chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Difficulty breathing at some times, mostly while exercising; Muscle and joint pain; Muscle and joint pain, joint pain in her fingers and toes; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 17Apr2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified medication for an unknown indication from an unknown date and unknown if ongoing. On 19Apr2021, the patient experienced difficulty breathing at some times, mostly while exercising, muscle and joint pain. joint pain in her fingers and toes and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events difficulty breathing at some times, mostly while exercising, muscle and joint pain, joint pain in her fingers and toes and tiredness was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
chills, convuls, fever tactile hot lethargy lt MD office, arrived home 630PM; pt sz 730PM; brought back to MD office;
Information has been received from a consumer concerning her daughter who was vaccinated with her third dose of GARDASIL (therapy started date, route, site unknown).  Subsequently the patient had been having pain all over her arm.  The patient didn't seek medical attention.  The patient's outcome was unknown.  Additional information has been requested.
Patient was supposed to get a flu shot but accidently got a covid shot. He had his 1 st pfizer vaccine on 03/20/21 and 2 nd on 04/13/21
Patient was given a 4th dose of COVID. No adverse reactions at the time of the event.
Patient is COVID positive on 11/13/2021. 3 doses of COVID vaccine given. Last dose given 11/9/2021. ED visit 11/13/2021. 77-year-old male presents complaining of cough, fever, myalgias, for the last day. States he has mild generalized weakness. He had an episode where he almost passed out when going from sitting quickly to standing. Treatment: Toradol, fluids, Decadron. Admitted 11/16-11/19. SOB, acute hypoxemic respiratory failure, Pneumonia due to COVID. Required supplemental oxygen and was admitted. Patient seen by Dr. and ID, was started on Decadron, Lovenox and Remdesivir. Was also given Lasix. Patient had steady improvement in symptoms and clinical status and was able to be discharged home with oral steroids.
Patient woke up the following day on 10/08/2017 with rash, swollen eyes and itchiness. She took some BENADRYL and by the time she called the Pharmacy claimed to have been getting better with the itching and swelling. She then went to see her Primary Doctor today 10/11/2017 and all the rash was cleared and her eyes were still a bit dry but Doctor told her that they should clear off in a few days. No more rash and no longer swollen. Patient claims to be doing well.
Began with tinnitus at both ears on the morning of March 31, 2021. On the morning of April 1, the left ear lost hearing and tinnitus appeared to better. In the afternoon around 12 noon felt nauseated, dizzy. At about 4:00p.m. vomited and felt the sky spinning with eyes open.
This spontaneous report as received from a pharmacist and pharmacy intern refers to unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 27-DEC-2015, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB injection, lot# K026666 with expiration date 22-OCT-2015 or lot# L019298 with expiration date 22-JUN-2017 (dose, route, lot # and expiration date were not reported). No adverse symptoms/effects were reported. This is one of the several reports from the same source. Additional information has been requested.
DID NOT TAKE VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case (PVX2019-1040) was received form a consumer on 29-Apr-2019. It describes a male consumer who "did not take Vivotif according to schedule". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer did not take Vivotif according to the recommended schedule. The doses were taken on 23-Apr-2019, 26-Apr-2019, and 29-Apr-2019 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "did not take Vivotif according to schedule" was unknown.  Company's Comment: The causality of the event "did not take Vivotif according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take Vivotif according to schedule" was considered as not applicable.
Vaccine given and was expired. Call placed to Merck and verified that vaccine counts and does not need to be repeated.
Information has been received from a medical assistant concerning a 24 year old female with no pertinent medical history and no drug allergies who on 24-FEB-2009 and on 24-APR-2009 was vaccinated with the first and second doses of GARDASIL (lot#661952/1129X). There was no concomitant medication. "Two days after the second dose", on 26-APR-2009 the patient felt lethargic and dizzy. She did not seek medical attention. No lab diagnostics studies were performed. One week after the beginning of the symptoms, the patient recovered. Follow-up information has been received from a certified medical assistant who reported that at 1:30 PM on 24-APR-2009 the patient was vaccinated with the second dose of GARDASIL (lot#661952/1129X) IM in her deltoid. Two days after the vaccination, the patient developed vomiting, fatigue and dizziness. Medical attention was not sought. The patient recovered approximately one week later. No further information is available.
