chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a patient (8 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F). It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day. Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm. Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the Center of Biologics Evaluation and Research and was released. Additional information has been requested.
Costal chrondritis; Atelectasis; Dyspnea; Her husband has partially collapsed lungs.; This is a spontaneous report from contactable consumer (patient) reported for himself. A 43-year-old male patient received second dose of bnt162b2 (Pfizer/BioNTech Covid-19 vaccine, Solution for injection, Lot/ Batch number: en6204), via an unspecified route in the left arm on 19Mar2021 (age at vaccination: 43-year-old) at 12:15, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer/BioNTech Covid-19 vaccine, Solution for injection, Lot/ Batch number: el9267) via an unspecified route in the left arm on 26Feb2021 at 12:15, as a single dose for covid-19 immunization. There were no reported allergies to medications, food, or other products. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient did not receive any other medications within two weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 20Mar2021 at 12:00, after getting the 2nd dose, patient experienced costal chrondritis, atelectasis and dyspnea. Adverse events resulted in doctor or other healthcare professional office/clinic visit. On an unknown date in Mar2021, patient had partially collapsed lungs. It was unknown if patient received any treatment for adverse events. The clinical outcome of partially collapsed lungs was unknown and costal chrondritis, atelectasis and dyspnea was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
This is an ongoing conditions that your originally reported having on all doses. It is an inflammatory condition of symptoms that occurs with each dose. I experienced head/facial-side of head pain which was diagnosed by my dental provider as trigeminal nerve. It included high inflammation of head and face. I do feel better and do believe that I am fully recovered.
Information has been received from a physician concerning an approximately 22 week old ("between 5 and 6 months") male patient with hemophilia and no drug reactions/allergies who on an unknown date was intramuscularly vaccinated with a dose of PEDVAXHIB (lot # and exp not reported). There was no concomitant medication. The reporter stated that the patient developed hematoma that was "more prominent than usual" but it slowly resolved within days. No lab diagnostics studies were performed. It was unknown if the patient sought medical attention. The physician also reported that the patient received PEDIARIX (lot #, exp unspecified) and PREVNAR (lot #, exp unspecified) via IM injection and developed hematoma. Additional information has been requested.
Vaccine was administered after vial was punctured and left at room temp for more than 2 hours.  Pt received vaccine about 4&1/2 hours after initial puncture.
Beginning on 01/26/2001, post-vax, the patient experienced general arm pain which localized to the injection site and increased with movement. Additionally, she experienced heaviness of the arm that was injected. There was no joint pain. No treatment was given. As of 04/27/2001 the adverse events were unresolved. The follow-up states the pt's medical history included osteoarthritis for which was received rofecoxib. She had no history of Lyme disease. On 07/28/2000, 09/01/2000, adn 01/10/2001, the vaccinee  received her first, second, and third .5ml left deltoid doses of LYMErix. There were no adverse events associated with dose 1 and dose 2 of LYMErix. She was treated with Vioxx from 05/03/2001 to 05/07/2001, and Darvocet N-100 one tablet three times daily as needed orally from 05/07/2001. Both MRI and X-rays were negative. The reporting physician indicated that the adversee vents were moderate in severity and were possibly related to LYMErix. He also stated that the adverse events could be associated with administration by chance injuring the sensory nerve. As of 06/29/2001, the adverse events were unresolved. On 10/11/2001m the physician stated that the vacinee had persistent but diminished pain in the area of the injection site. Some relief was obtained with Vioxx. She has seen an orthopedist but was not diagnosed. The physician stated that "it is questionalbe if related to injection or just related in time." The vaccinee had not contacted the physician about this pain for several months but it was reported by the husband one month ago. As of 10/11/2001, the adverse events were unresolved.
Pain in neck; Pain in left eye; Pain in head; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in neck), EYE PAIN (Pain in left eye) and HEADACHE (Pain in head) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On an unknown date, the patient experienced NECK PAIN (Pain in neck), EYE PAIN (Pain in left eye) and HEADACHE (Pain in head). At the time of the report, NECK PAIN (Pain in neck), EYE PAIN (Pain in left eye) and HEADACHE (Pain in head) outcome was unknown.            Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events pain in neck, pain in head and pain in left eye was not provided for humira.  No treatment medication were provided.
