chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a license practitioner nurse via a company representative concerning a 66 year old male patient. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On 05-DEC-2017, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, lot# and expiration date were unknown), subcutaneously for prophylaxis. Approximately on 06-DEC-2017 (reported as one or two days after received the vaccine), the patient experienced sweat, "all around achiness", chills, 100.3 F temperature and non-productive cough. It was reported that the patient called physician but no treatment was given for the reported adverse events. At the reporting time, the outcome of hyperhidrosis, chills, body temperature abnormal, pain and cough was reported as recovering. The causality between PNEUMOVAX 23 and the events of hyperhidrosis, chills, body temperature abnormal, pain and cough was not assessed. The reporter stated that the events were not life threatening.
Pt. states that after receiving the 1st dose of Shingrix 01/10/2022, started experiencing symptoms 01/17/2022 of a rash developing on the right side of the body and entire back area. Primary visit 01/20/2022 with recommendations Prednisone.
By the 3rd day i started getting leg pain really bad. I felt it down in the bone and muscle of both legs and felt like someone was cutting them up or chopping them up. Severe pain in the right side of the groin muscle. Basically there's pain from my middle down the legs. The groin pain is just in the right side but the rest of the pain was in my legs and i was incapcitated for almost a week.
Swelling of arm, across upper back, up neck and across the jaw Red hot area, fever in arm but very cold fingers Swollen elbow and finger joints Loss of voice (in 2 hours of shot with second dose - lasted 5+ days) Last nearly 2 weeks - but left arm still has outline of shot and you can see bullseye where given - elbow still swollen) Shot of prednisone, antibiotic (and following week oral steroids)
After first shot in April - general headache, arm soreness and tired. Then I noticed a nickle size lump in my left arm pit that was very sore at the end of April a few days before the 2nd shot.  It eventually went away.  I am prone to fibroadenomas, so made sure to tell my OB Gyn 11/12/21 and General Practitioner 11/5/21 at my annual exams.  I also experienced a pea size area on my upper left breast.  I also noted this on my yearly breast exam that was done on 9/7/21, which was normal except for notation of dense breast tissue.  Post my second shot i had one day of fever around 102 degrees, headache and tired.   I also only had one period 5/25/21 - 5/29/21 and then for months had very severe hot flashes and no periods until 11/26 - 11/28/21.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, The patient may have been vaccinated with a dose of improperly stored PNEUMOVAX23 (Lot number, expiry date, route and dose was not reported). No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Vaccinated person reports one day after loss of voice then one week later developing several canker sores on right side of  tongue. As of 1/18/21 vaccinated person now has multiple canker sores on right side of tongue & on left side as well along with sore under tongue. Vaccinated person reports pain with swallowing & lips & tongue are swollen. Can eat only liquids without pain. Can swallow solids, but very painful. Vaccinated person went to Urgent Care 1/16/21 & prescribed two suspensions to mix together to help the sores--Nystatin & First Mouthwash. Vaccinated person reports suspensions are relieving pain.
I had the Pfizer covid bivalent vaccine on 11/19/2022. Severe headache happened  to me on 11/20/22. Then I started to not feel well on 11/21/22. I had symptoms of cough,  running nose, and issues with my sinuses. On Wednesday, 11/23/22, I  had same symptoms plus I felt lightheaded like I was going to pass out around 3:30pm. I was at work at the time. I  went home feeling sick and later in the evening around 7pm I went to clinic and was tested on 11/23/2022. I  was positive for the flu. I am sharing this as a possible complication with the covid-19 booster. I  had already taken the flu vaccine about a month ago. I still got flu after recently getting the covid-19 bivalent booster on 11/19/2022.
SEVERE DIARRHEA 3 TIMES; STOMACH ACHES; VOMITING; FEELING OF GAGGING; This spontaneous report received from a consumer concerned an 86 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included bedridden. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced severe diarrhea 3 times. On 01-APR-2021, the subject experienced stomach aches. On 01-APR-2021, the subject experienced vomiting. On 01-APR-2021, the subject experienced feeling of gagging. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe diarrhea 3 times, stomach aches, vomiting, and feeling of gagging on 02-APR-2021. This report was non-serious.; Sender's Comments: V0: As per standard protocol ,MAC comment is not required for non-serious case
Patient presented to ED and was subsequently hospitalized two separate times within 6 weeks of receiving COVID vaccination.
