chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A clinic RN vaccinator administered a booster dose (0.25 mL) of Moderna to this patient too early (10 days early).  Per the Immunization Registry, this patient received dose 1 of Moderna on 4/22/2021 and dose 2 of Moderna on 5/20/2021.   This patient was eligible for the booster dose on 11/20/2021, 6 months after his 2nd dose, but received the booster on 11/10/2021.  No known adverse events.
Adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction). At the time of the report, ADVERSE REACTION (Adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Dizzy, sweats, two lumps at injection site, fatigue, almost fainted. We called 911 and they did an EKG and took to emergency room. Blood pressure was high.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent and concomitant medications were not reported.  On unknown dates, the patients were vaccinated with the improperly stored doses of ROTATEQ (orally, lot # L000434 with expiration date 10-JUL-2016 and lot # K004795 with expiration date 11-FEB-2016; dose was not reported). No adverse effects were reported. It was also provided that during the previous call on 23-OCT-2015 (no adverse event were reported at that time), the  medical assistant reported a vaccine temperature excursion and inquired about the stability of M-M-R II, PROQUAD (Merck), VARIVAX (Merck) and ZOSTAVAX, but none of these vaccines have been administered to the patients. Additional information has been requested.
Adverse events included bilateral leg numbness (loss of sensation) and weakness and fatigue, The patient received a diagnosis of AIDP (acute inflammatory demyelinating polyneuropathy) and ultimately of Guillain Barré syndrome.  No treatment given. The patient lost sensation in his extremities, experiences recurring neuropathy in the legs, and ultimately became bed bound after losing the ability to ambulate.
Jaw pain in both sides; Neck pain; Earache in both sides; Sore arm in left side; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm in left side), PAIN IN JAW (Jaw pain in both sides), NECK PAIN (Neck pain) and EAR PAIN (Earache in both sides) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included OMEPRAZOLE and CETIRIZINE HYDROCHLORIDE for an unknown indication.    On 29-Mar-2021 at 5:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm in left side). On 31-Mar-2021 at 9:00 PM, the patient experienced PAIN IN JAW (Jaw pain in both sides), NECK PAIN (Neck pain) and EAR PAIN (Earache in both sides). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 Tablets of Tylenol Extra Strength. At the time of the report, PAIN IN EXTREMITY (Sore arm in left side), PAIN IN JAW (Jaw pain in both sides), NECK PAIN (Neck pain) and EAR PAIN (Earache in both sides) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Blood pressure medications.
Mother stated that child had a seizure, 1 hour, post vax. Seizure was over as she was calling her mother.
Extreme redness in a large area under where the vaccine was given, hot to the touch compared to the rest of the arm, itchy. Went to primary care physician and he assumed it looked like cellulitis and I was put on doxycycline twice a day for seven days
p/vax upper arm red, swollen, hot & tender;T101 saw MD;AM & started on Zithromax;sx improved & fever gone;dx cellulitis of inj site;
Information has been received from a pharmacist concerning her 12 month old son who on 28-Apr-2004 at 10:00 was vaccinated with a dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # not reported) (SC). There was no concomitant medication. On 28-Apr-2004 at 15:00 the patient developed a fever of 104 degrees F which lasted over a period of 2-3 days. The patient also had shivers and shakes during this time. The fever was treated with acetaminophen 9TYLENOL). On 01-May-2004 the patient developed a rash of over 100 raised lesions on his body other than his trunk. The rash was not itchy. Unspecified medical attention was sought. At the time of this report the patient had recovered from the fever. The outcome of the rash, shivers and shakes was not reported.  Additional information has been requested.
101 y/O female resident of nursing facility sent to ER due to decreased LOC. Baselinr mental status unknoewn. She was found to be hypotensive and received IV fluids. WBC count wa noted to be very high approx 380000, Abd ct angio was neg. UA was positive for UTI. patient was treated for COVID infection in another faciliti from 9/3-9/12 and discharged. Code status assumed full code. 9/16/2021 tested positive
Information has been received from a physician concerning a female who was vaccinated intramuscularly with an initial 0.5 ml first dose of Gardasil.  Subsequently, one day after vaccination, the patient developed a fever.  At the time of the report the patient's outcome was unknown.  Additional information is not expected.