About 24 hours after the injection, I developed a very sudden, loud ringing in my ears to where I could barely hear anything else for about two minutes. The intensity subsided, but now two days later, I still have a faint ringing that I hear anytime I'm in a quiet place, which is extremely distracting when trying to fall asleep or when I wake up. I feel like I can no longer hear silence. The ringing is always there. I did contact my doctor, and if it doesn't go away by next week, she will refer me to an ENT.
a patient received V ARIV AX via Intramuscular route instead of subcutaneous route; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient concomitant medication, pertinent medical history and drug reactions or allergies were not provided.    On 16-NOV-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength was not provided; 1 dosage form, lot number T006345 and expiration date was 20-FEB-2022) intramuscularly for prophylaxis (incorrect route of product administration).
I broke out in a rash on my torso the next day-it lasted about 8 or 9 days-llittle red bumps and itchy (not measles!).
1705- Pt passed out right after vaccine. Pt regained consciousness about 3-5 seconds later, stated that she couldn't hear anything. Pt moved to the observation area in a wheel chair.    1715- Pt passed out again, ammonia inhalants used. Regained consciousness 3 seconds later. Pt sweaty. Ice placed to back of neck. Pt moved to cart.   First set of vitals @ 1717: Spo2: 100% HR: 53 BP: 83/42   Water and snack given to pt.   Second set of vitals @ 1720: Spo2: 95% HR: 54 BP: 88/48   Third set of vitals @ 1726: Spo2: 97% HR: 64 BP: 102/64   Pt sitting up and talking with staff an mother, color in face improving. Pt states she is starting to feel better.      Fourth set of vitals @1732: Spo2: 99% HR: 67 BP: 103/66   Pt sitting at 90 degrees, eating and drinking. States she does not feel nauseous.    Last set of vitals @ 1537: Spo2: 100% HR: 62 BP: 94/63   Per mother she normally faints with vaccines. Pt states she is feeling much better. Reminded pt and mother to keep up with fluids.
Fatigue x3 days. Interfered with activities. Reproducible, fatigue with # 1, 2, and 3.   Symptoms: OTHER FATIGUE(R5383).
Patient arrived at the Mobile Unit after being called by the school office to come. He identified himself and his identification was confirmed by  LVN. Vaccines were administered.  It was only after they were administered, that it was discovered there were two students with the same name.  The mother we had in the office didn't tell us that he was not her son and that her son had not yet arrived.  He received two vaccines that he had received previously (VZV and HPV).  Both these series had been completed and he didn't need the ones administered.  He had no adverse effects and was eager to get back to class. His mother was called and the situation explained. The school administration and the administration was also notified.
manufacturer date of expiry 3-apr-2022 and vail initialy stored in refrigerator on 15-apr-2022; I administered 2 doses of expired Moderna Covid-19 vaccine on 15Apr2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I administered 2 doses of expired Moderna Covid-19 vaccine on 15Apr2022.) and PRODUCT STORAGE ERROR (manufacturer date of expiry 3-apr-2022 and vail initialy stored in refrigerator on 15-apr-2022) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (I administered 2 doses of expired Moderna Covid-19 vaccine on 15Apr2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (manufacturer date of expiry 3-apr-2022 and vail initialy stored in refrigerator on 15-apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I administered 2 doses of expired Moderna Covid-19 vaccine on 15Apr2022.) and PRODUCT STORAGE ERROR (manufacturer date of expiry 3-apr-2022 and vail initialy stored in refrigerator on 15-apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The vial did not undergone any temperature excursion. No treatment medication was reported.  It was unknown if patient had allergies to medications, food and other products. It was unknown if patient  ever had COVID positive test or diagnosis. It was unknown if patient had history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.Other vaccines given within 1 month prior to Moderna COVID-19 vaccine were unknown.
pt had extreme swelling, fever of 102.7 when on APAP & Ibuprofen concurrently, lethargy, sz (more than 5, not more than 10) insomnia;
Pulmonary emboli with 3+ pitting edema of both lower extremities, abnormal EKG P waves.
