chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 13-month-old female who on 28-SEP-2007 at 9:30 am was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot# 658525/1255U). Subsequently, on an unspecified date, the patient developed mild chickenpox. No outcome was reported. Follow-up information indicated that the patient had a mild case of varicella and experienced no sequelae. It was reported that she appeared well as of 30-NOV-2007. No additional information is expected.
Resting heart rate of 116 bpm (standard ~55-60). (Also, ongoing exacerbated tinnitus/hearing loss - 5 weeks post first shot)
This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 21-JUN-2018 in the morning, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency and route were not reported) (lot # N020501, expiry date: 03-MAR-2019) for prophylaxis. In the late afternoon on 21-JUN-2018, the patient reported her arm (at the injection site) was swollen, sore, warm and red. No treatment was received for the events. Lab diagnostics/studies was not performed. The outcome of injection site pain, injection site erythema, injection site swelling and injection site warmth was reported as not recovered/not resolved. The relationship between the events and PNEUMOVAX 23 was not provided. No product quality complaint was involved.
Higher blood pressure; Body aches; extreme swelling of left eye; bruising; This is a spontaneous report from a contactable consumer. A 34-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in right arm on 02Apr2021 at 16:15 (at the of 34-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included metoprolol succinate (TOPROL), metformin (METFORMIN), metoprolol (METOPROLOL) and escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported other medications in two weeks. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No COVID prior vaccination. Facility type vaccine at Doctor's office/urgent care. On 15Apr2021 at 16:30, the patient experienced higher blood pressure, body aches, extreme swelling of left eye and bruising. The patient underwent lab tests and procedures which included SARS-CoV-2 test: (Nasal Swab) negative on 16Apr2021. Adverse event treatment include Antibiotics. The outcome of the events were not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I experienced a breakthrough case of COVID-19 with coughing, fever, pressure in my right ear, inflamed sinuses and lung issues.
Thirty minutes after the vaccination was administered, I developed sharp, stabbing pains in my heart in regular intervals every 2-3 minutes until I feel asleep around midnight that night. Each episode lasted approximately 10-20 seconds. I have not experienced the same pains since 7/05/21.
Patients were administered doses from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 03 Jan 2022.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2022-438672, MOD-2022-438657, MOD-2022-438669, MOD-2022-438671, MOD-2022-438673, MOD-2022-438674, MOD-2022-438675, MOD-2022-438676, MOD-2022-438677 (Patient Link).
Patient reports a fever of 100.2 and severe pain going up and down her arm into her neck.  Patient states that these symptoms started 12 hours after the second injection and lasted about 12 hours, with the inability to move her arm times two fays after the injection.  This was the worst encounter. The patient recieved the next shot in the series one week later, and experienced a degree of pain, but not as severe as the previous one.
Onset of profuse sweating accompanied by dizziness.  at approximately 5:30pm day of vaccination. Continued intermittently for 2 days.
Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Pt was 96 and on 2/25/21, his reported he was not doing well and was being place for hospice and not going to be able to get his second dose of his COVID vaccine. He passed on 3/25/21 without a documented cause of death. His comorbidities included advanced age, CAD, AAA, HTN, TIA, sick sinus syndrome and he had an ICD.
Client's power of attorney (brother) stated he was 65 years old and high dose influenza was given, but client's date of birth is incorrect which would make him 64 years old. No adverse effect.
Patient started menses in April 2020. She had a period every 7-8 weeks from April 2020 to May 2021. Mom reports that pt received first COVID vaccine in May 2021 and second in June 2021. Mom reports  that that pt went from May 2021 to August 2021 without menses. She had a short menses in August 2021 and has had no menses since (today is October 22, 2021). Mom is concerned this could be an adverse effect from COVID-19 vaccine & asked me to report it.
Low Blood Pressure, Vertigo, Dizziness, Continuously fall asleep, off balance.  If I trip on anything I tend to go way further over than normal.  Blood pressure resolved stopped taking blood pressure medicine for 2 days and ate salty foods to bring it up (4 days total 7/4-7/8  Went to the ER).  The Vertigo resolved after 2 days (7/4-7/5)  Dizziness resolved after 1 day 7/6-7/7.  The off balance started on the 8th and is still on going.  The falling asleep I noticed on the 10th and is still on going.
