chrisvoncsefalvay/vaers-outcomes huggingface dataset:
painful rash; severe pain in his arms; passed away; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the pt was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. After the receipt of the vaccine, the pt experienced a painful rash and severe pain in his arms. As a result of these symptoms, the patient was seen and treated by medical providers. The outcome of the events was unknown. On 18-JAN-2021, the patient passed away (cause of death and information if autopsy was performed or not were not provided). As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using the vaccine. As a further proximate result, the pt sustained severe and permanent personal injuries, suffered serious, progressive, permanent, and incurable injuries. The reporter considered the events of painful rash and severe pain to be related to zoster vaccine live (ZOSTAVAX). The causality assessment between the patient's death and suspect therapy was not provided.  The event of painful rash and severe pain were considered disabling by the reporter.
3 year old patient inadvertently received Flublock instead of Fluzone, no AE; 3 year old patient inadvertently received Flublock instead of Fluzone, no AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Pharmacy-Other).  This case involves a 3 years old patient who inadvertently received a dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (batch number, expiry date, route and site was not reported) instead of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 30-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administered and wrong vaccines administered.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
DOSE ADMINISTERED AFTER BEING STORAGE FOR 30 DAYS BETWEEN 2-8 DEBREE C
Client with self report of fear of needles. Received Tdap without incident. Was finishing receiving HPV when complained of burning at site and dizziness. At that time client became pallor and head dropped down, body slumped to left and eyes went back. Bil arms drew in towards her chest and legs stiffened. Client lowered from high back chair to floor and legs raised to be above clients head. Client remained unresponsive for 20-30 seconds. EMS and client's mother notified. After approx 30 sec client began kicking, swinging arms, and screaming...this lasted approx 2-3 minutes. Nurse stayed with her protecting her from harm and reassure her. After approx 3 minutes, client became alert "sorry I was yelling". Skin cont to be pallor, BP 92/56 P 66 R regular 16. EMS arrived- client signed waiver and declined service. Mother arrived and reports patient with history of fainting with lab work. Repeat BP check.. 90/54. After sitting with fan and cool drink of water for 15 minutes, client left with mother. Mother did also report client had a heart murmur as a child but has not been detected with most recent visits to PCP. Also reports client with history of low BP.
Information has been received from a health professional regarding GARDASIL in a prefilled syringe (lot # 0947X).  It was reported that the prefilled syringe leaked at the hub.  The patient was able to receive the dose.  No AE reported.  The SR# is 1-3272605316.  Additional information has been requested.
Whelps over body w/in 6 hrs of receiving HIB vax; t102;
The day of the injection I only had a swollen arm.  The second day was the worst, including continued swell of the arm, eczema on the site of the injection and below the armpit, and general feeling of weakness. I am writing this report on my third day and I still have a swollen arm, redness in both the arm and the armpit, and a swollen lympho gland.  I was administered one dose only since I had had covid last year, and so I was told one dose suffices.
Information was received from the parents of a 5 year old male patient with no pertinent medical history. On 05-JAN-2010, the patient received a routine vaccination with RECOMBIVAX HB (dose and route of administration not provided). Subsequent doses of RECOMBIVAX HB were received on 09-MAR-2010, 09-JUN-2010, and 12-AUG-2010. There were no concomitant medications. The parents explained that their son had adverse reactions after receipt of RECOMBIVAX HB with specific symptoms reported as: developing a fever of up to 104F, "yellowey" runny stools, pain in his joints, and irritability that lasted several days after receiving each dose. The parents stated that the symptoms began shortly after receipt of each dose and lasted for about 1 week. The patient experienced the same symptoms after receiving M-M-R II and VARIVAX (Merck) (WAES#1505USA001794). The patient has not had any further vaccinations with any of these products since 2011. The physician's office was called and treatment was reported as MOTRIN and tepid bath. The patient recovered about 1 week after each vaccination. No further information was provided. Additional information has been requested.
No additional AE reported; HCP reported that a patient received his 1st dose of RECOMBIVAX HB in June2021. He didn't get his 2nd dose until  July2022.; This spontaneous report was received from a nurse and refers to a 70-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date in June 2021, at the age of 69 years old, the patient was vaccinated with his first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis (dose, lot #, expiry date, anatomical location and route of administration were not provided). On an unknown date in July 2022, at the age of 70 years old, the patient was vaccinated with his second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis (dose, lot #, expiry date, anatomical location and route of administration were not provided) (inappropriate schedule of product administration).   There were no adverse events reported (no adverse event).