No additional adverse effect reported.; ROTATEQ, M-M-R II and VAQTA that underwent a temperature excursion were administered.; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.   On 25-MAY-2021, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHa) (M-M-R II) (lot # T007232, expiration date reported as 26-FEB-2022, but upon internal validation established as 27-FEB-2022) (exact dose, route of administration and anatomical location were not provided) and hepatitis A vaccine, inactivated (VAQTA) (lot # T035720, expiration date reported as 14-APR-2022, but upon internal validation established as 15-APR-2022) (exact dose, route of administration, anatomical location were not provided) for prophylaxis. The administered doses were stored in temperature above 46 Fahrenheit degrees (F) (46.8 F) for 30 minutes. No previous temperature excursion occurred. Digital data logger was involved. No additional adverse effect reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035720; expirationdate: 15-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA003900: US-009507513-2106USA003899: US-009507513-2106USA003901:
Fever, Aches/Chills, Headache set in about 12 hours after vaccine. Lasted about 24 hours
Patient received vaccine on 2/17/21 at approx. 1105, began noticing adverse symptoms at approx. 1115.  Patient reports symptoms are similar but slightly worse than what she experienced with 1st dose.  Patient reports throat tightness, lip and tongue tingling, and having slight trouble swallowing.  Patient reports she did see her physician prior to receiving 2nd dose and was recommended to take PO Benadryl prior to 2nd dose, which patient did.  Patient was closely monitored for an additional 15 minutes (approx. 45 mins. in total).  While patient was waiting she also took another PO Benadryl which was her own medication.  Paramedic was also on site and monitoring patient.  Patient reported her symptoms were beginning to resolve and she felt well enough to go home.  Patient refused to be assessed fully in the ER and went home on her own.  Advised if she notices any worsening to symptoms to seek emergency care, patient verbalized understanding.
About 6 minutes after a got first shot of moderna, I had felt fin. Then within 20-30 seconds I realized that my chest was heavy/pressure on my sternum, arms and torso went warm and sweaty, a bit light headed and had fast heart rate. I asked medical team for assistance. They took blood pressure/O2 levels and listen to my heart and lungs. Had epi pen ready, but never administered. Watched me like this for about hour and a half until my bp came back down to normal levels.
SWOLLEN LYMPH NODES IN ARMPIT, MILD PAIN AND INFLAMMATION Narrative:  PATIENT REPORTS SWOLLEN LYMPH NODES LOCATED IN THE ARMPUIT FOR ABOUT 2 DAYS, MILD PAIN AND INFLAMMATION
This spontaneous report as received from a pharmacist (also reported as certified medical assistant) refers to a 62 year old female patient with diabetes, allergy to IV (intravenous) contrast dye and allergy to most narcotics. The patient had a history of allergy while on previous therapy with amitriptyline hydrochloride (manufacturer unknown) (captured in MARRS#1411USA001759). On 23-OCT-2014 the patient was vaccinated with PNEUMOVAX23 (injection, batch/lot # K010016, expiration date 05-AUG-2015; dose number, route, anatomical location not reported). Concomitant therapies included lovastatin (manufacturer unknown).  On 23-OCT-2014, the patient experienced achiness throughout the whole body, a sore throat, swollen lymph nodes, fever (exact values and units unspecified) and chills. The patient did not seek medical attention and no specific treatment was given for the events. The outcome of the events was reported as recovering. Causality was not provided by the reporter. Additional information has been requested.
1st dose 2018, 2nd 4 months ago; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   In October 2022, the patient received the 2nd dose of Shingrix. In October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 15-FEB-2023 Reporter's Comments:  The patient self-reported this case. The patient received first dose of Shingrix in 2018 and second dose four months ago. The reporter did not consent to follow-up Additional Supportive Information: The patient received 2nd dose four months prior to reporting after receiving 1st dose, which led to lengthening of the recommended interval between vaccine doses. As per reported information patient received 2nd dose four months prior to reporting hence conservatively October 2022 was captured as vaccination date and event onset date.
