chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TIRED; SLIGHT HEADACHE; HALLUCINATING; COULD NOT MOVE; COULD NOT SPEAK; ALTERNATING BETWEEN HOT AND COLD; REMAINED AWAKE; ANXIETY; FEELING VERY HOT; FEVER; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20YA21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-MAY-2021 11:15 for prophylactic vaccination. No concomitant medications were reported.  On 16-MAY-2021 evening around 19:00 or 20:00, the patient, had a fever, however he did not get a definite temperature reading because he did not use a thermometer. The patient felt very hot and began hallucinating or anxieties. It was reported that throughout the night he was alternating between hot and cold. The patient could not move or speak and the fever got worse during the night. The patient remained awake from that evening until the reporting morning. The patient took unspecified pain reliever and dosage was unknown but it was two tablets and was taken at 11 am on the reporting day. At the time of this report the patient felt tired and had a slight headache but he felt better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hallucinating, could not move, could not speak, alternating between hot and cold, anxiety, feeling very hot, and fever on MAY-2021, was recovering from tired, and slight headache, and the outcome of remained awake was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210528105- Covid-19 vaccine ad26.cov2.s-Hallucinating. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient is an 11 year old male who presents due to concerns of COVID vaccine adverse effect.  He got dose #2 on 12/11.  He developed some chest pain about 13 hours after dose #2.  He had some chills.  He said he felt "flashes of nervousness" going through his body.  He slept well that night.  He had some intermittent chest pain for 10-15 minutes at a time on 12/12 and 12/13 which he rated at 1-2/10.  Yesterday he didn't have any chest pain.  He also hasn't complained of any chest pain today.  He has continued to be active, is playing basketball and doesn't seem to have any activity limitation.   He plays basketball in the driveway for about 30 minutes every night.  He is also very active at school, loves recess, plays a lot of tag and sprints away from people.  He has not had shortness of breath.  No swelling.  No difficulty sleeping.  No cough.  Had a temp of 99F on 12/11 but no other changes in temperature.
This case was reported by a healthcare professional and described the occurrence of "asthma related reaction" in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The reporter is the co-worker of the subject. On an unspecified date, the subject received a dose of Fluarix (number of previous doses and lot number not provided). On an unspecified date, post vaccination with Fluarix, the subject experienced an "asthma related reaction." The subject was seen at a physician's office. The subject "had to do breathing treatments within 5 days" of vaccination with Fluarix. The event improved "between 14 and 21 days after the (Fluarix) shot." Asthmatic reaction was assessed as medically serious by manufacturer (OMIC).
This spontaneous report was received from a nurse via company representative and refers to a 23 year old patient of an unspecified gender. The patient's medical history, drug reactions, allergies or concomitant therapies were not provided. It was reported that on 27-DEC-2017, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dosage, route, lot# and expiration date were not provided). Subsequently, on 04-JAN-2018 the patient received the second dose of GARDASIL 9 and finally on 04-JAN-2018, the patient received the third dose of GARDASIL 9 (inappropriate schedule of drug administration). No adverse effects were reported.
This case was reported by a physician via call center representative and described the occurrence of back pain in a male patient who received DTPa vaccine for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis and TYPHOID VACCINE for prophylaxis. On 20th November 2018, the patient received DTPa vaccine, Influenza vaccine Quadrivalent 2018-2019 season and TYPHOID VACCINE. In November 2018, 7 days after receiving DTPa vaccine and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced back pain, headache, diarrhea, vomiting, dry heaves, nausea and muscle twitching. On an unknown date, the outcome of the back pain, headache, nausea and muscle twitching were not recovered/not resolved and the outcome of the diarrhea, vomiting and dry heaves were unknown. It was unknown if the reporter considered the back pain, headache, diarrhea, vomiting, dry heaves, nausea and muscle twitching to be related to DTPa vaccine and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The age at the vaccination was not reported. A patient received an injectable typhoid vaccine, an unknown quadrivalent non-live influenza vaccine and an unknown brand Tdap vaccine on the same day. A week later, the patient developed adverse events including back pain, headache, diarrhea, severe nausea, vomiting, dry heaving and muscle twitching all over body. Symptoms were persisting for over 10 days. The health care professional and recipient (health care professional son) were unaware of the brand name of the vaccines received. The main concern of the call was the muscle twitching. The call was to see if that has been reported with Tdap vaccines.