lost 3 pounds, she lost weight after her first dose; tates the vaccine helped the fatigue, she felt much better; worried.; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (lost 3 pounds, she lost weight after her first dose), THERAPEUTIC RESPONSE UNEXPECTED (tates the vaccine helped the fatigue, she felt much better) and ANXIETY (worried.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 028A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WEIGHT DECREASED (lost 3 pounds, she lost weight after her first dose), THERAPEUTIC RESPONSE UNEXPECTED (tates the vaccine helped the fatigue, she felt much better) and ANXIETY (worried.). The patient was treated with LISINOPRIL for Blood pressure high, at an unspecified dose and frequency. At the time of the report, WEIGHT DECREASED (lost 3 pounds, she lost weight after her first dose), THERAPEUTIC RESPONSE UNEXPECTED (tates the vaccine helped the fatigue, she felt much better) and ANXIETY (worried.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-325633 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Nonsignificant followup appended.
chills; fever; aches; This case was reported by a consumer via call center representative and described the occurrence of chills in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, fever and pain. On an unknown date, the outcome of the chills, fever and pain were unknown.   It was unknown if the reporter considered the chills, fever and pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, however the patient's age group could be elderly. The patient received Shingrix and experienced chills, fever and aches.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (strength, dose frequency, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced mumps which was confirmed by a positive result on a real-time reverse transcription polymerase chain reaction (rRT-PCR) buccal swab test on 01-MAY-2016. The outcome of mumps was unknown. The relatedness between vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and the event was not reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no contact details to the physician.
Fast heartbeat, tingling in hands and fingers, dizziness, shaking, difficulty swallowing like muscles in throat are not working, panting, feeling like will pass out. 2 waves of these symptoms, about 5 min apart, each lasting about 10 min. Called an ambulance. EMTs took vitals - very high heart rate and blood pressure. Was told this resembled a panic attack.
Blood pressure of 171/87; heartbeat increases to 85 bpm; Fatigue; Headache; Muscle pain; Joint pain; Chills; Fever; Nausea; A spontaneous report was received from a consumer concerning a 67 year old male patient who experienced elevated BP/Hypertension, heartbeat increased/Elevated heart rate, fatigue/Fatigue,headache/Headache, muscle pain/Myalgia, joint pain/Arthralgia, chills/Chills, fever/Pyrexia, and nausea/Nausea.  The patient's medical history was not provided. Concomitant product use was not provided.  On 04-Jan-2021, prior to the onset of events,  the patient received the first of two planned doses of mRNA-1273 (Batch number 037K20A) (route and site not provided) for prophylaxis of Covid 19 infection.  The reporter (wife of the patient), stated that her husband was vaccinated with Moderna Covid-19 vaccine on 04-Jan-2021 at his place of employment, where he works as a nurse. Since 08-Jan-2021 the patient has been experiencing fatigue, headache, muscle pain, joint pain, chills, and nausea. She reported a fever of 100.9 degrees F. and a blood pressure of 171/87. She stated," if he is being stressed his heartbeat increases to 85 bpm when his usual is 60bpm". She further reported that on 09-Jan-2021, "they" (not defined)  recorded the patient's blood pressure at 184/104, a heartbeat of 87 bpm, and a body temperature of 99.2 degrees F.  Treatment was reported as Motrin 600mg for fever and Nyquil cold and flu. Regimen for these medications was not provided.  The reporter stated that the patient's symptoms continue to persist and they worsen at night time.  Action taken with mRNA-1273 in response to the events was not provided  The outcome of the events, fatigue, headache, muscle pain, joint pain, chills, nausea, fever, elevated blood pressure, and heartbeat increased were Not recovered/Not resolved.  Company comment:  The reported events, Hypertension, Elevated Heart Rate, Fatigue, Headache, Myalgia, Arthralgia, Chills, Pyrexia, and Nausea were considered possibly related to mRNA-1273.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the headache, fatigue, myalgia, arthralgia, chills, pyrexia and nausea, a causal relationship cannot be excluded. Very limited information regarding the cardiovascular events has been provided at this time. Further information has been requested.
Stated she felt nauseated and threw up. then began to feel itchy and noticed rash on back, stomach, and right foot. Everything else was fine. Denied difficulty breathing.
Heavy irregular menstrual bleeding.  I had been extremely regular prior to this. Injection was administered on cycle day 5, during my period. I continued my period for another day, which was normal. Heavy bleeding started again on cycle day 15, lasted for 6 days. Started again 3 days later, lasted for 6 more days. I have never had irregular bleeding like this before. My cycle has not returned to normal.
