chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female who was vaccinated subcutaneously with a dose of varicella virus vaccine live.  Subsequently, blood work was obtained and it was noted that the patient did not show antibodies for chickenpox.  The patient did no seroconvert.  The outcome was reported as not recovered.  There was no product quality complaint.  Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Sep2021 at 16:15 as dose 3 (booster), single (Lot number: FE3592) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WELCHOL, start date: 01Jul2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 11Jun2022 to 11Jun2022 (NDC 0069-1085-30). Known allergies reported as NA.
I noticed a rash on his neck under his chin. There were oval welted areas on his neck, arm pit, chest and groin. Sunday he developed a rash located all over the truck of his body. I gave him an antihistamine but the next morning it looked like it had gotten worse. He was very tired and had to stay home from school. We took him to the doctor and they said the rash was Pityriasis Rosea. They advised that it would take 6 to 8 weeks to resolve on its own. No medications were prescribed.
Day 6 - developed rash/hives and swollen area over injection site. Then developed hives on face. Hives on face disappeared after 4 hours. Rash/hives/swollen arm is still present 24 hours later.
12/01/2006 Nausea, headache, urticaria 12/04/2006. URI symptoms developed after rash. Treated with Benadryl, Prednisone, and Zyrtec. Phone call 1 week later, rash completely gone, urticaria due to vaccine VS intercurrent URI.
Extreme sore throat and headaches soon after administration of H1N1 nasal mist vaccine. Fatigue and wheezing days following. on 10/24/2009, chest pain during the day behind left nipple became sharp, extreme chest pains, numbness of left arm and hand, difficulty breathing, couldn't catch breath, rapid heart rate, blackout or memory several times before and during ambulance transport.
2 EPISODES OF VERTIGO ON JUNE 11TH AND SINCE THEN I HAVE HAD DIZZINESS, MY THINKING IS SLOW AND I  HAVE A GENERAL FEELING OF UNSTEADINESS. LOOKING AT A COMPUTER SCREEN TOO LONG INCREASES THE DIZZYING FEELING i HAVE.   I HAVE NOT BEEN TO A DOCTOR BECAUSE I DON'T HAVE HEALTH INSURANCE. I HAVE BEEN LAYING DOWN A LOT AND JUST TRY TO MOVE SLOWLY.
Mom noticed rash on arm, starting at site of vaccination & spread upward to shoulder area. Described as "huge, red, blotchy rash with little bumps". No other signs or symptoms. Rash had dissappeared by next morning.
afterl I received second MODERNA Covid 19 vaccine on March 9,2021 I have developed very bad psoriasis on my legs and mid section of my body..... I also developed EYE problems..... Should I receive a booster when available?????
Information has been received from a website. It was reported that on an unknown date, a patient was vaccinated with a dose of GARDASIL. The patient's mother stated that she took her daughter to a neurologist and "by that time he said her nerve pain had caused nerve damage. She had peripheral neuropathy and said it was directly related to the GARDASIL". Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.
started having joint pain, fatigue, n/v, h/a & ears stopped up (can't hear);had a rash on 27SEP x 2d;fever 101 on 27SEP lasted 4 day;felt disoriented & spacy;
I developed a Stye in my left eye and it kept getting worse. It was very red, tender, swelling, and my eye itself was very red and irritated. I went to the walk-in clinic and was prescribed Polymyxin B Sulfate Trimethoprim Ophthalmic Solution.  I used the medication and the Stye is gone now.
2pm - received shots.  2:08pm- developed hives.  EPINEPHRINE given at 2:10, BENADRYL given at 2:15.
Information has been received from a consumer concerning her 21 year old daughter with no pertinent medical history or known allergies who in approximately April 2007, was vaccinated with the third dose of GARDASIL 0.5 ml, IM.  Concomitant therapy included PAXIL and hormonal contraceptives (unspecified).  It was reported that after the patient received GARDASIL, had a Papanicolaou test positive for HPV.  The patient did not know which strain of the virus it is from.  There were no Papanicolaou test done during the series, so she did not know if she would have tested positive before or after it was reintroduced.  It was reported that a Papanicolaou test done before the vaccination series was "normal".  The reporter did not know where the series begun.  At the time of the report, the patient had not recovered.  Additional information has been requested.
