chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tellow Fewver, Polio and oraL 7/14/08 tYPOID ORAL -7/17/08eYHE AND LEG RASH AFTER TRAVEL 5 WEEKS LATER AND SWELLING OF THE TONUE AND LIP HAS OCCURRED 10 TIMES IN THE LAST 5 MONTHS. dOCTOROS- INTERNIST,GI,ENT ALLEGERY, TRAVEL DOCTOR, AND URGET CARE. Also got TDAP vaccine on 7/20 and sore arm and swollen tongue troube breathing within one hr. Emergery medical fire dept came and administred beneadryl. Took advil as well. Raytheon nurse adminstrted the TDAP. Zertec and benedryl seem to relive the problem whiich is intermittent and hard to detect. It is thought that the vaccine might be the cause of the problem. Verry healthy and never had this proble. Traveled to China, Finlnad, UK, Australia, Ireland and Norway
This spontaneous report was received from a pharmacist via company representative regarding a patient of unknown demographics. There was no information regarding concurrent condition and historical medication. On an unknown date, over 1 year ago the patient was vaccinated with first 2 doses of GARDASIL (dose strength, route and lot number was unknown) and now the patient would like to receive the third dose (inappropriate schedule of drug administration). No concomitant medication was reported. No product quality complaint was involved. No adverse effect was reported. The outcome of event was unknown. Additional information has been requested.
32 hours after shot severe flank kidney pain .   60 hrs after shot woke with what felt like hit to back of head .  Bad headache that night next 3 days slight headache on rt side of forehead .  Day six finally went to er for severe kidney pain left side worse than rt .         Went another 8 days with pain in kidneys  low energy slight headache .  Then  had loose stools start on  Jan 22nd 2021. Called  on call doc and said maybe it's diverticulitis   so was treated .  Stools slowly got bet. Loose stools  got some better  but kidney pain continued .  I went back to er on 1 25 2021   .  Missed 2 more days  of work then back to work in the 27th of January  starting to get  better...  I have a lot more energy but still have right kidney pain  and blood in urine
Day 1: Sore, a little swollen & tender to touch at the site and not able to fully lift arm. Day 2: Same symptoms as day one
Trembling; felt as if he had a flu; headache that is more like a pressure; little dizzy; little temperature (he feels hot his face and eyes); lot of pain in bones specially in shoulders; a little  headache that is more like a pressure; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 24-Mar-2021.    This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Trembling), INFLUENZA (felt as if he had a flu), HEAD DISCOMFORT (headache that is more like a pressure), DIZZINESS (little dizzy) and BODY TEMPERATURE INCREASED (little temperature (he feels hot his face and eyes)) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (In May 2020 he was 17 days hospitalized because of COVID) in May 2020 and Laser therapy (Two months ago had a laser surgery in the veins of legs).    On 17-Mar-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced TREMOR (Trembling), INFLUENZA (felt as if he had a flu), HEAD DISCOMFORT (headache that is more like a pressure), DIZZINESS (little dizzy), BODY TEMPERATURE INCREASED (little temperature (he feels hot his face and eyes)), ARTHRALGIA (lot of pain in bones specially in shoulders) and HEADACHE (a little  headache that is more like a pressure). At the time of the report, TREMOR (Trembling), INFLUENZA (felt as if he had a flu), HEAD DISCOMFORT (headache that is more like a pressure), DIZZINESS (little dizzy), BODY TEMPERATURE INCREASED (little temperature (he feels hot his face and eyes)), ARTHRALGIA (lot of pain in bones specially in shoulders) and HEADACHE (a little  headache that is more like a pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not reported.  It was reported that the patient was tested COVID negative before laser surgery.
had Covid diagnosis then treated with antibodies; This case was reported by a pharmacist via call center representative and described the occurrence of corona virus infection in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2020, the patient received Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced corona virus infection. The patient was treated with antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the corona virus infection was unknown.   It was unknown if the reporter considered the corona virus infection to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had Covid diagnosis and then treated with antibodies. The patient was due for the second dose The reporter did not consent to follow up.
