chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed shingles; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter does not remember patient's name and just wanted to relay that experience. The patient developed shingles after a few days of receiving first dose of shingrix. The reporter did not consent to follow up.
On 8/29/00 at 16:00, mother home from work and noted child had redness to left arm. "Playful but a little irritable". Area of redness at left deltoid and approx. size of 4 X 4 gauze pad.
Pfizer Covid 19: tender to his left arm/Pfizer Covid 19: minor pain to his left arm when he pressed on the area; Pfizer Covid 19: tender to his left arm/Pfizer Covid 19: minor pain to his left arm when he pressed on the area; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation; influenza vaccine (FLU VACCINE VII), via an unspecified route of administration from 24Sep2021 (Batch/Lot number was not reported) to 24Sep2021, at DOSE NUMBER UNKNOWN, SINGLE for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced pfizer covid 19: tender to his left arm/pfizer COVID- 19: minor pain to his left arm when he pressed on the area.Stated that with the first two shots that it was tender but no pain unless he pressed on the area and then it was minor. Stated the Pfizer COVID 19 shot was to his left arm. Stated that the right arm is where he got the flu shot and both arms felt the same. Stated that he wanted to say thanks for providing the vaccine The outcome of event was unknown.  The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 04-FEB-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L024250, expiration date 30-JUN-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Vomiting; Low blood sugar; unable to walk without help even sitting in wheelchair; Rash; had reaction to vaccine; Headache; Having hard time eating and drinking; This is a spontaneous report from a contactable consumer (parent). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Batch/Lot number was not reported), via an unspecified route of administration on 14May2021 (at the age of 12-years-old) as dose number unknown, single for COVID-19 immunization. Medical history included Immunodeficiency and Gene mutation. The patient's concomitant medications were not reported. Reporter stated, her child had his Pfizer vaccine (COVID vaccine) on Friday (14 May 2021) and he was fine on Friday, Saturday and Sunday but on Monday patient experienced vomiting, took him to the Hospital of (withheld), he had low blood sugar, he had rash, (headache) and was unable to walk without the help even sitting up in the wheelchair and patient is having hard time eating and drinking as of now. The outcome of the events was reported as unknown.  Information about Lot/Batch number has been requested.
ENTIRE FACE ON FIRE, RED RASH , FACE SWOLLEN, EYE EYELIDS FULL OF FLUID RED , UNDEREYE BAGS FILLED WITH FLUID AND RED   AND ITCHY, CHEST RED AND ITCHY
Front left thigh tender to touch followed by raised welt upper left side.  Smaller welt near 1st one next day followed by raised rash below back left waist.  Next day a line of rash spots from left side to front & inner thigh.
Syncope.  Rested and recovered.  Fainted about 5 minutes after receiving the vaccine- walked quickly from the vaccination station to the observation station, and was seen wobbling, caught her and laid her until she recovered.  She was embarrassed, indicated she has fainted with shots before.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On 14-JUL-2014 the patient was vaccinated with expired VARIVAX (injection, lot # J006359, expiration date 23-MAY-2015 (original), dose and route were not provided). The nurse reported that the VARIVAX had a previously reported temperature excursion (details not known or provided) and the nurse was told to change the expiration of the product to 12-JUL-2014 as a result of the in-house temperature stability evaluation. No adverse symptoms reported. Additional information has been requested.
I started to get a runny nose. I then started to get a sore throat. I started to have pain in my large muscles. My lower back and quadriceps were hurting. I went to Urgent care and I tested positive for Covid-19 on 08/28/2021. I was not prescribed anything, but the doctor called me and told me I was positive. She told me to call if my congestion got worse they would recommend Regeneron. I had heavy congestion and coughing and I was tired. I had a loss of appetite because I lost my sense of smell and taste. I took some Advil which helped the muscle aches. I started to feel better after about a week. It has been four weeks and I still have some loss of taste but my sense of smell came back gradually over the last week. I am still congested in the morning and it feels like my Sinuses are a little blocked. I took a home test after 10 days and it was negative.
VARIVAX had undergone TE and it was administered after the TE.; No reported adverse reactions; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.      On an unknown date, the patient was vaccinated with an improper store dose of  varicella virus vaccine live (oka/merck)(VARIVAX) lot # w039294, expiration date 11-DEC-2024  for prophylaxis (dose and route were not reported) (product storage error). No reported adverse reactions and nor product quality complaint.
