chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Im having fever; Im having  lot of body pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Im having fever) and MYALGIA (Im having  lot of body pain) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Im having fever) and MYALGIA (Im having  lot of body pain). At the time of the report, PYREXIA (Im having fever) and MYALGIA (Im having  lot of body pain) outcome was unknown.            Concomitant medication was not provided Treatment information was not reported
Arm/shoulder was sore upon first vaccination, thought was solely due to vaccination. My thoughts were this would eventually improve but continued to get worse. As time progressed, noticed that I was losing motion in my left arm/shoulder. The pain continued to get worse and the mobility grew less. I visited my primary care doctor's office on March 9th and was seen by PA. At that time I was given the diagnosis of frozen shoulder and was referred to PT. On March 23rd I had an appointment with the orthopedic doctor who previously had performed knew replacement surgery. This visit was a follow up to check mobility on the knee but during the visit I mentioned my arm/shoulder trouble. PA accessed the issue with my arm/shoulder and agreed with the frozen shoulder diagnosis. At that time he recommended a cortisone shot and referred me to MD.  Dr. administered the cortisone  shot on March 30th. At that consultation is when I was first informed that the vaccination likely was given in the Bursa muscle. Have been attending physical therapy since this diagnosis.
Information has been received from a registered nurse concerning an 11 year old male who on 01-AUG-2007 was vaccinated SC on right arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657649/0815U). There was no illness at the time of vaccination. On 02-AUG-2007 at 14:50 PM, the patient experienced injection site "puffy" and swelling of 2-3". The patient's body temperature was slightly elevated at 100.1. The patient had itchiness at injection site. On 05-AUG-2007, the patient recovered. No diagnostic laboratory tests were undertaken. Additional information has been requested. This is one of several reports received from the same source.
PATIENT CAME TO PHARMACY ON 01/14/2021 AT 4:45PM ASKING IF SHE CAN RECEIVE A BOOSTER DOSE OF MODERNA VACCINE. PATIENT FILLED OUT THE CDC QUETIONNAIRE FORM AND IT WAS REVIEWED PRIOR TO VACCINATION, HOWEVER THE BOOSTER WAS ADMINISTERED 1 MONTH BEFORE THE RECOMMENDED INTERVAL AT 4 MONTHS RATHER THAN AT 5 MONTHS APART. PATIENT WAS REACHED OUT NEXT DAY MORNING ON 01/15/2022 UPON FINDINGS OF THE MISTAKE AND COUNSELED ON POSSIBLE SIDE EFFECTS. PATIENT STATED SHE WAS ONLY HAVING MILD SORENESS AROUND THE INJECTION SITE. NO OTHER ADVERSE REACTIONS WERE REPORTED.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 20-MAY-2015 the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (strength, lot#, dosage, frequency and route unspecified). The temperature excursion for RECOMBIVAX HB was unsupported with in-house stability data and the initial temperature excursion was on 15-OCT-2014. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
increased blood pressure which will climb by approximately 20 points from his normal; sore arm; very nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (increased blood pressure which will climb by approximately 20 points from his normal), PAIN IN EXTREMITY (sore arm) and NAUSEA (very nauseous) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A, 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HYDROCHLOROTHIAZIDE), FLECAINIDE ACETATE and DILTIAZEM.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 20-Feb-2021, the patient experienced NAUSEA (very nauseous). On an unknown date, the patient experienced HYPERTENSION (increased blood pressure which will climb by approximately 20 points from his normal) and PAIN IN EXTREMITY (sore arm). At the time of the report, HYPERTENSION (increased blood pressure which will climb by approximately 20 points from his normal), PAIN IN EXTREMITY (sore arm) and NAUSEA (very nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. Treatment included Advil.
Patient developed rash after a few days and went to a doctor and was diagnoses with shingles
This spontaneous report as received from a nurse concerning multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. Approximately in October 2016 (reported as between 09-OCT-2016 to 21-OCT-2016), the patients were vaccinated with improperly stored ROTATEQ lot # M019706, expiry date: 24-OCT-2017 (dosing details and route were not reported) for prophylaxis. It was reported that the vaccines were exposed to the temperature of 30.2F during a time frame of 12 days. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA003199:
Minutes after receiving vaccines developed a red, flat rash on extremities and trunk. No respiratory distress or symptoms. Gave 3cc of BENADRYL. Rash started to resolve before giving BENADRYL and was completely resolved soon after.
The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.; No adverse event; doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) 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 EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 31 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case, Patient 1 out of 50 (Lot AS7143C was administered on 5-JUN-2023)
Patient had dizziness prior to vaccine which got worse after receiving vaccine. Has not tried any treatments. Dizziness is improving.
