chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The nurse told field employee that 2 adult patients with who have the same age of 43 years old received PROQUAD instead of VARIVAX and MMR II; No additional AEs were reported; The spontaneous case was received from a nurse via company representative referring to a 43-year-old patient of unknown gender.  The patient's concurrent conditions, historical conditions, concomitant therapies, past drug reactions or allergies, and risk factors were not reported.   On an unknown date, the patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) instead of varicella virus vaccine live (Oka/Merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered). Date rep learned of the AE was confirmed to be on 16-MAR-2023 also 16-FEB-2023, (conflicting information). No further information was provided. No additional adverse events (AEs) were reported (no adverse event).  This is one of two reports received from the same reporter; Sender's Comments:  US-009507513-2302USA006707:
Painful; Itchy rash; Hard at night; Bad rash on her back/ Bad rash on her stomach/ Bad rash up to her neck; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Painful), RASH PRURITIC (Itchy rash), SOMNOLENCE (Hard at night) and RASH (Bad rash on her back/ Bad rash on her stomach/ Bad rash up to her neck) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O35C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 15-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced PAIN (Painful), RASH PRURITIC (Itchy rash), SOMNOLENCE (Hard at night) and RASH (Bad rash on her back/ Bad rash on her stomach/ Bad rash up to her neck). At the time of the report, PAIN (Painful), RASH PRURITIC (Itchy rash), SOMNOLENCE (Hard at night) and RASH (Bad rash on her back/ Bad rash on her stomach/ Bad rash up to her neck) outcome was unknown.            Concomitant medications included vitamins (unspecified).  No treatment medications was provided by the reporter.   This case was linked to MOD-2021-228459 (Patient Link).
pt recv vax; sz w/ fever; adm to hosp for 2 days; on phenobarbital; f/u, had d during this time; no etiology given; has not returned to clinic
Pt developed a low-grade fever which began the day after receiving the immunizations. On the 3rd day, fever went to 101.8F and mother noticed he was having a seizure. She called the ambulance and was seen in ER. Rectal temperature was 102.2F and pt was given Tylenol and had no further episodes.
Headache, dizziness, hand and leg cramping, shortness of breath, nauseous, weakness.
12DEC91 vomiting w/low grade fever continue vomiting & dec fever; 15DEC91 fever 103 still vomiting-rash started; 16DEC91 admitted to hosp w/dx dehydration & dec urinary output;
On June 29, 2006 I received a Tetanus, Diphtheria Pertussis (Tdap) Vaccine.  On July 14, I felt achy all over and had a metal taste in my mouth.  By July 22, I was very ill with nausea, vomiting, diarrhea, and headache.  I was admitted to the hospital on 7/25/06.  After numerous tests I was  diagnosed with Guillain Barre Syndrome on August 2 and began plasmapheresis treatments the same day. Discharge summary states achey, nausea and vomiting, headache, weakness in extremities, back pain, weight loss, facial paralysis. msv
Patient had rash on front of both legs, 4 days after receiving the second dose of Moderna. Rash was not itchy or painful, and resolved within two days. Rash was splotchy and nondescript. Patient alleges no changes to diet/soaps/clothing/medications.
malaise lasting 3 days upon receipt of last dose (5th total dose, reported receiving in Jan/Feb 2023); This spontaneous case was reported by a patient and describes the occurrence of MALAISE (malaise lasting 3 days upon receipt of last dose (5th total dose, reported receiving in Jan/Feb 2023)) in an 83-year-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2023, the patient experienced MALAISE (malaise lasting 3 days upon receipt of last dose (5th total dose, reported receiving in Jan/Feb 2023)). In 2023, MALAISE (malaise lasting 3 days upon receipt of last dose (5th total dose, reported receiving in Jan/Feb 2023)) had resolved. Not Provided      For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.
