chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; nurse gave Moderna monovalent doses to two people who should have gotten the bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (nurse gave Moderna monovalent doses to two people who should have gotten the bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu shot on 27-Dec-2022. Past adverse reactions to the above products included No adverse event with Flu shot.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (nurse gave Moderna monovalent doses to two people who should have gotten the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (nurse gave Moderna monovalent doses to two people who should have gotten the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (nurse gave Moderna monovalent doses to two people who should have gotten the bivalent booster).    Concomitant products were not provided. Treatment medication were not reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-694841 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694841:1 patient out of 2
Initial solicited report received on 18 September 2017 and follow up information received on 19 September 2017 from an investigator participating in the below mentioned study. This case involves an 87-year-old female subject who had seizure secondary to low potassium during the study participation. It was reported that there was no medical history to report. Subject received concomitant therapies of paracetamol (Tylenol) orally for osteoarthritis from 2015 (ongoing),  levofloxacin (Levaquin) orally for inflamed gall bladder from 17 September 2017 to an unknown date and metronidazole (Flagyl) orally for inflamed gall bladder from 17 September 2017 to an unknown date. On 17 September 2017, 09 days after receiving a first intramuscular dose of blinded therapy in the right arm (upper) on 08 September 2017, the subject had seizure secondary to low potassium. The event appeared after visit 01. As per subject report, subject experienced a seizure shortly after hospitalization for gallbladder infection. She was told her potassium was low at discharge and was advised to eat bananas, which she had been doing. She felt flat on her back during the seizure and hit her head. Records have not yet been received for this event. Maximum intensity considering the entire AE duration was reported as Grade 03. The subject's weight was 145.0 lb (65.77kg). Lab investigation included subject underwent cat scan of head which was negative for abnormalities, right elbow x-ray, also negative, and negative chest x-ray, initial labs showed mild hyponatremia, otherwise unremarkable. The subject's corrective treatment details were not reported. The event seizure secondary to low potassium was resolved on 17 September 2017. The subject was discharged from the hospital on 19 September 2017. According to the investigator, the event was not related to concomitant therapy, study vaccine or trial procedures. Relationship to investigational product according to company: not reportable. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Follow up information received on 26 April 2018. Concomitant medication was updated. Sae narrative was updated. Lab data was updated. Corrective treatment was updated. Discharge date was updated. (previously reported as 17 September 2017). Follow-up information received on 16 May 2018; Database lock: Study unblinded on 16 May 2018: INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (TIV-HD2).; Sender's Comments: Follow-up information received on 26 April 2018 does not change the previous medical assessment. An 87-year-old female subject had seizure secondary to low potassium, nine days after receiving a dose of study product. Based on available information, the sponsor assesses the event as not related to study product or trial procedure, in agreement with the investigator.
Even had them in my arm pits; Mild but drove me nuts; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and feeling irritated. On an unknown date, the outcome of the shingles and feeling irritated were recovered/resolved.   It was unknown if the reporter considered the shingles and feeling irritated to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient himself/herself. The age at vaccination was not reported. The patient received the 1st dose of Shingles vaccine and patient stated that he/she had same reaction, mild but drove him/her nuts and even had shingles in arm pits, but it certainly beat having a bad case. The reporter stated that research said to get the second shot even though you reacted to the first. The reporter stated that absolutely no reaction to the 2nd shot.
Flushing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose., On my ears, and my nose was hot and red. Also, on my chest and neck.), administration date: 2021, for COVID-19 immunization, reaction(s): "Flushing"; Bnt162b2 (First dose., I felt extremely dizzy and extremely awkward for 2 or 3 days), administration date: 2021, for COVID-19 immunization, reaction(s): "Extremely dizzy", "Extremely awkward"; Flu vaccine (had these reactions when she received the flu vaccine), for Immunization, reaction(s): "Reactions". The following information was reported: FLUSHING (non-serious), outcome "unknown".  Additional Information:.For the first dose, in 2021, I had some flushing. On my ears, and my nose was hot and red. Also, on my chest and neck. Later on, I felt extremely dizzy and extremely awkward for 2 or 3 days.For the second dose, I had the flushing again. No dizziness. I was curious, because I was kind of energized and there were no other symptoms other than the initial flushing.For the third dose I don't remember any particular symptom.Now, for the fourth dose, my last one, the flushing appeared once again. On my face and ears, and I didn't detect anything else.Within the next two weeks, after 20May2022 I've had severe cramping. My legs, calves, and feet. Also, hands and arms. It's random. It doesn't happen all the time, it's not continuous, but it's there every day.Caller stated that she also had these reactions when she received the flu vaccine.First dose she had blushing and dizziness. Second and third doses she didn't seem to have much of a reaction. Fourth dose there was something that kind of happened but she didn't think it was related to the vaccine but her doctor said it might be. Would Pfizer be able to say if it is likely her event was caused by the vaccine?.Product clarified to COVID-19 vaccine MRNA, Pfizer Inc from her vaccine card. On her vaccine card there is a number on there that says: EL9264. Caller does not know what that number is for, not indicated on her vaccine card. That is the only information on her vaccine card. COVID-19 vaccine MRNA cap color unknown by caller.Declined report and requested transfer to Medical Information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Syncope twice within 5-10 minutes of vaccination. Responded to lying down, juice, snacks.