No adverse effects were reported; Multiple patients were administered improperly stored PROQUAD. Temperature -3 C; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions/allergies, concurrent conditions and concomitant medication were not reported.      On 10-JUN-2019, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030805, expiration date: 22-APR-2020, albumin status: rha) (dose number, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot #, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA010323: US-009507513-1906USA010324: US-009507513-1906USA010325: US-009507513-1906USA010330: US-009507513-1906USA010328: US-009507513-1906USA010329: US-009507513-1906USA010327: US-009507513-1906USA008695: US-009507513-1906USA010326: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662:
Administered wrong Covid Pfizer dose (based on age).  Inadvertently Administered Pfizer Covid Gray top (0.3ml) 12+ yrs to a female that is 11 yrs old (weight 203lbs).  I immediately informed the doctor, my supervisor and the patients Mother of the error.  Patient was advised to wait and additional 15 minutes after administration to watch for side effects.  No side effects were observed and patient left with her Mother.
This spontaneous report was received from a nurse and refers to a 27-year-old female patient. The patient's concurrent conditions included immunodeficiency. The patient's medical history included kidney transplant she received as a toddler. There was no drug reactions or allergies reported. Concomitant therapy included sulfamethoxazole, trimethoprim (BACTRIM), azathioprine(IMURAN [AZATHIOPRINE]), intrauterine contraceptive device(PARAGARD T380A), prednisone, montelukast sodium(SINGULAIR) and lisdexamfetamine mesilate(VYVANSE). In approximately 2016 (reported as approximately 5 years ago), the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0.5 ml, intravenously (anatomical location, lot number and expiration date were not reported) as Human papillomavirus (HPV) vaccination. The nurse reported that the patient went to her dermatologist who confirmed she had warts on her hands (skin papilloma); the exact date of the dermatology appointment was unknown. It was reported that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) series was completed prior to confirmed case of warts. There were no specific details about treatment since the reporter practice was not the treating provider. At the time of the report, the outcome of the event was unknown. The relatedness between the event of skin papilloma and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
pain at injection site; arm was red throughout the entire arm; swelling at injection site / arm was puffy; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (For tolerance to 1st dose refer linked case US2019AMR146569).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site swelling, injection site pain and erythema of extremities. On an unknown date, the outcome of the injection site swelling and erythema of extremities were recovered/resolved and the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site swelling, injection site pain and erythema of extremities to be related to Shingrix.  Additional information received were as follows: This case was reported by the patient who himself/herself was a Pharmacist. The age at vaccination was not reported. The patient did not experienced swelling or pain other than just where injection was given. The patient inquired, what do you considered a severe reaction to the vaccine. The patients arm was puffy and red throughout the entire arm and hand for over a week. The patient inquired, should he/she have not taken the 2nd dose with this kind of reaction. The patient decided to take the 2nd dose and got basically no reaction but was prepared for possible more severe response.
overall body stiffness; tightness on the injection arm; discomfort the injection arm; tingling on the injection arm; itchiness on the injection arm; redness on the injection arm; tenderness on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (overall body stiffness), VACCINATION COMPLICATION (tightness on the injection arm), VACCINATION SITE DISCOMFORT (discomfort the injection arm), VACCINATION SITE PARAESTHESIA (tingling on the injection arm) and VACCINATION SITE PRURITUS (itchiness on the injection arm) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (overall body stiffness), VACCINATION COMPLICATION (tightness on the injection arm), VACCINATION SITE DISCOMFORT (discomfort the injection arm), VACCINATION SITE PARAESTHESIA (tingling on the injection arm), VACCINATION SITE PRURITUS (itchiness on the injection arm), VACCINATION SITE ERYTHEMA (redness on the injection arm) and VACCINATION SITE PAIN (tenderness on the injection arm). At the time of the report, MUSCULOSKELETAL STIFFNESS (overall body stiffness), VACCINATION COMPLICATION (tightness on the injection arm), VACCINATION SITE DISCOMFORT (discomfort the injection arm), VACCINATION SITE PARAESTHESIA (tingling on the injection arm), VACCINATION SITE PRURITUS (itchiness on the injection arm), VACCINATION SITE ERYTHEMA (redness on the injection arm) and VACCINATION SITE PAIN (tenderness on the injection arm) outcome was unknown.            This case was linked to MOD-2021-031381 (Patient Link).
Patient received Tdap & PNEUMOVAX (R) upper extremity on 3/9/11 - had immediate onset redness, pain & swelling.
JUST TIRED FOR A DAY; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (JUST TIRED FOR A DAY) in a patient of an unknown age and 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (JUST TIRED FOR A DAY). At the time of the report, FATIGUE (JUST TIRED FOR A DAY) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment details were reported.
UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. 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 was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the patient experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.
pt recv vax; erythema, fever 99.5; swelling & tenderness of arm from fingers to axillae; no adenopathy;
Start feeling like bugs crawling all over; About 4 hrs after shot tongue swelled up to fill inside her mouth; This is a spontaneous report from a non-contactable consumer (patient).   A 45-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, in the right arm, on 09Aug2021 at 02.15 PM, at single dose, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included allergy from an unspecified date. The patient had not experienced Covid-19 prior vaccination. Concomitant medications were unknown. On 09Aug2021, at 04:00 PM, about 2 hrs after the vaccination, the patient experienced crawling sensation of skin described as "start feeling like bugs crawling all over". On 09Aug2021, about 4 hrs after the shot, tongue swelled up to fill inside her mouth. The patient was treated with Benadryl and 1hr or so later it started going down. The patient recovered from the adverse events on an unspecified date. Post the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sudden extreme sciatic pain in both legs and unable to walk without limping for the next 5 days, then it got better and went away. But as the sciatic pain diminished, diarrhea began and lasted for 27 days with episodes each morning.  I didn't have sciatic pain prior to this for years, which was only minimal at times. It never was severe or hindered walking. I was not having any GI issues before the diarrhea began within the 1st week of the 2nd vaccine. I did have the common reactions to the 2nd dose within the 1st 24 hour period.  The sciatic pain stopped and I hope the diarrhea has stopped!
A report has been received from a Health Professional concerning a 6 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST (Intranasal) started on an unknown date (Lot no. BJ2109 Exp date: 23-Dec-2013). It was reported that the patient was administered expired dose of drug on 26-Dec-2013. The outcome of the event of administration of expired dose is unknown. The report was considered to be non-serious.
C/O pain, erythema, swelling 3-4" in diameter 24 hours after receiving shot.  Warm compresses and Benedryl advised.
Day 2 mother said she noticed redness and edema to site, brought patient in for evaluation. Provider observed and verbal instructions as cooling compress given with mediation (ibuprophen).
This medically confirmed spontaneous report (initial receipt: 16-Sep-2011) concerns a 25 year old female pregnant patient, who was allergic to oxycodone and bee stings. Concomitant medications included cetirizine hydrochloride, rizatriptan and omeprazole. On an unknown date the patient received unspecified flu vaccine (manufacturer unknown). On 16-Sep-2011 the patient also requested to receive her first dose of 0.5 mL of GARDASIL (batch number: 0841AA) intramuscular injection. After receiving her first dose of GARDASIL, the patient requested to be on birth control pills. The standard policy of the office was to do a urine pregnancy test prior to receiving birth control pills. The patient was found to be positive for pregnancy. The event outcome was not reported. In the absence of a reported date of last menstrual period (LMP) or estimated date of delivery (EDD), CSL has approximated the EDD to be 11-May-2012, using the CSL receipt date of this initial report to be the date of six week gestation. Follow up (29-Sep-2011): concomitant medication (dose, frequency, indication for use).
About Feb 18 she started display sudden signs of delusion, confusion, major Cognitive issues, unable to find words for speach and erratic behavior.
Large patch of redness surrounding injection site (4" x 3"); sub cu raised swelling at injection site 3" x 3"; pain and itching at injection site. Symptoms lasting through 01/15/2013.
Within minutes rapid onset feeling of facial and neck flushing + rapid heartbeat + increased resp rate + shaking.  Lasted approx 2 minutes.  Subsided then returned a few minutes later for approx. 20 to 30 seconds then subsided.  Left facility with no treatment.  Onset of swollen tongue evidenced by scalloping approx. 1.5 to 2 hours after.
I received my 2nd dose on April 1st; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my 2nd dose on April 1st) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concomitant products included BUDESONIDE, POTASSIUM CHLORIDE, METOPROLOL TARTRATE (LOPRESSOR), CALCIUM, MULTIVITAMIN [VITAMINS NOS], IRON and CYANOCOBALAMIN (B12-VITAMIIN) for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my 2nd dose on April 1st). On 01-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my 2nd dose on April 1st) had resolved.            No treatment medication was reported by reporter.  Due to hospitalization for acute pancreatitis patient could not get second shot in 28 days window and took it 42 days after.   This case was linked to MOD-2021-062263 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Follow-up was received and contains no new information.
erythematous rash on bilat elbows, wrists, knees & fingers;initially treated w/motrin no effect, then successfully treated w/pred taper;suspect serum sickness, doubt SLE;
Entire body had flu-like soreness, both muscles and joints. Throbbing headache. Severe intestinal pain & diarrhea unlike anything she had ever experienced from her Crohn's. Started the evening of the shot, lasted about 3 days.
Information has been received from a healthcare worker referring to a 21 year old female patient. The patient's pertinent medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was previously vaccinated with her first dose of (Oka/Merck) VARIVAX (start date, lot#, expiration date, dose and route were not reported). On 10-OCT-2016, the patient was inadvertently administered a dose of ZOSTAVAX (lot # M013377, expiration date 25-MAY-2017; dose not reported), intramuscularly, instead of a second dose of (Oka/Merck) VARIVAX (Wrong drug administered, incorrect route of drug administration and inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.