Unable to raise arm; numbness; diagnosed as inflamed nerve-prescribed MEDROL Dose pak.
Temperature of 100.1 about 5 hours after administration with mild frontal headache. Today - about 24 hours after adminstration - herpetic rash developed along the left mandibular branch of the trigeminal nerve.
Adverse event-directly after receiving the vaccination, it felt as if I was having a serious allergic reaction as I had just consumed tree nuts or dates (for which I am most allergic)-my throat felt super funny and itchy-my chest got tight-was working harder to breath-got a rash that covered my hands and arms-felt dizzy/light headed and weak Treatment-Benadryl (IV 9:18pm given) and pepcid (10:28pm given) Outcome-benadryl was able to stop the allergic reaction and took about 36 hours to fully recover with continued allergy medication and one more dose of benadryl the next day
DEATH Narrative: patient's wife reported he had gone in an outside hospital, had held his brilinta as advised anticipating shoulder surgery "and he threw a big clot and died."
This is a spontaneous report from a contactable office staff (other HCP) from physician's office. A patient of unknown age and gender received on 11AUG2014, PREVNAR13 at single dose. Vaccines given on the same day and vaccines taken within the last four weeks wre unknown. Relevant medical history and concomitant medications were unknown. It was reported that on 11AUG2014, when PREVNAR13 vaccine was administered to the patient, the vaccine leaked out at injection site. Relevant lab tests and sibling information were unknown. At the time of the report the clinical outcome of above mentioned event was unknown. Follow-up (17OCT2014): Follow-up attempts completed. No further information expected.
Meniere's Disease; Heart started racing; Throat began to get itchy; Extreme dizziness; Nausea; Severe allergic reaction; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MENIERE'S DISEASE (Meniere's Disease) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical information provided). Concomitant products included BETAHISTINE for an unknown indication.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN (Sore arm). On 31-Mar-2021, the patient experienced PALPITATIONS (Heart started racing), THROAT IRRITATION (Throat began to get itchy), DIZZINESS (Extreme dizziness), NAUSEA (Nausea) and HYPERSENSITIVITY (Severe allergic reaction). On an unknown date, the patient experienced MENIERE'S DISEASE (Meniere's Disease) (seriousness criterion medically significant). On 03-Mar-2021, PAIN (Sore arm) had resolved. On 31-Mar-2021, PALPITATIONS (Heart started racing), THROAT IRRITATION (Throat began to get itchy), DIZZINESS (Extreme dizziness), NAUSEA (Nausea) and HYPERSENSITIVITY (Severe allergic reaction) outcome was unknown. At the time of the report, MENIERE'S DISEASE (Meniere's Disease) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included "Diazepam, Zofran and Tylenol PM" Action taken with mRNA-1273 in response to the events was not applicable..; 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.
Symptoms: Face puffiness, feeling of uneasiness but able to talk and breathe without difficulty. Vitals: BP 185/110, Po2 sat 98%. Received 50mg Benadryl and taken to ED. Symptoms subsided. ED, left prior to exam by ED MD.
Fever 100.3 circa; crying; in and out of consciousness; eyes rolling back (showing the white of the eyes); called the pediatrician hotline and following their advice gave the child acetaminophen 125 ml.
This spontaneous report was received from a nurse and health professional and refers to a 4 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-DEC-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (rHA), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Weakness-Severe, Additional Details: pt fell to th floor 10 minutes afterward,called paramedics and was transported to ER
allergic reaction; 8cm sized hive at the injection site; redness and swelling to about 10 cm; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15 months old patient who experienced allergic reaction [Hypersensitivity], while he/she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose 2 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ058AB via intramuscular route in left leg in vaccine subcutaneous layer.  On 17-Jun-2019 he/she also received a dose 1 of the same vaccine lot UJ058AB via intramuscular route in left leg in vaccine subcutaneous layer.  On an unknown date, the patient developed a non-serious allergic reaction (hypersensitivity) along with symptoms of 8cm sized hive at the injection site (injection site urticaria) and redness and swelling to about 10 cm (injection site swelling) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Other tests included no lab data.  Final diagnosis was allergic reaction.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as Recovered / Resolved on an unknown date for allergic reaction, as Recovered / Resolved on an unknown date for 8cm sized hive at the injection site and as Recovered / Resolved on an unknown date for redness and swelling to about 10 cm.
received first dose, developed shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number t333te, expiry date 15th April 2023) for prophylaxis.   On 2nd December 2021, the patient received the 1st dose of Shingrix. On 10th January 2022, 39 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details reported were as follows: The age at vaccination was unknown. The reporter consented to follow up.
