chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare providers recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2015, a pharmacist administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 24-OCT-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine.  As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Administered expired moderna vaccine.  Vial was unopened, but had been in the fridge for longer than 30 days.
HEADACHE; body aches; FATIGUE; SORE ARM; This case was reported by a physician via sales rep and described the occurrence of headache in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of influenza like illness (received flu vaccine on 27th August 2019).   On 17th June 2020, the patient received the 1st dose of Shingrix. On 17th June 2020, 8 hrs after receiving Shingrix, the patient experienced headache, general body pain, fatigue and pain in arm. On an unknown date, the outcome of the headache, general body pain, fatigue and pain in arm were recovered/resolved.   It was unknown if the reporter considered the headache, general body pain, fatigue and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient experienced symptoms on evening of the day of vaccination.  Approximately 8 hours following administration. The patient slept the entire day following the vaccination. No fever was reported.  Symptoms resolved after the second day. The outcome for events was reported as recovered/resolved with sequel however it was captured as recovered/resolved in the case. This case has been linked with US2019158430, reported by same reporter. The reporter consented to follow up.
Had a cough for two weeks and still is present Doctor prescribed Sudafed cough got worse and so did my anxiety so I quit taking it multiple COVID tests were negative anxiety still present.
Weakness in hands and upper extremities. Started a few d after a cold but 34d after Tdap. Onset was sudden and progressed quickly over 4-8hr.
Really bad lower back pain; Couldn't get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Couldn't get out of bed) in an 84-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) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced LETHARGY (Couldn't get out of bed). At the time of the report, LETHARGY (Couldn't get out of bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Advil and Heating pad used as a Treatment medication    Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up information included reporter details; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Change in menstrual cycle. My cycle has always been exactly on time. Since getting the shot it arrived a week late with my first period following the shot. My second period has now come a week early. Other symptoms that I havent experienced before with both periods have included extreme bloating, & thin menstrual blood. Before I have always experienced heavy periods with extreme cramps.
Lack of Effect; had the Pfizer Covid 19 Doses already; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (172086). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis Treatment" (unspecified if ongoing), notes: Arthritis Treatment. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Lack of Effect; had the Pfizer Covid 19 Doses already"; COVID-19 (medically significant), outcome "unknown".  Clinical course:  Reporter had a caller on the line that was treated for arthritis when she started using Paxlovid. The caller mentioned she had the Pfizer Covid 19 Doses already. The caller states she had some reactions medical but she did not say it was from the Covid 19 Vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Severe, Systemic: Vomiting-Medium, Additional Details: Patient began to seize/faint in chair within 5 minutes post-vaccination. Paramedics were called as I stabilized patient on floor. Consciousness regained within 60 seconds, patient confused/unaware of what had occured. Patient flush, lightheaded, vomiting. Paramedics arrived and confirmed patient was stable and safe to leave scene without further intervention.
14JUN96 mom reports pt had fever of 105 1wk p/vax 13JUN;pt was crying & moaning throughout the noc;MD did not find a cause on exam-ordered motrin & APAP;t102 today
Mumps-like break out on arms and face, petechia on face, neck and chest, high fever, malaise, blotching all over body, anorexia, unable to sleep.
Moderna COVID-19 Vaccine EUA severe itching around injection site, no rash visible, started about 1 1/2 weeks after injection, lasted for 4-5 days
Pt recv vax on 11/9/98; on 11/12/98 pt exp sore throat
Information has been received from a registered nurse concerning her 13-year-old daughter with no pertinent medical history and no drug reactions/allergies who on 09-OCT-2006 at 17:00 was vaccinated SC with the second dose of Varivax (lot # 654030/0913F). Concomitant vaccination included influenza virus vaccine (unspecified). There was no illness at the time of vaccination. On 11-OCT-2006, 24 hours post vaccination, the patient experienced pain, swelling, redness (1.5 inch circle around the site), and itching at the injection site. Unspecified medical attention was sought. There were no lab diagnostic studies obtained. Additional information indicated that on 10-OCT-2006 at 15:00 the patient developed a large red wheal approximately 3" at the injection site with pain and redness and that was warm to touch and itchy. Subsequently the patient recovered. There was no product quality complaint. It was reported that at 5 years old the patient had a local reaction following the fifth dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. No additional information is expected.
Client reports redness, pain and swelling of left arm at injection site area beginning 4 weeks after MMR injection. Had fever (100-101) for 5-6 days with diarrhea, sore throat, and nasal congestion. Was seen with diagnosis of delayed reaction to MMR.
Patient was given 3rd dose of hepatitis B too early (first dose was given 9/7/22 and second dose 10/6/22). Doctor reached out to parents to inform that the patient will need an additional dose.
Headache, Fever, Sore Arm Narrative:  Other Relevant History:
The patient received all four vaccines and was asked to wait in the store for 10-15 minutes to make sure everything is good. The patient let me know she is waiting for another prescription and I had the patient come to the drop off window to check. The patient then sat on the bench to wait for the prescription to be completed. More than 15 minutes had passed I checked in with the patient and asked how she was doing and she said she was fine and noticed her prescription is almost ready for the patient. The prescription is done for the patient and she picked up and walked out of the store. The patient was in the store for over 30 minutes almost an hour after the immunizations are completed before leaving the store.