This spontaneous report as received from a medical assistant refers to a 6 patients of unknown age and gender. On an unknown dates the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose, lot # and expiration date were not provided). No adverse effects reported. Additional information has been requested.
inadvertently pulled up 11 doses from, with no AE; Initial information received on 04-Nov-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 8 years old male patient who inadvertently pulled up 11 doses from of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On 04-Nov-2020, the patient 11 doses of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ506AA) via intramuscular route in the left deltoid for prophylactic vaccination.  This was potential medication error case due to extra dose administered.  The patient did not present any adverse event.   No laboratory test was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Initial report received from a consumer on 15 November 2007. A 47 year-old female patient with a history of a penicillin allergy, had received an intramuscular left deltoid injection of FLUZONE (lot number not reported) on 13 November 2007 and the evening of vaccination developed warmth, redness, itching and swelling at the injection site; reported to be the size of a softball. The patient had not received any vaccines during the four weeks prior to receipt of FLUZONE. The patient reportedly experienced this same type of event in the past after receipt of Lovenox and heparin. The patient had not been evaluated by a physician and had not received any doses of FLUZONE in the past. At the time of the report, the patient had not recovered from the event. Follow-up information received on 11 January 2008 from a physician. The patient was taking "Lovaxil" at the time of the vaccination on 13 November 2007. The FLUZONE was reported as U2531AA and the vial had an expiration date of 30 June 2008. The adverse events that was previously reported started at 1:30 p.m., one hour post-vaccination with FLUZONE vaccine on 13 November 2007. At the time of this report, the patient had recovered. No further information is expected.
Pulmonary embolisms Hospitalized and put on Heparin for 1.5 days.  Released on blood thinners within 4 days.
Patient's mother called to report a possible adverse event. Start date is approximate but she thought it was within a week of the first vaccine dose. Patient developed an itchy rash on his buttocks and waist. Mom described the rash as small pinpoints. She thinks it lasted 1-2 weeks. Treated with OTC hydrocortisone, no medical care. Rash was fully resolved when patient received his second Pfizer dose on 6/10/21 and he has not developed a similar rash; advised family to call back if he experiences the reaction again.
nausea; Terrible headache; Joint pain is unreal; Had a fever of 101; So sick she thought she was going to die; Sick as ever been; Set off her degenerative arthritis in back and neck; Threw up twice; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (So sick she thought she was going to die), MALAISE (Sick as ever been), ARTHRITIS (Set off her degenerative arthritis in back and neck), VOMITING (Threw up twice) and HEADACHE (Terrible headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in August 2020 and COVID-19 in December 2020. Concurrent medical conditions included Joint pain, Cholesterol, Immunodeficiency and Ulcer. Concomitant products included LEFLUNOMIDE (ARAVA) for Arthritis, ROSUVASTATIN CALCIUM (ROVASTAT) for Cholesterol, AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for Upset stomach.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ILLNESS (So sick she thought she was going to die), MALAISE (Sick as ever been), ARTHRITIS (Set off her degenerative arthritis in back and neck), VOMITING (Threw up twice), ARTHRALGIA (Joint pain is unreal) and PYREXIA (Had a fever of 101). On 06-Mar-2021, the patient experienced HEADACHE (Terrible headache). On an unknown date, the patient experienced NAUSEA (nausea). The patient was treated with HYDROCODONE for Pain, at a dose of 6 a day and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (VANQUISH [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Headache, at an unspecified dose and frequency. On 06-Mar-2021, VOMITING (Threw up twice) and PYREXIA (Had a fever of 101) had resolved. At the time of the report, ILLNESS (So sick she thought she was going to die), MALAISE (Sick as ever been), ARTHRITIS (Set off her degenerative arthritis in back and neck), HEADACHE (Terrible headache) and ARTHRALGIA (Joint pain is unreal) outcome was unknown and NAUSEA (nausea) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had a low immune system.  The patient also mentioned that she will not take the second dose of vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: No specific follow-up information recorded.
This spontaneous report as received from a nurse practitioner via Company Representative refers to a female patient in her early 20's. On an unknown dates the patient was vaccinated with series of three doses of GARDASIL (doses, Lot# numbers and routes of administration were not reported). On an unknown date, after receiving all three doses of GARDASIL the patient developed genital warts. On an unknown date the patient recovered from genital warts and on an unknown date the genital warts returned again. The patient was treated in unspecified way. The patient sought medical attention by visiting the office. The patient's present status was unknown. Relatedness between genital warts and GARDASIL was not provided. Additional information has been requested.
pt recv vax & devel about 6 to 8 bloody noses all w/in 24 to 36hr from vax lasted approx 2-3min;no hx illness, prev bloody noses, med etc, no tx resolved;
Severe headache, nausea, fainting, body aches beginning at 5:00am morning after the injection. Patient fainted and hit head causing a bloody contusion on forehead.