My Left arm swollen when I woke up , My Dr. informed me to place a cold compress on the swollen site. However, If not better in a couple hours to come in for exam. Left arm improved after cold compress.
Signignicant swelling of the occipital lymph node for about one month with radiating pain at touch. Lymph node continues to swell periodically.
Parents report 2-3" erythema left leg at injection site with baby fussy 3-4 hrs after vaccination. Taken to ER where BENADRYL and TYLENOL given. Sx resolved within 1 hr. Baby fine without Sx today.
This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent condition, drug and allergy history was not reported. On an unspecified day in August of 2015, the patient was vaccinated with an unspecified dose of GARDASIL (strength, dose, route of administration, lot # and expiration date were not provided) for prophylaxis. Then, on an unspecified day in July of 2016, the patient was vaccinated with an injection of GARDASIL 9 (strength, dose, route of administration, lot # and expiration date were not provided) for prophylaxis. It was reported that both vaccines were administered prior to the patient's 15th birthday. Adverse events were not reported. Additional information has been requested.
Client received immunizations on 12-21-2004 at 4:30 pm. At 6:30 pm that same evening her mother noticed bumps around injection site on clients right thigh. By 10:00 pm client was becoming fussy and irritable. Skin felt cool and was sweaty. Client had Tylenol at 6:00 pm. Slept that night but by 6:00 am had temp of 102.2 rectally. Mom gave client Tylenol again at this time. Client had rash on entire leg and it had spread to her stomach. By late morning on 12-22-2004 the client had a rash over her entire body. By 6:00 pm client's mom said client was having some difficulty swallowing her supper. Then at 8:00 pm client was having more swelling. At 9:30 pm eyes were almost swollen shut and hands were swelling. Mom call hospital ER dept and they told her to call an ambulance. The ambulance arrived and administered Epinephrine and Benedryl by injection. Client arrived at the hospital by 10:30 pm and was assymptomatic on arrival. Received pediatric dose of prednisone and was released. Client will continue with Benedryl and pediatric prednisone for 1 week.
Regarding the Health on the following COVID Vaccine Moderna. Please see the following determination; Doses Administered from 4.6.2021 to 5.21.2021:Based on the information you have provided and the lack of temperature data, we are not able to conduct an analysis or guarantee the doses administered between 4/6/2021 and 5/21/2021 provided the necessary protection against a COVID-19 infection. Please continue with the original plan of action on revaccination and completing a VAERS Reports on the all clients you have identified.
pt recvd flu vax 26OCT93; lump in lt axilla 2 days later w/fluid; more painful now w/pain down arm & fingers;
ADVERSE EVENT: DEEP VEIN THROMBOSIS SYMPTOMS:  RIGHT INNER THIGH PAIN TIME: 9 DAYS POST VACCINATION
Initial unsolicited report received from a pharmacist on 12-Oct-2016. This case was linked with cases 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837,2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. (Same vaccine). This case involves a patient (gender and age not reported) who was vaccinated with a dose of Fluzone Quadrivalent via intramuscular route (Batch number: UI669AA, expiry date: 30-Jun-2017, dose, dose in series and site of administration were not reported) on 04-Oct-2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was unknown. Illness at the time of vaccination was also reported as unknown. No further information regarding medical history was available. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unspecified date and duration following the vaccination, the patient developed local swelling, induration, vaccination site pruritus and vaccination site reaction (reported as 'within our hot itchy, swelling flat hard baseball size knot'). Patient required emergency room (ER)/ doctor visit. Laboratory investigations was not reported. Corrective treatment was reported as 'no'. The outcome of events was reported as unknown. Follow up information received from a pharmacist on 28-Nov-2016: It was reported that a 39-year-old female patient was vaccinated with Fluzone. List of documents held by sender: none.
Dizziness/lightheadedness, diaphoretic/pale, tinnitus, and blurred vision. This lasted approximately 15 minutes.