65 year old female resident was admitted for respiratory failure and Covid-19 infection. She is on 6L NC in the daytime and Trilogy at night as baseline. She required BiPAP initially and later changed to HFNC. She is now back at 6L. She also tested (+) for C diff colitis and diverticulitis. She has been on appropriate antibiotics. She finished treatment with Remdesivir. She will be discharged back today in stable condition
12 year old patient rec'd Fluzone High Dose, no treatment necessary, no adverse reaction.
insomnia, nausea, rash, burning face, vomiting, apprehensive;
MOTHER CALLED AND STATED HE HAD SHOTS YESTERDAY, WHEN SHE GOT HOME WITH THE CHILD HIS LEGS WERE VERY SWOLLEN, STATED HE STARTED SWELLING INTO HIS GROIN AREA AND STATED HE WAS INCONSOLOBLE , VERY FUSSY, MOTHER TOOK HIM TO THE ER BECAUSE SHE THOUGHT HE MAY HAVE HAD A SMALL SEIZURE, HE DID NOT HAVE A TEMPERATURE AT THAT TIME, MOM STATED HE WAS SO UPSET COULD NOT TELL IF HE WAS HAVING TROUBLE BREATHING, BY THE TIME SHE GOT TO THE ER HE HAD CALMED DOWN SOME AND BREATHING WAS BETTER, SHE STATED ALL THEY DID WAS GIVE TYLENOL.  TODAY THE SWELLING IS A LITTLE BETTER TODAY BUT MOM STATED THAT HIS GROIN AREA WAS STILL A LITTLE SWOLLEN. MOTHER INSTRUCTED TO GIVE 1/4 TSP BENADRYL Q 6 HOURS
woke at 3:30 am on Feb 12, 2021 with severe vertigo that caused him to fall with no injury, he could not get up crawled back to bed.  Awoke again at approximately 7:00am with feeling feverish, shills fatigue with no vertigo.  At 5:00pm patient stood to walk to bathroom, felt chills and flushed and "passed out" and fell hitting his chin on the kitchen table awoke on the floor did not remember passing out or hitting his chin.  He stood up did not feel dizzy, just tired continued to the bathroom.  No episodes after that just tired.  Patient had been taking fluids throughout the day and eating.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to RASH. At the time of the report, RASH (Rash) had resolved.            Patient is on some concomitant medications but no information provided. No concomitant medication information was provided No treatment product information was provided  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded. Further information has been requested.
Patient agreed to receive COVID booster in office today, only two vaccines documented in our symtem. After receiving booster patient recalled receiving  COVID booster at outlying facility in September.
No additional AE; PNEUMOVAX 23 expired on 1/13/2023 and was administered on 3/3/2023; This spontaneous report was received from a pharmacist, referring to a patient with unknown age and gender. The patient's concomitant therapy, concurrent condition, medical history and drug reactions/allergies were not reported.  On 03-MAR-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot number U021995 has been verified to be a valid lot number, expiration date was reported as 13-JAN-2023, dose, route and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse event (AE) reported (no adverse event).
Eye tenderness, sensitivity to light, pain with light - diagnosed as iritis - went to doctor on 12/7/2013 and again on 12/9/2013 - diagnosis of iritis and prescription of prednisolone acetate ophthalmic solution and cyclopentotlate drops.
The following day after her Moderna Covid vaccine she experienced high blood pressure and swelling of the feet. She reports she does not remember the exact reading of her blood pressure, she believes the top number was >170. She said it lasted for about a day. She said she did not seek medical attention. I advised her if this happens again she should seek emergency medical attention.
fever 100.3, body aches, tiredness, dizziness lasting 3 days. Swollen lymph node under left arm pit for 8 days.
Hearing loss. My ears feel stuffed with cotton, and my eustachian tubes are clogged
A patient was administered an expired dose of Daptacel in error, no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a nurse via physician via Medical Information (Reference number- 00640271).  This case involves a 1 years old male patient who was administered 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5624AA, expiry date: 10-Jun-2021) via intramuscular route in the right thigh for prophylactic vaccination on 14-Jun-2021 (Expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HIB VACCINE for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  A Nurse reported that an expired dose of Daptacel was administered in error and was seeking a guidance.  At the time of report, no adverse event was 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. 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.
Within hours mild mental fog and fatigue. Intense fatigue leading to bed rest last four days accompanied by mild mental fog, myalgia, intermittent low grade fever and marked depressed mood. Severe left breast pain and left axilla pain on the third day severe enough to wake from sleep. Lasted about 48 hours.