PATIENT REPORTED ON SAT 6/18/22 ~3:10PM VIA TELEPHONE TO EXCESSIVE SORENESS/ TENDERNESS AT INJECTION SITE INCLUDING EXTREME RESNESS & WARMTH TO AREA
After this second vaccine was administered, I did feel tired for a few days and shaky. I had to stay home from work for one day after. I do not and have never had to take any medications for anything and was in perfect health before I was given the second vaccine. No history of high or low blood pressure and perfect pulse rate. On September 19, 2021, four days later after receiving the second vaccine, I became unresponsive and even flat lined. I was taken by emergency to the hospital and had several episodes of unresponsive. The doctors told me that I had developed Bradycardia and would need to have a pacemaker surgically implanted. I did have the surgery on September 20, 2021 and still recovering. I firmly beleive that receiving a combination of my first and second Covid19 vaccinations caused these problems to develop  with my heart.
on her 16th birthday she found out she had cancerous cells related to HPV; on her 16th birthday she found out she had cancerous cells related to HPV; This spontaneous report was received from a consumer (patient's mother) and refers to a 16-year-old (currently 28-year-old) female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates in 2006, when the patient was 12 or 13-year-old, she was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) shots (dose, route of administration, lot number and expiration date were not reported) for human papilloma virus (HPV) prophylaxis. On an unknown date in 2009, on her 16th birthday, the patient found out that she had cancerous cells related to HPV (captured as cancer and HPV infection). She sought medical attention and went to the doctor. She received several unspecified procedures as treatment for the events. The patient's last check for the cancerous cells, performed on an unknown date, was clear. However, the patient's mother stated that it did not mean that her daughter was totally cured. The patient's mother did not know which strain of HPV the patient developed. The outcome of the events was reported as recovering. The relatedness between the events and suspect therapy was not provided.  Upon internal review, the event of cancer was considered to be medically significant.
CHILLS AND SHAKES FOR 1HR, AND FATIGUE FOR 24HRS.
I  had pain at the site for the first couple days. After one week my arm was the size of a grapefruit, hot to touch and huge spot on my arm. The spot was the size of a silver dollar. I called the Dr. and said it was a delayed reaction and said to use ice and take Benadryl. This was significantly painful for about 2 days then gradually went away. My arm felt heavy, I think it was from the swelling.
She got her vaccine, she didn't have symptoms right away.  On 3/25/23 she started having chills at home, she just felt extremely nauseated, shaky and aching legs, going from warm to cold.  She did not have any vomiting or fever.  She did not know what was going on.  Mother was wondering if she was going to have a seizure or something, but that did not occur.  Pretty much from that point on she has lost 20#, her diet changed completely for a couple of months, she was not eating much.  Just started with a liquid diet to get her back to eating, then to a bland diet.  She has been to the ER twice with abdominal pain and nausea.  Also there is an acid feeling in her mouth as she describes it.In the ER she was tested with different things, had COVID and flu tests that were negative.  She had x-rays and US, and was started on Omeprazole in the morning, Pepcid, and then intermittently she takes zofran for nausea.  These medications have been helping her as mother says she has been making some slow progress.  She looks back to where she is now to the last 2 months as she is eating more.  She was taking Benadryl to help her sleep, which her doctor said was OK, but is no longer taking it now.  Her PCP is keeping her on the same medicines.  It took a long time for them to get into a GI, but had that about a month ago and she wanted her daughter to start periactin.  A week before that she had seen a psychiatrist as she was experiencing some anxiety and she started Lexapro before she saw the GI doctor.  She was started on Periactin and the next day she was extreme fatigued, extremely agitated and stopped that and the GI doctor is aware of that.  She is continug to take the Lexapro at this time.   Mom did not remember that she had the first vaccine, but they had the dates, but she did not have any issues with that.  She had some GI issues when she was much younger in elementary school, she would have complaints of stomach problems, but changed her to almond milk and chocolate milk at lunch and those symptoms went away.  GI doctor diagnosed her with function gastrointestinal disorder, and she continues to see him as well.  She has scheduled an upper endoscopy in September.   This has significantly changed the daughter and the mom's life that it used to be.  She went to an OMT,  and asked if the vaccine could have anything to do with that and he said that yes it could be.
how do I handle the swollen are; will I have an allergic reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (will I have an allergic reaction) and PERIPHERAL SWELLING (how do I handle the swollen are) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (will I have an allergic reaction) and PERIPHERAL SWELLING (how do I handle the swollen are). At the time of the report, HYPERSENSITIVITY (will I have an allergic reaction) and PERIPHERAL SWELLING (how do I handle the swollen are) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Pain/Swelling at site - and on front & back neck area.  Still swollen after 1 week.
