chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 10Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 17Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 25 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Polycystic ovary syndrome" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; BUSPAR; PANTOPRAZOLE; SPIRONOLACTONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: During treatment, the Paxlovid interacted with something else she was taking and spiked her blood pressure,causing akathisia-like symptoms which resolved with Propranolol. Three days after finishing the course of Paxlovid she started having nasal drainage and fatigue which she believe was a rebound of symptoms (she did not have seasonal allergies which would cause these symptoms). Yes vaccine received. No other medication in 2 weeks. Anti viral COVID 19 treatment was started from 14May2022 till 18May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Elevated blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Elevated blood pressure) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Elevated blood pressure). At the time of the report, BLOOD PRESSURE INCREASED (Elevated blood pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
I received the Moderna shot for my primary vaccine series in April and May 2021. I had a bad reaction to the second shot (and reported it through the VAERS system), so I decided to try Pfizer instead for my booster. I received the booster on Jan 12 and had what I consider normal symptoms for two days (headache, nausea, swelling at the injection site). On the third day Jan 15, I began to have sudden violent menstrual bleeding two weeks before my period normally would have started, and it lasted longer, was much heavier, and left me fatigued compared to my normal regular periods. I had that exact same reaction to the second Moderna shot (which I reported through VAERS). When the bleeding stopped, the real problems began. On Jan 22nd, I began having muscle weakness and numbness in my hands that made it difficult to grip objects and do normal things (cooking, washing my hair, drinking from a cup, holding the phone). It started in my right hand. On the 23rd it spread to my left hand  and both arms from my fingertips to elbow. By the night of the 23rd / morning of the 24th, I woke in the night and couldn't feel my legs or the roof of my mouth and tongue. On the morning of the 24th I had someone drive me to the doctor and they sent me to the ER. I was admitted under the care of neurologist. By the 25th while in the hospital the numbness spread to my face as well.  A CT scan ruled out a brain tumor and blood work showed no sign of infection or heart problems. An MRI of my head, neck, and lumbar regions of my spine showed no distinctive nerve damage that could account for the symptoms. On the 25th and 26th it began to recede.  The muscle weakness and numbness are not gone, but they are sending me home to recover since it's not getting worse currently.
administered vaccine at 1202pm, pt had itching so patient had and took 3 benadryl after the administration, throat started itching so epinephrine pen administered at the pharmacy and 911 was called and patient was then observed by EMTs.
Given 11:55AM client noticed discomfort in Deltoid region of arm at approx 1:45PM. Redness began at 2:30PM and client began to feel bad at 2:30 and went to sleep. Awakened around 4:30PM and called nurse call at 6:49PM, and was sent to ER with code JT2. Got to ER at 9PM, temp 101.7. BP reported normal, was given 2 Tylenol, 1 Benadryl and 1 Pepcid
Developed hives and red, itchy rash at injection site on April 21, 2021. No other exposure to new potential allergens.  Rash spread over arm for 1 day, went away with application of topical diphenhydramine.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On 22-FEB-2018, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 PFU vial, lot # M041669; expiry date 09-JAN-2018, subcutaneously. No information regarding sterile diluent (STERILE DILUENT) was provided. No adverse effect was reported.
Patient had flu-like symptoms. Mostly muscle aches in neck and back. Went away in 3-4 days. Both shots administered in right arm due to radiation in left arm.
FEMALE CUSTOMER 18 YEARS OLD WITH PRIOR HISTORY OF FAINTING AFTER RECEIVING VACCINES, RECEIVED PFIZER COVID-19 VACCINE DID FEEL FAINT AND STATED SHE LOST HEARING. FEMALE DID BECOME FLUSH AND DIAPHORETIC BUT RECOVERED. 911 WAS CALLED. PATIENT RMA
Got sick as a dog; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got the Shingle shots and got sick as a dog. For the tolerance of other dose, refer case US2021AMR198024, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR198024:Same reporter
I had a fever under 100 degrees day and night for 3 days, coughing that lasted 3 to 4 weeks after testing negative. I lost of smell and test. Occasional coughing now, long standing fatigue. Infusion of antibodies administered on 11/16/2022 at the clinic.
Patient came for a doctor's visit on 12/02/2013 and came to the clinic for a lab appointment on 12/04/13. The patient voiced the inflammation on his left arm has been spreading. PCP, assessed area as cellulitis and prescribed antibiotics. Patient to go to E.R. if gets worse.
Shots given on 4/30/2004. Cranky, pale , not sleeping well. Low grade temp.
