chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; CONSTANTLY NEEDING TO URINATE; TROUBLE SLEEPING; KIDNEY PAIN; BAD STOMACH CRAMPS; SHOOTING PAIN AT BACK OF NECK/NECK ACHES; SHOOTING PAIN IN EARS; LOW BACK PAIN; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 72 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy, and other pre-existing medical conditions included: Patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose, 1 total, start therapy date were not reported on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-JUN-2022, the patient experienced horrible taste in mouth, neck and body aches, shooting pain at back of neck and in ears, temporal headache, bad stomach cramps, low back and kidney pain, nausea, occasional vomiting, fluid diarrhea, no appetite, trouble sleeping, constantly needing to urinate and had diarrhea movements which indicates suspected covid-19 infection. On an unspecified date, the symptoms resulted into suspected clinical vaccination failure. The patient took non-company drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered first dose on 11-JUN-2022 and last dose on JUN-2022 for treatment of covid 19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with Paxlovid was drug discontinued. The patient had not recovered from suspected covid-19 infection, constantly needing to urinate, trouble sleeping, kidney pain, bad stomach cramps, shooting pain at back of neck/neck aches, shooting pain in ears, and low back pain, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000237104.; Sender's Comments: 20220642549- COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Patient describes a rash on a majority of her body. It is tolerable during the day but is quite itchy at night. Has taken diphenhydramine to help with itch.
Eight days after the vaccine I developed a large rash at the site of the injection.  It covers my entire upper arm, is very red and very itchy.
Dose 1: arm was itchy at injection site and a little spotty red.  Felt a little off for a week.  7 days after shot I got 'covid arm, or moderna arm' that grew to 12 cm x 12 cm on left arm.  Was completely gone 7 days after it started.  Dose 2: Covid-arm 2 days after the shot and grew to 12 cm x 12 cm on right arm.  Other side effects were uncontrollable body shakes and fever (started about 11 hours after injection), sore arm, body aches, headache, brain fog, and fatigue.  Most symptoms subsided after one day of onset.  Covid arm went away after 4 days (maybe slightly still visible).
Subcutaneous injection of varivax given in back of right arm on 8/6/10.  On 8/8 patient seen by MD in office for local reaction to injection.  Complained of pain at site and redness 13cmx13cm with hardness no lymphadenopathy noted, afebrile.
This spontaneous report as received from a nurse practitioner (NP) refers to a patient of unknown age. The patient was vaccinated with a first dose of GARDASIL on 27-JAN-2012, a second dose of GARDASIL on an unspecified day in April 2012 and a third dose of GARDASIL on 31-JUL-2012. The NP reported the second dose was administered while the patient was away at college and she just learned that this dose was not stored properly, as well as administered on time. No adverse symptoms reported. NP was unable to provide the improper storage details, lot #/expiration date for the GARDASIL in question. Additional information has been requested.
Severe limping, pain, soreness and weakness of the left leg, causing child to at times collapse or be unable to stand
A report has been received from a Pharmacist concerning a 1 year old, Male patient, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 Millilitres. FLUMIST quadrivalent (intranasal) started on 22-Oct-2015. It was reported that the FLUMIST was inadvertently administered to a 15 month old infant. The outcome of the event of given to 15 mo old was unknown. The report was considered to be non-serious.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose and the 3rd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain, circumstance or information capable of leading to medication error and extra dose administered. On an unknown date, the outcome of the injection site pain, circumstance or information capable of leading to medication error and extra dose administered were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional was also the consumer. The retired physician assistant stated that he had some local tenderness at injection site after SHINGRIX. In addition, the patient believed he already received 2 doses of SHINGRIX, however, patient stated that the doctor's office called him to come in for his 2nd dose of SHINGRIX; however, the patient already thought he got both doses of SHINGRIX; however, the doctor's office only had record of patient receiving their 1st dose of SHINGRIX, which led to circumstance or information capable of leading to medication error and extra dose administered. The patient was deciding whether to go in to get another dose of SHINGRIX, which the patient believed would be his 3rd dose of SHINGRIX, or, by the doctor's records, it would only be his 2nd dose of SHINGRIX since physician's office only had a record of 1 dose of SHINGRIX so far for this patient. The patient also did not wish to be contacted by patient safety. The patient did not consent to follow-up.
