chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child was given preservative free vaccine 0.25ml at 11am about on 11/07 and by 6pm she had a fever of 101 and was shaking. She started to vomit by mid night and threw up x 3. She was given clear liquid and was improving by the afternoon of 11/08.
fever; chills; swollen lymph nodes under the left arm; body aches/ pain; Flu like symptoms; This case was received via VAERS on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever), CHILLS (chills), LYMPHADENOPATHY (swollen lymph nodes under the left arm) and PAIN (body aches/ pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 29-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (chills), LYMPHADENOPATHY (swollen lymph nodes under the left arm) and PAIN (body aches/ pain). On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever), CHILLS (chills), LYMPHADENOPATHY (swollen lymph nodes under the left arm) and PAIN (body aches/ pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.
EXPIRED VACCINE GIVEN TO PATIENT. KINRIX EXPIRED  ON 5/7/23 VACCINE ADMINISTERED 5/8/23. NOT CAUGHT BY PHARMACY OR NURSING STAFF.
Presented due to epistaxis and melena; COVID-19+, tx w/steroids, O2, abx; weaned to RA for dc home
She had a bad reaction and ended up in the Emergency Room after the 2nd shot.; This is a spontaneous report from a contactable Physician and a non-contactable consumer. A female patient of 72 age (age units: unknown) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown, expiry date: unknown) via an unspecified route of administration on an unspecified date (2-3 weeks ago as reported) as DOSE 2, SINGLE for Covid-19 immunization. Patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via unspecified route of administration on an unspecified date as DOSE 1, SINGLE for Covid-19 immunization. Patient had a bad reaction and ended up in the Emergency Room after the 2nd shot on an unspecified date. 5 days after she recovered without any issues. The outcome of the event was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch cannot be obtained.
The pt developed 30-40 spots on his trunk, face, neck, back, axilla, groin and legs that started 1 day ago.
Patient over 65 had bigger side effects; Initial information was received on 08-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.   This case involved an 65 year old patient had bigger side effects (Unevaluable event), after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had bigger side effects (Unevaluable event), unknown latency following the administration of INFLUENZA VACCINE.   Relevant laboratory test was not reported.   Final diagnosis was Unevaluable event.  It was not reported if the patient received a corrective treatment.   At the time of reporting, the outcome was unknown for the reported event.   There would be no information available on batch number for this case.
FEVER OF 105 DEGREES FOR 3 DAYS. FRIDAY THROUGH SUNDAY.
Infant had 2 seizures; One of which occurred 27MAR91, the 2nd 1APR91; mom stated arm shaking , then head shook p/his lt arm stopped; Neck arched w/2nd one;
strong flu like symptoms: all over body ache (muscle, teeth, everywhere), moderate chills, mild headache.  I treated symptoms with Tylenol (2 capsules every 4 hours) and the symptoms began to weaken after a couple of hours.
Mother reports that infant started to break out with a rash that looks like chicken pox on abd., bottom, and under arms. Has siblings, Mom reports no rash.
Patient was given expired Menactra vaccine/ No AE; Initial information received on 26-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves female patient of an unknown age who received 0.5 mL dose of expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U5948AB, expiry date- 03-Jul-2019 via intramuscular route in the arm nos.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  The patient has not reported any symptoms.  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 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.  Documents held by sender: none.
Hives on hand (1), hip (1), back (1); total of 3 hives. Advised Benadryl PO q 4 hrs x 24 hrs.
Swelling in arm nausea fever fatigue headache my fever is 101 202 I take Tylenol and appreciate the fever for 4 hours and then it comes back
Muscle pain in the left arm for 3 days, fever for 24 hours, headache on and off for a few days, fever blisters and mouth soreness developed  after the fever, queasy stomach until Monday the 12th, overall fatigue for a few days as well
Labored breathing; Burning at injection site that was on and off for two weeks; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Burning at injection site that was on and off for two weeks) and DYSPNOEA (Labored breathing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced INJECTION SITE PAIN (Burning at injection site that was on and off for two weeks). On 06-Feb-2021, the patient experienced DYSPNOEA (Labored breathing). The patient was treated with DIPHENHYDRAMINE at an unspecified dose and frequency. On 07-Feb-2021, DYSPNOEA (Labored breathing) had resolved. At the time of the report, INJECTION SITE PAIN (Burning at injection site that was on and off for two weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment:Put ice and benedryl on injection site to help with symptoms. Conmed:blood pressure medicine and statin
Information has been received from a Registered Nurse for VARIVAX (Merck), a Pregnancy Registry product, regarding female baby. The Registered Nurse stated that the mother received had her first dose of VARIVAX (Merck) on 02-JUN-2000 for negative varicella antibodies, and the second dose of VARIVAX (Merck) was given on 16-AUG-2013 "as a booster shot." The mother had a last menstrual period of 16-JUL-2013. EDD (Estimated Delivery Date) was assessed as 22-APR-2014. The mother was not seen at the clinic for her obstetrical care, but did deliver with this clinic. On 30-MAR-2014, 37 weeks gestational age, the mother had a caesarean section due to eclampsia (onset date unknown); she was experiencing seizures. The female baby was 6 pounds, 3.5 ounces and born with no congenital anomalies on an unknown date in 2014. The mother and baby were both transferred to another facility; (unknown). The baby was in Neonatal Intensive Care Unit (NICU) for an unknown amount of time and for unknown reasons. It was reported that "the patient and baby were both doing well now." Relatedness between use of the VARIVAX (Merck) and the adverse events was unknown. No further information is available at this time. Additional information has been requested.