Post vaccinations in about 48 hrs pt started having fever and congestion and sore throat and rash; rash-fever persisted for about 10 days. Rash involving from 3/7/04. Rash morbiliform spread on trunk approximately 20-25cm in diameter.
Information has been received from a registered nurse concerning a 22 year old female with a history of migraine headaches, "rapid heart beat" and no drug allergies who on 21-DEC-2006 was vaccinated with 0.5 mL IM first dose of GARDASIL (lot #653978/0955F).  On 20-FEB-2007, patient was vaccinated with 0.5 mL IM second dose of GARDASIL (lot #655619/1427F) and on 08-JUN-2007, patient was vaccinated with 0.5 mL IM third dose of GARDASIL (lot #657736/0389U).  Concomitant therapy included ORTHO TRI-CYCLEN.  In March 2010, the patient had an abnormal PAP.  The PAP result was Low grade Squamous Intraepithelial Lesion (LGSIL), mild dysplasia.  The nurse stated that an HPV test was negative for HPV 16 and 18.  Patient had a visit to the physician's office.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Information has been received from a registered nurse concerning a 59 year old female with a history of shingles (13-JUN-2000) who on 21-DEC-2006 at 09:00 AM was vaccinated SC in the left arm with a first dose of Zostavax (lot #654603/1405F). On 08-FEB-2007, the patient experienced pain in the right middle back. On 09-FEB-2007, the pain continued. On 10-FEB-2007, a rash below the right breast appeared. The same day, the patient was started on VALTREX 1000mg, one every 8 hours for 7 days. It was noted that the patient's adverse began on 06-FEB-2007. The patient recovered on an unspecified date. The patient's experienced were considered to be other important medical events by the reporter. No further information is expected.
pt reported sore arm days 1-4. lethargy days 5-8. itchy erythematous rash at site of vaccination days 9-12, approx 2 inches in diameter that expanded to 5 in diameter before reducing day 12.
101.6 degree fever; muscles from her thighs to her neck hurt; body aches; headache; arms were sore and hurt; chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a 57-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 8th December 2022, the patient received the 1st dose of Shingles vaccine and Flu vaccine. On 8th December 2022, less than a day after receiving Shingles vaccine and Flu vaccine, the patient experienced pain in arm and chills. On 9th December 2022, the patient experienced fever, muscle pain, general body pain and headache. The patient was treated with paracetamol (Tylenol) and theraflu (nos) (Theraflu). On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the muscle pain, general body pain, headache and pain in arm were not recovered/not resolved and the outcome of the chills was unknown.   It was unknown if the reporter considered the fever, muscle pain, general body pain, headache, pain in arm and chills to be related to Shingles vaccine and Flu vaccine.     Additional Information: GSK Receipt Date: 09 DEC 2022 Reporter's comment:  The patient reported that got Shingles vaccine in right arm and Flu vaccine in left arm . The patient reported after she went to bed in the evening on 8th December 2022 and had chills the patient said her arms started getting sore and that they hurt a few hours after getting the vaccines on 8th December 2022. The patient woke up on 9th December 2022 and had headache, body aches, a 101.6 degree fever, and the muscles from her thighs to her neck hurt.  Patient said that she then took a tylenol and her temperature came down to 100.7 degrees and took a 1 hour nap and waited. Patient said later she took more tylenol and theraflu. She said the fever is coming down a little but still present. Patient said her normal body temperature is 96.5 degrees. Patient said she can not take ibuprofen because she "can't take non steroidal non inflammatory drugs. The patient did not know if she received the Shingrix vaccine, just that that she received the shingles vaccine.  Patient did not know the lot number or expiration date of the shingles vaccine she received. Reported did not consent to follow up.
patient received vaccine that was improperly stored. it should have been disposed of on the use by date of 1/27/23
TC per mom Tdap is only new vaccination client received on 9/27. By evening client had developed a fine rash on ant post torso described as prickly heat type of rash. By morning rash was more extensive over torso. No other s/s.
