chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse symptoms reported.; the patient was "administered the first dose of GARDASIL 9 on 09/19/2019, then administered the second dose of GARDASIL 9 on 10/17/2019 and then administered the third dose ofGARDASIL 9 today, 11/21/2019."; the patient was "administered the first dose of GARDASIL 9 on 09/19/2019, then administered the second dose of GARDASIL 9 on 10/17/2019 and then administered the third dose ofGARDASIL 9 today, 11/21/2019."; This spontaneous report was received from a physician referring to a 25 years old female patient. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.        On 19-SEP-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage detail, strength, route, lot # and expiration date were not reported) for prophylaxis.  On 17-OCT-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage detail, strength, route, lot # and expiration date were not reported) for prophylaxis (Inappropriate schedule of vaccine administered).  On 21-NOV-2019, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage detail, strength, route, lot # and expiration date were not reported) for prophylaxis (Inappropriate schedule of vaccine administered).  No adverse symptoms were reported.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, the patient was treated at a clinic for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
pt recv vax 22NOV96 & 1JAN97 pt devel fever, rash, coryza, conjunctival inj, clear watery discharge & yellow discharge from nose, swollen & red tympanic membranes & petechia on palate & cheeks & was seen by MD;
I Took pt to get X-Ray done and after grabbed a Tdap vaccine From Fridge. Administered Tdap. Completed order + task and saw Doctor had ordered Dtap.
vax failure to produce Hep BsAb p/completion of recommended series; booster given 6AUG93;
It started on the 1st day with really bad pain in left arm. Then large muscle spams. I begin to have chills and sore throat. Few dizzy spell vomiting and diarrhea. My arm hurt really bad. It lasted for a week.
Offender received 2nd dose 22 days after 1st dose.  Offender denies adverse reactions.
No further adverse events; administered dose of MMR II using expired diluent; administered dose of MMR II using expired diluent; This spontaneous report was received from a pharmacist and refers to an adult female patient of unknown age (reported as "in her 20s"). There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 21-MAY-2022, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. The vaccine was diluted with an expired sterile diluent (lot # S007823 confirmed to be valid with an expiration date: 22-JUN-2021) (product preparation issue) (expired product administered). There was no prior temperature excursion and no further adverse events were reported (no adverse event).
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received bnt162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing), notes: I take blood pressure medication. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "sore arm". 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-202300332493 same patient/event, different vaccine doses;
This spontaneous report as received from a health care worker refers to a 23 year old female patient. The patient's medical history was unknown. On 12-MAR-2013 the patient received her first dose of GARDASIL lot # H014645, administered intramuscularly in the left or right arm at a dose of 0.5 ml, for prophylaxis. Concomitantly, the patient was using an unspecified oral contraceptive. On 12-MAR-2013, after receiving GARDASIL, the patient experienced right sided jaw pain. She called the physician's office the next day and was instructed to go to an emergency room. It was unknown if the patient went to an emergency room or if she received any treatment for the adverse event. The right sided jaw pain resolved on an unknown date. The reporter did not provide a causality assessment for the jaw pain and GARDASIL. Additional information has been requested.
Patient noticed hives around injection site the day after administration. Then bruising developed at site of injection and a red area approx. 2" round near injection site. This red area developed day after administration as well as bruising and red hives disappeared.
no adverse event; Customer calling for TE evaluation of VARIVAX. Customer states she called yesterday 5/24/2022 to report a TE but they just found out they had another TE 1 week ago and they need to report that at this time.; This spontaneous report was received from a costumer referring to an unknown age and gender patient.  The patient's concurrent conditions and medical history were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On an unknown date in May 2022 (between 11-MAY-2022 and 24-MAY-2022), the patient was vaccinated with a varicella virus vaccine live (oka/merck) (VARIVAX) that underwent a temperature excursion (TE) (Product storage error). The time frame of the temperature excursion was -14 degree Celsius (C) up to -10C for 2 hours 5 minutes 0 seconds; -10C up to 8C (-0.4C) for 1 hour 25 minutes 0 seconds. A previous temperature excursion occurred with temperatures of -14C up to -10C (-12C) for 0 hours 50 minutes 0 seconds. No adverse event occurred.   This is one of 13 reports received from the same reporter.