Patient states that within two minutes, she began feeling nauseated and lightheaded. Patient waited 15 minutes in the pharmacy, then decided to drive home. Patient developed a sore neck and muscle aches once home. Patient also stated that she experienced throat clinching, although she never had closing of the airways or difficulty breathing. Patient called her doctor when she experienced the throat clinching and the doctor told her to stay home since she did not have difficulty breathing. Patient stated that she took Tylenol and rested for 3 days and that the symptoms were completely resolved after 3 days. Patient called the pharmacy on 10/4/21 to report these adverse events and she stated that she has no lasting adverse effects two weeks post-vaccine.
Swelling and redness in right deltoid increasing over the next 24 hours. Prescribed Omnicef 125 mg bid X 5 days.
Information has been received from a physician concerning a 19 year old female, who, on an unspecified date was vaccinated with a 0.5mL second dose of Gardasil.  Subsequently the patient fainted.  The patient sought unspecified medical attention.  At the time of the report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Breakthrough case admission after 2 vaccines Moderna 1/5/21 Lot# 025J20A;  Moderna 2/2/21 Lot# 011L20A
This spontaneous report was received from a pharmacist (also reported as a nurse) concerning her 11 years old daughter with no history of gastrointestinal disease who in April 2012 was vaccinated with the first dose of GARDASIL (dose, route and lot # not provided) and early in June 2012 received the second dose of GARDASIL (dose, route and lot # not provided). In the beginning of June 2012 "early in June 2012", the patient developed severe gastroparesis after her second vaccination with GARDASIL and was hospitalized for 2 weeks. On an unknown date, feeding tube was placed as a treatment for the event. At the time of the report, the patient had not recovered from the event. The relatedness for gastroparesis was unknown for GARDASIL. Gastroparesis was considered to be disabling an other important medical event (because required intervention to prevent serious criteria: feeding tube) by the reporting pharmacist. Additional information has been requested.
Contacted patient regarding swelling in the left deltoid after COVID -19 injection 8/5/2021. Patient didn't notify clinic until two days after the injection. Patient took Naprosyn 125mg for pain and Benadryl for the swelling and itching. Patient states currently the swelling is going down but site still itches and red and warm to the touch. Patient denies any fever able to move her arm no problem breathing. Patient has an appointment 8/30/2021 and states she is feeling better.   Patient reported reaction to COVID vaccine 8/18/2021 received vaccine on 8/5/2021; filed with VAERS on 8/20/2021.
10:33 c/o mild "tingling in lips and toes" color good; p64-68, RR12-14; observed one-on-one by clinical coordinator RN; alert. 10:43 OK on feet, still c/o mild dizziness and tingling in feet.  p70, alert, color good.  drank juice and walked to nurses office. 10:50 Dr was called to discuss; OK to discharge to school nurse.  Mother agreed with discharge plan. 11:15 Symptoms resolved and student returned to class.
None. Pt was given a ZOSTAVAX at Phy. on 4/16/12. Then she got a Rx for a ZOSTAVAX from the GYN to take to pharmacy and they gave her one on 3/7/13.
Information has been received from a nurse concerning a female who on unspecified date was vaccinated with a of VARIVAX (Merck) 0.5ml (route and lot number was not provided) and GARDASIL (Merck) on the same day. The nurse reported "one day after vaccination" the patient experienced a 103 fever and a localized rash on the arm the VARIVAX (Merck) was given. The patient's outcome was reported as recovered. The patient sought unspecified medical attention. Additional information has been requested.
Fever, dizzy; would fall down without warning and not put hands out. Stopped eating, projectile vomiting, stopped talking, glazed over look in eyes, screamed non stop, acted as if could not hear anymore. Complete different child. These symptoms never went away.
3 minutes after receiving the Moderna vaccine, she stated she did not feel well. Asked her to sit down. BP 110/70, Pulse 76 bpm, Resp 18/min.  States she has "cool" pressure in her chest and a warm rush to the top of her head.  She states that she has panic attacks and this is how she feels during an attack.  After 10 minutes she states she feels better and feels this may have been a panic attack but wanted to let us know how she was feeling.  Felt well enough to drive home.
The night of 2nd vaccine:  Extreme soreness and pain in left arm, from shoulder down to hand, to the point I could barely move arm; pain/soreness in right arm as well,  even though this was not the arm that received either of the shots; headache; chills the night of vaccine and then again about 30 hrs after vaccine; sweating(unsure if I had fever that night), but this afternoon I did check temperature and it was 100.4; entire body ached the night of vaccine and into the following day; brain fog (like I'd been drinking alcohol); swelling at injection site that is still present; swelling of fingers (I can tell because I couldn't get my ring off without forcing it).  This morning, Monday the 10th, awoke to  still a lot of brain fog and feeling exhausted   still swelling at injection site, but pain in the arm is almost gone. As of today at 1:30 p.m., found my abdomen (upper and lower) and entire back is covered in bright red (almost sunburn like) rash with a few small raised bumps here and there - the majority of the rash is smooth, but when you touch it it turns white like with a sunburn. I was in bed all day yesterday, Sunday, sleeping due to Extreme fatigue.
