chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to a 22 year old male patient. Information about the patient's medical history, concurrent conditions and concomitant medication was not reported. On 18-DEC-2013, the patient was vaccinated with the first dose of GARDASIL (dose, route, anatomical location, Lot # and expiration date were not reported). Then, on 20-DEC-2013, the patient received the second dose of GARDASIL (dose, route, anatomical location, Lot # and expiration date were not reported). The reporter stated that the patient received (also reported as would receive) on 01-NOV-2016 a dose of GARDASIL 9 (lot # L038503, expiration date 18-DEC-2017, dose, route and anatomical location were not reported). No adverse effect was reported. Additional information has been requested.
Patient developed a severe headache, nausea, and vomiting on 4/5 PM.  She continued to have severe headache, improving to a 5 and then worsening to a 10 for several days. She had some chills develop the AM of 4/6, but no fevers, myalgias, rash, or other side effects. She went to ED on 4/9 and was transferred to our facility. Found to have subarachnoid hemorrhage.  CT angio without evidence of clot. No clear etiology for bleed per neurosurgery
DYSPNEA, RHINORRHEA, WHEEZES APPROX 30-40 MINS AFTER MULTIPLE INJECTIONS.  TREATED SUCCESSFULLY WITH ALBUTERAL/IPRATROPIUM, PREDNISONE, O2 AND BENADRYL.   SHE THEN DEVELOPED A RASH BUT NEVER HAD ANY RASH OR ERYTHEMA AT INJECTION SITES.  SHE WAS DISCHARGED WITH FLOVENT, RANITIDINE,ZYRTEC,ALBUTERAL MDI RXS.
Patient began experiencing facial drooping to one side on Saturday 4/10/21. Patient's wife is a nurse and felt that this was Bell's Palsy. She monitored his vital signs to be sure a stroke was not occurring. Since his vital signs were stable, they followed up with his Primary MD in office on Monday 4/12/21. The PA gave the DX of Bell's Palsy and stated it was probably related to having COVID-19 illness around Christmas 2020. The patient did to tell the PA he had been vaccinated on 3/22/21 with Moderna. Occurance was discovered when patient was phoned to confirm his appointment for his 2nd dose of Moderna vaccine. Vaccination held at this time until improvement of symptoms & further direction from Medical Director.
hives all over the body, angioedema on lips (severe swelling), stomach bloating and acid reflux
adverse reactions after second shot.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reactions after second shot.) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse reactions after second shot.). At the time of the report, VACCINATION COMPLICATION (adverse reactions after second shot.) outcome was unknown.            She does not want to share any information with the safety department. She states that the side effects she has are relating to what women usually have but does not want to go into further details. No concomitant medication were provided. No treatment details were provided.   Reporter did not allow further contact
Patient stated he gets light headed from getting blood drawn, but thought he wouldn't have an issue getting the Immunization. The patient remained seated in the IMZ booth.  The administering pharmacist turned around and entered the pharmacy to discard of used wrappers.  He turned around and saw the patient was ok.  The pharmacist was about to remove my gloves when he hard a loud crash. The patient passed out and leaned on the privacy panel. The panel fell over along with the patient.  The pharmacist immediately checked for responsiveness and the patient was moving slightly.  He told the technician to call 911 and  the store manager. The patient got up on his own and was leaning on the chair after.   After a minute the patient was sitting on the floor and was able to answer our questions. The paramedics arrived and checked his vitals . The patient told paramedics he felt ok and didn't need to go the hospital. The patient said he was going to call his mother to pick him up as suggested by the paramedics.