Right upper arm swollen halfway between shoulder and elbow. 5x7cm area of redness and induration - warm and tender to touch. Mom states temp was 101.2 this AM. Has been giving PO Benadryl and Tylenol. Appt made with pediatrician for this AM.
Patient had a syncopal episode around 12:00 pm to about 2011. Patient was positioned on he back on examining table then she came conscious. VS were taken and were normal. She was A/O 3x. She was sent to urgent care for evaluation.
His arm was hurting real bad.; sleepy; He felt real tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (His arm was hurting real bad.), SOMNOLENCE (sleepy) and FATIGUE (He felt real tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (His arm was hurting real bad.), SOMNOLENCE (sleepy) and FATIGUE (He felt real tired). At the time of the report, PAIN IN EXTREMITY (His arm was hurting real bad.), SOMNOLENCE (sleepy) and FATIGUE (He felt real tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.    Reporter did not allow further contact
3 Days after receiving the 1st dose, I had bloodwork completed for my TSH level. This was scheduled routine labwork. This was completed on 2/26/21 - 4 days after the 1st shot. My doctor reviewed the results on 3/5/21. TSH levels for me are typicall between a range of .3 to .6.  This labwork showed the TSH level to be 24.58. This is off the charts, Dr.  increased my Levothyroxine 2 levels from 75 mg to 100  mg.  An ultrasound was also scheduled since Hashimotos Disease means a goiter is present on the thyroid gland. I was diagnosed in 1994. Up to this time, I have NEVER had a TSH level of 24.58. My level has been consistent in the range required or varied slightly. I will be having the TSH level tested again on 4/29/21. Results should be available a couple of days after that. I received the 2nd Covid vaccination on 3/17/21.  The ultrasound on my throat was scheduled on 3/22/21. The results showed significant changes in size of the lymph nods and more importantly the nodule on the right side of the goiter has now increased in size. Prior ultrasounds have shown no change in growth and one test showed a decrease in size of the goiter. The recommndation was to have a CT scan for further evaluation. The CT scan was scheduled on 4/6/21. The results showed the lymph nodes to be reactive which is not a concern. However, the right side nodule on the goiter now requires a fine needle aspiration to send for a biopsy. The fine needle aspiration is scheduled on 4/19/21. The results should be available in approx 5 days (4/23 or 4/26) I have an appointment scheduled with an Endocrinologist to review all test results. This issue can result in necessary surgery to remove the Thyroid gland. I now have difficulty swallow whole food unless chewed thoroughly.  This whole situation has become unsettling and scary.  As I mentioned before  - since 1994 I have never had any issues with growth of a nodule or a TSH level of 24.58
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: Spoke with pt around 6:50pm (4/3/2021). she stated she was currently home and feeling a lot better. she denied anymore dizziness, flushing or feeling lightheaded. she is considering coming in with her husband when she comes for the second dose just in case she feels the same way
I was sore to touch on my side and back after a couple days I developed a rash at the site of the injection and still have this
GENERAL FEELINGS LIKE I HAD FLUE, LOST STRENGTH IN MY LEGS AND HAD PROBLEMS MOVING ABOUT
pt devel fever,chills,& gen pruritic,maculopapular vesicular rash (15-20 lesions) 2 1/2 wk p/1 dose of vax given;
w/in 24hr of vax began high pitched screaming w/sleeplessness for 4 days;stopped briefly if held;t100 ax;sx stopped p/4 days;pt OK;
A report had been received from a pharmacist concerning a 51 year old female patient. No concomitant medication and no medical history were provided. An off-label prescription of trivalent attentuated flu vaccine, traduced as FLUENZA by the pharmacist, was reported from a pharmacist concerning a 51-year-old female patient, treated with immuno-depressant (preparation before graft). The outcome of the event of off-label prescription of attenuated trivalent flu vaccine, traduced as FLUENZ, for an adult treated with immuno-depressant and prescription of flu vaccine concerning a 51-year-old female was unknown. The company physician considered the events to be non-serious.