Mother reported that pt had facial redness and swelling with hives or angioedema. My other exposure was cantaloupe on 7/25/04 and 7/26/04. Other than varicella vaccine on 7/26/04. Was also seen in the office 7/30/04 for local reaction to mosquito bites.
Pt had right arm erythema, and induration along with swollen axillary lymph nodes and pain with movement of right arm.
Swollen lymph nodes; Difficulty swallowing.; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 12Mar2021 at 12:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included cetirizine hydrochloride (ZYRTEC) for seasonal allergy from an unknown date and unknown if ongoing. On an unknown date in Mar2021 the patient experienced swollen lymph nodes and difficulty swallowing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lymph nodes and difficulty swallowing was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from an assistant head nurse referring to a 7 month old female patient. The patient had no known medical allergies. On 31-MAY-2016 when the patient was 32 weeks and 1 day, the patient was vaccinated with ROTATEQ (lot # L042214, expirations date 14-APR-2017, 2 ml, oral). Concomitant therapy included PREVNAR 13. Additional information has been requested.
Janssen Covid -19 Vaccine EUA  Fever for about 2 hrs.  Starting at 0230 on 03/23/2021 took Acetaminophen stopped about 04:30 03/23/2021.  Top fever detected about 101.5F
Prolonged elevated fever 2 days after receiving 1 yr immunizations fever lasted more than 1 week. Work up all neg. Resolved for 3 days then fever again to 101.7 Positive URI signs/symptoms. Still with fever 4-7-04 though prior to that afebrile for 3 days.
Pt. received vaccine 3/31/09. Presented with vomiting, lethargy on 4/14/09. Required surgery for Intussusception.  5/14/09 hospital discharge summary recieved DOA 4/9/09-4/13/09. FINAL DIAGNOSIS: Intussusception Post vaccination emesis, abdominal distention, lethargic, blood clots around anus.
This spontaneous report was received from a nurse practitioner referring to a male patient of unknown age. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On an unspecified date in November 2015, the patient was vaccinated with the first dose of VARIVAX for prophylaxis (dose, frequency, route lot number and expiration date were not provided) and the first dose of M-M-R II (dose, frequency, route lot number and expiration date were not provided). 23-MAY-2017, the patient was in the nurse practitioner's office and was not scheduled to receive any vaccines, however, the office staff inadvertently administered the second dose of VARIVAX (lot # M041513) for prophylaxis (dose, frequency, route and expiration date were not provided) and the second dose of M-M-R II (lot #M037096) therapy type (HSA) (dose, frequency, route and expiration date were not provided). Other suspect therapies included sterile diluent (manufacturer unknown). No adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Bruised for about 3 weeks, little bigger then half dollar, heat to touch,  Painful to the touch,  I still have a little lite inside bruise
This spontaneous report as received from a 51 years old female patient with asthma, type 2 diabetes and no drug reactions/allergies. The patient's medical history included sleep apnea, prior history of "crack cocaine" abuse seven years ago. The patient was vaccinated with a dose of ZOSTAVAX approximately in 2011, about a year ago. No other co-suspects were reported. Concomitant medications included albuterol, allopurinol, XANAX, NORVASC, vitamin D (unspecified), BENTYL, fluticasone propionate, ADVAIR, LASIX, LANTUS, lisinopril, pravastatin sodium, SEROQUEL, ZANTAC and NASACORT AQ. The patient stated that she had a history of frequent shingles for many years. About a year ago she received ZOSTAVAX, and a the time of reporting she reported that she had an outbreak of shingles every other month and the outbreaks were more severe. The patient also mentioned that VALTREX made her "sick". The patient sought medical attention by an office visit. At the time of reporting, the patient was not recovered. Additional information has been requested.
Pain and swelling of elbow on the same arm as the shot was given. Started 3 weeks, post vax, and lasted about 1 week.
pt states about 20 minutes after taking the vax she developed a rash on her right breast.  She had a slight headache and dizziness.  On 4/13/2021 she still has the rash but all of her other symptoms have subsided.
No adverse symptoms reported; Improperly stored dose of varicella vaccine administered; This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 09-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Red, dry, scaly rash on left forearm - lasted approximately 3 days so far. No pain, itching, or swelling.
Tennis ball size (diameter) knot at injection site, very itchy and hot to the touch. Sore lymph nodes under arm, on the same arm as the injection.