This spontaneous report as received from a other health professional refers to 15 patients of unknown age. On unknown dates the patients were vaccinated with improperly stored doses of VARIVAX lot # N008829 for prophylaxis. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to VARIVAX. The reporter considered no adverse event to be not related to VARIVAX. Additional information has been requested.; Sender's Comments: US-009507513-1708USA005788:
Initial unsolicited report received from a physician on 10 March 2016. This case involves 6 patients (age and gender not reported) who were vaccinated with a dose of FLUZONE (batch number, expiry date, route and site of administration were not reported) on an unspecified date in September 2015. Medical history and concomitant medications were not reported. On 10 March 2016, following the vaccination patient experienced "flu like" symptoms and tested positive for A and B strains of "flu virus". It was also vaccination failure case. Laboratory investigation and corrective treatment was not reported. The outcome of event was unknown. Upon internal review, the company decided to consider the event serious because of important medical event tested positive for A and B strains of "flu virus", flu like symptoms and suspected vaccination failure. List of documents held by sender: none. Sender's Comments: As with any vaccine, vaccination with influenza vaccine may not protect 100 percent of susceptible individuals. However, additional information on the patient's immune status at the time of vaccination (medical history, concomitant medication), previous vaccinations, infectious work-up results to rule out alternative etiology and details of tests used to identify the influenza strain (e.g. PCR, nasal swab, etc.) are needed to further assess this case.
11AM felt like could not breathe-throat constricted;blacked out while driving car;came to by 11:05 but blacked out 2 more times;felt sick until 2PM that day;
problems with her stomach; She has a bit of fluid coming back and acid and a bitter taste in her mouth.; She has a bit of fluid coming back and acid and a bitter taste in her mouth.; she has fatigue, she is so tired she can't get up; she has fatigue, she is so tired she can't get up; nausea; This is a spontaneous report received from a contactable consumer or other non hcp. A elderly female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 26Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced her first Pfizer covid vaccine on 26Mar2021. She had a little nausea for the first three days, but it was fine. Now on the 6th and 7th day, she has fatigue, she is so tired she can't get up and what worries her more is problems with her stomach. She is not bringing food down. She has a bit of fluid coming back and acid and a bitter taste in her mouth. She has not been eating anything spicy or salty and has had the same diet. She is worried about her liver. Is this related to the vaccine Age 66 unit attempted transfer to safety, but all agents were busy. The clinical outcome of the event nausea recovered and other was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
SLEPT FOR TWO DAYS; PINCH-LIKE PAIN AT INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. No concomitant medications were reported. On MAR-2021, the subject experienced slept for two days. On MAR-2021, the subject experienced pinch-like pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pinch-like pain at injection site and slept for two days was not reported. This report was non-serious.
muscle aches (left arm, upper back, neck); headache; mildly nauseated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hayfever and related allergies" (unspecified if ongoing); "Hayfever and related allergies" (unspecified if ongoing). Concomitant medication(s) included: XYZAL; MONTELUKAST SODIUM; MOMETASONE FUROATE. Vaccination history included: BNT162b2 (Lot number: 501458A, Route of administration: Intramuscular, Dose: 3, Location: Left arm), administration date: 30Oct2021, for Covid-19 immunization; BNT162b2 (Lot number: EL3247, Dose: 2), administration date: 29Mar2021, for Covid-19 immunization, reaction(s): "soreness at injection site", "headache", "Mild nausea"; BNT162b2 (Lot number: EL3247, Dose: 1), administration date: 08Mar2021, for Covid-19 immunization, reaction(s): "Sore arm at injection site", "felt jittery". The following information was reported: HEADACHE (non-serious) with onset 26Apr2022 at 19:00, outcome "recovering"; NAUSEA (non-serious) with onset 26Apr2022 at 19:00, outcome "recovering", described as "mildly nauseated"; MYALGIA (non-serious) with onset 26Apr2022 at 19:00, outcome "recovering", described as "muscle aches (left arm, upper back, neck)". Therapeutic measures were taken as a result of myalgia, headache, nausea.  Additional information: The patient did not receive any other vaccine in four weeks. Prior to vaccination patient has no covid and patient not tested covid after vaccination. Patient had no known allergies. The patient received Acetaminophen to treat the events. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Questionable chickenpox, had one "bump" on forehead 2/19/04, headache and several days later had 3 more spots on back, no fever.
