chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started to feel like he had the flu; Achy; Couldn't really move much; Felt like everything was heavy; Hard to get up out of bed; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Started to feel like he had the flu), PAIN (Achy), HYPOKINESIA (Couldn't really move much), DISCOMFORT (Felt like everything was heavy) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hard to get up out of bed) in a male patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Started to feel like he had the flu), PAIN (Achy), HYPOKINESIA (Couldn't really move much), DISCOMFORT (Felt like everything was heavy) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hard to get up out of bed). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Started to feel like he had the flu), PAIN (Achy), HYPOKINESIA (Couldn't really move much), DISCOMFORT (Felt like everything was heavy) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hard to get up out of bed) outcome was unknown.      Concomitant product use was not provided by the reporter.  The patient received 3 doses of the Moderna covid-19 vaccine. He started to feel like he had the flu. He was achy, couldn't really move much, felt like everything was heavy, and it was hard to get up out of bed. He took ibuprofen after the 3rd dose of the vaccine. Dates of administration and lot numbers unknown.   This case was linked to MOD-2022-568850 (Patient Link).
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to urgent care reporting hives, more prominent on upper extremities, 45 minutes after receiving immunization. Patient reports no symptoms during observation at vaccine facility. Vital signs within normal ranges, no evidence of angioedema, dexamethasone administered, instructed to use over the counter antihistamines, and patient discharged home stable.
Bursitis in left shoulder. Left shoulder continues to be painful when pulling or pushing. Minimal response to Naproxen 500 mg. I have tried to see my PMD for further evaluation, but she had to cancel my appointment and I have been unable to reschedule.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 10-DEC-2012, the patient was vaccinated with the first dose of GARDASIL (dose, lot # not reported). On 10-APR-2013, the patient was vaccinated with the second dose of GARDASIL. On 16-MAY-2013 the patient was vaccinated with the third dose of GARDASIL. No adverse effect reported. Additional information has been requested.
On 1/3/2009, post vaccine day 29, he suffered a new onset grand mal seizure.  He deployed abroad 3 days prior.  He was airlifted finally to home.  The seizure was felt to be caused by Mefloquine prescribed 12/9/2008.  He developed severe headaches, chest pain and suffered injuries to his back.
Large hive approximately 2 inches below injection site, swelling and mild redness 4 inches circumference from center of injection site, urticaria, feels warm. Bruising from injection. Similar to reaction from bee sting.
Patient was administered vaccine, as per protocol moved to the vaccination wait area for 15 minute observation.   She passed out about 5 minutes later, she came to and said she was fine, then passed out again.  I called 911 when she passed out the second time, I also administered an Epi-pen injection just in case she was having an allergic reaction.   Shortly after the injection she came to and by then the paramedics had arrived. They took her BP it was 130/80 they also said they see this a lot with injections and that it was syncope and that it is pretty common.  We followed up with her the next day and she was fine, she feels she didn't eat that day and she a little frightened and that is why she passed out.
Erythema and edema approximately 8 cm x 7 cm to site, fever of 102.9 F on evening of 9/16/17, with fever resolved 9/17/17.
Five days after my second vaccine, my lower back went out as if I had sustained the same injury in my lumbar as I had in a car accident in 2003. I was unable to walk for 4 days, despite acupuncture and muscle relaxers/pain relievers. It was as if the old injury was re-activated. I had done some light yoga the day before my back went out, but as a practitioner for 25 years, I have never had that outcome before from a practice. When I woke up the next morning, I was in tremendous pain & had difficulty getting out of bed, walking, or sitting up. The acute pain got better after about a week, and my full mobility returned. But I had residual lingering pain with varied severity until a recent epidural steroid injection received on 3/14/22 relieved the on-going symptoms.
She came in 12/01, reported rxn with Flu shot on 11/20/14. Pt has uncontrolled shaking starting about 5 hours after shot. Took ASA and BENADRYL and it went away after few hours.
fainting; Extreme pain in left arm to the point of barely moving; hitting head; vomiting; Slurred speech; Chills; sweats; aches; This is a spontaneous report from a contactable consumer (the patient). A 22-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number ER8731), via an unspecified route of administration in the left arm on 18Apr2021 at 12:30 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient had no medical history. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included: sertraline hydrochloride (ZOLOFT). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 06:00, the patient experienced extreme pain in the left arm to the point of barely moving, fainting and hitting head, vomiting, slurred speech, chills, sweats, and aches. No treatment was received. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Local allergic type symptoms on my upper left arm: redness, itchy, a bit painful, firm/swollen, and warm. This lasted for about 48 hours. I also felt a little "off" systemically- no fever but I was a bit lethargic and dizzy. I took benadryl (either 25 or 50mg) at night before bed and this did not help the first night, but it helped immensely almost immediately the 2nd night I took it, and then the next morning it had pretty much gone away.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012817, exp date: 10-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of plenty reports received from the same source. Additional information has been requested.