Weakness with muscular and joint pain. Intermittent prickling sensation in upper back and lower limbs. Fatigue and aching persisted throughout the day. Area where the injection occurred on the left shoulder is red, swollen & tender.
The baby cried for two days straight; This non-serious spontaneous Safety Report, with reference number 02462961 (Interaction # 02462959), was received by partner on 30-AUG-2023 and forwarded to company on 31-AUG-2023 from a physician.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "The baby cried for two days straight".  Further information is expected.
While in observation area, patient c/o "dizziness and hot." RN in monitor area noticed patient was "shaky." Cool compresses applied to neck/upper back and gatorade water was given. Vital signs stable; BP 120/84, P90, SpO2 99% on room air.  After approx 3 mins, patient stated, "I feel better." Vital signs remain stable; BP 118/82 P 80, SpO2 99% on room air. Patient declines EMS notification and to be transported to hospital for further evaluation. Patient ambulated from facility with husband.
Breaking out in rash almost 2 weeks after the shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Breaking out in rash almost 2 weeks after the shot) in an 80-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Breaking out in rash almost 2 weeks after the shot). At the time of the report, RASH (Breaking out in rash almost 2 weeks after the shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant medications reported by investigator   No treatment medications provided by the reporter.
ZOSTAVAX given on 6-13-07 a few days later, water-filled vesicles scattered on both legs, rare on chest, lasting 2-3 wks with new crops developing till now.
Numbness and tingling in my tongue; pain in my left jaw; pain in my left knee and hip; pain in my left knee and hip; Numbness and tingling in my tongue; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: ER8727), via an unspecified route of administration in the left arm on 18Mar2021 at 11:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had a medical history of COVID-19 on an unspecified date and had received unspecified medications within 2 weeks of vaccination as concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 18Mar2021 at 12:00, 15 minutes after vaccination, the patient reported that she experienced numbness and tingling in tongue, pain in left jaw, pain in left knee and pain in hip was still ongoing and it was never been there before. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The clinical outcomes of numbness and tingling in tongue, pain in jaw, pain in knee and pain in hip were resolved with sequelae on unspecified dates.   No follow-up attempts are needed. No further information is expected.
Sever headache with nausea. Headache has been constant for nearly 36 hours. Excedrin migraine helps, but only for a few hours.
pt devel fever-temp not measured by parents-w/altered LOC; taken to hosp following 2 convuls;
hives; fever; chills; headache; muscles and joint pain; muscles and joint pain; fatigue for several days; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 70 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 31Mar2021 08:30 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, arthritis from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing, lung neoplasm malignant from an unknown date and unknown if ongoing and surgery, the oncologist said that's body's reaction to gaining antibodies. they weren't itchy, no other effect on her. Concomitant medication(s) included phenazepam (PHENAZEPAM) taken for an unspecified indication, start and stop date were not reported; nitrazepam (NITRAZEPAM) taken for an unspecified indication, start and stop date were not reported. The patient experienced fever on 01Apr2021 02:00 with outcome of recovered, chills on 01Apr2021 02:00 with outcome of recovered, headache on 01Apr2021 02:00 with outcome of recovered , muscles and joint pain causing myalgia on 01Apr2021 02:00 with outcome of recovered, muscles and joint pain causing arthralgia on 01Apr2021 02:00 with outcome of recovered, fatigue for several days on 01Apr2021 02:00 with outcome of unknown and hives causing urticaria on 01Apr2021 08:30 with outcome of unknown. Therapeutic measures were taken as a result of this with Tylenol.  Follow-up(05Apr2021) : This is a follow-up spontaneous report from the same contactable consumer, new information received which includes that : relevant medical history added and concomitant drugs added.  No follow-up attempts are needed. No further information is expected.
