chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reconstituted with a diluent other than the liquid conjugate portion; Reconstituted with a diluent other than the liquid conjugate portion; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA605A, expiry date 31st May 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comments: The medical assistant reported that a patient received a dose of Menveo that had been reconstituted with a diluent other than the liquid conjugate portion of Menveo. The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up by email. Additional supportive information: The use of Menveo dose that had been reconstituted with a diluent other than the liquid conjugate portion of Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Patient developed large area of erythema and induration at site of immunization approx. 24 hours after receiving the vaccine.
my period was delayed; I am having cramps but no period.; This is a spontaneous report from a non-contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EW0185) via an unspecified route of administration, administered on the left arm on 23Jun2021 (at the age pf 23-year-old) as dose 2, single for COVID-19 immunisation. The patient had no medical history. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 02Jun2021 on the left arm for COVID-19 immunization. The patient's menstrual cycle was delayed. She has a very regular cycle and do not experience delays, but after her second dose, her period was delayed. She was having cramps, but no period. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
8:45am flu vaccination given, reports she had dull headache by 1 hr after injection, c/o weakness, nausea, flush fleeing. By 2 hrs report she had vomiting, increased headache. 10:50 pt describing symptoms, no SOB, hives, swelling of throat. Advised to take po Benadryl. 2:45pm reports feeling flushed. No headache. Did not take Benadryl.
Two hours post vax, the pt developed a fever of 103, constant vomiting for 12 hours, and a heart rate of 180 beats per minute. The infant slept for 13 hours. He was taken to the ER where a urinary tract infection was reportedly ruled out. The infant was treated with ibuprofen. Follow up info received from the vaccine provider on 6/13/00 confirmed this event and provided the Prevnar lot number.
This spontaneous report was received from a physician refers to a 41 years old male patient. The patient was vaccinated with a single dose of 0.5 ml PNEUMOVAX 23, Lot number reported as H013847, Expiration date 15-MAR-2014 on 05-OCT-2012 in the physician's travelling clinic. Concomitant medications included cyanocobalamin and an unspecified flu shot. On 05-OCT-2012, the patient experienced high fever of 104 degrees, aches and pain, dizziness and excruciating pain in the armpit area after receiving the vaccination. There were no treatment information reported. The outcome of the events were unknown at the time of this report. The patient did not seek medical attention. This is one of the several reports received by the same reporter. Additional information has been requested.
Hurts when swallow; Swollen gland on left side above collar bone up into ear; Had a stiff neck; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8732) via an unspecified route of administration in the left arm on 31Mar2021 at 15:15 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Mar2021 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021, 5 days after the second dose, the patient had a stiff neck. On 06Apr2021 at 00:00, 6 days after the second dose, the patient had a swollen gland on left side above collar bone, up into ear and hurt when patient swallowed. The swollen gland was persisting at the time of reporting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events had a stiff neck, hurts when swallow and swollen gland on left side above collar bone up into ear was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse practitioner refers to multiple unspecified patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown date in September and October 2016, patients were vaccinated with improperly stored ROTATEQ (lot # M019691 and expiration date 02-NOV-2017, orally, dose was not reported). The vaccine was exposed to temperature excursions described as: minimum temperature 47.0 (unit not provided) and maximum temperature 48.2 (unit not provided) for 48 hours and minimum temperature 32.1 (unit not provided) and maximum temperature 35.9 (unit not provided) for 80 hours. There was no previous temperature excursion. It was not because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Immediately when given the flu shot had extreme pain in arm. I have had several flu shots in my life and nothing felt like this. My arm was  sore for a few days and then after a week had extreme pain in left arm with movement and cannot sleep on my left side. The injection was given quite high on my arm and may have gone into my joint capsule. I continue to have pain and have to go to PT to help with  movement and pain.  I also have numbness and tingling in my left hand.
Head pressure started occurring 3/3 and tinnitus started occurring 3/8. Both are still happening.