Coughing started about three hours after the shot and my throat was so sore the next morning, went to doctor thinking it might be strep . It was not strep or flu but three days later (night of 4-27-19) completely lost balance and was unable to stand without assistance.  Went to Emergency Room and was admitted.
arms & legs ached like a virus & was in bed x 2 days; very tired, equilibrium off, sore head still; 1 wk p/vax started a lump or puffy area appeared in LUQ abdomen, itched; seen by MD on 3NOV92 given Lodine;
devel encephalitis on 22JAN92 & on 27JAN92 devel transverse myelitis; tx w/IV steroids; adm to hosp 21JAN92 x 3 days w/h/a & neck stiffness followed by generalized sz; on morning of admit tx w/ATB;
Has been running around, playing this AM with no complaint of pain. Mom saw small area of redness yesterday PM about 30 hours after vaccine given, about 1/2 inch in diameter. Late this AM redness increased to 5 - 6 inches in diameter about 44 hours after vaccine.
Fever, chills, pain and swelling right upper arm starting approximately 24 hr after injection.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 2:59 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 2:59 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially moved to the fridge on 09-Mar-2021 and proposed beyond use date was 08-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and at 10:00 A.M., the temperature recorded was 30 degree Fahrenheit that has been reached by the vial.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
This spontaneous report as received from a nurse via field representative refers to 2 patients of unknown demography. The patients pertinent medical history and drug allergies were unspecified. Approximately on an unknown date in 2007 (reported as approximately 8 or 9 years ago), the 2 patients were vaccinated with GARDASIL (dose, frequency and lot# were not reported) intramuscularly. Concomitant medications were unspecified. Approximately on an unknown date in 2007 (reported as approximately 8 or 9 years ago) subsequently after vaccination, the 2 patients experienced seizures. The outcome of seizures was unknown. The relatedness of the seizures with GARDASIL was not reported. No product quality complaint was reported for GARDASIL. Upon internal review, the seizures was determined to be medically significant event. Additional information is not expected as the reporter did not wish to contact.
No adverse event noted at this time.  Patient was a 16 year old that was administered Moderna vaccine.  Person completing this form was not the person that administered the vaccine.
10 mins following vaccination. Client stated, she?s not feeling well, and her husband slowly guided her to the ground. Paramedics provided oxygen and checked the blood pressure 132/78, P 82.  Ambulance called. On arrival paramedics took client to ambulance, client refused to go to hospital.  Client was monitored on vaccination bus until 1:50 pm,  and at that point a he was ready to go.  Client walked away from vaccination site with her husband.