Itch; Stinging; Rash on back of neck, rash on front of shoulder; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on back of neck, rash on front of shoulder), PRURITUS (Itch) and PAIN (Stinging) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced RASH (Rash on back of neck, rash on front of shoulder). On an unknown date, the patient experienced PRURITUS (Itch) and PAIN (Stinging). At the time of the report, RASH (Rash on back of neck, rash on front of shoulder), PRURITUS (Itch) and PAIN (Stinging) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included cold compress, oil and peach aesthetics.  No relevant concomitant medications were reported.
PT WAS HERE TO GET A COVID BOOSTER AND A FLU SHOT, HE RECIEVED BOTH SHOTS AND WE WERE TELLING HIM TO HAVE A SEAT OUT FRONT FOR 15MIN AND LOOKED AND HE WAS SLUMPED OVER. HIS GIRL FRIEND WAS ALSO IN THE ROOM, THEY BOTH STARTED CALLING FOR HELP. I WENT IN THE ROOM AND THE PT WAS PALE, SWEATY, HIS EYE WERE OPEN AND HIS BODY WAS RIDGE. HIS WHOLE BODY TWITCHED SEVERAL TIMES AND THEN HE CAME TOO. AT FIRST HE DIDN'T KNOW WHERE HE WAS OR WHAT HAD HAPPENED. HE WAS STILL VERY PALE AND SWEATY AND HE WAS NAUSOUS. WE CALLED FOR MANAGEMENT AND AN EMT WAS WALKING BY AND HEARD. EMT CAME IN AND CHECKED ON THE PT. HE TOOK PTS BP WHICH WAS NORMAL. WE GOT PT ORANGE JUICE AND HE DRANK THAT AND WAS FEELING BETTER.
Starting 06/20/2022, he had developed symptoms. He tested positive for COVID on 06/23/2022. On 06/23/2022, he got an antiviral and he started it the next day on 06/24/2022. He took it for 5 days then tested himself again and he was negative. Then, 3 days later he became positive again. He had mostly mild symptoms during this event: severe runny nose, super sore throat, fatigue and an ear issue. He is still having an ear issue and fatigue to this day, and he is still testing positive to this day.
This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored VAQTA (dose, route, lot number and expiration date were not reported). No adverse experiences reported. This is one of several reports from the same source. Additional information has been requested.
Site: Pain at Injection Site-Medium, Additional Details: Difficulty reaching back behind her to reaching her arms over her head. It is painful/sore and more difficult to do those things than before the vaccine.  Also unable to sleep with her arm under her pillow because it hurts and is uncomfortable.
Swollen lymph node at the side where the shot was given. It is ''very swollen and tender, under the arm pit; swollen lymph node at the side where the shot was given. It is ''very swollen and tender, under the arm pit; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on Monday, 19Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient had swollen lymph node at the side where the shot was given and it was very swollen and tender, under the arm pit. The patient asked how long this possible side effect would last and that whether she could use medication, put ice etc. The events were reported as non-serious. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
SHORTNESS OF BREATH, HARD TIME "GETTING OXYGEN"; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced shortness of breath, hard time "getting oxygen". On APR-2021, the subject experienced abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal pain on APR-2021, and had not recovered from shortness of breath, hard time "getting oxygen". This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
I began having headaches again and difficulty concentrating as well as fatigue. I had issues with joint pain that wasn't at first significant or terrible. I would have emotional fluctuations. I thought it was situational for a while but then we ultimately decided to give me my infusion of Rituximab early and they reduced 60% full time effort for 4 months. After my first and second dose of my Moderna vaccine, I had severe joint pain, fatigue, inability to concentrate, emotional liability, chest pain, and difficulty breathing, joint swelling and stiffness, and severe headaches. At the time I attributed these things to Lupus, but ultimately my doctor decided that he believes that these flare ups were associated with my COVID-19 vaccines as I had never had nerve or CNF involvement before and he has seen similar things in other patients.
On Apr  7th at 11:30 Pm my wife went to  hospital. not being able to breathe sufficiently. This started the day before on the 6th while out walking.  She is in the hospital being treated for embolisms of the lungs on both sides with multiple blood clots.