse effects; a patient only received a partial dose of GARDASIL 9; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.       On an unknown date, the patient was vaccinated with a partial dose (underdose) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (route of administration, anatomical location, and dosage regimen were not reported; lot number 1637642, which has been verified to be valid, expiration date reported and validated as 28-MAY-2022) as prophylaxis. No known adverse effects. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637642; expirationdate: 28-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Immediately after vaccine I got a warm, tight feeling in my upper chest, lower neck and shortness of breath briefly. That dissipated after a few minutes but he warmth and tightness remained, in addition to the start of itchiness in my throat and right ear.
Grandma came to hlth dept to report that pt had been having tremors of rt hand for the past week, so much so that pt can not hold fork to eat; wondered if it might be a reaction to MMR given on 17SEP92;
This spontaneous report as received from a Nurse Practitioner refers to an unknown number of patients were inadvertently vaccinated with GARDASIL, RECOMBIVAX HB, VAQTA and PEDVAXHIB had been improperly stored. No further information was provided. Additional information was received from Nurse practitioner, who reported that GARDASIL, RECOMBIVAX HB, VAQTA, and PEDVAXHIB went through multiple unsupported temperature excursions from 10/09/2013 to 10/17/2013. The Nurse practitioner reported GARDASIL (Lot# J003727, expiration date 11/07/2015) was administered to 2 unspecified patients on 10/10/13 (MARRS# 1310USA015162), 2 unspecified patients on 10/12/13 (MARRS # 1401USA000269), 1 unspecified patient on 10/14/13 (MARRS# 1410USA000273), 1 unspecified patient on 10/17/13 (MARRS# 1401USA000271) and 1 unspecified patient on 10/19/13. GARDASIL (Lot# J008423, expiration date 01/21/2016) was administered to 3 unspecified patients on 10/25/13 (MARRS# 1401USA000268) and 1 unspecified patient on 10/26/13 (MARRS# 1401USA00027). VAQTA (Lot# J008090, expiration date 08/23/2015) was administered to 1 unspecified patient on 10/17/2013 (MARRS# 1401USA000279) and 1 unspecified patient on 10/25/2013 (MARRS# 1401USA000278). RECOMBIVAX (Lot# H012250, expiration date 02/06/2015) was administered to 1 unspecified patient on 10/26/2013 (MARRS# 1401USA000277). PEDVAXHIB (Lot# J005670, expiration 12/17/2015) was administered to 1 unspecified patient on 10/15/2013 (MARRS# 1401USA000275), 1 unspecified patient on 10/25/2013 (MARRS# 1401USA000276) and 1 unspecified patient on 10/29/2013 (MARRS# 1401USA000280). No adverse effects reported. No further information was provided. Additional information has been requested.
Pt was given flu vaccine at about 10:00 am. At 10:25am pt c/o feeling flushed, itching and tingling in arms and hands and back. BP 120/80. Pulse 90. Given Diphen 50mg tab po. Pt stated felt better after 15 mins. No tingling and only minor itching. Decreased flushing. BP 120/80. P 80. Advised school nurse of pt's condition and above medication.
The symptoms, sore throat, sneezing, runny nose, nasal/ear congestion, sore arm, tired/fatigue, occasional lightheadedness, headache.
Patient was given covid Pfizer bivalent ages 5-11 instead of Moderna dose 2 6 months- 5 yrs.   Tolerated with no problems, no fevers or other side effects.   This was given in place his 2nd dose of Moderna primary series on accident.
Still rapid antigen positive on day 20; Still rapid antigen positive on day 20; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (COMIRNATY), on 18May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Still rapid antigen positive on day 20". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive; (Jun2022) Negative, notes: Negative tests on day 8, 9, 10, maybe; (Jun2022) Positive, notes: Still rapid antigen positive on day 20. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PATIENT HAD A SEVERE MIGRAINE THE NIGHT OF GETTING THE 2ND MONDERNA VACCINE. THE NEXT DAY SHE HAD A TONIC-CLONIC SEIZURE. PATIENT IS BEING SEEN BY ER AND PCP THEY HAVE DONE SEVERAL TEST AT THIS TIME-EEG/CT SCAN OF HEAD. PHARMACY WAS NOTIFIED TODAY OF EVENT AND PATIENT WAS STILL UNDERGOING TESTING BUT HAD NOT HAD ANOTHER SEIZURE AT TIME OF CONVERSATION.
injection administered at 1100. No adverse symptoms noted at time of release 1115. Had no problems with first injection other than expected vaccination symptoms. At 1130, patient contacted me, stating she'd developed a rash to her R forearm with itching. Advised to return to clinic ASAP. Returned at 1143, red rash noted to R forearm/wrist area with pruritis. States "throat feels a  little tight" Benadryl 50 mg IM given, tol well. Monitored until 1310, o2 sats remained 96-99%, P-81-92, RR-16-20, last BP 112/76. Released to family with instructions to call 911 if any further problems, voiced understanding.