Headache; Unfocused feeling; Cramping in back of both thighs / back cramps; Nausea; Dizziness; Diffuse skin hypersensitivity; Anorexia; Flu-like feeling; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Internal shingles 2 years ago, was ill for 8 weeks with this). Concomitant products included covid-19 vaccine (Covid 19 Vaccine).   On 28th April 2021, the patient received the 1st dose of Shingrix. In April 2021, 12 hrs after receiving Shingrix, the patient experienced headache, mental concentration impaired, cramp, nausea, dizziness, hypersensitive skin, anorexia and influenza like illness. The patient was treated with ibuprofen and excedrin (nos) (Excedrin). On an unknown date, the outcome of the headache and mental concentration impaired were not recovered/not resolved and the outcome of the cramp, nausea, dizziness, hypersensitive skin, anorexia and influenza like illness were recovered/resolved.   It was unknown if the reporter considered the headache, mental concentration impaired, cramp, nausea, dizziness, hypersensitive skin, anorexia and influenza like illness to be related to Shingrix.  Additional details were provided as follows: The patient was the reporter. The patient completed her COVID vaccination in January 2021, she did not provided date. On 29th Apr 2021, the patient experienced headache and unfoccused feeling. On the same day, 16 hours post vaccination with Shingrix, the patient had cramps in back of thigh and also had back cramps, nausea, dizziness, diffuse hypersensitive skin, anorexia and flu like feeling. The patient did not provide lot and expiration dates of Shingrix vaccine. The patient gave consent to follow up with her HCP (health care provider).
nausea, vomiting bile, diarrhea, soreness, muscle spasms
soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (The patient's medical history was not provided.).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). On 16-Mar-2021, VACCINATION SITE PAIN (soreness at injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not unknown by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-081645 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081645:Case for dose 2
developed a severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (developed a severe headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (developed a severe headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HEADACHE (developed a severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Initial vitals:   BP: 146/91, HR 115, 100% O2, RR 16   Benadryl 25 mg po given at 9:50am    EMS notified and first injection 3mg Epi pen injection given at 9:51am; swelling decreased briefly, then after 5-7' swelling got worse.   911 called. BP 139/97, 128, RR 16, O2 sat 100% 9:50am. Second epinephrine 3mg injection given at 10:03am. Swelling decreased, but periorbital swelling and somnolence, and flaccidity persisted. BP 135/88, HR 116, RR 16, O2 sat 100% at 10:05am. Ambulance arrived at 10:05 and she was brought to hospital.
Red, hot-to-the-touch, itchy rash near the injection site with initial onset on Saturday, March 6, which was 8 days after vaccine administration. Affected area grew in size and intensity of redness over the next several days, peaking on Monday, March 8.  Borders were irregular but encompassed the injection site.  By Thursday, March 11, the rash was mostly gone and seems to have completely resolved as of March 21.   No treatment was necessary.
Focal seizure (premonition, aura, aphasia) lasting less than 2 minutes. Triggered by stress associated with vaccination (I also reported 4 seizures associated with second dose).
No additional AE/PQCs reported; administration of improperly stored PROQU AD.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 24-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) lot # T015598, expiration date 02-NOV-2021 for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). No additional adverse events reported.   The vaccine was stored in a temperature of 20.5 degree Fahrenheit (°F) for 1 hour 54 minutes as recorded by a data logger. There was a previous temperature excursion of 6°F to 14°F (12.3F) for 23 hours reported.