Since I had COVID in May I had hair loss in a rapid rate. I did see the dermatologist in October. I am unsure if it is related to the vaccine.
Information has been received from a physician concerning a patient who on 15-FEB-2007 was vaccinated, intramuscularly, into the deltoid muscle with the first 0.5 ml dose of Gardasil (lot not reported). It was reported that during the administration of the first dose there was some leaking of the vaccine at the injection site. The patient was not able to receive the complete dose. No adverse experience related to this event. Additional information has been requested.
This spontaneous report was received from a licensed practical nurse, and concerns to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 26-FEB-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) by subcutaneous route, lot # L024255 with expiration date of 01-JUL-2017. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Severe
Macular, papular, blanching rash on face, trunk, extremities. Take Benadryl 4ml every 6 hours if needed.
Bilateral arm and leg pain with sligh headache around 3/2/21 Worsening pain with occasional diplopia at our first visit 3/16/21 Left upper lid ptosis 3/17 with ophthalmology consult through urgent care Progressive/worsening weakness of extremities and bilateral ptosis seen through ophthalmology and sent to ER on 3/22
No adverse event.  Mother brought in patient and told us his date of birth was 10/11/2008.  Administering pharmacist then went to confirm with Mom patient's age because he appeared young, had no insurance and no immunization history in the state.  Mom  confirmed patient's DOB was 10/11/2008 and that he was 12 years old.  She was informed it was only approved for down to age 12 and she confirmed that patient met requirement.  After administration we found an immunization history in the ALERT Registry for the patient with same name and same address, but a DOB of 10/11/2010 and learned that patient is very likely only 10 years old.
Shortness of Breath  Fatigue  Muscle or body aches  Headache  Congestion or running nose  Nausea or vomiting  Diarrhea
Myalgia, Arthralgia, Fever, Diarrhea, eyes burning, light headed
Fussy infant with left leg skin peeling from thigh to calf after giving a bath and placing him for a nap.
no signs or symptoms reported; Was there a product qulaity complaint- yes; was the vaccine/ vaccine-device used accroding to the instruction leaflet?- no; Improperly stored administeted vaccines; This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drugs reations or allergies were not provided.  On 07-JUL-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T017686 with expiration date 21-MAY-2022, subcutaneously, in the right arm for prophylaxis. Varicella virus vaccine live (oka/merck)(VARIVAX) was placed in the refrigerator for 648 hours, instead of the freezer. The vaccine was stored in 40.4 Farenheit (F) degrees fo a time frame 1386 hours. There was no revious temperature excursions. No signs or symptoms reported. Data logger was not involved. Product quality complaint was reported. The vaccine was not used according to the instruction leaflet (product storage error, no adverse event, wrong technique in product usage process and product quality issue).
This spontaneous report as received form a physician refers to a 16 year old female patient with no pertinent medical history or drug reactions/allergies. On 07-FEB-2014 the patient was vaccinated with the first dose of GARDASIL (lot # J009788, expiration date 17-MAR-2016). Other suspect therapies included flu vaccine (manufacturer unknown). Concomitant therapies included MENACTRA. The patient fainted after receiving GARDASIL. The patient was fasting prior to being vaccinated. The patient sought medical attention via office visit. There was no treatment was given for the AE. No lab diagnostics studies were performed. The physician had the patient lie down with her feet elevated and the patient recovered quickly on the same day. Additional information has been requested.
pt recvd vax 7FEB95 & on 11MAR95 devel t104 & inguinal lymphadenopathy;
Sore arm; Felt the arm weird; Headache; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizzy), LIMB DISCOMFORT (Felt the arm weird) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced DIZZINESS (Dizzy). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), LIMB DISCOMFORT (Felt the arm weird) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. On 12-Mar-2021, DIZZINESS (Dizzy) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and LIMB DISCOMFORT (Felt the arm weird) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.   This case was linked to MOD-2021-378026 (Patient Link).
Tinnitus, I've NEVER experienced it ever before and now it can get so bad, it'll wake me up at night. I have this constant pressure / fullness feeling in my ears. I experienced a bout of vertigo 1.5 / 2 weeks after receiving my first shot that required an ER visit - another first in my life.  I've never had any of these symptoms (the vertigo or tinnitus). I've seen ENTs and my primary care doc, they see no reason for me to be experiencing either of these symptoms.
This spontaneous report was received from a nurse via a company representative referring to a 62 year old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 14-DEC-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot # M037654, expiration date on 29-NOV-2017, subcutaneous (strength and  dose number were not provided). Concomitant therapies included sterile diluent(manufacturer unknown). No adverse events reported.
A couple days of sore, red arm immediately following injection.  Then, 10 days later return of round, red, raised, warm area at injection site, lasted about 5 days, 1st days was quite tender and hot to touch, gradually spread out a bit and became less tender and went away after 5 to 7 days.
I have a rash about 3 inches around the injection site.  It is red and itchy.