On/Off Head Cold On/Off Hot/Cold Chills One Hour of the Runny Defecation.  Loss of Apatite General Feeling of being Unwell
Since receiving the second dose of the Moderna COVID-19 vaccine my balance has been way off. In April 2021 I fell backwards and hit my head, I went to the ER where they found that I had a brain bleed and a concussion. My coordination is still off but getting better. I have an appointment with a neurologist in June.
Hives 2 hr post vaccine administration.  Uticarial lesions persist 12 hours post vaccine. No respiratory distress or airway obstruction.
Heart racing High fever, heart  102.4  about 5 hours took Tylenol.
Costochondritis, recurring ( developed same day as 2nd shot and lasted 4 months), this time more severe sharp chest wall pain ribs and sternum, 2 weeks after booster. ,Continuous, does not subside, to date, no easing of pain.
Sore injection site; joint aches; Chills; headache; nausea; vomiting; muscle pain; listless; fever; no appetite; Not feeling well; still tired; sleeping a lot; Very fearful of taking the second shot; This is a spontaneous report from a contactable consumer.   A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Feb2021 (Lot Number: EM0910) as single dose for covid-19 immunization.  Medical history included mild chronic obstructive pulmonary disease, asthma, bronchitis, sinus infection and sulfa allergy from unknown dates.  The patient previously took  and experienced allergies to acetaminophen, montelukast sodium, hydroxyzine, budesonide-formoterol fumarate and pseudoephedrine hcl.  On 09Feb2021, at 01:00, the patient experienced sore injection site with outcome of unknown; joint aches with outcome of unknown; chills with outcome of unknown; headache with outcome of unknown; nausea with outcome of unknown; vomiting with outcome of unknown; muscle pain with outcome of unknown; listless with outcome of not recovered; fever with outcome of unknown; no appetite with outcome of unknown; not feeling well with outcome of unknown; still tired with outcome of not recovered; sleeping a lot with outcome of not recovered; very fearful of taking the second shot with outcome of not recovered.  No treatments were given for the events. Details were as follows: the adverse events included sore injection site, joint aches, chills, headache, nausea, vomiting, muscle pain, listless, fever, no appetite, not feeling well, all in that order. Worst side effects were  gone by the third day; she was still tired, sleeping a lot  and was listless. The patient was also very fearful of taking the second shot. The events resulted in doctor or other healthcare professional office or clinic visit on an unspecified date.
Patient reported feeling tired and sore as expected. Then 6 hours following vaccination the patient experienced labored breathing and a drop in oxygen saturation from baseline and increase in HR from baseline. Baseline O2 saturation: 99% & Baseline HR: high 50's. O2 saturation  6 hours after vaccination: 96-97% & HR 6 hours after vaccination: high 80's  Patient reports feeling like someone was "sitting on her chest" for the remainder of the day.
My blood Platelets Dropped to 14,000 before receiving a large dose steriods to increase the platelets   I started getting bruising all over my body and I started feeing very tired.