A few hours after the injection, my left arm started to hurt more than expected and decreased my arm mobility for the day. When I try to use it, it caused mild pain. After waking up, my left arm deltoid muscle was visibly swollen and has a medium amount of pain and significantly decreased range of motion. Because this event has not yet resolved, I may seek advice from my primary care doctor later today
Information has been received from a physician concerning a 34 year old female American Indian pt in marketing with hypothyroidism who on 05NOV2003 was vaccinated in the left deltoid with a second IM 0.5 ml dose of pneumococcal 23v polysaccharide vaccine . Concomitant vaccinations on 05NOV2003 included a second IM dose in the R deltoid of influenza virus. Concomitant therapy included "replacement" for hypothyroidism. There was no illness at the time of vaccination. Upon receiving the vaccine on 05NOV2003, the pt developed asthenia, malaise, body aches, subjective fever and a local reaction around the injection site., which progressed to swelling, edema, pain, redness/ erythema and +/- hyperemia. The pt went to the ER, but treatment was not required and laboratory tests were not performed. The local rxn resolved in a few days with, but the asthenia and malaise were still present three weeks later. On 25NOV2003,the he pt was documented as recovered. It was noted that the experience resolved with time and local measures. A product quality complaint was not involved. Additional info is not expected.
This case was reported by a pharmacy student and described the occurrence of injection site infection in a subject of unspecified age and gender who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On an unspecified date the subject received unspecified dose of Fluarix (.5ml, unknown).  At an unspecified time after vaccination with Fluarix, the subject experienced injection site infection.  At the time of reporting the outcome of the event was unspecified.
This spontaneous report as received from a pharmacist refers to a 65 years old female patient. The patient was vaccinated SC, with a dose of ZOSTAVAX (lot number reported as "H011331", expired date 08-SEP-2013) in the morning of 24-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 24-SEP-2012 the patient saw her physician in the afternoon and was diagnosed with shingles. The physician prescribed VALTREX for the patient. Appointment had been scheduled. The outcome of shingles was unknown. Additional information has been requested.
injection site - Swollen, red and very itch; injection site - Swollen, red and very itchy; injection site - Swollen, red and very itchy; Injection site redness; she could not sleep last night; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (she could not sleep last night), VACCINATION SITE SWELLING (injection site - Swollen, red and very itch), VACCINATION SITE ERYTHEMA (injection site - Swollen, red and very itchy), VACCINATION SITE PRURITUS (injection site - Swollen, red and very itchy) and INJECTION SITE ERYTHEMA (Injection site redness) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INSOMNIA (she could not sleep last night). On an unknown date, the patient experienced VACCINATION SITE SWELLING (injection site - Swollen, red and very itch), VACCINATION SITE ERYTHEMA (injection site - Swollen, red and very itchy), VACCINATION SITE PRURITUS (injection site - Swollen, red and very itchy) and INJECTION SITE ERYTHEMA (Injection site redness). At the time of the report, INSOMNIA (she could not sleep last night), VACCINATION SITE SWELLING (injection site - Swollen, red and very itch), VACCINATION SITE ERYTHEMA (injection site - Swollen, red and very itchy), VACCINATION SITE PRURITUS (injection site - Swollen, red and very itchy) and INJECTION SITE ERYTHEMA (Injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
This is a spontaneous report from a noncontactable consumer (patient). A 23-year-old female patient received BNBNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# and expiration date: not reported), at the age of 23, via an unspecified route of administration, in left arm, on an unspecified date, single dose, for COVID-19 immunization. Medical history included major depressive disorder. The patient was not pregnant at the time of vaccination. The patient's concomitant medications not reported. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient experienced 100ºF and had repeated extreme vomiting on Apr 15, 2021. The patient did not receive treatment for the events. The outcome of the events: recovering. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
exposed to COVID-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer(son) reported for a male patient(dad) that: A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection;), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced exposed to covid-19 The events were assessed as Non serious health authority. And outcome of the events unknown.  Follow-up attempts are completed. No further information is expected.
Nausea and vomiting starting 12/8/07 in morning.  Also, diarrhea, abdominal cramping, aches and low grade fever.  No respiratory symptoms.
I had symptoms of A Fib, but didn't know what it was. I went to sleep and the symptoms stopped. Then I had another vaccine dose on 3/30/22. Then on May 27 at around 10 pm the a fib symptoms returned, and again I didn't know what it was. On the morning of May 28, I put on my watch and after a few minutes, an alert went off from my watch saying I symptoms of a fib. My wife, a nurse,  verified the irregularity with her stethoscope, and we went to the ER. Everything had subsided, and I scheduled a cardiologist appointment.