16 year old received Moderna dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received Moderna dose) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received Moderna dose). On 22-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received Moderna dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. No Treatment medication reported. The pharmacist stated that a 16-year-old was accidentally given a first dose. .
Patient fainted after vaccination while he was seated during the 15 minute observation window.  Patient quickly recovered (less than 1 minute) but was feeling cold and clammy.  Patient was given water to rehydrate and stay seated for observation; Pt did not require EMS to be called as he recovered quickly on his own.  Patient left with his friends when he recovered. A follow-up phone call to the patient was made a few hours after vaccination and patient was doing well.  Patient instructed to rest up and contact MD if needed.
Client completed registration form for Moderna vaccine POD but was not age eligible to receive the vaccine. This was not caught prior to her receiving the first dose. She completed a paper registration form at the end of the clinic day, thus she was not preregistered in prepmod nor did she need registration staff assistance that would have caught her age as well. She was nervous and did not want to discuss the vaccine. Since her vaccine screening questions were all answered NO, she was administered her first dose. As the vaccinator, I had not been checking client ages as I believed that eligibility was being handled by registration.
This spontaneous report was received from a registered pharmacist concerning a 20 year old female patient with penicillin allergy. There was no pertinent medical history. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (Merck) (lot number, expiry date, dose and route unspecified) when she was a child. On 13-AUG-2013 (two days ago), the patient was vaccinated with the second dose of, 0.5 milliliter (ml) of VARIVAX (Merck) (lot number and expiry date reported as H018758 and 11-OCT-2014 respectively), subcutaneously. There were no concomitant medications. On 15-AUG-2013 (today), the patient visited the pharmacy. Approximately on an unknown date in August 2013, the patient experienced redness, a ring around the point of injection, itchiness, swelling, hot and a hard spot at the site of injection. Patient also called her unspecified physician who advised the patient to go to an unspecified emergency room as a result of the injection site reaction. It was unknown if the patient actually visited an unspecified emergency room or if she was admitted to an unspecified hospital. It was unspecified if any treatment was provided. The patient was not recovered from redness, a ring around the point of injection, itchiness, swelling, hot and a hard spot at the site of injection. The relatedness for redness, a ring around the point of injection, itchiness, swelling, hot and a hard spot at the site of injection was unknown for VARIVAX (Merck). Additional information has been requested.
4 year old ex32 week IVF twin F with no past medical history who presented to an OSH on 7/25 with fever (Tmax 104), emesis, rash, and respiratory distress for 3 days after receiving her varicella vaccine on 7/22. On presentation to OSH, she was in significant respiratory distress and had a CXR that was consistent with ARDS. She was transferred to hospital where she was intubated and required pressors (dopamine) and steriods. Started on vanc and cefotax and got 6 day course for sepsis rule out. Her blood cultures were all negative, and a respiratory viral panel on admission was negative for EBV, CMV, mycoplasma. However, her throat culture was group A strep postive and she got a 10 day course of amoxicillin. On HD 6 started on 10 day course of azithromycin for concern for Legionella.  During her ICU stay she was also found to be anemic with a negative hemolysis work up. On HD 2 she had one GTC but had a normal EEG. On 8/1 she was successfully weaned off sedation and extubated and was at her neurological baseline. Has been afebrile since 8/2. However on 8/3 her mental status worsened and became unresponsive to external stimuli and began displaying abnormal limb movements. A repeat EEG demonstrated right sided periodic lateralizing epileptiform discharges (PLEDs). She was started on Keppra at this time. An LP on 8/5 had 1 RBC 4 WBC with a glucose of 66 and protein of 24. Viral studies for HSV, VZV, and enterovirus were negative. An MRI on 8/5 demonstrated region of diffusion restriction in the right temporal lobe, and she was started on acyclovir for presumed HSV encephalitis. On 8/6 she was found to have a E.coli UTI that was highly resistent and started on Cipro. Patient remained stably encephalopathic  not following commands or verbalizing with purposeless stereotyped movements of her left arm. Transferred to hospital on 8/11 for further management.
Shortness of breath and respiratory distress resulting in mechanical ventilation. Some concern for myasthenia crisis due to presentation, started on course of IVIG.  Possible azithromycin (home medication) could have been contributing to this as well.  Also in septic shock with extensive lung infiltrates started on broad spectrum antibiotics with vancomycin and Zosyn - Zosyn was transitioned to cefepime. Lactic acidosis secondary to shock (initially 7.2 which has trended down to 2.5 at time of submission).
Itchy, swelling, lungs filling up, swollen feet, fever within 5 mins. Within 24 hours.
Nerve pain left arm to shoulder and ring and pinky finger weakness in l hand and arm pain and heart; concussion symptoms, severe headaches, body weakness and disorientation, lights bright and sensitive.  ER visit 1/9/2021 - ER referral to Ortho Spine. Continuing pain radiates to different degrees l arm to hand to include burning shoulder pain,  concussion symptoms, severe headaches, body weakness and disorientation, lights bright and sensitive.
raised red area at injection site 7 days after injection. Grew to size of tennis ball. Severe joint pain. Observe area for injection.