chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her first dose of Shingrix December 7, 2019; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 7th December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The patient could not recall the route of administration. The reporter consented to follow up.
pt recvd vax; 1 hr after vax, pt devel lethargy;
Developed pancreatitis; This case was reported by a other health professional via interactive digital media and described the occurrence of pancreatitis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced pancreatitis (serious criteria GSK medically significant). On an unknown date, the outcome of the pancreatitis was unknown.   It was unknown if the reporter considered the pancreatitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient developed pancreatitis. The patient was wondering if he should receive his 2nd dose.
pt recvd vax & dev urticaria; 24 hrs later meds given;
This spontaneous report as received from a register nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX (dose, strength, frequency and route were not reported) lot # K010647, expiration date 30-OCT-2015 and lot # L002422, expiration date 23-APR-2016. No adverse effect reported. Additional information has been requested.
This spontaneous report as received from a pharmacist via field representative refers to a 60 years old male patient. On an unknown date in approximately December 2013 (also reported as 4 months ago), the patient was vaccinated with ZOSTAVAX, dose (unknown) and route of administration (unknown). Other suspect therapy was an unspecified flu shot (cannot rule out) AFLURIA administered on an unknown date in approximately December 2013 (also reported as 4 months ago). No concomitant medications were reported. On an unknown date, the patient developed Bell's palsy. The patient was not hospitalized. Action taken with respect to ZOSTAVAX and AFLURIA was not applicable. No Product quality complaint was involved. The outcome of Bell's Palsy was unknown. Causality was not provided. No further information provided. Additional information has been requested.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored PNEUMOVAX 23, lot no. M012156/expiration date-15-OCT-2017, (incorrect product storage). No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
patient was administed an expired dose of TENIVAC, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00663918) and transmitted to Sanofi on 30-Jun-2021.  This case involves a 58 year old female patient who was administered an expired dose (0.5ml) of the suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number: U6265AA; expiry date: 19-Apr-2021; form: solution for injection) via unknown route in the right deltoid for prophylactic vaccination on 30-Jun-2021 (expired product administered).  Medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to expired vaccine used (latency same day).  The reporter wanted information as to repeat the vaccination or not.  At the time of report, no adverse event was reported.
Chills (big time, could not stop shaking), body ache, sore injection site/arm. Swelling of arm that got the shot. Treated with Tylonal and rest
CDC reports: 2 mo infant developed inject site rxn & screaming episode following DTP/OPV immunization.
100-degree fever for 24 hours. Full-body aches 48 hours. Tiredness 48 hours.
The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022; Expired Moderna Covid-19 vaccine adminsitered on 13May2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine adminsitered on 13May2022) and PRODUCT STORAGE ERROR (The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine adminsitered on 13May2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine adminsitered on 13May2022) and PRODUCT STORAGE ERROR (The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Number of doses reported were 9 doses, (3 of 0.5mL and 6 doses of 0.25mL booster).  Date of refrigeration was reported as 12-May-2022.  No temperature excursions were reported.No treatment medication was reported.   This case was linked to MOD-2022-568784 (Patient Link).
Fever; Increase heart rate; Body ache; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis and DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On 21-SEP-2023, the patient received Shingrix, Flu vaccine and Tdap Vaccine. On an unknown date, an unknown time after receiving Shingrix, Flu vaccine and Tdap Vaccine, the patient experienced fever (Verbatim: Fever), heart rate increased (Verbatim: Increase heart rate) and general body pain (Verbatim: Body ache). The outcome of the fever and general body pain were resolved and the outcome of the heart rate increased was not resolved.   It was unknown if the reporter considered the fever, heart rate increased and general body pain to be related to Shingrix, Flu vaccine and Tdap Vaccine.   It was unknown if the company considered the fever, heart rate increased and general body pain to be related to Shingrix, Flu vaccine and Tdap Vaccine.   Additional Information: GSK Receipt Date: 6-OCT-2023 The reporter was the patient who received Shingrix and was having an increase in her heart rate since then.  According to reporter she also had fever and body ache that went away.  Reporter stated that she received 2 other vaccines the same day Flu and Tdap booster, she did not know the names of the vaccines.  Reporter went to the doctor, had an EKG and was okay. The reporter did not consent to follow up.
mouth and lips felt numb; tightness under the collar bone on the same side as injection; two hives developed on her face; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (mouth and lips felt numb), MUSCLE TIGHTNESS (tightness under the collar bone on the same side as injection) and URTICARIA (two hives developed on her face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021 at 11:35 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021 at 11:40 AM, the patient experienced HYPOAESTHESIA ORAL (mouth and lips felt numb), MUSCLE TIGHTNESS (tightness under the collar bone on the same side as injection) and URTICARIA (two hives developed on her face). At the time of the report, HYPOAESTHESIA ORAL (mouth and lips felt numb) and MUSCLE TIGHTNESS (tightness under the collar bone on the same side as injection) outcome was unknown and URTICARIA (two hives developed on her face) was resolving. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPOAESTHESIA ORAL (mouth and lips felt numb), MUSCLE TIGHTNESS (tightness under the collar bone on the same side as injection) and URTICARIA (two hives developed on her face) to be possibly related.    Treatment information and concomitant medications were not provided. Patient reports the areas stayed numb and tingling for a few hours. The hives have gone down now ~ 5:30pm. She stated she has this type of reaction with IV contrast and has to take 150 mg of prednisone, 50 mg of Benadryl before IV contrast for scans. She has her 2nd dose scheduled in one month.