PATIENT DESCRIBED SUDDEN TEMPERATURE ELEVATION AND SWEATING. TEMPERATURE RECORDED WAS 97.6 WITH INFRARED THERMOMETER. PATIENT WAS GIVEN TWO DOSES OF ACETAMINOPHIN 325 MG TABLETS AND TWO DOSES OF DIPHENHYDRAMINE 25 MG CAPSULES. PATIENT STATED TINGLING IN THE HANDS OF BOTH ARMS. PATIENT WAS GIVEN WATER AND ASKED TO REMAIN SEATED FOR 30 MINUTES FOR FURTHER EVALUATION. PATIENT DECLINED OFFER TO CALL EMERGENCY CONTACT. AFTER 30 MINUTE EVALUATION, PATIENT STATED THEY WERE FEELING NORMAL AND DROVE HOME. FOLLOW UP CALL MADE ONE HOUR LATER AND PATIENT WAS AT HOME AND FEELING GOOD
Case number PHEH2014US022652, is an initial spontaneous report from a pharmacist received on 11 Nov 2014. This report refers to a 70-year-old male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1412301A) intramuscularly twice in this flu season on 04 Sep 2014 and on 10 Nov 2014. No adverse event was reported following this medication error.
This spontaneous report was received from an office manager referring to 6 unspecified patients of unknown ages and genders. The patients' concurrent conditions and medical histories were not reported. Since 19-OCT-2016, the patients were vaccinated with GARDASIL 9 (Lot number reported as M01180, expiration date 01-FEB-2018) dose and route were not provided. There was no concomitant medication reported. The temperature excursion was 33 F for 15 hours. It was also reported a previous temperature excursion of 33F for 15 hours, the call was not because of a "data logger". The excursion was reported as "supported: yes". No adverse effects reported. Additional information has been requested.
Right leg redness larger than a softball in size & circled around back of the leg. Little pain, warm to touch, itchy, tender to touch but child was okotherwise.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Gastroesophageal reflux. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She was taking  thyroid medication and gastric reflux medication on regular basis.  Treatment information was not Provided.
Pain from elbow to wrist. Ongoing pain to elbow. Nearly no mobility in left arm. Unable to lift anything. Severe pain with any sort of usage or flexibility. Progressively got worse from time of injection to current time. Has had cortizone shot with no relief. Has had 15 session of physical therapy. Stopped physical therapy after no more progression. Has had laser therapy for 6 session. Stopped laser therapy after no progression. Scheduled for graded motor imagery and mirror therapy. Will start on the 4th.
Information has been received from a registered pharmacist concerning a 70 year old female patient who 10 or 15 years ago, in approximately 1995, was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown) (Lot #, expire date and route not reported). In approximately 1995 after being vaccinated with RECOMBIVAX HB (manufacturer unknown) the patient's arm swelled. The patient also had redness and pain. On an unspecified date, the patient recovered. Additional information is not expected.
I first thought I was getting a sinus infection or I may have been out in the heat to long. I started to have nasal congestion and my salivary gland on the left side of my face was swollen and hard. I also experienced sweating under my arms and had mild chills. I went to a Medical Center and they gave me a COVID test, which came back negative. I was also tested for the flu which came back positive for Influenza-Strain A. They would not provide me with any medication because I had been experiencing symptoms for three days. They told me to continue with Mucinex and ibuprofen. During this time, my salivary gland has become hard and swollen, but I have not felt sick during. I did receive my flu-vaccine in October 2020. I am very grateful that we have the vaccines.