pt recvd 1st dose of Engerix-B & 21AUG92 pt exp swelling, numbness, tingling in both hands & both elbows; numbness & tingling prevents sleep; 24AUG92 swelling in fingertips;
redness on face and chest. Sensitivity to heat and sunlight, Sensitivity to area being touched
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender (encounter key # 141586). The patient's concurrent conditions and medical history were not provided. On 23-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (VIs 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) dose, route and anatomical location were not provided. There was no concomitant medication provided. On unknown dates, PNEUMOVAX had temperature excursions for 72 hours with lowest recorded temperature of 28F (-2.2 Celsius) and 40 hours with highest recorded temperature 47 F (8.3 Celsius). The vaccine status was reported as "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved and no adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Patient received the 1st dose on 11Jan2021 and on 03Feb2021 she tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient received the 1st dose on 11Jan2021 and on 03Feb2021 she tested positive for COVID) 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 medical history provided).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Patient received the 1st dose on 11Jan2021 and on 03Feb2021 she tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient received the 1st dose on 11Jan2021 and on 03Feb2021 she tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Sars-covid 2-antibody test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment and concomitant medication provided
Pt. developed rash behind his leg, forearms and few spots on trunk.  Describes as itchy, appears dry, Flat.  Began approx.  24 hours post 2nd dose HEP A vaccine.  Pt. had sunburned skin on same areas prior to vaccine and rash
78-year-old female history of COPD O2 dependent at 2 L nasal cannula continuously history of peripheral vascular disease fibromyalgia DVT in the past COVID-19 pneumonia in the past history of pyelonephritis History of cervical cancer treated about 10 years ago with radiation therapy History of pulmonary nodules she presented to the emergency room with flu-like symptoms muscle aches generalized fatigue has been tested positive for COVID-19 has had a week of fever and chills no nausea vomiting or diarrhea no loss of consciousness
Patient came into clinic for her first covid vaccine on 02/24/2021 and received the moderna vaccine in her left deltoid. She then came to a mass vaccination clinic at a pop-up location on 2/25/2021 and received a second COVID-19 vaccine in her right deltoid. Patient was screened prior to the second vaccination and denied getting the previous vaccine in order to obtain the door prizes that were being given out for getting vaccinated on that day. As the location was a pop-up site, the vaccinators did not have access to her chart prior to vaccinating the patient. Patient was contacted to report any adverse events to the clinic in relation to receiving two vaccinations in a span of two days. Patient has no complaints currently.
active shingles rash; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (active shingles rash) in an 87-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.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (active shingles rash). At the time of the report, HERPES ZOSTER (active shingles rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   no concomitant medications reported. no treatment details reported.
Throat started to close up after 1 hour (took Benadryl which alleviated problem) Cough started next day, lungs still feel a little dry. Biggest problem are my joints, they hurt non stop - my fingers, my toes, my wrists, my knees, my spine - hurt, hurt, hurt. The joints started hurting the day after the shot and have not let up since.  Also have muscle pain in my thighs  which started at the same time as the joint pain. The pain is affecting my ability to go up and down stairs. Suffered from total exhaustion for about 2 weeks. Still get tired easily but not as bad. Taking acetaminophen which is not working.
Headache, Fever, NauseaVomiting, Fatigue, pain at injection site, stuffy nose, chills Narrative:
2 weeks after second dose my child woke up with a red hot rash on her face from cheek to cheek nose to chin. It was a painful itchy rash that got progressively worse and infected. After treatment and time it went away. Then on February 23rd the exact same thing happened, only this time the rash had spread to her forehead and neck. She has never had anything like this in her life. She had not eaten or been exposed to anything new before the incident. The doctors have come to the conclusion her uimmune system is on high alert and over reacting .
Patient came to pharmacy today to report that her left arm is painful all the time with some tingling in fingers and this has been the case since her HIGH DOSE FLUZONE IM injection on 12-12-13. Arm is not red or swollen. Pain wakes her up, she can't get comfortable. I advised her to call her doctor. TYLENOL does not relieve pain.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 07-JAN-2016, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot# and expiry date were not provided). There were no concomitant therapies reported. The pharmacist stated that she administered the ZOSTAVAX to the patient on 07-JAN-2016, and upon injection of the vaccine, some of the dose leaked out of the syringe and dripped down the patient's arm. The reporter also confirmed that she was not exposed to the ZOSTAVAX. No adverse effects were reported. There was no product quality complaint involved. Follow up information has been received from a pharmacist on 29-FEB-2016. The patient's demographics were updated. The patient was a retired, 84 year old female. The pharmacist stated that on 07-JAN-2016 in the afternoon, the patient was vaccinated subcutaneously with the first dose of ZOSTAVAX injection, lot# L034726. The vaccine leaked from the needle/syringe connection, and some of the leaked dose dripped on the patient's arm. The pharmacist wiped it off with alcohol. On 05-FEB-2016 in the afternoon, also reported as 4 weeks later, the patient's vaccination with ZOSTAVAX injection (lot# L034726, route of administration: subcutaneous) was repeated due to not receiving a full dose on 07-JAN-2016. Additional information is not expected as all the required correspondence has been received. Reporter details, patient details, products, events and narrative were updated.
Received 4/1/16 at 11:30 am, then mid afternoon area felt painful and increased redness from (L) deltoid to elbow, inner aspect of arm. This lasted x 48 hours and now redness and swelling resolving in the last 24 hours.
pt recv vax 30JUN95 & 2JUN97 pt exp fever 99.8 & devel fifteen lesions;
The vaccine was given past the beyond use date. The clinic is currently working creating guidlines and processes for this not to happen again.
Patient inadvertently received Moderna vaccine, even though it is currently not FDA approved for individuals under the age of 18. Pediatrician reached out to the CDC, and was advised to  continue with the Pfizer series. Patient did not develop any acute severe s/sx from the vaccine and is expected to return to the clinic within the next week to complete his COVID-19 series.