Right after getting the vaccine patient felt funny, sweaty and unable to keep her eyes open, patient helped to lie down in the exam table. Patient almost passed out. 7 PM VS taken BP 90/60, Pulse 60, Resp 18, temp 97.3. Medical alert bell pressed, pharmacy manager and store manager came to the clinic. Sent them back patient lying in exam table in no acute ditress. 7:05 PM, patient asking to drink some thing, asked boy friend to bring some drink. Boyfriend brought drink. Patient asked for water, water given to the patient to drink. Boyfriend in the room supporting patient. 7:10 PM,  patient sipping on drink and states feels weak but ok. VS taken BP 90/60, Pulse 56, Resp 18, temp 97.3. 7:15 PM patient still weak, will continue to monitor. Patient requesting her Hep A vaccine; discussed with patient in detail not to take 2 vaccines especially if she had a reaction. MOC called and notified about the incident, NP suggests she come another day to get another vaccine. 7:20 PM patient states ok but wants to sit up. VS taken BP 110/70, Pulse 60, Resp 18, temp 97.3. 7:30 PM VS taken BP 100/60, Pulse 54, Resp 18, temp 97.3. 7:45 PM patient states much better getting out of bed, able to ambulate, boyfriend is driving and discussed with boyfriend not to let her drive, he verbalizes understanding states will watch her.
Polymyalgia Rheumatica ( see attached page) Pseudo - Gout
On the way home from the doctors office she complained of feeling nausea. We thought it was the heat along with being in the car as she is suceptiable to migraine headaches, or that she may have been hungry, because she hadn't eaten much in the morning. She had a little something to eat, came home and went to sleep. Woke up in the evening had a little dinner did some homework and went back to bed. All this time complaining of not feeling well. When she woke the next day and tried to get ready for school she felt dizzy, and right before we were to leave to take her to school, she vommited. She stayed home from school not feeling well throught the day. Having dry heaves, afraid to eat or drink much. Also complaining of body aches, continued dizziness. We are now into the next day and she is still not feeling well. Sleeping alot, body aches, dizzy, a bit of a dry/sore throat, and having a slight fever.
Nausea and vomiting - until it stopped 10 hours later. Began at 0700 - Vomited every 45-60 minutes first 6 hours.
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT, UNSPECIFIED VEIN ACUTE DVT OF LEFT PERONEAL VEIN HYPOTENSION 1/22/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient received Dose #1 of JYNNEOS intradermally. Lead RN was approached by patient who said he was "not feeling well" Lead RN noted that patient looked diaphoretic and lethargic. Auxiliary RNs came to assist patient to seated position on floor with back against wall. Patient stated that he felt very tingly all over and warm. "Seeing stars". "Like I'm going to pass out". Patient stated experience was first time. Incident protocol activated.  1428: BP 115/70; HR 56; RR 22; Diaphoretic; Lung Sounds Bilateral Clear; Able to drink a cup of water sans emesis. 1433: BP 124/84; HR 64; Skin Dry; Skin Tone Normal; Patient reports vision normal again. Patient stated he felt normal again.  Patient observed for another 30 minutes and discharged from field clinic.
I had a horrendous headache for @ a week along with extreme, nonstop nausea. At several points I thought I was having a stroke. I was "between" insurance at the time and did not get medical attention. I felt like I was in a mental fog for weeks thereafter. I received the shot as it was required by my employer at the time. Note- I've received numerous shots in the military at one time with zero reactions.  Incidentally, I've recently had Covid anyways.
PATIENT DESCRIBED NEW ONSET DIARRHEA, SWELLING, ERYTHEMA AT INJECTION SITE STARTING 3/17/21
PATIENT REPORTS GETTING RED/HOT TO THE TOUCH/ITCHY RASH AT INJECTION SITE ON 2/6/2021. SHE RECEIVED VACCINE ON 2/1/2021
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age/gender. The patients' concurrent or historical conditions were not provided. Concomitant therapies were not reported. On an unknown date the patients were vaccinated with improperly stored ROTATEQ oral (dose and frequency were not reported). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
RA flair up; sore arm; sore knees; tiredness; This case was reported by a consumer and described the occurrence of rheumatoid arthritis flare up in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis, fibromyalgia and diverticulitis.   On 6th May 2021, the patient received the 1st dose of Shingrix. On 6th May 2021, less than a day after receiving Shingrix, the patient experienced rheumatoid arthritis flare up (serious criteria GSK medically significant), pain in arm, knee pain and tiredness. On an unknown date, the outcome of the rheumatoid arthritis flare up was unknown and the outcome of the pain in arm, knee pain and tiredness were recovering/resolving.   It was unknown if the reporter considered the rheumatoid arthritis flare up, pain in arm, knee pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. After receiving Shngrix, the patient experienced arm soreness, tiredness and knees soreness. The patient believed that the sore knees were a result of rheumatoid arthritis flare up not the vaccine. The reporter consented to follow up.