The rash she has now / is very itchy/rash presented on her torso and back.; feel very tired; The rash she has now / is more like red dots/rash presented on her torso and back.; receive her first dose in November 2020/ received her second dose 1/11/2021; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (started on 19th January 2019), skin lesion (on her stomach and back) and blister (large). Concurrent medical conditions included celiac disease and diabetes. Concomitant products included Herpes zoster (Shingrix).   On 11th January 2021, the patient received the 2nd dose of Shingrix. On 11th January 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. In February 2021, the patient experienced itchy rash, tiredness and red rash. On an unknown date, the outcome of the itchy rash, tiredness and red rash were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the itchy rash, tiredness and red rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, however could be 57 or 58 years. In November 2020, the patient received 1st dose of Shingrix. On approximately 18th February or 19th February 2021, five weeks after receiving 2nd dose of shingrix vaccine, a rash presented on patient's torso and back. The patient also started to feel very tired. The rash she had was similar but not as bad and the rash was more like red dots not full blisters but it was very itchy. The patient received 2nd dose earlier than the recommended interval, which led to shortening of vaccination schedule. The patient declined to answer any further questions. The reporter did not consent to follow up.
swollen; itchy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen) and PRURITUS (itchy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (swollen) and PRURITUS (itchy). At the time of the report, SWELLING (swollen) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported
Pt received vaccine and reports started experiencing fever, chills, diarrhea 1 hr after vaccination. Symptoms resolved next day late morning per pt.
Immediately after injections- tingling/numbness in left arm/hand. April 25th - numbness in both hands, neck fatigue, difficulty swallowing, tingling along jaw line, severe upper back pain (thoracic spine), panic attacks, memory issues, severe fatigue. I stopped having a menstrual cycle.
Decrease of vision in left eye/decreased vision in his right eye; This is a spontaneous report from a contactable consumer or other non hcp from a sponsored program. A 93-years-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration number were not reported), via an unspecified route of administration, administered in right arm on 12Jan2021 at 16:30 (at the age of 93-years) as single dose fore COVID-19 immunization. Medical history included ongoing renal disorder , hypertension and macular degeneration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient was not diagnosed with COVID-19 infection prior to vaccination and has not been tested for the infection since the vaccination.On 13Jan2021 at 05:30, the patient experienced decrease of vision in the left and right eye. The outcome of event was recovering.  Follow-up (01Feb2021): New information included clinical course.  Information on the lot/batch number has been requested.
Extreme fatigue, slight headache...otherwise I feel fine, but the fatigue has made it hard to do things.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable Nurse. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in left arm on 25Jan2021 08:00 (Batch/Lot Number: EL3248) as 1st dose, single, and intramuscular, administered in left arm on 15Feb2021 08:00 (Batch/Lot Number: EL3248) as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced tested positive for COVID on 02May2021. Symptoms began a couple days prior with congestion and loss sense of taste/smell. The adverse event resulted in doctor or healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19 via Nasal Swab on 02May2021 with positive result. The outcome of the event was recovering/resolving.; Sender's Comments: The reported Tested positive for COVID-19 after immunization is considered vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
FREQUENT DIARRHEA; STOMACH ACHE; FEELING HYPER; MILD ARM SORENESS; This spontaneous report received from a patient. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and  expiry: not reported) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced frequent diarrhea, stomach ache, feeling hyper, and mild arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild arm soreness, stomach ache, frequent diarrhea and feeling hyper was not reported. This report was non-serious.
Experiencing severe soreness, tingling from clavical to thumb and shooting pain in shoulder/arm following receipt of the COVID vaccine. Limited range of motion and difficulty carrying out daily tasks. REACTON Type  Neuralgia.
The day after the shot  1) 103 degree fever  2) Muscle aches that left me in bed for a day and a half  3) Joint pain that continues to persist (further description at the end)  4) headaches for several days that I needed to take my migraine medication to  help 5) Fatigue that has eased up but still currently affecting me  6) Chills that came and went for several days   The First week after  1) Left shoulder muscle pain on the opposite side from injection site but in  the same location of where I got it (right shoulder)  2) Continued joint pain that mostly persists but with waves of agitation  3) Still some muscle pain that comes and goes  4) Waves of nausea that has affected how much I'm eating in a day (mostly down  to getting one small meal in the evenings)
Confirmed Breakthrough 1st Dose - 2/26/2021 - en6201 2nd Dose - 3/19/2021 - en6198 3rd dose - 10/21/2021 - ew0162 4th Dose - 5/16/2021 - fk9894
No adverse effect reported; were inadvertently administered doses of MMR II, that had been improperly stored; Information has been received from a registered nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. The patient's pertinent medical history, drug reactions/allergies and concurrent condition were not provided.      On 01-JUL-2019 the patient were inadvertently administered doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: recombinant human albumin(rHA); lot # R028224, expiration date reported as 04-OCT-2020, but upon internal validation established as 02-OCT-2020; strength, dose and route were not reported) for prophylaxis (product storage error). The administered doses experienced a temperature excursion of 15.9 degree Celsius for 5 hour and 15 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effect was reported.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA002125: US-009507513-1907USA002218: US-009507513-1907USA003025: US-009507513-1907USA003024:
12 hours after my second Moderna shot, had severe chest pain and shortness of breath. Admitted to emergency room later in the week for myocarditis as a result of the vaccine.