Pt experienced nausea and vomited 2 times after being vaccinated within 5 minutes
Herpes Zoster diagnosed in multiple dermatomes with associated severe pain.  Hospitalized for 3 days and treated with IV acyclovir.  Discharged home on oral acyclovir when symptomatically improved and rash no longer worsening.
My head was on fire; Throat got sore; Might have had it COVID-19; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (My head was on fire), OROPHARYNGEAL PAIN (Throat got sore) and SUSPECTED COVID-19 (Might have had it COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HEAD DISCOMFORT (My head was on fire), OROPHARYNGEAL PAIN (Throat got sore) and SUSPECTED COVID-19 (Might have had it COVID-19). In March 2021, HEAD DISCOMFORT (My head was on fire), OROPHARYNGEAL PAIN (Throat got sore) and SUSPECTED COVID-19 (Might have had it COVID-19) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: 8/12 current result lesser that 0.8 SARS- Spike AB interp says POSITIVE. In 2021, Body temperature: 98.4 98.4 degree F.   Patient wants to know if the test result is in the high or low end and how to interpret the results. Patient had no side effects. Patient head was on fire, although he did not have a temperature and throat got sore. Patient took medication and woke up fine. No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-620775 (Patient Link).
shingles rash; pain; This is a spontaneous report from a contactable healthcare professional via a Pfizer-sponsored program. A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on an unspecified date. The patient developed shingles after the second dose of the Pfizer covid 19 vaccine. He received the vaccine on 29Jan2021 and developed a shingles rash on Sunday (31Jan2021). The healthcare professional wanted to know if he can take antivirals, if it is safe for him to get antivirals, and what he could take for pain on an unspecified date in 2021.   Information on the lot/batch number has been requested.
No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 12-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.    This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
Pt received 2 Pfizer covd vaccines. 3/14/21 and 4/4/21.  Then received Moderna booster on 12/3/21.  Pt then had a seizure on 12/16/21 and was seen in ER. Pt had another seizure on 1/30/22.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated (date not reported) with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient developed a painful rash appearing on his lower back, legs, arms, chests (as reported) and head. In response to these complaints, the patient presented to a physician (date not reported) and was diagnosed as suffering from dermatitis, shingles, and post herpetic neuralgia. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Very itchy red rash on my back on thr right.  Beginning to ease up after 6 weeks
Hard, red, swollen upper arm; Muscle Aches, fever, headache, shivering.
Approximately 5 min after vaccines given, patient laughing hysterically then crying. Several cycles of this laughing/crying for no reason. Pt monitored x 1hr. vss alert + oriented x 3. Mom in with patient and states "not usual for her" Episodes resolved after appox 1 hour Pt d/c'd to  home with mother
positive COVID 19 test; Fully vaccinated and confirmed positive COVID 19 test and symptomatic; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE, and also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Jul2021 fully vaccinated and confirmed positive COVID 19 test and symptomatic (medically significant). On 17Jul2021 Confirmed positive test result on Saturday. On 14Jul2021 started showing symptoms as sinus infection, headache, cough, fatigue. Further reported as event did not take place after use of the product. The outcome of events was unknown.  Information about lot/batch number is requested.
Patient received a COVID Pfizer bivalent booster in error, it was dose 4 (2nd booster). After the CMA reviewed the vaccine consent form and discussed the Pfizer bivalent vaccine with him, he didn't indicate he didn't want the bivalent booster or that he was there for influenza only, the vaccine was administered.  Following administration of the COVID booster he indicated he was there for influenza only and became very upset that as he states he was given the wrong vaccine.   Then he consented to also getting the influenza vaccine and this was administered.
Information was received from a pharmacist via a company representative concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The pharmacist reported that the patient came into the pharmacy to pick up an unspecified prescription and stated that in early May 2017 (reported as "within the last week"), she was vaccinated with the PNEUMOVAX 23 (lot number, dosage, and route of administration not provided) during an office appointment with her physician, for the prevention of pneumonia. It was reported that the patient was now experiencing a "frozen shoulder which she finds difficulty in moving" (exact onset date not provided). It was unknown if the patient contacted her doctor's office. The pharmacist reported that it "looks like it was administered at the top of her arm and not in the muscle." The outcome of the events is unknown. No further information was provided. Additional information has been requested.