After my first shot I woke up early the next day - during the night - started running fever and achy and stomach hurt.  Next day still had intestinal issues and very tired. I developed a rash on my arm near the injection site. I was very lethargic for about 6 days. I stopped eating due to my intestinal issues. When I got my second shot they asked if I had reaction to first shot, I told them yes. They wouldn't let me get the second shot. I was referred to the doctor at the Health Dept. He allowed me to get the second shot. After the second shot I had the same reaction with exception of the rash.  My symptoms included headache this time. After the Booster shot I had headache and upset stomach and the Monday I thought I was fine. But Tuesday I went for a walk - I was so exhausted. I walked to vote and to the Post Office and couldn't walk home. I was so exhausted and out of breath I had to call my husband to come get me. I was unable to do my normal exercise. I have recovered from everything with exception that I am still unable to continue my exercises as normal. I cannot walk like I did before my vaccines.
On the following day of my vaccine, which was 01-13-2013 I started to have body aches and on 01-14-2021 trough 01-16-2021 I began to pee blood.
I experienced a pause or cessation of menses, itchy skin and inflammation of joints. Because this is similar to symptoms of thyroid, I did get a test to determine my levels. The tests returned normal. My symptoms are still present.
extreme shortness of breath; possible exercise induced asthma; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (extreme shortness of breath), ASTHMA EXERCISE INDUCED (possible exercise induced asthma) and FATIGUE (fatigue) in a 45-year-old female adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the adult was diagnosed with DYSPNOEA (extreme shortness of breath), ASTHMA EXERCISE INDUCED (possible exercise induced asthma) and FATIGUE (fatigue). The Adult was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  The adult was treated with ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency. At the time of the report, DYSPNOEA (extreme shortness of breath), ASTHMA EXERCISE INDUCED (possible exercise induced asthma) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
2 pts (husband & wife), both vaxed from the same vial exp inject site react; husbnad, who had reaction, devel swelling & erythema @ the inject site; no known allergies;
Thursday Feb. 5, 2009 fever 102- C was the highest the fever and slight rash on face, no energy, red eyes not eating. Fr. Feb 6, 2009 fever and rash not on face moving to neck and chest. Saturday Feb 7, 2009 no fever but rash moved to chest and back. Urgent care in afternoon for vomiting and diarrhea. Monday Feb 9, 2009 rash still covering body, still not eating, no energy. Tuesday Feb 10, 2009 rash still covering body.
redness; lump has not gone down; hives; arm is swollen, hot, and red; arm is swollen, hot, and red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), INJECTION SITE MASS (lump has not gone down), URTICARIA (hives), PERIPHERAL SWELLING (arm is swollen, hot, and red) and FEELING HOT (arm is swollen, hot, and red) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02A23A) for COVID-19 vaccination.     Concomitant products included RAMIPRIL, BISOPROLOL, CLOPIDOGREL BISULFATE (PLAVIX) and ROSUVASTATIN for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness), INJECTION SITE MASS (lump has not gone down), URTICARIA (hives), PERIPHERAL SWELLING (arm is swollen, hot, and red) and FEELING HOT (arm is swollen, hot, and red). At the time of the report, ERYTHEMA (redness), INJECTION SITE MASS (lump has not gone down), URTICARIA (hives), PERIPHERAL SWELLING (arm is swollen, hot, and red) and FEELING HOT (arm is swollen, hot, and red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details pertained to the events were not provided.  The action taken with mRNA-1273 in response to the event was not applicable.
Had a reaction to first flu shot & Dr. had suggested trying egg-free.  That one was OK, so had requested egg-free shot.  Fell asleep early that night & woke after about 15 mins. with my heart racing.  First night & second pain in arm interrupted sleep.  First night woke with nausea early hours of following morning.  Headache lasted for several days.  Occasional but infrequent chest pain (inflammation/numbness sensation) over next 5 days.  Major concern is the heart-racing and subsequent chest pain.  No allergy to eggs; regular part of diet.
After the vaccine, the whole body has been allergic and itchy, and the skin will appear red rash when scratching.
Pt developed swelling of the upper arm and upper thorax in the area of the injection site. This was associated with myalgias and arthralgias. He was treated conservatively and the swelling subsided over the next 2-3 days.
Patient received the vaccine at pharmacy. Lot number, vaccine route unknown. Right shoulder red and swollen. Denies pain.
1st dose administered in 2019. Second dose not yet received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on August 2019, batch number: 3TP42, expiry date: 31st August 2020).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24th March 2022 Reporter's Comments: The pharmacist reported late 2nd dose of Twinrix. The second dose not received per health care professional. The reporter consented to follow up but declined to provide additional contact information other than telephone number. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose of twinrix which led to incomplete course of vaccination.