joint pain in lt arm that spread to the rt hip & rt shoulder anxiety, pain & travelled around joints;alleges the above & that is much better now;says rt shoulder had stabbing pain;
15 y.o. male seen 7.29.13 at PCP office for well exam, given Hep A vaccine left arm. Reported fever x 2 days and pain in left arm. Seen at PCP's office 8/5/13 for c/o symptoms evaluated and referred to hospital.
chills; dizziness; runny stuffed nose; upper abdominal pain, right under the breast; very bad sleep problem; massive headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), RHINORRHOEA (runny stuffed nose), ABDOMINAL PAIN UPPER (upper abdominal pain, right under the breast), SLEEP DISORDER (very bad sleep problem) and HEADACHE (massive headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neuropathy, Shingles and Epstein Barr virus positive mucocutaneous ulcer.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DIZZINESS (dizziness), RHINORRHOEA (runny stuffed nose), ABDOMINAL PAIN UPPER (upper abdominal pain, right under the breast), SLEEP DISORDER (very bad sleep problem) and HEADACHE (massive headache). On an unknown date, the patient experienced CHILLS (chills). At the time of the report, DIZZINESS (dizziness), RHINORRHOEA (runny stuffed nose), ABDOMINAL PAIN UPPER (upper abdominal pain, right under the breast), SLEEP DISORDER (very bad sleep problem), HEADACHE (massive headache) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported    This case was linked to US-MODERNATX, INC.-MOD-2021-100878 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received on 20-JUL-2021.Updated events outcome .Added  reporter causality.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-100878:
Immediately at time of injection, felt arm soreness to be expected, but came home worked out, and then felt nausea and tired.  Took Tylenol last night at 7 pm, this am at 2 am and then again at 12:30 pm. At midnight, could not sleep well, felt cold, body aches, restless , feverish, left shoulder really sore. Today , woke at noon today, did not sleep well last night at all, ate bananas, and vomited at 1:30 pm, Feeling better now, 234 pm,
Information has been received from a physician concerning an 84 year old male patient with diverticulitis and a history of malaria who on 05-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck), 0.65ml. Concomitant therapy included influenza virus vaccine (unspecified), COUMADIN, "ECOTIN", LANOXIN and simvastatin (MSD). On 08-DEC-2008 the patient experienced elevate white blood cell count, profuse sweating, decreased appetite and pain between his shoulder blades. The patient noted that the symptoms are similar to the symptoms he experienced when he had a malaria infection. The patient underwent urinalysis (results not reported), chest x-ray (results not reported) and complete blood cell count that revealed an elevated white blood cell count. At the time of report on the 16-DEC-2008 the patient was recovering. The patient sought medical attention seen by the physician. Follow up information has been received from a Physician via medical record concerning an 84 (also reported as 85 year old) year old male patient who on 05-DEC-2008 received a dose of ZOSTAVAX (Oka/Merck) (Lot # 662969/1206X) in the arm at AM. Concomitant therapy included influenza virus vaccine (unspecified), COUMADIN, LANOXIN, simvastatin (MSD), TENORMIN and ECOTRIN. On 05-DEC-2008 the patient experienced fever, sweats, generalized weakness, stomach pain and pain in chest below breasts. On 08-DEC-2008 the patient experienced elevate white blood cell count, profuse sweating, chills, decreased appetite, pain between his shoulder blades and fever. On 15-DEC-2008 complete blood cell count was performed and showed high white blood cell count (20.7 K/micro l), low neutrophils (13%), high blood lymphocyte count (84%), high absolute blood lymphocyte count (17.4%) and many atypical lymphocytes. Also blood culture was performed with no growth in 5 days. On 15-DEC-2008 PA and lateral chest were performed and were compared with multiple chest regress date on 09-OCT-2006. The cardiac silhouette was enlarged, but stable. There were persistent postoperative changes of a right upper lobectomy with volume loss on the right, elevation of the minor fissure and sixth rib resection. There was a stable right fifth rib fracture, which was unchanged in appearance. There was mild scarring in the left lung base. There was no local consolidation, effusion, or pneumothorax. There were degenerative changes of the spine. There were no acute cardiopulmonary process identified and stable postoperative changes of a right upper lobectomy. The patient sought medical attention by the physician. On 06-JAN-2009 patient was recovered. Fever, sweats, generalized weakness, stomach pain, pain in chest below breasts, profuse sweating, decreased appetite, chills and pain between his shoulder blades were considered to be disabling. Additional information is not expected. All available medical records will be provided upon request.
Member's arm was extremely red and swollen at the vaccination site. Member noticed the reaction starting Thursday evening (3/4/21) into Friday morning (3/5/21).
20 1/2 hours after 2nd injection I developed chills, achiness in upper back and neck, headache and joint aches.  Fever developed rose to 101.  Symptoms subsided after approx. 8 1/2 hours
With each IZ, client developed flu-like symptoms, nausea, vomiting, malaise. Was ill off and on form months. Finally consulted physician who conducted tests. Was referred to another facility which also conducted test and determined the the mono spot gave a false positive. A liver biopsy revealed autoimmune hepatitis. Pt is chronically ill to date and is taking prednisone, Imuran, Prelone.   Doc # 198362 states that on 8/27/01 mother reports that child is still on Prednisone, Imuran, plus he is being followed by Children Hospital in Indianapolis every 3 months.