COVID-19 pneumonia; COVID-19 pneumonia; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4480335-00 (Company).  A 58-year-old female patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Batch/Lot number: unknown), on 09Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 10Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 PNEUMONIA (hospitalization, medically significant), outcome "recovered" and all described as "COVID-19 pneumonia". The action taken for adalimumab was unknown.  The reporter considered "covid-19 pneumonia" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid-19 pneumonia,drug ineffective.
Non-immunocompromised patient received a dose of 100mcg, a full dose of Moderna instead of a Booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Non-immunocompromised patient received a dose of 100mcg, a full dose of Moderna instead of a Booster dose) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040D21A, 014M20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Blood pressure) and Tachycardia. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, PROPRANOLOL for Hypertension and Tachycardia, DUTASTERIDE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 microgram. On 21-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Non-immunocompromised patient received a dose of 100mcg, a full dose of Moderna instead of a Booster dose). At the time of the report, ACCIDENTAL OVERDOSE (Non-immunocompromised patient received a dose of 100mcg, a full dose of Moderna instead of a Booster dose) outcome was unknown.            The patient took DUTASTERIDE for Prostate.  No treatment details were reported.
Varicella vaccine breakthrough. Had varicella vaccine on 9-4-03 and 8-28-07. Diagnosed with varicella on 10-22-07. Had 6 papular-lesions on shoulder and back, some with pustules, one with scab. Afebrile.
At 30 mins he began shaking and appeared to pass out for a moment. He became confused. This morning he had fever, oxygen was low, not speaking not walking.
20 Y male presented to the ed  12/24/21 with substernal, pleuritic cp and sob which started last pm.  Patient returned from college a week ago and 6 days ago got a Phizer COVID booster immunization.  Three days ago developed URI sxs and since has had 2 neg outpatient COVID tests(home test and PCR).  Spoke to his pcp yeterday and requested a strep-test(not yet done).  Chest pain and SOB started last pm before he went to bed and went away at one point but came back at 4 am which prompted him to come to the ed.  Patient was discharged to home on 12/25/21.
On July 18, 2011, I went to the Pharmacy and received a ZOSTAVAX Inj. My arm did hurt for several hours afterward. The next day I felt miserable. It felt even worse than the flu! I developed swollen neck glands, sore throat, coughed, coughed, coughed, lost my voice and my ears ached. This went on until July 22, 2011 when I went to my family dr. He said I had Sinusitis and otitis media. He ordered BACTRIM DS twice a day for 10 days. I feel better now and still have a mild sore throat. I believe this was a definite reaction to my Shingles/ZOSTAVAX injection.
vasovagal syncope, nausea, weakness, dizzy, headache, fever - I was weak upon waking, went to  taking a shower and felt nauseous, and my legs collapsed, got dizzy and I tumbled out onto the floor of the bathroom .  I couldn't get up or clear my head for a  few minutes.
This spontaneous report was received from a physician and refers to unspecified patients of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates in 2017, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M039061 with expiry date 28-APR-2018) (dose, route and anatomical location not reported) for prophylaxis. Exact time frame and temperature at which the vaccine underwent excursion was unknown. However it was reported that the lot # M039061 underwent a temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for a cumulative time frame of 2 hours on 13-MAR-2017 and 27-MAR-2017. Maximum individual time frame was reported as 1 hour for each cycle. There was no previous temperature excursion. The call was not because of data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA005439: US-009507513-1705USA005436: US-009507513-1705USA005438: US-009507513-1705USA005437: US-009507513-1705USA005435: US-009507513-1704USA014447: US-009507513-1705USA005463.
2nd dose of moderna covid-19 dose given too early. was administered at only 21 days after 1st moderna vaccination.