Patient experienced dizziness after vaccine. No loss of consciousness. Patient reported prior similar reactions with other injections or blood draws.
Severe body aches, severe headache, sore throat, and low fever. Same symptoms as when I actually had COVID-19.
Montelukast 4 mg chewable tablet 1 tablet every day at bedtime for 30 days, cetirizine 5 mg/5 mL oral solution 5 mL every day at bedtime.
Pfizer Dose 1 4/15/21 (EW0153) Pfizer Dose 2 5/7/21 (ER8736) COVID Positive 12/29/21  1/8/22: A 46-year-old female with past medical history of seizure disorder, chronic immunosuppressive treatment, SLE, lupus nephritis, CKD stage 4, hypertension, bronchial asthma, GERD, DVT anticoagulated with Eliquis, morbid obesity, obstructive sleep apnea was brought in by EMS after patient was found to be confused   And is poor historian but per ED provider patient missed hemodialysis and family called EMS as patient was not answering calls.  Upon examination patient is uncooperative sleepy only briefly answers questions   Patient was saturating well on room air  Lab was significant for anion gap metabolic acidosis, elevated glucose, elevated creatinine of 10.81, ammonia was less than 70.  White cell count was not elevated  CT of the head without contrast was showing septal region of hypoattenuation of the left cerebellar hemisphere favored to be artifactual.  However, if there is concern for acute infarct, MRI could be considered.  Chest x-ray showed Mild patchy bilateral airspace disease, suspicious for multifocal infection  1/11/22: 46-year-old female with past medical history of seizure disorder, chronic immunosuppressive treatment, SLE, lupus nephritis, CKD stage 4, hypertension, bronchial asthma, GERD, DVT anticoagulated with Eliquis, morbid obesity, obstructive sleep apnea was brought in by EMS after patient was found to be confused.  Patient was then admitted with metabolic encephalopathy from uremia and rule out CVA.  Patient workup for CVA was unremarkable.  Patient mental status significantly improved after hemodialysis. EEG was done which was unremarkable except metabolic encephalopathy features.  Patient will be discharged home to follow-up with PCP
On second day after vaccine-1/8/21-shakes, chills, left arm swollen, bruised, tender, warm, and sore with a knot at injection site. Nausea and fever of 101.8-patient took Zofran=8mg. All over body aches and joint tenderness and soreness. Day 3-1/9/21-extreme fatigue and body aches, no fever or chills. Day 4 and 5 only had headaches, and on Day 6 no symptoms at all.
He has been sleeping all day and at 1:30 pm he has started throwing up and has a fever of 100.9. This is less than 24 hours after receiving his first dose of his vaccine.
Called in c/o chest discomfort. Has Hx heart disease (CABG 13 yrs ago). Had called PCP - who told him to call and ask if chest discomfort was from YF-VAX; if not, go to ER. Treated, tested and released. No problems noted.
Started with local reaction at injection site (swollen/redness), then moved to underarms and down underside of arms bilaterally almost to elbow [looked like a friction burn (bright red)].  Patient said it burned- was getting better with Benadryl.
Patient developed an allergic reaction (skin rash on trunk). Given Benadryl 50mg orally. Symptoms and vital were monitored every 5 minutes for at least 40minutes and rechecked prior to discharge, more than an hour after his shots were given. The rash did not progress any further. He did not develop hypotension, wheezing, shortness of breath, or oral or throat swelling. EpiPen was not required.
rash on my left arm only, the arm I got my shot; hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st August 2019, the patient received the 1st dose of Shingrix. In August 2019, 2 days after receiving Shingrix, the patient experienced hives. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the hives was recovered/resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the hives and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient stated that had hives that cleared up but now at the time of reporting experiencing a rash on left arm.
Became very weak, limp, like a jelly-fish; all night & into the next day; Had fever 102-103 ax & was giving APAP every 4 hrs; Did not take to MD;
Nausea, followed with vomiting. @3.25 - Began to have itching in her throat. Benadryl 50 mg was administered
A couple days after receiving the bivalent dose of Moderna, I started to experience some dizziness. I thought it may have been my new prescription of contacts, but I changed them out and nothing changed. I tried the Epley maneuver, but it did not help. I started experiencing some heart palpitations also and decided to spend the day resting. I woke up the next day and started experiencing vertigo. By Monday, the heart palpitations somewhat diminished and turned into a flutter. I went to the doctor. She checked my BP and performed an EKG. Both tests came back normal. I went and saw my ENT and she did the Epley maneuver and it helped a bit. I am still experiencing dizziness plus hearing loss in both ears, but it is more pronounced in my left ear. The dizziness becomes worse if I am looking down trying to read or write. I have an appointment with my audiologist and she is going to do an audiogram.
Extreme dizziness, fever, body aches, vomiting, swollen lymph nodes.  Still experiencing extreme dizziness, exhaustion and naseau on 4/24/2021.