FEVER of 103 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (FEVER of 103 degrees Fahrenheit) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     Concomitant products included APREMILAST (OTEZLA).    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced PYREXIA (FEVER of 103 degrees Fahrenheit). At the time of the report, PYREXIA (FEVER of 103 degrees Fahrenheit) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.
Pt got a pfizer covid vaccine at 117pm on 8/11/21 and at 127pm mom reported to pharmacist that patients throat felt tight. EMS was called and 10 mls of liquid diphenhydramine (25mg) was given and pharmacist remained with patient to observe, during observation patient was alert and responsive, talked fine and even used aps on cellphone. At 138pm EMS arrived and checked patients vitals which were all within normal limits. EMS offered to take patient to hospital and mother and patient declined. Everyone left at 150pm.
Patient felt achy, tired, and believes she had a low grade fever the day after receiving first dose of SHINGRIX IM. Lasted until that evening when she took an OTC pain reliever.
Maculopapular rash ondorsal aspects of hands anand forearm starting 2 days after rash. Both arms swelled up. Left arm- one which gt vaccine- had more serious symptoms. Scaling of skin subsequently with hyperpigmentation in the left forearm.
Fever of 101.6, intense headache, myalgia, fatigue  As of 46 hours from vaccination fever 100, headache not so intense, muscles still ache
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (318 patients received dose from vials beyond 30-day use by date) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Jul 14, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jul 14, 2021, patient administered expired product (318 patients received dose from vials beyond 30-day use by date). On Jul 14, 2021, administered expired product (318 patients received dose from vials beyond 30-day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Date of refrigeration: May 7, 2021. This case linked to MOD-2021-363762 (patient link).
First vax, after 10 days still had skin allergy at injections site. Hard, red, hot. Treated with steroid cream. Swollen lymph nodes in armpit,   Second vax, fever of 102 for 3 days, chills, fast resting heart rate (90 bpm instead of 62), fatigue, and puffy skin (like you could see spreading from injection site). Took benadryl night after injection based on advice from ER.
Patient Stated 1 week after receiving 2nd dose, patient started period and it was worse than it had ever been before.
Patient started with itchy, watery eyes after 2nd dose of zoster vaccine.  symptoms started on the 2nd day,  on the 3 rd day  with blurry vision. patient has a follow up with eye doctor. condition is stable now.   Patient had no problems after the 1 st dose. not allergic to any ingredients in the vaccine
large red spot around white center of inj site; 02DEC94 follow up: unable to ID lot# of DTP combined w/ACTHIB; 6 days p/vax red area around site, t100, area non-tender; next day area sl larger, central clearing (1x2cm), area sl hot, raised
Pt called stating 2 hrs after getting vaccine she was vomiting, diarrhea, dizziness. Vomited all night. Today weak but no more vomiting.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients. The patients received doses of Oral ROTATEQ on unspecified dates that were improperly stored since an unspecified date in April 2012 until an unspecified date in April 2014. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
fever onset 29APR98-103PM;30APR98 PM fever inc to 104 p;/vax APAP & infant motrin;took pt to ER fever 105 treated w/suppositories & sent home w/100 temp devel fine, red rash on trunk;
hives; swelling; rash on legs, knees and ankles; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), SWELLING (swelling) and RASH (rash on legs, knees and ankles) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced URTICARIA (hives), SWELLING (swelling) and RASH (rash on legs, knees and ankles). At the time of the report, URTICARIA (hives), SWELLING (swelling) and RASH (rash on legs, knees and ankles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Developed paresthesias of the right foot, then the left foot, then to the upper extremities characterized by numbness. No motor deficits. Symptoms worsened over the week, then was admitted to hospital on 12/19/14. MRI done was suspcious for multiple sclerosis in the cervical region. Symptoms responded to high dose IV steroids over 3 days. No fevers. No rash.
Took shot Thurs. 17th- I was dizzy Thurs night, Sat. and Sun. When I moved my head too fast in any direction.