Swollen lymph nodes in the right under arm around 11:30 AM to 12:00 PM on 1/4/2021 Swollen lymph nodes spread from right under arm into chest around 8:00 AM.  Swollen lymph nodes spread from right under arm into chest and then spread down right arm by 12:00 PM.   Areas of swelling also have pain to the touch or movement or breathing.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. Patient was inoculated with zoster vaccine live (ZOSTAVAX) in 2008, as prescribed and/or administered by a healthcare provider at a Public Health District for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by the physician for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Itchy hives but it was worse yesterday; He also slept for like 10-11 hours last; Hives; Itchy hives; This is a spontaneous report from a contactable consumer reported for a patient. A 13-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Jun2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration for covid-19 immunization, past drug event was reported amoxicillin and experienced urticaria, azithromycin and experienced urticaria (had hives before after taking amoxicillin and azithromycin but they were smaller and stopped after a day or two, as reported). On 29Jun2021, the patient experienced hives, on an unspecified date of 2021 itchy hives, but it was worse yesterday on 12Jul2021, he also slept for like 10-11 hours last on Jul2021. Reportedly, a friend wrote [Son] has had terrible hives for 2 weeks. I feel so bad for him. We went to an allergist yesterday who put him on a ton of meds- it seems to be helping. I asked what is triggering the hives. She responded I can't tell you. Because she knows I'm obligated to report AEs. Then she wrote: Actually the allergist isn't sure. It's not food and she thinks environmental is unlikely. But we are waiting for bloodwork. So could be normal allergy. I feel terrible for him, he so uncomfortable. The increased meds yesterday seemed to help bc his whole body isn't red and hot. He still has itchy hives but it was worse yesterday. He also slept for like 10-11 hours last night, so he had enough relief to actually sleep. He has had hives before after taking amoxicillin and azithromyocin but they were smaller and stopped after a day or two. Therapeutic measures were taken as a result of hives, itchy hives. The outcome of the events hives, itchy hives was not recovered, the outcome of other events was unknown.  Information on lot/Batch number has been requested.
Patient is a 16 year old female that received the first dose of the Moderna vaccine in March. Today 4/23/21, she received the second dose of the Moderna vaccine. Her father accompanied her and gave his written consent. Vaccinating nurse also signed consent form. Patient received vaccine on her left arm, no adverse effects noted.
-Head ache lasting almost all day.  No particular region of the head -Started  06/01~ 06/02 . Persistent upto  now  06/09.  - Taking ~ 75 mg Aspirin  1 X day,  since 05/06.  Pain intensity is  lower  now.  -Patient has minor history of  muscle twitching , no particular history of head ache - Will consider visiting primary care physician , if pain doesn't subside in the next few days
patient suffered a DVT; This spontaneous case was reported by a pharmacist and describes the occurrence of DEEP VEIN THROMBOSIS (patient suffered a DVT) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 003B21A) for COVID-19 vaccination.     Concomitant products included ANTICOAGULANT CITRATE DEXTROSE (ANTICOAGULATION) and APIXABAN (ELIQUIS) for an unknown indication.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced DEEP VEIN THROMBOSIS (patient suffered a DVT) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (patient suffered a DVT) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Laboratory data was mentioned as the ultrasound  and result was not given. No treatment information was provided by the reporter.  Company comment- 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. Further information has been requested.; 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. Further information has been requested.
After 2 minutes my tongue started getting numb.  Racing heart and standard sore arm. To date my tongue and roof of mouth are still numb (sensitive to touch), in addition... my lips feel full and on occasion my muzzle area of my face feels tingly.  Slight headaches on a daily basis.  Brain fog and some blurry vision on occasion.   Right ear has a swishing (sounds like my heart beat) Constipation (need to take laxatives to go)... heavy feeling in my lower back and buttock. Leg muscle pain (as if I walked or climbed a ladder all day) this is ongoing all day - every day - even upon waking in the morning.