Pt was 17 when he got first shot.  He was given the option to delay his second shot until he was 18 or continue completing his series as scheduled.  He preferred and opted to get his 2nd dose as scheduled
pt received vaccination at 1300 hrs (11/29).   By 2200 hrs she developed chills and intense pain at injection site.  She presented to office at 1000 (11/30) with severe pain at right upper arm inclusive of Rt shoulder with intense warmth and mild erythema.  Pt was febrile in office, 102.5. Duricef 500 mg bid prescribed for 10 days along with an NSAID for pain and tylenol for fever reduction. Pt was scheduled for f/u appt on 12/5.
I had numbness in the left half of my face that felt similar to coming off of Novocain.    I could move my face, and could feel touch,  but had a feeling of numbness on my left cheek,  left nostril, left lower part of eye, tongue.  Soreness
PT felt nausea, dizziness, and light headed after injection. Transported to med obs 1 via wc with mother. PT reports working out earlier today. Vitals taken and monitored. Per on-site physician - pt experienced vasovagal reaction - resolved. released at 1:55 with mother 1340 LYING - BP: 98/63, HR: 50, Sp02: 99 1343 LYING - BP: 104/68, HR: 71, Sp02: 98 1345 LYING - BP 112/74, HR: 76, Sp02: 99 1354 Standing - BP: 138/81, HR: 78, Sp02: 99
Early AM 3MAR92; fever 102, irritable; unconsolable crying; refused to eat; refused to drink; could not sleep; pt seen by MD 6MAR92 who advised parents "rxn to Pertussis" vax; also throat red; pt given ATB;
The booster by far the worse; I experienced electric-like sharp pains radiating from within (not from injection site.); sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 (Lot number: FG3527) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ew02017, Location of injection: Arm Left), administration date: 08Jun2021, when the patient was 63 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0816, Location of injection: Arm Left), administration date: 17May2021, when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 09Dec2021, outcome "recovered", described as "The booster by far the worse"; PAIN (non-serious) with onset 09Dec2021, outcome "recovered", described as "I experienced electric-like sharp pains radiating from within (not from injection site.)"; ILLNESS (non-serious) with onset 09Dec2021, outcome "recovered", described as "sick".  Additional Information: Each dose resulted in greater side effects. The booster by far the worse. in addition to all the normal side effects, patient experienced electric-like sharp pains radiating from within (not from injection site.), was miserably sick for four days, and considered going to the hospital. NO MORE SHOTS FOR ME. By far, this is the sickest patient had been in her entire life. Patient was not diagnosed with covid prior vaccination and was not tested for covid post vaccination. Patient did not take any other vaccine in four weeks. Patient did not take any other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
Information has been received from a 71 year old female registered nurse who on approximately 14-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck). There was no concomitant medication. Within a day or two of vaccination, on approximately 15-MAY-2007, the patient experienced itchiness all over her body and had some rashes. The patient stated that the rashes may have developed due to the itching. She had no skin lesions. A blood test was performed (results not provided). Unspecified medical attention was sought. At the time of the report, the patient had not recovered. A product quality complaint was involved. Additional information has been requested.
Narrative: Patient is a 61 yo F with HTN and history breast cancer, s/p lumpectomy & chemoradiation with one year remission who resents complaining of perioral numbness, lip swelling and chest rash within 15 minutes of receiving  the vaccine. No chest pain, SOB, stridor, palpitations or lateralizing weakness. - She has a latex allergy and was concerned about getting the vaccine today - Per  Pfizer, there is no latex in the vaccine vials
Brief episode of vision corruption.. perceived colors changed. White toilet bowl appeared pale blue. Preceded by strong headache behind eyes.
Recieved vaccine 8-13-07  Approx. 2pm on 8-14-07 c/o pain in right arm. Developed fever 103 right arm swollen motrin given. Visit to office 8-15-07 with fever 99.4 right deltiod swollen and tender, red area extending 7X13cm at injection site and additional red are 4X7cm in SQ area. Pt did not get any SQ vaccines. Ice, pain med & monitor.