Rash/she started getting a rash all over; Eczema; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "not recovered", described as "Rash/she started getting a rash all over"; ECZEMA (non-serious), outcome "unknown". The events "rash/she started getting a rash all over" and "eczema" required physician office visit.  Additional information: Patient was also the reporter. Patient had an issue when she received the COVID-19 Vaccine through Pfizer. Patient broke out in a rash after she got the vaccine. Caller does not provide a phone number when queried. Patient said it was ok for someone to contact her about this if need be. Patient has eczema as well. Once patient received the COVID-19 Vaccine, she started getting a rash all over. It's still ongoing, and pretty much the same. Patient has been going back and forth to the doctor. Clarified with caller that patient just happened to reach his department. Caller confirmed with the patient that she was not involved with a clinical trial. Eczema was mentioned throughout the conversation between the patient and the caller. However, patient did not clarify if her eczema began prior to or after receiving the Pfizer COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
swollen lymph nodes in his left armpit; sore shoulder; arm and shoulder soreness; booster Pfizer Biontech COVID-19 shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 (Lot number: FJ8762) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose: 21Apr2021 , Lot: Unknown), administration date: 21Apr2021, for Covid-19 immunization, reaction(s): "Arm and Shoulder Soreness", "Arm and Shoulder Soreness"; Bnt162b2 (Second Dose: 18May2021 , Lot: Unknown), administration date: 18May2021, for Covid-19 immunization, reaction(s): "Arm and Shoulder Soreness", "Arm and Shoulder Soreness", "Knocked him out the day after, it felt like a bad case of the flu and lasted that day and the next day he felt 50% better and the next day 80-90% better and then he was fine". The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021, outcome "unknown", described as "booster Pfizer Biontech COVID-19 shot"; LYMPHADENOPATHY (non-serious) with onset 15Dec2021, outcome "recovering", described as "swollen lymph nodes in his left armpit"; ARTHRALGIA (non-serious) with onset 14Dec2021, outcome "recovered" (16Dec2021), described as "sore shoulder"; PAIN IN EXTREMITY (non-serious) with onset 14Dec2021, outcome "recovered" (16Dec2021), described as "arm and shoulder soreness". Therapeutic measures were taken as a result of immunisation, lymphadenopathy, arthralgia, pain in extremity.  Additional information: The patient had sore shoulder that had already gone away and wanted to know how long would the side effects last. NDC number and expiry date was unknown. There were no other products and no investigation assessments done. The age and age at vaccination was over 50 years-old. The patient got his shot on Monday, 13Dec2021 and his shoulder was sore Tuesday, and he noticed the swollen lymph nodes in his arm pit the next day. The arm and shoulder soreness was just like the other 2 times, it last for 2 days. The patient was treated with Advil and stated that it was basically sore to the touch, if he was not touching it, there was no pain, but if he moved the muscles a certain way, he felt it. There were no additional vaccine administered on same date of the pfizer suspect. The time of onset of the adverse event was the next day. There was no emergency or physician office visit for any adverse event. The patient did not take any vaccinations within 4 weeks. There was no family medical history or relevant tests done.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101807340 same patient/drug, different AE and dose.;US-PFIZER INC-202101807341 same patient/drug, different AE and dose.
Redness, warmth, swelling, hardness from left shoulder down to elbow times 4 days. Ice to area as necessary, Benadryl cream as necessary, Tylenol.
Dose given 16 days after initial dose in series, 8-12 days too early
This literature marketed report as received from a health professional refers to unspecified number of female patients (<9 years old) who started therapy with quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) (dose, route and lot # not reported). The literature backgroup was to describe population-based rates of quadrivalent human papillomavirus (HPV40 vaccine uptake and coverage from its licensure in June 2006 through December 2008. In this period, quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) was licensed for use in 9-26 year old females. Methods: Data were from 4 managed care organizations in the Vaccine Safety Data link. It was described uptake of quadrivalent human papilloma virus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) (number of doses given per month) in all persons aged 0-39, and coverage (percentage of eligible persons who received 2:1 dose) in all females aged 0-39, stratified by age and history of HPV-related disease. Results: In this study period, 166,975 quadrivalent human papillomavirus (types 6,11, 16, 18) recomb. vaccine (manufacturer unknown) doses were administered to 79,235 persons, with the greatest number given in the 3rd and 4th quarters of 2007. The therapy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) coverage increased steadily; by December 2008, coverage rates were 1% (females 9-10 years old), 34% (11-12), 55% (13-17), and 36% (18/26). The rate of increase in coverage was reduced by late 2008. After mid-2007, females aged 9-26 with a history of HPV-related disease had significantly lower rates of HPV4 vaccination than those without HPV disease. It was reported that minimal off-label use occurred: 6 males received vaccine; 153 doses were given to girls < 9 years old, and 3,518 doses to women 27-29 years old. This is one the several reports from the same reporter. Additional information has been requested.