Waited 5 months to get the second dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jul-2021 and was forwarded to Moderna on 28-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Waited 5 months to get the second dose) 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 08-Feb-2021, 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 (Waited 5 months to get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Waited 5 months to get the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
pt recv vax 19FEB97 & 3hr post vax it was reported that pt exp h/a, thumb was swollen & warm to touch;also exp inj site redness & swelling for 5 days;site redness & swelling tx w/OTC DPH;h/a tx w/Aleve;thumb swelling relieved by Aleve;
Patient was immunocompromised and should have received 3rd dose of 0.5 ml but only received booster dose 0.25
per patient report, received Dose 1 of Pfizer COVID-19 vaccine on 3/17/21 at outside facility. 2 weeks later patient emailed PCP a secure message reporting abdominal pain. Patient has known history of ulcerative colitis. 4/2/21 patient was admitted to hospital after CT scan revealed massive portal vein and SMV thrombus.
feeling weak; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220122000095.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "recovered", described as "feeling weak".  Additional Information: Patient reports he received 2 Pfizer covid-19 vaccination doses & experienced feeling weak for a couple of days after the vaccinations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had not gotten a full night sleep since the vaccine, kept tossing and turning at night; Loss of appetite; Metallic taste every time eat something; Lost 5 pounds since receiving the vaccine; Increased frequency of headaches; This is a spontaneous report from a contactable other healthcare professional, the patient. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 31Mar2021 at 13:00 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medications within 2 weeks of vaccination. 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. The patient had no known allergies to medications, food or other products. On 01Apr2021, since the vaccine, the patient had not gotten a full night sleep, kept tossing and turning at night, experienced loss of appetite and lost 5 pounds since receiving the vaccine. The patient experienced metallic taste every time patient ate something and increased frequency of headaches. 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 events. The clinical outcome of the events the patient had not gotten a full night sleep, kept tossing and turning at night, experienced loss of appetite and lost 5 pounds since receiving the vaccine, metallic taste every time patient ate something and increased frequency of headaches was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
EXCESSIVE AND PROGRESSIVE UNNATURAL HAIR LOSS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the patient experienced excessive and progressive unnatural hair loss. Laboratory data (dates unspecified) included: Blood test (NR: not provided) showed no reasonable indication for the hair loss. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from excessive and progressive unnatural hair loss. This report was non-serious.
MILD WEAKNESS BEGINNING LATE AT NIGHT, 24 HOURS FOLLOWING IMMUNIZATIONS. PROGRESSED THROUGHOUT THE NEXT SEVERAL DAYS, BUT MOSTLY IN THE LEGS. SEVERE WEAKNESS IN LEGS.  PATIENT REPORTS ON 9/14/2020 THAT SYMPTOMS HAVE IMPROVED SLIGHTLY, ENOUGH TO ALLOW RETURN TO WORK . PRIMARY CARE PRESCRIBER HAS BEEN NOTIFIED.
Mother states she noticed a rash at injection site on the night the vaccine was administered. Left arm is not swollen or warm to touch.
The area on my left arm where the vaccine was administered had healed nicely after about 4 days.  Then on Day 8 in the evening, the shot area on arm started to itch and feel warm.  As time progressed, there was a huge (approx. 2.5 inches wide and long) bump.  The itching, heat, and redness increased.  Slight poking pain came and went, not consistent
p/inj felt warm; had N&v & diarrhea, flushed & clammy; rested x 20 mins drank coke; no redness @ site; advised to contact MD w/change of sx; p/5mins lt arm swollen, throat felt like it was closing up; hard time thinking, sl confused; cramp
Had received Covid booster vaccination on 09/25/2021. Symptom onset was 10/02/2021. Symptoms: cough, shortness of breath, loss of taste, sore throat, runny nose, poor appetite, headache, fatigue.  Tested positive on 10/06/2021. Admitted to hospital around 10/11/21. Release date unknown.
a dose of PEDVAXHIB was administered to an adult patient; No adverse event; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown age and gender. There was information regarding the patient's medical history, concurrent condition or concomitant therapies details.  On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional details were provided. No additional adverse event or product quality complaint was reported.
Dose 1 Pfizer given 4/1/2021 lot # ER8737 Pt was hospitalized and died at Medical Center. This is not a Covid death.
pt recv vax 1APR94 & shortly p/vax pt exp severe dizziness;pt recovered from dizziness;
PATIENT HAD SWEELING TO RIGHT ARM. PAITNET TREATED WITH DIPHENHYDRAMINE 25 MG PO.