Temperature excursion reached minimum of 15.6A°F for 21 hours out of range. Administered to 1 patient.; No adverse event; Vaccine was administered to patient after temperature excursion occurred; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion reached minimum of 15.6A°F for 21 hours out of range. Administered to 1 patient.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred) and NO ADVERSE EVENT (No adverse event) in a 72-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 5yp3l) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion reached minimum of 15.6A°F for 21 hours out of range. Administered to 1 patient.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion reached minimum of 15.6A°F for 21 hours out of range. Administered to 1 patient.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion reached minimum of 15.6A°F for 21 hours out of range. Administered to 1 patient.) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred).    No concomitant medication was reported.  No treatment information was reported.
1st Day on October 11th, 2021 I only had a sore arm. No side effects besides the sore arm where the Moderna Shot was injected in my right arm from October 11th until on October 14th in the middle of the night around 9 P.M. I felt lightheaded, nauseous, felt like I couldn't breathe and started vomiting for no apparent reason for almost 1 hour. I felt a tingling sensation all around my body and had to take a liquid form of Benadryl to help ease the severe side effects as I was having an allergy reaction. I didn't eat anything different in the course of time before or after this event on October 14th took place around 9 P.M. After the events of October 14th, I felt fine up until October 17th and then October 18th where I felt worse side effects. I suddenly had a severe fever on October 17th that appeared around 10 P.M. in the night and my heart was beating very fast, I also vomited and had diarrhea for several hours in the night I had to get up from my bed to use the bathroom and then go back to sleep. The next day on October 18th around 7:00 P.M. my heart was beating very fast and I felt like I was going to faint and then had a severe fever once again that now on October 19th in the morning disappeared.
After the second dose of moderna I started having an unusual and excessive menstrual flow. Went to the OBGYN for a check up and nothing seems to be wrong and it all started after the second dose.
I started having chest pains early in the morning. On November 29, 2021 at about 7:30pm  I went to the ER. I had severe chest pains. The doctor said I was having a heart attack. I had stents punt in, and they did a cardio catherization. I was then hospitalized for 2 days. I was prescribed Atorvastatin 40mg 1xday, Aspirin 81mg 1xday, Carvedilol 3.125mg 2xday, and Brilinta 90mg 2xday. I am still out of work and recovering from this.
About 3 or 4 hours after shot the site had a little redness and itching about it. No real pain / soreness. The next day the patient noted she was sore all over, legs, back, (generalized). She states this problem has not been resolved at all and keeps her from alot of activities; until this date 08/27/01, still having problems. No fever during this episode or any problems.
Pt was administered Prevnar 20 simultaneously  with  Moderna Covid 19 vaccine.  The patient has only reported sore arm.
Patient is a 71-year-old male with a past medical history of COPD, bronchiectasis, asthma, dilated cardiomyopathy, last ejection fraction 20% who presents to our facility with concerns of dyspnea, malaise, fatigue. Symptoms present for the last 3 days. Of note, patient recently admitted to her SOB for similar complaints. At this time he did not have COVID. He presents to our facility hypotensive with heart rate near 150s. He currently denies chest pain but admits to mild increased work of breathing and shortness of breath. No nausea, vomiting, or abdominal pain. He follows up with his cardiologist. He is currently on torsemide daily which was switched by his cardiologist on the 23rd. He is compliant with his other medications. He was recently started on entresto.
PATIENT DEVELOPED A DRY RED ITCHY SPOT AT SITE OF INJECTION.  PATIENT JUST NOTICED A WEEK TO 10 DAYS AGO WHEN IT STARTED TO ITCH.  SHE RECEIVED THE SHOT OVER A MONTH AGO 10/18/2011 IN THE RIGHT ARM.  SHE DID HAVE A LITTLE SWELLING RIGHT AWAY BUT DID NOT HURT.