Patient came in stating her date of birth was one date but her actual date of birth was another date. She was given vaccine at the age 15 before it was approved.
Arm redness extending beyond elbow joint, c/o rash, and swelling. ED visit states rash onset was sudden and symptoms occurring 2 days. S/S x 48 hours after receiving vaccine.
Information has been received from a health professional concerning a 58 year old female with fibromyalgia, allergies, and allergies to aspirin, duloxetine (CYMBALTA) and sulfonamides who on 16-AUG-2007, and 18-SEP-2007, received her first and second 1.0 ml intramuscular doses of RECOMBIVAX HB (lot#"0042U").  Concomitant therapy included mometasone furoate (NASONEX), montelukast sodium (MSD), bupropion HC1 (WELLBUTRIN XL), cyclosporine (RESTASIS), estrogens, (PREMPRO), calcium (unspecified), dicyclomine HC1, nefazodone HC1 and clindamycin.  On 23-AUG-2007, and on 25-SEP-2007, (1 week after each vaccine administration), the patient experienced sharp pain in the back of her neck that resolved within 3-5 days without treatment.  The patient sought unspecified medical attention in the physician's office.  There were no laboratory or diagnostic tests performed.  A product quality complaint was not reported.  No further information was available.  Additional information has been requested.
Patient came to get his first dose of Moderna vaccine, and anaphylaxis happens after 3-4 minutes. Patient seems to gasp for breath.  He did not respond to call/touch. Pharmacist ran out to give EpiPen, then laid patient down onto the floor with his legs up onto the chair while the tech called 911. EMS came and took it over. Patient however denied to go to hospital.
Developed swollen, reddened, hot spot at injection shot at DTaP. Rash and fever, vomiting within 72 hours - saw doctor- dx chicken pox (had previous illness in 1999 - "bad case").
presented w/vomiting, diarrhea, fever, petechiae & purpura;adm to hosp studies revealed ITP w/platelets 14,000;rotovirus positive in stool;
Arms go limp; Patient reports experiencing hairloss; Patient reports experiencing stomach upset; Shortness of breath, I can't breathe; Patient report experiencing fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTONIA (Arms go limp), ALOPECIA (Patient reports experiencing hairloss), ABDOMINAL DISCOMFORT (Patient reports experiencing stomach upset), DYSPNOEA (Shortness of breath, I can't breathe) and FATIGUE (Patient report experiencing fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-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 HYPOTONIA (Arms go limp), ALOPECIA (Patient reports experiencing hairloss), ABDOMINAL DISCOMFORT (Patient reports experiencing stomach upset), DYSPNOEA (Shortness of breath, I can't breathe) and FATIGUE (Patient report experiencing fatigue). At the time of the report, HYPOTONIA (Arms go limp) outcome was unknown and ALOPECIA (Patient reports experiencing hairloss), ABDOMINAL DISCOMFORT (Patient reports experiencing stomach upset), DYSPNOEA (Shortness of breath, I can't breathe) and FATIGUE (Patient report experiencing fatigue) was resolving.            Concomitant medication was not provided. Treatment information was not provided.
Patient with chest tightness, generalized fatigue, and mild shortness of breath 24 hours after receiving the COVID-19 vaccine We will obtain chest x-ray, EKG, and lab work All results reviewed in detail and with the patient Patient states that she is feeling better and she is pleased at the results Patient's oxygen saturation is 99 to 100% throughout her ED course
Approximately 8 weeks post vax, the pt experienced mild flu symptoms, total body muscular, joint pain. The pt required assistance to get around. Treated with Prednisone for 2 weeks with complete relief. Symptoms returned after stopping Prednisone. The symptoms tapered to mildly disabling after 8-10 months. Symptoms persist to this day. A follow up report received 10/09/2003 adds: Continual joint pain and stiffness since 2nd injection (Apr 1995). Continual use of NSAIDs of some relief.
didn't feel well; felt foggy; low grade fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (didn't feel well), FEELING ABNORMAL (felt foggy), PYREXIA (low grade fever) and HEADACHE (headache) in a 60-year-old male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (didn't feel well), FEELING ABNORMAL (felt foggy), PYREXIA (low grade fever) and HEADACHE (headache). At the time of the report, VACCINATION COMPLICATION (didn't feel well), FEELING ABNORMAL (felt foggy), PYREXIA (low grade fever) and HEADACHE (headache) outcome was unknown.            Concomitant medications were not provided by the reporter.  Treatment information was not reported.   This case was linked to MOD-2021-042832, MOD-2021-042505 (Patient Link).