A 39 year old female reported that she received the Typhoid vaccine, Orimune vaccine, and MMR vaccine on 5/5/99. Within 12 hours she developed a 5 inch area of redness, hardness and pain at the site of the Typhoid vaccine. She also developed a fever of 99.0. She recovered within 5 days.
swelling of nose; throat itching; This spontaneous report was received from a nurse regarding a 12-year-old patient with unspecified reactions to bug bites and seasonal allergies to pollen, trees, grass. The patient's medical history included a laser removal of lip hemangioma, concomitant therapies were not reported. On 01-JUL-2019 at 11 am the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, frequency were not reported, lot # R022422 and expiration date) via intramuscular route for prophylaxis (also reported as to prevent HPV). On 01-JUL-2019 at 1:30 pm, the patient's mother  called later to report that patient had developed swelling of nose (nasal oedema) and throat itching (throat irritation). The patient had received treatment for the adverse events. It was unknown if lab or diagnostic studies were performed. The patient did not sought medical attention she has called to the office. There was no involvement of product quality complaint (PQC). The patient had recovered from the events, nasal oedema and throat irritation. Causality assessment was not reported.
Thrombocytopenia 11/21/22 Biliary dyskinesia 01/12/23
Swelling, redness and tenderness at the injection site about 3 inches in diameter. Headache and body aches.
Starting 11/25/2021, I started having diarrhea, cramps, and bloating. I was diagnose with Celiac disease.
12:10 pm, blood pressure 142/86; pulse 80. At 10:36 pm, blood pressure 162/89; pulse 92. 12/15/2021, local pain at injection site spread and got worse as the day went on. Then in evening, I had severe back pain, which progressed to chest tightness and heartache like heart and lungs being squeezed (versus stabbing pain). I had shortness of breath. I had to breathe thru my mouth to get enough air. About 10:40 pm, I called a nurse, as well as, a friend. I took two Aspirin 325mg at 10:38 pm. My friend came over so I was not alone. At 11:30 pm, I went and spent the night at my friend's house so I would not be alone. I used heat compress to relieve back pain/spasms and tried to relax to lower blood pressure and be able to breathe better. 12/16/2021, I woke 10 am with minimal back pain (mid-back), but have had slight heart ache (like muscle soreness after working out) all day and into the night. Breathing has been a lot better today - more normal than what occurred last night. Did not call 911 or emergency room due to potential exposure to COVID-19 virus on top of having adverse reaction to vaccination. I figured if I could get my blood pressure down in a safe environment with someone nearby in case things progressed even more, that was the safest option given the current circumstances at hospitals. I called my cardiologist today (12/16/2021) and told earliest appointment availability is late January. I could not get in sooner to verify all ok.  Will go to urgent care tomorrow if still having heart ache/abnormal feeling.
I was walking home after work and I noticed that my left leg was very weak. Laid down when I removed my pants I could see that it was swollen. Called my primary doctor sent me to the ER. Where they gave me high doses of Eliquis (blood thinner) and was discharged with a prescription for the same. 8 inch blood clot from the vena cava to the iliac.  Experienced a stroke after the blood clot was removed. Stroke affected the right side occipital lobe.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 3rd July 2018 14:30, the patient received the 1st dose of SHINGRIX 50 mcg/mg. On 3rd July 2018 11:00, 8 hrs 30 min after receiving SHINGRIX, the patient experienced muscle pain, chills, fever and weakness. In July 2018, the patient experienced poor sleep. The patient was treated with naproxen (Aleve). In July 2018, the outcome of the poor sleep was recovered/resolved. On an unknown date, the outcome of the muscle pain, chills, fever and weakness were recovered/resolved. The reporter considered the muscle pain, chills, fever and weakness to be related to SHINGRIX. It was unknown if the reporter considered the poor sleep to be related to SHINGRIX. Additional details were provided as follows: The patient started to experience all the symptoms the evening after receiving the shot, the patient estimated it to be around 11:00 pm. Less than a day after receiving the SHINGRIX, the patient did not sleep well all night due to the symptoms. The patient took Aleve which helped with the aches. The symptoms started to resolve on 4th July 2018 (in the afternoon). The patient did not actually take her temperature but said she just felt feverish.