Pt fainted approximately 10 minutes after injection. After administering vaccines & TB test pt was asked if she does OK getting shots. Pt, "I just don't like them, I get tattoos & the needles are a lot worse". Pt stood up, stated ok - went to lobby to pay bill. Pt. fainted while at lobby counter, fall to floor. Had pt lay on floor until dizziness passed, about 20 min. No apparent injuries someone escorted pt. home. Advised to call Dr. if concerns arise. Slightly nauseated (only ate red licorice this morning). Clinic supervisor in attendance.
No additional adverse events were reported, no further information provided; The patient received an expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered; At which point the medication error ocurred: Preparation for administration; This spontaneous report has been received from a pharmacist, concerning to 66-year-old female. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 15-DEC-2021, the patient was vaccinated by a health care provider, with an expired first dose (expired product administered) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) given intramuscularly as prophylaxis (dose, anatomical location and vaccine scheme were not provided; lot number S029542 has been verified to be a valid lot number, expiration date reported and established as 10-JUN-2021). It was reported that the medication error occurred at the time of preparation for administration of the vaccine (product preparation error). Also, that the vaccine was disposed. The patient was notified, and no adverse reaction occurred (no adverse event). Subsequently, on unspecified date in December 2021, the patient was re-vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) as prophylaxis (dose, route of administration, anatomical location, vaccine scheme, lot number and expiration date were not provided).
Pt. states that after receiving the 2nd dose of Moderna 09/24/2021, started experiencing symptoms 10/14/2021 of extreme fatigue, exhaustion. No noted Primary visit/communications.
heart failure; Has fluid build up; has fluid around his heart; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 32-year-old male patient received bnt162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), as dose 2, single (Lot number: 025B21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1), for COVID-19 immunization. The following information was reported: PERICARDIAL EFFUSION (hospitalization) with onset 14Jul2022, outcome "unknown", described as "Has fluid build up; has fluid around his heart"; CARDIAC FAILURE (hospitalization, medically significant) with onset 14Jul2022, outcome "unknown", described as "heart failure". The patient was hospitalized for cardiac failure (start date: 14Jul2022); for pericardial effusion (start date: 14Jul2022, hospitalization duration: 2 days). Clinical course: the patient was in the hospital and had heart failure. The patient had fluid buildup, specifically fluid around his heart. Additionally, the reporter stated the patient was in the hospital (further hospitalization details were not available) and had heart failure because of the vaccine. The reporter wanted to know what they had to do to "get on the lawsuit." The patient received two Moderna vaccines and one Pfizer vaccine ("COVID-19 Booster shot").   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Upper lip puffy following immunizations at 2 months. Swelling started 5-6 hours after, lasted just a few hours, no respiratory distress.  Also had a low grade temp.  Had total of 3 doses of tylenol for fever, crying.
Patient had a localized injection site reaction covering approximately half of her upper arm. It was red and inflamed and she thought that it was getting worse. I instructed her to  monitor the size of the reaction and make sure that is isn't getting larger and to take some over the counter benadryl to help with the reaction. She also mentioned she was going to go to her primary care physician and have him look at her arm as well. He marked her arm with a line to help measure the size of the reaction site. She received her vaccine June 11th.
Patient fainted shortly (5 min) after being given the shot but awakened almost immediately, felt tingly feeling down fingers and legs that went away after being given water and snack. Chest pain and shortness of breath, ear ringing that subsided within minutes. No nausea reported.
This is a spontaneous report received from a consumer, concerning a 76-year-old female patient, who received the Moderna COVID-19 (mRNA-1273) vaccine and experienced adverse events: body aches, red rump, warm-to-the-touch and mild tingling in the arm. The patient's medical history and concomitant medications not provided. On Jan 14, 2021, prior to the onset of the events, patient received the first of two planned doses of mRNA-1273 (batch/lot# 028L20A), intramuscularly, in the left arm, for prophylaxis of COVID-19 infection. On Jan 17, 2021, patient experienced body aches. On Jan 26, 2021, patient experienced red rump, warm-to-the-touch and mild tingling in the arm. Treatment details not provided. Action taken with mRNA-1273 in response to the events not reported. On an unknown date, the outcome of body aches, red rump, warm-to-the-touch and mild tingling in the arm: not resolved. Reporter's comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.