Presented to clinic on 11/19/20 - reports persistent right arm weakness since immunization received 1.5 years ago - declines future immunization due to this reaction. States she spoke with the Nurse Practitioner 2 months after the vaccine and told her she felt right arm weakness. NP recommended follow-up with a primary care provider. She states she did not follow-up due to no health insurance. Today states the generalized weakness in her right arm has persisted and never resolved. States she notices it most when using the computer or playing the guitar. States it is difficult for her to describe the exact changes, but feels her arm has never been the same. Reviewed resource list for primary care provider visit.
p/vax pt devel a mild breakthrough case of chickenpox w/about 20 lesions;pt sought unspecified medical attention;
01/19/2021 - My throat started closing and my breathing became labored 45 minutes after administering the shot. 01/20/2021 - Same side affects as above, my O2 dropped to 88 and I was administered IV Steroids by MD.
Entire body joint and muscle pain,; pain in areas injured 40 years prior, ie Bennetts fracture; groin pain,; inflammation,  I took an NSAID for several weeks per vaccine guidelines if reaction occurred. It is now 3 months later and pain has not gone away.  I am just beginning chelation in order to flush any toxins and heavy metals from my body.  I just saw a rheumatologist who has prescribed a 2  week round of prednisone
felt incredibly sick; no appetite; coughing; really feeling awful; weakness; low grade fever; chills; tiredness; body ache/felt like her body was run over by a truck; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt incredibly sick), DECREASED APPETITE (no appetite), COUGH (coughing), FEELING ABNORMAL (really feeling awful) and ASTHENIA (weakness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048FZ1A, 012M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy, Drug allergy and Drug allergy. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), GABAPENTIN, ALPRAZOLAM (XANAX), METOPROLOL and LAMOTRIGINE (LAMICTAL) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Sep-2021, the patient experienced MALAISE (felt incredibly sick), DECREASED APPETITE (no appetite), COUGH (coughing), FEELING ABNORMAL (really feeling awful), ASTHENIA (weakness), PYREXIA (low grade fever), CHILLS (chills), FATIGUE (tiredness) and MYALGIA (body ache/felt like her body was run over by a truck). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg; ZINC at a dose of Zinc 1 tab for the first two days and AMOXICILLIN on 10-Sep-2021 at a dose of 875 mg twice a day. At the time of the report, MALAISE (felt incredibly sick), DECREASED APPETITE (no appetite), COUGH (coughing), FEELING ABNORMAL (really feeling awful), ASTHENIA (weakness), PYREXIA (low grade fever), CHILLS (chills), FATIGUE (tiredness) and MYALGIA (body ache/felt like her body was run over by a truck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative.         This case was linked to MOD-2021-316466 (Patient Link).
w/in 2 days p/shot sudden & immed drop in libido & sexual desire; difficulty maintaining erection; no problems prev to shot;
Flare-up of gout; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 25Mar2021 at 09:45 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included coronary angioplasty (cardiac stents) and coronary artery disease (CAD). The patient had no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications within 2 weeks of vaccination.  On 28Mar2021 at 20:00, the patient experienced flare-up of gout. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of gout and included treatment with NSAID prescription. On an unknown date, the patient underwent blood testing and the result was unknown. The clinical outcome of the event flare-up of gout was resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Itching of hands and swelling of hands on day 2. of 1st vaccine.  Headache, tinnitus, body aches, rash, and overall tiredness. Itching on feet ,hands,  arms, and hives on back, ribs, core body and neck  with second vaccine
BUZZING OR INTERNAL VIBRATION IN FEET, MOVED TO MY TRUNK AND NECK; ANXIETY; I DON'T FEEL THE NEED TO MOVE MY BODY WHEN IT HAPPENS; IT'S JUST A SENSATION; This spontaneous report received from a patient . The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced buzzing or internal vibration in feet, moved to my trunk and neck. On MAR-2021, the subject experienced anxiety. On MAR-2021, the subject experienced i don't feel the need to move my body when it happens; it's just a sensation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from buzzing or internal vibration in feet, moved to my trunk and neck, anxiety, and i don't feel the need to move my body when it happens; it's just a sensation. This report was non-serious.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age. Medical history and drug allergy were not reported. On unknown dates the patients were vaccinated with improperly stored ZOSTAVAX (dose, route, lot# and expire date were not reported). Concomitant drug was not reported. No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
This non-serious intitial spontaneous case, was received on 11-Sep-2017 from pharmacist, concerning a male patient of an unspecified age. On an unspecified date, the patient was administered with FLUVIRIN THIOMERSAL (dose: 0.5 ml, batch number: 1720801 (as reported), expiry date: Apr-2018, route of administration: intramuscular and anatomical location: not reported). The administered vaccine reached 64.9-degree F instead of storing at 36-46 degree F for up to 12 hours, which was considered as incorrect product storage and drug administration error. It was reported that, no adverse reactions were observed. The outcome of the events was not reported. The reporter assessed the report as non-serious.