RN administered empty clean syringe into L deltoid. Pt aware and was OK with vaccination with new clean syringe into L deltoid
Information has been received, though the varicella virus vaccine live pregnancy registry, from an office manager in a physician's office and a 23 year old female with no allergies who in approximately February 2002 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant therapy. The pt reported that, a month later, in approximately March 2002, she found out that she was pregnant. Unspecified medical attention was sought. The office manager in a physician's office subsequently reported that the pt decided to have an elective termination early in the pregnancy. Additional info is not expected.
18 hours after the shot I started getting side effects with it reaching the worst symptoms 24 hours in. A fever just over 101, body aches, nauseous, and very strong chills for about 4 hours. These chills were intense and kept me from sleeping. Arm pain at injection site was strong. By 36 hours the chills had passed along with the other symptoms. I had rotated acetaminophen and ibuprofen every 4 hours from the beginning of symptoms.  My daughter (21 years old) had these same symptoms (from her vaccine from the same site as mine) and in addition had intense vomiting for a few hours. Her symptoms started about 12 hours prior to my intense symptoms. Both she and I tested positive for Covid at the very beginning of February. We are near the end of our 90 day post-Covid window, but we?re still a few weeks out at the time of our immunizations.
COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.   Previously administered products included for Product used for unknown indication: omeprazole. Past adverse reactions to the above products included Allergy with omeprazole. Concurrent medical conditions included Chronic kidney disease (mild). Concomitant products included EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA) from January 2022 to an unknown date and EZETIMIBE from October 2021 to an unknown date for an unknown indication.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 15-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 23-May-2022, the patient had rebound COVID symptoms and positive test 8 days after completing Paxlovid.  The patient did not receive any treatment for the rebound COVID symptoms.  Company comment: This case concerns a 73-year-old male patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown date after the fourth dose of mRNA-1273. The patient received treatment with NIRMATRELVIR, RITONAVIR. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 73-year-old male patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown date after the fourth dose of mRNA-1273. The patient received treatment with NIRMATRELVIR, RITONAVIR. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.
12 month old infant with fever and morbilliform rash on 1 day s/p MMR and Varicella. Infant active and looked well as active and alert (playful)
Resident unresponsive.  Responds to painful stimuli.  Arms flacid.
A few hours after injection I have egg size swelling at injection site, pain. I have taken otc pain relief and ice arm.
MMRV Vaccine given in error when MMR vaccine should have been given.  Patient received Varicella vaccine in the other arm at the same time.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-APR-2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and on an unknown date the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated for a blistering vesicular outbreak that was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Information has been received from a registered nurse, concerning a female who was vaccinated with GARDASIL that was stored improperly at 32 F. No adverse effect noted. The patient sought medical attention at the nurse's office. Additional information has been requested.
morning after vaccination, patient was fatigued, and unable to move legs for a few hours. Fell to floor and unable to put weight  for about 2 hours. Temp was 103 at the time. Went to hospital and released after 2 hours. Has slight residual on left leg which lasted approx. two days.
Head started feeling groggy at 3:30 pm. At the time of writing this it is about 6:30 pm and it feels like I have a mild flu?chills, headache, general body aches, pressure when sitting up. Chills in particular started at about 3:45 pm. Around 4:15 I had to lay down because I believe the shivering was exacerbating my aching.
pt recvd flu vax & exp redness & swelling @ inject site; reaction lasted 10 to 14 days;
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
On June 15, 2006 patient was admitted at the hospital for an event that was described as paroxysmal event after electroencephalogram was normal and seizures were ruled out.  On 08/01/2006 mother reported that child was awake in bed and she began to have "big hiccups" that lasted for 5 minutes, no cyanosis, no loss of consciousness.
green watery stool, very painful muscle cramps, worsening of narcolepsy symptoms, extreme anxiety (only at night)
1/4/21 noon C/O nausea and Headache, 1/5/21 C/O body aches, "COVID symptoms", fever, chills, headache, and body rash. Symptoms improved expect for rash which patient states is very itchy. NP instructed her to take Claritin daily, use hydrocortisone cream, and Benadryl at night time. Patient is also reporting all symptoms to VSAFE.
This spontaneous report as received from a male patient consumer of unknown age reporting on himself. On 24-JUN-2014, the patient was vaccinated with a first dose of ZOSTAVAX on the back of the arm (lot number, dose and route were not reported). On 26-JUN-2014, 2 days after onset of therapy, the patient had a red mark at the injection site and it lasted for four days. The outcome of the event was reported as recovered on 30-JUN-2014. He did not see a doctor about it. Relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
45 minutes after the immunization, pt experienced gradual pain from the injection site (left arm) and spread to left chest area. Pt states that pt has not been gone since and have been to ER twice.