Fever, arm pain, exhaustion, swollen lymph nodes, body aches (3 days)
Injection site pain, fatigue, headache, muscle pain, joint pain, chills.  No treatment.  Self resolution.
erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above occurred 12 hrs p/flu vax give & resolved w/in 48 hrs;
This spontaneous report was received from a licensed practical nurse and refers to a 23 month old patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions and concomitant medications was reported. On 26-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L044475, expiry date 12-MAY-2017 (dose, frequency, route of administration and anatomical location were not specified). It was not reported it if was first, second or third dose of GARDASIL 9. The administered dose underwent temperature excursion at 1.5 Celsius degrees for 15 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Verbal permission from pt's mother to obtain information over the phone. 5 minutes, post vax, pt had localized red area approximately 4cm-5cm, itchy, no hives, blotchy noted. Ice pack applied and about 25 minutes later, redness was less but remained itchy. Call placed to mother and to child's Pediatrician.
fatigue began about 5 hours after injection. Then chills about 6 hours after and lasted about 3 hours. Severe muscle, joint and body aches for 3+ hours with chills, then fever of 102 for 6-8 hours. Severe headache in facial area during fever and chills, dizziness, continued low grade fever of 99.8 for additional 12 hours.  Stiff neck began after fever was gone and comes and goes. 72 hours after injection,  headache in facial area when working on computer, reading or watching tv and some tiredness.  Loss of appetite.  800mg ibuprofen given 48 hours later due to headache.
Gastrointestinal- vomiting, diarhea. Over a two hour period until empty.
On the evening of 6/14/01, pt had fever. She had no other signs/symptoms. This resolved. On 6/17/01, she became fussy and on 6/18/01, she had rash on back and face. This lasted 24 hours. Symptoms all resolved.
They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case contains information for the 10th of 24 patients described by the reporter.  Concomitant medication was not provided. Patient age was between 6 months to 5-years. The vaccination clinic received incorrect guidance from the Department of Health in regards to the vaccination, who instructed to order and administer the vials with pink top to 6month-5year previously unvaccinated patients when the switch from monovalent to bivalent happened. This resulted in 24 patients being under vaccinated.  It was reported that 24 pediatric patients were administered underdose bivalent vaccine doses for either their first or second doses. They received 0.2 ml dose from the pink vial instead of the 0.25 ml dose from the blue cap vial. The patients were being contacted and revaccinated with the correct dose. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
had both COVID vaccines and the booster dose and developed COVID; had both COVID vaccines and the booster dose and developed COVID; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 85 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 85 years as dose 3 (booster), single, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Dementia" (unspecified if ongoing); "cognitive age related impairment", start date: 2017 (unspecified if ongoing); "subdural hematoma" (unspecified if ongoing), notes: 2 years prior; "horrible twisted feet/ bunions and are torched to the side" (unspecified if ongoing). Concomitant medication(s) included: CLINDAMYCIN taken for localised infection (ongoing); PREDNISOLONE taken for localised infection (ongoing); ARICEPT taken for dementia alzheimer's type, start date: 2021 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022, outcome "unknown" and all described as "had both COVID vaccines and the booster dose and developed COVID". The patient underwent the following laboratory tests and procedures: computerised tomogram: (24Sep2021) unknown results; laboratory test: (2017) cognitive age related impairment, notes: initial testing; (Mar2021) showed definite change; lumbar puncture: (01Oct2021) leptin lymphocytic meningitis, notes: she was diagnosed with that on 01Oct2021 but those symptoms developed on 22Sep2021; magnetic resonance imaging: (Mar2021) loss of volume in regions, notes: that are pretty commonly associated with Alzheimer's; sars-cov-2 test: (unspecified date) positive, notes: developed COVID. Therapeutic measures were taken as a result of covid-19. Patient has been diagnosed with COVID, she has had both COVID vaccines plus the booster, but she got COVID. The patient basically started with coughing and other symptoms around 20Jan2022 and her doctor prescribed her a steroid, Prednisolone 20 mg and PAXLOVID 4 mg BID for 5 days.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2.
sore arm; Aches for 2 days; chills for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE PAIN (Aches for 2 days) and CHILLS (chills for 2 days) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma chronic. Concomitant products included METOPROLOL TARTRATE (METOPROLOL [METOPROLOL TARTRATE]), MONTELUKAST, SERTRALINE, LORAZEPAM (ATIVAN) and ZOLPIDEM TARTRATE (ZOLPIDEM [ZOLPIDEM TARTRATE]) for an unknown indication.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE PAIN (Aches for 2 days) and CHILLS (chills for 2 days). In April 2021, PAIN IN EXTREMITY (sore arm), VACCINATION SITE PAIN (Aches for 2 days) and CHILLS (chills for 2 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication were not reported.   This case was linked to MOD-2022-455481, MOD-2022-455496 (Patient Link).