Sore arm; I was tired; This is a spontaneous report from a contactable consumer (patient). This 31-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) intramuscularly on 01May2021 (at the age of 31-years-old) as a single dose in the left deltoid for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS). Concomitant medications included ethinyl estradiol, ferrous bisglycinate, levonorgestrel (BALCOLTRA) from an unknown date for birth control. On an unspecified date after dose 1, the patient did not have any complication but a sore arm for a week and she was tired. The patient did not receive any treatment for the events. The outcomes of sore arm for a week and was tired were unknown.
Swollen, itching eyes with discharge; swollen hands and feet; severe difficulty breathing; throat closing up; hives; stomach ache; headache; fever of 101; joint pain; severe congestion; ear ache.  Onset 3 hours after vaccine. Lasted 12 hours. Still have some congestion and itching eyes.
Pt had trouble breathing lasting about 30 seconds, flushed face, increased respiratory rate, and increased heart rate and blood pressure. Within 30 seconds, pt's breathing returned to normal & pulse began dropping to normal values. I can't comment on blood pressure because I only got the one reading of ~130/90, taken about 2 minutes after pt notified me of the breathing changes. This was elevated from pt's baseline, but only mildly. Pt was observed for ~20 minutes following initial reaction, and given water shortly after taking blood pressure. I told pt I was reporting the reaction to VAERS, and that I would be happy to talk to her doctor about what I observed. Pt was released after ~20 minutes observation at which time pt was feeling ok following the intial reaction
Chest pain/heart pain. I laid on my stomach yesterday and I felt a pain in my heart that I never have before.
Headache; Diarrhea; Back pain; Itchy body; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), DIARRHOEA (Diarrhea), BACK PAIN (Back pain) and PRURITUS (Itchy body) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     no medical history is provided. and concomitant drugs are provided.  Concomitant products included Medication for Bloodpressure for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HEADACHE (Headache), DIARRHOEA (Diarrhea), BACK PAIN (Back pain) and PRURITUS (Itchy body). At the time of the report, HEADACHE (Headache), DIARRHOEA (Diarrhea), BACK PAIN (Back pain) and PRURITUS (Itchy body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
24APR95 pt running fever >104 told by MD to contact MD & call back p/speaking w/MD: 12MAY95 unable to phone; no contact-sent letter; 21JUN95 no response, but found father work# states pt had temp 3-4 days p/vax; MD advised APAP
Patient was given MMR booster for travel on 4/23/2019.  On 5/3/19 pt informed the clinic that she is pregnant and it has been less than 1 mo since getting the MMR vaccine.   This is brand new pregnancy so didn't list any outcomes yet?
Tested positive for COVID.; Tested positive for COVID.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 63-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Tested positive for COVID.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Tested positive for COVID.  Clinical Course: It was reported that: etransmitting possible duplicate AE details as call was transferred agent, Caller was pharmacist and states "I have a 63-year-old female patient that I am trying to prescribe Paxlovid for, but she already had it in May2022. She got her COVID booster (from unknown manufacturer) on Monday and tested positive for COVID on Tuesday. Do you have any information on retreatment with Paxlovid. Upon follow up on 29Sep2022 it was reported, Pharmacist calling because she has a patient, she is trying to prescribe Paxlovid for. Patient already had Paxlovid back in May2022 and had a COVID vaccine on Monday and tested positive for COVID on Tuesday. Cannot confirm vaccine manufacturer at this time. Verified above information with caller. Declines to complete report. Has patients she needs to call. No report related to a study or programme. Product complaint to report was Yes. Description of Product Complaint: Description of complaint: Had a COVID vaccine on Monday and tested positive for COVID on Tuesday. Product strength and count size dispensed: not provided. Additional lot numbers: not provided. Is a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact: Not provided.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events 'Drug ineffective', 'COVID-19' and the suspect drug BNT162B2 cannot be excluded.
nonstop crying x 3 hrs as if in pain 8NOV92 9P-12A then fine;
Bruise on foot due to fall of shampoo bottle; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONTUSION (Bruise on foot due to fall of shampoo bottle) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ). Concomitant products included RIVAROXABAN (XARELTO) for Atrial flutter.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced CONTUSION (Bruise on foot due to fall of shampoo bottle). At the time of the report, CONTUSION (Bruise on foot due to fall of shampoo bottle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-074278 (E2B Linked Report).; Sender's Comments:  MOD21-074278:MOD-2021-075192 - 2nd dose of vaccine
This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 20th July 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 20th July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were unknown. It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The patient called the Pharmacy complaining about her arm being sore and red following the injection. The patient felt the injection was administered lower on the deltoid muscle than usual. This was all the information the sales representative received. The reporter agreed to be contacted for follow up.