Fever of 100.7 chills muscle aches flu like symptoms run down fatigued
This case was reported by a consumer via call center representative and described the occurrence of seizure like phenomena in a 17-year-old female patient who received MENVEO for prophylaxis.  Co-suspect products included duloxetine (Cymbalta) unknown for an unknown indication. The patient's past medical history included syncope (occurred over the last two years before the reporting).  On 19th September 2018, the patient received MENVEO. On an unknown date, the patient started Cymbalta at an unknown dose and frequency. On 25th September 2018, 6 days after receiving MENVEO and less than a year after starting Cymbalta, the patient experienced syncope (serious criteria hospitalization) and head injury. On 2nd October 2018, the patient experienced seizure like phenomena (serious criteria hospitalization and GSK medically significant). The action taken with Cymbalta was unknown (Dechallenge was unknown). Rechallenge with Cymbalta was unknown. On an unknown date, the outcome of the seizure like phenomena, syncope and head injury were unknown. The reporter considered the seizure like phenomena, syncope and head injury to be unrelated to MENVEO and Cymbalta. Additional details were provided as follows: This case was reported by the patient's mother. The reporter's daughter had a two year history of syncope which were thought to be related to panic attacks. These episodes occurred when she was running for cross country and track. On 25th September 2018, the patient had syncope and hit her head. She went to the emergency room (ER) then was sent home. On Tuesday 2nd October 2018, while getting out of her car in the school parking lot, she had syncope again with seizure-like movements. She went home and later returned back to school on the same day. She had another syncope episode with seizure-like movements. On 3rd October 2018, the patient stayed home and was told by her physician to reduce her dose of Cymbalta from 40mg to 20mg because it was thought might be this medication might be causing the episodes. She did not have any episodes for the whole day. She went back to school on 4th October 2018 and had another syncope episode with seizure-like movements while sitting in the classroom. The nurse from school called the reporter and told her it looked like her daughter was having a seizure. On Friday, 5th October 2018, she went to the clinic where an EEG (electrocardiogram) was performed.  The physician told the reporter that her daughter's syncope episodes were not related to medication.  On Tuesday, 9th October 2018, the patient was admitted to the Clinic for a three day study. She did not experience any episodes while at the Clinic. Unable to determine the cause at this time although the reporter felt that it was related to the MENVEO product. The reporter gave permission for her daughter's (patient's) physician to be contacted for follow up. Unable to obtain additional information.
Information has been received from a medical assistant concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported) that after delivered, had sat on a counter overnight and for half the next day before it was refrigerated. Subsequently, the patient complained of muscle soreness at the injection site and painful arm. The patient mentioned it on their next office visit. It was unknown if the patient sought medical attention. On an unspecified date the patient recovered. The medical assistant contacted during telephone follow-up could not supply the following information: patient name, date of birth, date of vaccination, lot number or date of event. This is one of several reports received from the same source. No further information is available.
SICKER THAN A DOG; This spontaneous report received from a patient via a company representative via social media (Johnson and Johnson) concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total dose, start therapy date were not reported for covid-19 prophylaxis.  On an unspecified date, the patient experienced sicker than a dog (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced sicker than a dog (Dose number in series 2). It was reported as "I wish the Covid boosters didn't make me so darn sick!!!"..."I got the. Johnson one shot, then I got the booster, then I got a 2nd booster! Everyone made me sicker than a dog!" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sicker than a dog was not reported. This report was non-serious. This case, involving the same patient is linked to 20221234602 and 20221234672.
Covid vaccine dose #1 2/10/2021 Moderna Lot # 024m20A dose #2 3/1/2021,  Moderna, lot # n/a  pt died on 9/16/2021 in the hospital from cardiac arrest, aspiration, prolonged hospitalizations for chronic illnesses, not a covid related death.
10 days p/MMR/HIB inject pt was seen w/sl fever & generalized maculopapular eruption;
Patient has right arm discomfort, pain and redness for the past couple of days, no fevers. Vaccine administered on 5/14 and patient reports to clinic on 5/17 (Monday). PCP exam results: right arm mild localized reaction over biceps, mild warmth and no induration, swelling, or abscess.
Patient caregiver called and said he was experiencing fever of 101 and confusion and delirium. Patient received vaccine 4/26/2021. Did not report side effects until 4/27/2021. Delirium had resolved but is going to follow up with primary care provider.
Tinnitus in right ear. Numbness in right ear and on right side of face, reaching to cheekbone and above upper jawbone.
Sore lump on collarbone. Spoke to nurse at hospital, said its a swollen lymph node from reaction from shot. Said to put heat on it.
Minutes after receiving the hpv vaccine, which came last in the series, patient broken into a profuse sweat with chills. He became dizzy, lightheaded, and very nauseous. The nurse had just left the room right before the symptoms started and we had been cleared to leave. Patient ended up vomiting into the garbage can. We stayed another 15-20 minutes after the injection because he felt too awful to leave the room.
Lower lip swelling starting with the right side. As hours go by, the inflammation travels to the rest of the lower lip.