Information has been received from a medical assistant concerning a 2 month old male with jaundice at the time of vaccination who on 24-JUL-2006 was inadvertantly vaccinated with a dose of Pneumovax 23 (lot #650456/0974P), instead of a dose of Prevnar. On 24-JUL-2006 the patient was concomitantly vaccination intramuscularly in the right thigh with a first dose of DTaP (lot AC143032), intramuscularly in the right thigh with a first dose of Hib (unspecified carrier) (lot UE816AC), and intramuscularly in the left thigh with a first dose of poliovirus vaccine inactivated (unspecified) (lot 2000). At the time of report, no symptoms had been reported. The medical assistant also reported that the Risk Management Department of her organization, which includes 30 clinics, was working on an company-wide program to develop a standardized protocol for vaccine administration. Some of the issues it was addressing included identifying the correct patient and rechecking the vaccine with another person. She noted that it was to protect both the patient and the health care professional who was administering the vaccine. Her office also sent a letter to the parents of the children who was administering the vaccine. Her office also sent a letter to the parents of the children who had received the Pneumovax 23 (lot #650456/0974P), instead of a dose of Prevnar. No product quality complaint was involved. No additional information is expected.
Per Pt-Felt itchy on Wed and Thurs and Fri had a full body rash - Went to clinic and received Rx for Hydroxyzine 50mg - IHS PRN and MEDROl Dose pak.
About 5 minutes after vaccination patient reported "not feeling well." Upon questioning he said his chest felt tight and he was having trouble breathing and requested his inhaler. Jail nurse brought his inhaler and listened to his lungs with a stethoscope. She reported that his lungs sounded clear bilaterally. Pt reported that using his inhaler helped his breathing and made his chest feel better. He also complained that his legs and head were "burning." When asked to elaborate, he said it felt hot and like he was experiencing pressure but not pain. His legs and face were expected skin color, dry, and without any raised or itchy patches. Pt was able to speak coherently and without difficulty throughout, and muscle tone was strong during entire reaction. Nurses remained with pt for approximately 35 minutes post vaccination. Epi was prepared but not administered. About 30 minutes after vaccination patient reported feeling better and was breathing smoothly.
upon administration of Adacel vaccine, very pale, began to shake for about 15-30seconds. Did not lose consciousness able to communicate. Stated he is fine, he is okay.
On 12/18/01 at 08:00, woke up feeling weak and body felt heavy and felt feverish. At 08:30, began having hot flashes, breathing difficulty and needing to take deep breaths. At 14:00, face and hands turned red and started itching. At 15:30, went to MD's office and was developing hives, mottling and itching over entire body. On 12/19/01, continued itching but redness resolving. Received Depo-Medrol 40mg, IM. Now am taking Zyrtec 10mg 1 Tab for allergic reaction.
Documented on 12/3/15 during office visit: "appx 1 1/2 weeks ago went to pharmacy for vaccinations. Got Zostavax in right arm and Prevnar and another vaccine in left. Developed swelling, pain, redness, warmth in right arm. Initially had some itchiness over various parts of body - now still occasional itchy areas."
Severe bilateral leg cramps, arm cramps, incontinent of diarrhea.  Lasted about 30 minutes.
This spontaneous report as received from a physician refers to a 14 years old female patient who on 30-JUL-2012 was vaccinated with the a dose of ZOSTAVAX (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that on 30-JUL-2012, the patient was vaccinated with ZOSTAVAX instead of VARIVAX (Merck). The patient was supposed to get a second dose of VARIVAX (Merck) but instead received ZOSTAVAX. There was no adverse reaction. No treatment information was reported. Additional information has been requested.
UNSTEADY ON HER FEET; DIZZY AND LIGHTHEADED; HEADACHE; VERY FATIGUED; BODY ACHES; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included consumer was instructed to take hydrate.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Antibody test (NR: not provided) Unknown. On 08-MAY-2021, the subject experienced body aches. On 08-MAY-2021, the subject experienced headache. On 08-MAY-2021, the subject experienced very fatigued. On 11-MAY-2021, the subject experienced unsteady on her feet. On 11-MAY-2021, the subject experienced dizzy and lightheaded. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient recovered from body aches, and very fatigued on 09-MAY-2021, and headache on MAY-2021, and had not recovered from dizzy and lightheaded, and unsteady on her feet. This report was non-serious.