Fatigue/extreme tiredness, sound sensitivity, pain at the injection site, brain fog (lack of mental acuity),  dull  persistent headache even after tylenol, aspirin, and ibruprofen,
No additional adverse effect reported; Caller stated that GARDASIL 9 that underwent a temperature excursion was administered.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-MAY-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection in prefilled syringe, lot # 1691180, expiration date: 15-NOV-2022 (exact dose, injection site and route of administration were not provided) for prophylaxis.  The administered vaccine experienced a temperature excursion of 9 degrees Celsius to 25 degrees Celsius (9.92 degrees Celsius) for 1 hour and 21 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.  This is one of three reports received from the same reporter. 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: 1691180; expirationdate: 15-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA000775:
This spontaneous report as received from a pharmacist refers to an unspecified number of patients. On unknown date the patient was vaccinated with ZOSTAVAX (strength, dosage and route unknown). On unknown date the patients experienced injection site reactions involving redness. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Was extremely tired on the 2nd day after the shot with no energy but then felt better.  4 days after the second shot developed dizziness when rolling over in bed or getting up from lying down.  Has continued for 2 days now.  Seems to be BVVP.
Patient had fever and myalgia following the vaccine. Symptoms got better  but on day 3 he developed chest pain and progressed with SOB. He presented to the ED and working diagnosis is perimyocarditis . Patient is still hospitalized
No additional AE reported; an expired dose of MMR II was administered to a 28 year old female patient; This spontaneous report was received from an office manager concerning a 28-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 18-OCT-2021, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 milliliters, lot # S031482, expiration date 07-OCT-2021 (route not reported) for prophylaxis (expired product administered). No additional adverse event was reported.
Information has been received from a certified medical assistant concerning her 12 year old daughter with no pertinent medical history drug reactions or allergies who in 2008, was vaccinated with a dose of GARDASIL (Lot# unknown). There was no concomitant medication. In 2008, after received GARDASIL, the patient developed headache that resolved shortly after receive MOTRIN. The patient sought medical attention with the certified medical assistant. Follow up information has been received from the medical assistant concerning her daughter with no illness at time of vaccination. The medical assistant initially reported that on 08-AUG-2010, her daughter had been vaccinated subcutaneously in the left arm with a second dose of VARIVAX (Merck). However, this information was clarified by herself stating that her daughter did not have any adverse event on VARIVAX (Merck) and that her daughter had received GARDASIL (Lot# 660389/1968U) and subsequently experienced a headache, which she recovered from. There were no laboratory tests or diagnostic studies reported. Additional information is not expected.
A report has been received from a Pharmacist concerning a 3 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 03-Jan-2013. EXPIRED FLUMIST GIVEN to the patient on 03-Jan-2013. The outcome of the event of EXPIRED FLUMIST GIVEN is unknown. The report was considered to be non-serious by the reporting pharmacist.
I received the J&J vaccine back in March of 2021 and actually went to the ER due to an extremely high fever. A few days ago, I received the Moderna booster and once again had an extremely high fever of 101+, accompanied by excruciating pain in my right arm upon waking up the day after. At the end of that day, the 19th, my fever had felt like it was mostly gone however I was still left with extreme pain in my arm. Now, at 5 AM on the 21st, unable to sleep due to the pain in my arm that is now particularly swollen with a large red area on it along with "chicken skin", I am not having the greatest time. I plan on going and getting it looked at later today.
Breakthrough case after Covid vaccination. Dose # 1 01/04/2021 Dose #2 02/01/2021. C/O runny nose, headache, and cough. Onset 8/16/2021
Fever up to 103.2 for 3 days. Horrible joint pain, body aches & headaches. Extreme fatigue. Was unable to go to work. Used Tylenol & Ibuprofen and slept most of the time. After 3 days, returned to normal functioning.