PSA indicator very high; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA indicator very high) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Prostate cancer. Concomitant products included OLAPARIB (LYNPARZA) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA indicator very high). At the time of the report, PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA indicator very high) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided
(L) arm turned red and about 1 1/2" across. Itchy. No sx til this AM. Recommended warm compress, hydrocortisone cream for itch. TYLENOL PRN.
received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number unknown, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 18th January 2023, unknown after receiving Twinrix and Twinrix 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 Information: GSK Receipt Date: 19-Jan-2023 Reporter's Comments: The pharmacist reported that a patient inadvertently received an expired dose of Twinrix. The reporter consented to follow up. The healthcare professional could not provide the patient demographics or lot number of dose Additional supportive information: The patient was administered an expired dose of Twinrix, which led to expired vaccine used.
Pt recvd vax late afternoon of 17MAR93 & mom states that pt had a fainting spell the next morning; pt  collapsed momentarily then recovered;
Post 3rd dose in series, this child experienced bacteremia. Unspecified blood work was positive for Haemophilus influenzae type B. Vax failure was noted.
Information has been received from a wholesaler calling on behalf of a physician concerning three pt's who were each vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644106/0819M). Subsequently, the pt's developed inflammation around the injection site that included redness and soreness. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from a physician concerning the three pt's, which included a 68 year old pt, who between 06/01/03 and 06/04/03 were each vaccinated SC with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644106/0819M). Subsequently in approximately June 2003, all three pts developed local swelling, malaise and were not feeling well, "i.e. local reaction". Within three to five days, all three pt's had recovered with no residual problems. The reporter noted, "we had 2 more bottles of the same batch, will return". The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The other two pt's included a 69 year old pt (WAES # 0307USA03537) and an 89 year old pt (WAES #0307USA03535).  Additional information is not expected.
Information has been received from a physician concerning a 2-month-old patient who on 28-MAY-2008 was vaccinated orally with an incomplete first dose of ROTATEQ.  The patient spit up immediately after the oral administration.  No problems reported.  A product quality complaint was not involved.  No further information is available.
Patient received the dose for the 5-11 age group instead of the 12 and up dose. She received the the 12 & up  dose for her initial dose.
Information has been received from a registered nurse concerning a 26 year old female patient with no pertinent medical history and no known drug allergies/drug reactions, who on 12-DEC-2008 was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (lot #658424/1181U). There was no concomitant medication. It was reported that the patient developed three spots on the left side of her neck on 13-DEC-2008. It was noted that one spot appears like a vesicle while the others just look like red mosquito bites. It was reported that the spots were unchanged since 13-DEC-2008. The patient sought medical attention. Additional information has been requested.
Patient received second dose of Pfizer vaccine 2/21/21. Patient is unable to recall the name of facility that he received the vaccine, but states that it was at a clinic. Patient's vaccination card was left at home. Patient developed symptoms of shortness of breath on 2/24/21, which were mild at first but progressed to severe and resulted in him coming to the hospital on 2/26/21. Patient had a thorough cardiac work-up and it was found that patient has severe aortic regurgitation. Patient is still hospitalized waiting for a TAVR on Monday, 3/8/21.
Red area on L upper thigh where varicella vaccine was given. Warm to touch. Fevers off and on all weekend 11/17 and 11/18. No other Sx.
Angioedema; Tongue started swelling; her tongue started swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANGIOEDEMA (Angioedema) and SWOLLEN TONGUE (Tongue started swelling) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Angioedema (Patient has a history of angioedema to ACE inhibitors). Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), GABAPENTIN, POTASSIUM, NIFEDIPINE, ISOSORBIDE, ESOMEPRAZOLE, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 11-Feb-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criteria hospitalization and medically significant) and SWOLLEN TONGUE (Tongue started swelling) (seriousness criterion hospitalization). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; METHYLPREDNISOLONE at an unspecified dose and frequency and FAMOTIDINE at a dose of Famotidine for 5 days. On 12-Feb-2021, ANGIOEDEMA (Angioedema) had resolved. At the time of the report, SWOLLEN TONGUE (Tongue started swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,  a causal relationship cannot be excluded.