I felt fine for the fors 24 hours. Limited arm soreness, no other symptoms. At 11:00Am Sunday I began to get achy at my joints. I was out on a 5 mile hike and unable to turn around. When I got home took Tylenol and rested. At 11Pm Sunday night I started feeling itchy and discovered a full body rash. They were raised patches and if i scratched myself the area would swell up like a hive. Took Benadryl and it was mostly gone by morning. At 11:00pm Tuesday night I started feeling itchy again and discovered the rash had returned again. Again took Benadryl and it was mostly gone by morning.
Left arm is very sore he can barely pick it up. His fingers are numb and he has a sciatic pain going in both side.
Vaccine expired on 02-Apr-2022 and vaccine removed from fridge on 18-Apr-2022; Vaccine expired on 02-Apr-2022 and vaccine administered on 18-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 02-Apr-2022 and vaccine administered on 18-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and vaccine removed from fridge on 18-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 02-Apr-2022 and vaccine administered on 18-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and vaccine removed from fridge on 18-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 02-Apr-2022 and vaccine administered on 18-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and vaccine removed from fridge on 18-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The BUD date was reported as 02-Apr-2022.  Vaccine was removed from fridge on 18-Apr-2022.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-571103, MOD-2022-571106 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2022: Vaccine start date, expiry date and new event were added.
Vomting, joints hurt, frequent headaches, general feeling of unwell, feeling dizzy, painful hands, feet, arms, legs, nausea, muscle weakness, tiredness, missing more school from not feeling good.
extreme pain in lower back to the extent that any movement was almost intolerable......occurred within an hour after injection and only had some lessening of pain on the 8th day ( today).   Also had a large  red rash below the injection site but this was not a problem.
Pt returned for PPD read 48 hrs after vaccine administered. Had 24x32mm redness with induration on left deltoid muscle.
This spontaneous report as received from a nurse practitioner refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA, (dose, route, lot number and expiration date were not reported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Pt. received a flu & pneumonia vaccine yesterday 10-26-10. Today while undressing she noticed 5 lumps (prune & walnut) size on her arm (lymph nodes?) advised to have her doctor check it out.
Seen in ER 4-25-08 for left thigh cellulitis, started on augmentin.  Returned to clinic 4-26-08 after one dose of antibiotic as erythema had slight extension very subtly outside skin marking. ENC to cont augmentin
Pt had brief LOC episode lasting 20--30 seconds.  Pt with previous Hx of syncope  had a flu vaccine at 11:45 am and felt dizzy at 11:50  as she was standing while waiting for her mother to get d/c paperwork and was observed to fall backwards hitting back of her head on the carpet covered floor.  Mother states that pt's arms stiffened for 1--3 seconds.  I heard the sound of pt falling and got to pt right away and observed pt's hands to be clenched and elbows to be stiffened for 3--5 seconds.  Episode lasted 20--30 seconds. Pt was immediately alert right after and stated "I fainted."  Pt dines any headache or pain. No loss of bladder or bowel control.  Was able to walk to stretcher. Vitals wnl.  Denies dizziness, nausea.  911 was called and pt was sent to Hospital ER for evaluation
Information has been received from a 74 year old female with asthma and no allergies who on 25-Sep-2007 was vaccinated SC with a 0.65 ml dose of Zostavax.  Concomitant therapy included mometasone furoate (Asmanex), albuterol sulfate (+) ipratropium bromide (Duoneb) and triamcinolone acetonide (Azmacort).  On 25-Sep-2007 the patient stated that she became dizzy after vaccination and that went away and she experienced a very dull headache that lasted about 24 hours.  No medical attention was sought.  No diagnostic laboratory tests were undertaken.  On 27-Sep-2007 the patient recovered.  A product quality complaint was not involved.  No further information is available.
No adverse effects; improperly stored vaccines were administered; This non-valid spontaneous report has been received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unspecified dates from 16-OCT-2017 through 04-DEC-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N012093, expiration date 13-JAN-2020 (dose and route of administration were not reported), of ROTATEQ orally, lot # reported as N046006, expiration date 28-JUN-2018 (dose was not reported) and LIQUID PEDVAXHIB lot # N012120, expiration date 30-JAN-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 52.7 degrees Fahrenheit for 25 minutes. Digital data logger was involved. There were no previous excursions reported.