I originally reported that I had an allergic reaction within 30 mins of getting vaccinated. I was admitted to the hospital for heart conditions and the reaction to the vaccine. I continued to remain sick after that time. I was recently diagnosed with SLE/Lupus and I am still sick. I did not have these conditions prior to taking the vaccine and they appear to be related to the vaccination.
pt sibling dx w/chicken pox 30NOV96 (had recv vax 28JU95);mom called office 17DEC96 & reported pt breaking out that AM-zovirax called in;
Patient experienced swelling, redness, itchiness on the left arm hours after vaccine administration on 11/14/21. It spread from the injection site down to the left elbow. Compresses did not relieve the adverse reaction. Symptoms did improve over the next 2 days but the area from injection to the left elbow was still inflamed. She was seen by urgent care on 11/14/2021. She was prescribed dexamethasone 10mg to be taken once.
GAVE BOOSTER DOSE TO PATIENT OF 15 YEARS. BOOSTER NOT APPROVED FOR PATIENTS <16 YO AT THE MOMENT. patient observed for 15 minutes without adverse reactions. went home with mother and has not reported problems since. patient told to call pharmacy if observe adverse reactions
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillin" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "known allergies morphine". Vaccination history included: Influenza vaccine, reaction(s): "known allergies Influenza vaccine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. 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.; Sender's Comments: As per the available information the causality of the events drug ineffective and covid-19 with the suspect BNT162b2 can not be ruled out completely.
Expected symptoms included fever, malaise, and injection site pain.  However, I also had an unexpected reaction of acute hypertensive crisis with BP 189 / 120.   Three readings validated the initial reading. Hypertensive crisis was associated with inability to walk more than a couple of steps without feeling I was going to pass out and incohorence. My regular BP is always in normal low range, once resolved at 9am on April 17, 2021 was 96/58.
LOSS OF HEARING; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic (amikacin allergy).   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was unknown.   It was unknown if the reporter considered the hearing loss to be related to Flu vaccine.  Additional details were provided as follows: The case was reported by the mother of the patient. The age at vaccination was not reported. The patients mother stated that, the patient was allergic to amikacin.  The reporter inquiring about amikacin in the flu shot currently.  The reporter stated that, her daughter received the flu shot (by unknown manufacturer) previously and loss her hearing due to the daughter's allergy to amikacin. The reporter wanted to know if amikacin would be in the flu shot presently. The reporter did not provide time frame or timeline when the flu shot was administered to her daughter previously.  The reporter did not provide any specific details about the flu shot such as vaccine name, dosage details, lot number, expiration date, etc.  No additional patient information related to patient. The reporter abandoned the call before further details were obtained. The reporter did not provide permission to follow up with doctor.
Information has been received from a nurse concerning a female who on 11-SEP-2008 was vaccinated with the first dose of GARDASIL Lot # was not available. Per nurse, the patient fainted after receiving the first dose of GARDASIL. The same day the patient recovered from fainted. The patient was seen by the physician. Additional information has been requested.
I was giving the injection, it leaked onto my hand, and it was close to the barrel, no AE; I was giving the injection, it leaked onto my hand, and it was close to the barrel, no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a female patient who was giving the injection INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ236AA, expiry date: 04-Apr-2019) and half of the dose was leaked onto his hand on 19-Sep-2019  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of vaccine exposure via skin contact and syringe issue.  At the time of reporting the patient had no adverse event.  It was also reported that screwing the needle on tight for injecting the dose her gloved hand was suddenly wet from the vaccine leaking. She stated the leaking must have come from the barrel of the syringe on the side or perhaps the orange part of the needle because that is where her finger was resting. Rph mentioned the other doses in the carton were fine to administer. She asked if the dose should be repeated, she will call the patient back to the pharmacy.  Needle type: Safety, BD safety glide, 25g by 1 inch.  List of document held by sender: none.
Approximately 3 1/2 hrs after receiving my 1st shot, my face turned beet red, was very hot to the touch, burned like a sunburn and both my eyes were very itchy.  This lasted approximately 48 hrs. The 24-he nurse line at my insurance company suggested I see someone at an urgent care facility. On Sunday, I started taking Benadryl, which seemed to help my symptoms.
In 1996 the pt was vaccinated with Engerix B. The pt now has a negative antibody titer. The most recent information received does not provide an outcome.
Initial misuse report received from a healthcare professional on 30 July 2013. A 5-year-old patient was administered ADACEL vaccine instead of DAPTACEL for the fifth dose in DTaP series. No adverse event was reported. List of documents held by sender: none.
Big area above injection site was red and painful after injection. Redness resolved in 2 days. Pain still persists. Any movement that involves left arm is painful.