Patient started to have food poisoning like feeling that lasted for about 12 hours.  She had extreme GI upset and Myalgia.
NO ADVERSE EFFECT, REPORTING AS PER PUBLIX PHARMACY PROTOCOL: VACCINATION GIVEN BEYOND USE DATE OF 07/13/2023
he has body ache; his pulse is 105-107; feels like he has the flu,; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (he has body ache), TACHYCARDIA (his pulse is 105-107), INFLUENZA LIKE ILLNESS (feels like he has the flu,) and HEADACHE (headache) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN (he has body ache), TACHYCARDIA (his pulse is 105-107), INFLUENZA LIKE ILLNESS (feels like he has the flu,) and HEADACHE (headache). At the time of the report, PAIN (he has body ache), TACHYCARDIA (his pulse is 105-107), INFLUENZA LIKE ILLNESS (feels like he has the flu,) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment drugs were reported.
Pt stated that on the day she received her injections, her arm was sore, red, and at one point, had swollen to the size of a grapefruit. By the next day, the swelling had subsided, but her arm was still sore and red. She took TYLENOL, rested, and it was suggested that she apply a cold compress to the affected area.
Felling faint, nausea, SEVERE pain daily since February 10th of unknown origin. They did CT scans,  ultrasounds, lab work, and I?ve seen a GYN specialist to rule out an ovarian cysts.  They gave me  Ibuprofen and Diazepam. And now they?re calling in Cipro to rule out a kidney infection. They don?t know why I?m having severe left side pain. Oh I was also given Morphine in ER
fatigue; moderate body aches; Poor sleep for the one night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 14:00 as dose 1, single (Lot number: HF9275) at the age of 39 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 10Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 05 (Booster), Manufacture: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 04 (Booster), Manufacture: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 03 (Booster), Manufacture: Unknown), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization Series Completed, Manufacture: Unknown), for COVID-19 immunization. The following information was reported: POOR QUALITY SLEEP (non-serious) with onset 10Oct2023 at 23:00, outcome "recovered" (Oct2023), described as "Poor sleep for the one night"; FATIGUE (non-serious) with onset 11Oct2023 at 23:00, outcome "recovered" (Oct2023); PAIN (non-serious) with onset 11Oct2023 at 23:00, outcome "recovered" (Oct2023), described as "moderate body aches". Therapeutic measures were not taken as a result of poor quality sleep, fatigue, pain.  No follow-up attempts are possible. No further information is expected.
On Oct 13th I got the shot - 45 min. later - I had the diarrhea and it lasted almost a month. I went to the emergency room on the 20th of Oct.
Patient received her first dose of Moderna Covid 19 vaccine and was asked to wait for 15 minutes post vaccine. 5 minutes later patient said her throat and arms were itchy. Pharmacist asked to check on the injection site and to observe patient's lips and throat. They all look normal, not red or swelling. At 11:50am pharmacist gave patient Benadryl 25mg in liquid form to help with the itchiness. Pharmacist checked on patient 10 minutes later, she stated that itchiness remains around her throat and there was a dull pain in her throat. pharmacist checked her throat and lips. there was no anaphylactic reaction. Pharmacist gave patient second dose of Benadryl 25mg and informed patient that it will take about 10-15 minutes for the itchiness to go away. Pharmacist measured patient's blood pressure and pulse at 12:00pm. Readings were 129/90 for blood pressure and Pulse was 69. Again there was no signs and symptoms of anaphylactic reaction. However, pharmacist offered if patient wanted us to call her an ambulance but patient refused. 10 minutes later, patient came to inform pharmacist that she was feeling fine and no itchiness in her throat or anywhere in her body. Patient wished to leave the pharmacy and headed home. Pharmacist advised patient to monitor the signs and symptoms of any type of reaction. If the itchiness and sore throat came back, patient should seek medical help immediately. Patient acknowledged that she would do so.
I developed pityriasis lichenoide (per biopsy) within close proximity to booster with Pfizer. Per dermatologist could have been triggered by booster dose, also had flu vaccine 2-3 weeks prior.  If/when next booster is needed I will get Moderna.