Information has been received from an unspecified reporter via a field employee referring to a 18 year old patient of unknown gender. On an unknown date the patient was vaccinated with (Oka-Merck) PROQUAD (lot#, expire date, strength, dosage, frequency and route unspecified) (drug administered to patient of inappropriate age). No adverse effects were reported. Additional information has been requested.
Two days after the shot (2/28 in the afternoon) I began to have difficulty walking.  I continue to have this problem with difficulty increasing .  I began to have numbness in my left foot, now in both feet.  Also have feet cramps.
Patient had onset of redness and swelling in left deltoid on 4/19. On 4/20 had systemic signs/symptoms of nausea, vomiting, fever. These had resolved by 4/21 but redness/swelling/pain of left shoulder remained.
CANNOT URINATE; LOSS OF SENSE OF TASTE; BREATHING ISSUES; EPISODES OF CONSTIPATION (NOT GONE TO THE BATHROOM IN 5 DAYS); PAIN IN THE ABDOMEN; COLD SWEATS; BOWEL MOVEMENT ISSUES; LOSS OF APPETITE; LOST 20 TO 30 POUNDS; CANNOT GO TO WORK; CANNOT GET OUT OF BED; LOSS OF SENSE OF SMELL; CHILLS/SHIVERING; FEVER; DIARRHEA; VOMITING; TIRED; This spontaneous report received from a patient concerned a 60-year-old male. The patient's height, and weight were not reported. The patient's past medical history included: broken ribs, bacterial pneumonia, and hematoma, and concurrent conditions included: non-alcohol user, and smoker, and the patient had no known drug allergies and was healthy overall before getting the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 17-AUG-2021 at right arm for prophylactic vaccination into. No concomitant medications were reported. On an unspecified date (for couple of days), the patient experienced fever, chills, diarrhea, could not urinate and pain in the abdomen. The patient stated that since then patient has been tired and sometimes cannot get out of bed and cannot go to work. Patient lost sense of taste and smell and patient also had breathing issues. The patient had symptoms started getting better but 2 weeks ago, woke up with fever and was shivering. Patient vomited and had episodes of constipation and diarrhea, lost taste and smell again and also patient had cold sweats. Patient had issue with bowel movement and lost appetite. The patient was constipated and has not gone to the bathroom in 5 days. The patient lost 20-30 pounds, Patient took acetylsalicylic acid and ibuprofen few times a day which seems to help a little bit but then wane off. The patient was concerned that patient was not tested at the facility before getting the shot and what if patient had COVID-19 before and did not know because patient was never tested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cannot urinate, tired, cannot get out of bed, and cannot go to work, had not recovered from episodes of constipation (not gone to the bathroom in 5 days), and the outcome of fever, chills/shivering, loss of sense of taste, breathing issues, diarrhea, vomiting, pain in the abdomen, cold sweats, bowel movement issues, loss of appetite, lost 20 to 30 pounds and loss of sense of smell was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20211059177-covid-19 vaccine ad26.cov2.s- Can not urinate. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
my hands got arthritis; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 14Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that she got the first shot yesterday, they put them down to 'Easter' to get and she didn't know that was the date on the 14th when they did and she can't get any help, her 'Ackey' will not come on that day, she is taking her family and she can't find anybody take my to take her place and she won't mean she will even get ambulance to go because very short of help that day. On an unspecified date, the patient hands got arthritis. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
second dose for moderna vaccine was scheduled for May 24 I missed it; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose for moderna vaccine was scheduled for May 24 I missed it) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (second dose for moderna vaccine was scheduled for May 24 I missed it). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second dose for moderna vaccine was scheduled for May 24 I missed it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.