SORENESS; MIGRAINE HEADACHE; FATIGUE; CHILLS; TREMORS; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included none. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced tremors. On 08-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced soreness. On 09-APR-2021, the subject experienced migraine headache. On 09-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tremors, and chills on 08-APR-2021, and migraine headache on 09-APR-2021, and the outcome of soreness and fatigue was not reported. This report was non-serious.
Fever, headache,dizzy, muscle pain, pain at injection site, fatigue, weakness.
Information has been received from a registered nurse concerning a patient who on 06/10/1996 was vaccinated with a dose of varicella virus vaccine live.  Subsequently, on 06/04/1998, the patient developed chickenpox.  The patient was seen in the office.  The reporter also indicated that 30 other patients were vaccinated with varicella virus vaccine live.  No further information is expected.
Patient was coming in for booster dose of Pfizer vaccine due to being immunocompromised.  He showed his card with his previous 2 Pfizer doses.  After trying to run the 3rd dose through his insurance and receiving a rejection,  I looked on the site and saw that in addition to his 2 previous Pfizer doses, he had also received a Janssen vaccine in June at a other facility.  Patient did not report previous Janssen vaccination on his signed form.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:18 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:18 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 23.29.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 08 AM, temperature was 32, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 31-Mar-2021. 4 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Warm to touch with pain, redness and swelling.  was given Motrin 400mg and Hydrrocortisone1%
Starting in June, I had terrible congestion. I tried to get in to my regular doctor for what we thought was allergies, but her schedule didn't allow. The congestion got worse, and my heart rate was climbing. July 7th I went in to Primary Care and they took an ray and found fluid in my lungs, so they tried treating it as pneumonia. The antibiotics did not work. I went back for a recheck July 19th and they sent me to the ER for a CT scan where they found I had fluid around my heart, and suspected myocarditis. I was transported to the hospital where they confirmed the myocarditis with a decreased ejection fraction (29%). I spent a few nights there. We have to date found no underlying cause, no viral infection, no lifestyle issues, in the months leading up to it that we're aware of, and no genetic factors. It is non ischemic. I am on a course of daily heart medicines and am in a life vest defibrillator. The only non routine thing that I did leading up to this was get vaccinated.
This case was reported in a literature article and described the occurrence of clinically isolated syndrome in a unk subject who received Hepatitis B vaccine. On an unknown date, 1 year after receiving Hepatitis B vaccine, the subject developed clinically isolated syndrome. Serious criteria included GSK medically significant. The outcome of clinically isolated syndrome was unknown. It was unknown if the investigator considered the clinically isolated syndrome to be related to Hepatitis B vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a clinically isolated syndrome in a subject of unknown age and gender who had been vaccinated with an unspecified hepatitis B vaccine (manufacturer unknown). No information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, from 1999 onwards, the subject received a dose of either ENGERIX B (GlaxoSmithKline; dosage, administration route and site unknown; batch number not provided) or RECOMBIVAX HB (Merck Sharp and Dohme Corp; dosage, administration route and site unknown; batch number not provided). On an unknown date after 1 January 2000, 1 year after receiving the vaccine, the subject developed a clinically isolated syndrome. Treatment was unknown. The outcome of the events was unspecified at the time of reporting. The authors did not comment on any causal relationship between the vaccine and the events. The authors concluded that "Findings from the present study show no long-term association of vaccines with an increased risk of multiple sclerosis and other central nervous system demyelinising diseases. In younger subjects, they observed a short-term increase in risk after vaccination of any type, which suggested that vaccines (like infections) could accelerate the transition from subclinical to overt autoimmunity in subjects with existing disease. The authors found no association between hepatitis B vaccination and an increased risk of multiple sclerosis or other central nervous system demyelinising diseases up to 3 years after vaccination. The results for human papillomavirus vaccine were inconclusive given the small number of cases and the paucity of previous studies on the topic. The findings reconciled the anecdotal clinical reports of a central nervous system demyelinising diseases onset shortly after vaccination with the larger body of epidemiologic literature showing no long-term increased risk of multiple sclerosis or other forms of central nervous system demyelinising diseases following vaccination. The findings do not warrant any change in vaccine policy". This case is 1 of the 9 valid cases reported in the same literature article (see case US2014GSK053625).
Moderna COVID-19 Vaccine EUA  Side effects: Severe rash on the body
Patient was given DTaP instead of tdap.  Mother says patient is fine, no adverse effects.
Approximately two hours after administering Prevnar and Fluzone High Dose the patient experienced excessive coughing.
Presented with syncope, hypotension, mild covid symtpoms (runny nose, fatigue); admit with syncope; covid (no pna)-
Redness in my arm about 4 inches and pain in my arm. It was there for 3 or 4 days.