Fever 105.7 poss early respiratory infection; will use ped DT in future;
The morning of 7/6/19 (L) upper arm was noted to be  erythematous, with moderate edema. Upper arm was warm  to touch & indurated. Child was taken to an  Urgent Care where the diagnosis of vaccine reaction  and cellulitis were made. Child was started on  Clindamycin & told to use warm compresses 3x/day.  To f/u with our office in 2-3 days.
Left upper and lower arm tingling and pain and numbness intermittent starting 2-3 days post injection, has persisted for 20 days, without resolution. May have started earlier, but thought it was just due to recent injection.  8/19/08 Reviewed pcp office records of 12/19/07-7/16/08. FINAL DX: none provided. Records reveal patient experienced good health.  HPV #1 given 5/13/08, lot 0152X, IM, LA;  HPV#2 given 7/16/08, lot 0152X, IM, LA.  No indications of complaints at either vaccine nursing visit.
Admit 10/24/22 with stroke. Symptoms started 10/20/22.  Stopped warfarin 10/22/22 for spine stimulator placement. CTA showed large right MCA stroke and large distal ICA cavernous saccular aneurysm.  Subsequent brain MRI shows a right MCA mass, concerning for malignancy.  Currently on decadron. Still hospitalized.
Raised red bump with bruising, raised bumps around injection site and along back of arm near injection site.
pt recv vax MAY95 & on 7NOV96 pt devel two lesions;the next day pt devel 6 lesions on trunk which looked like classic chicken pox lesions;
Localized rash and swelling at site of injection. Patient reports fever and night sweats over the weekend. Patient also reports soreness at site of injection, too.
11/21/02 Patient started running fever. Left thigh site hard, swollen at site. Mother gave Motrin for 2 days. Child RTC on 11/23/02 for TB reading. Site evaluated by doctor; possible infection. Child paced on Keflex 250mg PO TID for 5 days.
Patient received 0.2 mL of the Pediatric (Orange Cap) Pfizer Covid-19 Vaccine (NDC: 59267-1055-01) undiluted. Patient was observed for 45 minutes to 1 hour after receiving the vaccination and had no adverse reactions, reported feeling normal. Patient (and parent) were informed they may have stronger local side effects and systemic effects, but if anything severe were to occur to call 911. Patient left after this. This entire event occured between 3pm - 4:45pm PST.
Sore arm (L arm pain); sore, stiff neck; Sore, stiff neck; Baseball sized lump at the injection site; injection site warmth; Injection site itch; hard, red, baseball sized lump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm (L arm pain)), MUSCULOSKELETAL STIFFNESS (sore, stiff neck), NECK PAIN (Sore, stiff neck), INJECTION SITE MASS (Baseball sized lump at the injection site) and INJECTION SITE WARMTH (injection site warmth) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm (L arm pain)), MUSCULOSKELETAL STIFFNESS (sore, stiff neck), NECK PAIN (Sore, stiff neck), INJECTION SITE MASS (Baseball sized lump at the injection site), INJECTION SITE WARMTH (injection site warmth), INJECTION SITE PRURITUS (Injection site itch) and INJECTION SITE ERYTHEMA (hard, red, baseball sized lump at the injection site). At the time of the report, PAIN IN EXTREMITY (Sore arm (L arm pain)), MUSCULOSKELETAL STIFFNESS (sore, stiff neck), NECK PAIN (Sore, stiff neck), INJECTION SITE MASS (Baseball sized lump at the injection site), INJECTION SITE WARMTH (injection site warmth), INJECTION SITE PRURITUS (Injection site itch) and INJECTION SITE ERYTHEMA (hard, red, baseball sized lump at the injection site) had resolved.            No concomitant medications were provided. No treatment medications were provided.  Action taken in response to mRNA-1273 is considered to be not applicable.   This case was linked to MOD-2021-013182, MOD-2021-013182 (Patient Link).
Myalgia, Fever, Tachypnea, Rash, Increased Heart Rate for 8 hours, Rash, Myalgia, Fever, Night Sweats, Fatigue Narrative:
Menstrual bleeding started about 2 hours later. Fever, chills, aches, joint pain, sharp headache, around that afternoon at 7PM. Fever and chills went away after 24 hours. Joint pain and stabbing headache remained for about 48. Currently still bleeding on day 5 and getting occasional sharp headache pains that last around 5 minutes and go away for hours. Joints still feel a lingering ?soreness? almost. Last night, day 4 the cramps that accompanied the bleeding intensified greatly and were very painful. Today I have much more ?period like? cramping still. Previously cramps were there but minimal and occasional.