This spontaneous report was received from a registered nurse and refers to a 16 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012132 with expiry date: 17-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Covid monitoring documentation. PT admitted 1/6/22 documented to have positive covid. PT received Moderna 3/5/21 Lot 027A21A for dose 1. Dose 2 was Moderna given on 4/2/21 Lot 017B21A. PT received Moderna Booster on 11/23/21 Lot 017B21A.
Patient came home from school and I notices arm was red, hot, swollen and sore. It took a week for swelling to decrease.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated intramuscularly with the first, second and third 0.5 ml dose of GARDASIL (Lot # not reported) respectively on 30-SEP-2011, 02-DEC-2011 and 06-JAN-2012. It was not known if the patient sought for medical attention. No adverse effects were reported. Additional information is not expected.
Vaccine administration error. There was an error discovered that the Pediatric Covid vaccine was mistakenly not diluted prior to administration of vaccine to child resulting in higher than authorized dose (0.2 mL of undiluted vaccine administered).  Upon discovery of error, management consulted Health Department pharmacist, Medical Director, Administration, and Pfizer. Parent was notified on 03/22/22 of error and given guidance based on CDC and manufacturer's recommendation to not repeat dose and inform recipient of the potential for local and systemic adverse events.  Mother states child has not had any adverse effects after his vaccine. States had a sore arm for which she gave him Tylenol for this morning. Child went to school today, and mother has not been contacted about any issues today from school.  Questions answered.  Informed to seek medical care and inform us immediately if child experiences adverse effects. Health Department to follow-up with family over the next days and week.
erythematous area starting at the deltoid now spread to bicep. Area is warm to the touch. No other symptoms. patient was ancouraged to use cold compresses, Tylenol, and he was given an antibiotic
This spontaneous report as received from a medical assistance refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-JUL-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042266, expiration date was not reported) (dose and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
missed her day 3 vaccine; Initial information received on 10-Dec-2021 regarding an unsolicited valid non-serious case received from pharmacist via phone via Agency (Reference number- 00893374).  This case involves a 66 years old female patient who missed day 3 dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (product dose omission issue).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect RABIES (HDC) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for unknown indication.  It was an actual medication error due to missed dose (same day).  It was reported "Caller reported she has a patient who presented on day 7 after exposure and missed her day 3 vaccine. Caller wants to know how to proceed with IMOVAX RABIES series.".   At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on batch number for this case.
Pt recvd 3 doses of a vax series; 24JUN91 pt exp a raised area & itching @ site; 25JUN91 pt exp entire upper arm red, itching, t99 & arm was sore; 26JUN91 exp h/a, nausea & t100.4;
Bilateral itchy eyes, watery, redness, yellow drainage. Sxs lasted until 10/20/2013. Redness and swelling of the left arm around injection site. Treated on 10/17/2013.  Prescribed Cephalexin for 10 days to treat cellulitis of left arm. Flu shot was administered subcutaneously, and OTC eye drops for allergic conjunctivitis.
Ongoing moderate vaginal bleeding started the morning after my vaccine; vaccine administration in Leg Left; This is a spontaneous report from a contactable other hcp. A 40-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EW0217), dose 1 via an unspecified route of administration in Leg Left (Vaccine administered at inappropriate site) on 22Jul2021 at 11:30 as single dose for COVID-19 immunisation. Medical history included asthma and Mild thyroid disorder treated with levothyroxine from an unknown start and stop date. No known allergies were reported. Concomitant medication(s) included spironolactone taken for an unspecified indication, start and stop date were not reported. No COVID prior vaccination and not tested for COVID post vaccination. The patient experienced ongoing moderate vaginal bleeding started the morning after vaccine on 23Jul2021. Patient had a clockwork cycle of 27-29 days, and this was her ovulation week (so day 15 of cycle). Patient did not receive treatment for the adverse event. The outcome of the event was reported as not recovered and outcome of Vaccine administered at inappropriate site was unknown.  Follow-up attempts are completed. No further information is expected.