developed temp 99.7F and  wet cough- tested positive for covid on abbott id now molecular test 9/17/2022
Red; Feels hot; Diarrhea; Very weak; Lymph node in the elbow underneath it, my left arm its very swollen; Vomited; Nausea; Headache; Stomachache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red), FEELING HOT (Feels hot), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomachache) and ASTHENIA (Very weak) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus syndrome (autoimmune).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomachache). On an unknown date, the patient experienced ERYTHEMA (Red), FEELING HOT (Feels hot), DIARRHOEA (Diarrhea), ASTHENIA (Very weak), LYMPHADENOPATHY (Lymph node in the elbow underneath it, my left arm its very swollen), VOMITING (Vomited), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, ERYTHEMA (Red), FEELING HOT (Feels hot), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomachache), ASTHENIA (Very weak), LYMPHADENOPATHY (Lymph node in the elbow underneath it, my left arm its very swollen), VOMITING (Vomited), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
17 years patient received the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years patient received the first dose) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years patient received the first dose). On 01-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years patient received the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       In concomitant medications birth control medications was also reported.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 010A21A) with no associated AEs reported.
Pt. received vaccines at 1 pm. Mother states by evening her arm was red and swollen. This morning pt. has a temp of 101 degrees Rt arm is red, swollen and hard. Mother has been giving her MOTRIN. Pt. is pale and vomiting. Instructed mom to continue monitoring temp. Administer MOTRIN and BENADRYL due to pt. history of allergies.
when parent arose @ 530AM 3DEC96 found child unresponsive & noted sz activity;transported to ER per amb & adm to hosp;d/c 4DEC96 w/o any meds w/dx of febrile sz d/t pertussis vax;
No additional AEs.; a 53 year old patient received PROQUAD instead of MMR II on 2/26/2021.; This spontaneous report was received from a registered nurse and refers to a 53 year old patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 26-FEB-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 mg injection, for prophylaxis, lot # T009930 with expiration date of 16-SEP-2021 (route of administration was not reported) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered). No additional events was reported.
Instantly after receiving flu vaccine, patient developed a small rash on her chest.  Within minutes, rash disappeared, no other allergic symptoms.  No Treatment.
Patient stated she was diabetic, confirmed by metformin filled on profile, also stated she had no allergies, patient states she felt bad and had fever after shot, advised her to take some tylenol, she states she felt better
Pt recvd 3 Hep B vax given 26JUL89, 29AUG89 & 25JAN90; Following these, titer=20; 7MAR91 titer=2; Pt was given 4th dose of Engerix-B vax on 9MAY91; P/4th dose titer=256;
12/28  Vaccination Later that evening, muscle aches and HA.  12/29 Joint pain, HA, and mild cough 12/31 Severe cough, lost voice, unable to sleep 1/2021 Urgent care; COVID  test; Positive  Bamlanivimab; treatment/infusion; 3 hours  15 days isolation 1/18/2021
One week after I started  a rash that was itch. The following morning I started getting small itchy blisters on my ankle and wrist. I would get a new batch of blisters everyday. They weren't going away so I went to see a Dr.  to see if it was from the vaccine. She said it looked like a allergic reaction but I have not done anything  different.  So I got a prescription cream and it helped, about three weeks later they stopped occurring.  I got my second dose but not no allergic reaction.