According to hospital records, patient became ill ~48 hours after vaccination with nausea, vomiting, diarrhea which lasted for one week. He went fishing and traveled to another state. On returning home he bacame confused and hypotensive. He was admitted to the hospital on 10/29/04 with septic shock. All cultures are negative. No etiology for his illness have been determined. He has evidence of CNS, renal,liver involvement. He is currently hospitalized. No longer requiring artificial support.
Felt very warm, took temp was normal, felt fatigued, c/o fatigue, loss appetite, dizziness;
Few hours after shots evening time/bedtime woke with with severe pain and some fever and had seizure like sykptoms and had to call 9-1-1.
PATIENT RECEIVED THE FIRST DOSE OF MODERNA COVID VACCINE AT APPROXIMATELY 1930. FIVE MINUTES OR SO PASSED. THE PATIENT CAME UP TO THE COUNTER AND EXPLAINED HE WAS FEELING "A LITTLE NAUSEOUS" AND ASKED TO LEAVE THE OBSERVATION AREA TO USE THE RESTROOM. BEFORE LEAVING THE COUNTER THE PATIENT FAINTED AND FELL TO THE FLOOR. THE PATIENT WAS QUICKLY AWAKE AND ALERT, ALTHOUGH RATTLED. HE APPEARED TO RECOVER NORMALLY AND REQUESTED TO NOT HAVE PARAMEDICS COME TO THE SCENE. HE WAS PLACED IN A CHAIR AND ASKED TO REMAIN IN THE OBSERVATION AREA FOR ADDITIONAL 15-20 MINUTES BEFORE LEAVING UNDER HIS OWN POWER.
pt stated to father that felt nauseated;pt then had total contraction of both legs and arms, eyes rolled back in head, loss of consciousness for 10 seconds;recovered immed w/complete consciousness-alert to time, place, person, p80;BP 82/56;
Sudden, severe, persistent crying.  Blue feet and dusky legs and abdomen.  Lips color was ok. Loud, non stop crying.  Did not respond to any comfort measures, change of position, change of clothing, feeding, pacifiers.  Gave Tylenol dose that MD recommended.  Took to MD office.  Total crying non-stop for about 2.5 hours.  Body was stiff.  Temp was only 97.7.  Eyes appeared glassy during worst of crying episode. Very very loud non stop crying.  Refused to eat.
This spontaneous report has been received from a physician who was referring to his son, a 13 year old male patient with none pertinent medical history. On 04-OCT-2012 the patient was vaccinated with the first and only dose of GARDASIL (lot#not reported) dose reported as 1 vial, intramuscular. No concomitant therapies were reported. On 04-OCT-2012 the patient experienced injection site pain. The patient was treated with TYLENOL. None lab diagnosis was performed. The patient did not seek medical attention. The outcome of injection site pain was reported as recovered, on approximately on 08-OCT-2012 reported as 4 days after vaccination. The relatedness between the therapy with GARDASIL and injection site pain was not assess by the reporter. This is one of the multiple reports from the same reporter. Additional information has been requested.
Pt received Moderna vaccine at community event. Pt reported an allergy and monitored for 30 minutes post administration. Approximately 15 minutes post administration, the patient reported tingling around her lips. She agreed to take Benadryl 25mg PO. The patient reported feeling well upon leaving the site. I contacted the patient approx. 1 hour later to check in. She replied via email "I am not feeling well but I am doing okay. I have a follow up appointment with my doctor this afternoon." I followed up again on Monday March 1st, and she replied, "I saw my doctor late afternoon Friday. When I got home my face was puffy and my throat felt weird so she sent over a prescription for prednisone. Saturday I developed hives. I ended up seeing three doctors in total over the weekend, all said due to my reaction I should not be getting a second dose. I appreciate you emailing to check in. I'm happy that now all of my symptoms have cleared and I am feeling much better. " After this email the follow up concluded.
Information has been received from a medical assistant to a 6 month old female patient. No relevant medical history or concurrent conditions were reported. On 02-JUL-2015, the patient was inadvertently vaccinated with improperly stored oral, ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.