Initial side effects of muscle aches legs, arms and light headedness after all shots 11/6, 11/9, 11/13 and 11/20. Contacted Health Department 11/30 questioned how long side effects should continue..was told they should have already gone away.  Mine were not resolving and in fact got worse. Within 3-4 wks post last injection have ongoing symptoms:  Muscle pains buttocks,legs, arms;  Intermittent sharp nerve pains anywhere on the body, pins, needles, numbness hands/feet. Intermittent ice pick pains head/scalp.  Saw Neuro Dr. 1/24/20. Possible Small fiber Neuropathy discussed due to adverse reaction to vaccine. Prescribed Gabapentin for nerve pain.
Patient received vaccines and was standing in a corner of the room and passed out in a sitting position not hitting her head on anything. Patient was then lowered safely to floor protecting her head. Blood pressure was taken and Ammonia smelling salts waved under patient's nose. Patient came to and was moved to exam table where she was monitored for 1 hour. Patient was still dizzy so 911 was called to transport to ER - EMT's arrived and cleared her as stable. Mom signed EMT papers for clearance and took patient home.
3 separate occasions of nose bleeds; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 12May2021 at 17:00 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any allergies to medications, food, or other products. Concomitant medications included desogestrel, ethinylestradiol (KARIVA) from an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13May2021 at 14:00 the patient experienced 3 separate occasions of nose bleeds the day or two following vaccination. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event nose bleeds was recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Covid-19 positive test results; Covid-19 positive test results; This is a spontaneous report from a contactable consumer.   A 61-year-old male patient that the patient received bnt162b2 (Pfizer; formulation: solution for injection) dose 1 via intramuscular route administered in left arm on 12Mar2021 (Lot Number: EN6207) as dose 1, single and dose 2 via intramuscular route, administered in left arm on 02Apr2021 (Lot Number: ER8727) as dose 2, single (both doses at the age of 61 years) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Prior to vaccination, was the patient diagnosed with COVID-19. The patient covid-19 test showed positive results on 28Jul2021. Events are assessed as serious medically significant. Patient visited doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which included Covid-19 test positive results on 28Jul2021, Rapid antigen test (nasal swab) showed positive on 02Aug2021. Patient did not receive any treatment for Covid-19. The outcome of the event Covid-19 was not recovered, and vaccination failure was unknown.  Follow-up attempts are completed. No further information is expected.
first Shingrix vaccine over 2 years ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first Shingrix vaccine intramuscularly over 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 11-Jul-2022 Reporter's comment: The healthcare professional called to report about the second dose of Shingrix for one of his patients. The reporter reported that the patient did not receive the second dose of Shingrix. No other information was available. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Red, raised area of vaccination; headache, tender, burn/itch at site; area warm to touch.
Fever; Chills/rigors; Nausea; Vomiting (one episode); Headache; Myalgia; Change in taste; Generalized weakness; This is a spontaneous report from a non-contactable physician (patient). A 44-year-old male patient received one dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: 1647, expiration date not reported), via an unspecified route of administration (left arm), on 21Dec2020 at 12:30 at a single dose, for COVID-19 immunization. Medical history included hypertension and COVID-19 from an unknown date. Concomitant medication included lisinopril and amlodipine. On 22Dec2020 at 04:30, the patient experienced 8 hours of severe symptoms: fever, chills/rigors, nausea/vomiting (one episode), headache, myalgia, change in taste, generalized weakness. The patient took Tylenol and naproxen as treatment. The patient was recovering from the events.  No follow-up attempts are possible. No further information is expected.
Couldn't get out of bed 10/16/99, severe dizziness, room spinning, felt like motion sickness; better if I was horizontal. No fever, achiness or headache. Dizziness w/quick movement on 10/17/99, but less severe than on 10/16/99.