chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received SHINGRIX. On 24th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient had pain at the injection site which lasted for about 2 days. The patient had denied permission to contact their physician.
Same evening arm soreness + swelling - ice applied 4/2/09 arm increased soreness, increased swelling, warmth, elevated temp + not feeling well. To ER labs drawn + antibiotic started. 4/3/09 to ER again as increased swelling of arm. Continue TX. 4/6/09 to MD for follow-up. Continue TX Cellulitis. Return to work 4/8/09.
COUGH, SINUS DRAINAGE, WET EYES, NOSE DRIPPING, SORE THROAT, PROBABLE INFLAMED TRACHEA/ AIR-WAY.
Breakthrough case admission after 2 vaccines Pfizer 4/12/21 Ew0150;  Pfizer 5/3/21 Lot# Ew0164
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 20-AUG-2015, the patient was vaccinated with an improperly stored dose of VAQTA "10pk 25U/0.5ml SD LLok wCap Ped" which had a lot number of L013324 and expiration date on 24-APR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the VAQTA vaccine had one temperature excursion of 24 hours. The lowest recorded temperature was 33 F (0.555555556 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Fever 101 this evening very mild diarrhea.. this is six days after the shot. Took ASA drinking lots of water
Left arm with severe swelling, redness, and induration worse from the site of application of DTAP down to elbow.  Meds. Benadryl 12.5/mL, 1 1/2 tsp, PO every 6 hours for 3 days, cold compresses, Tylenol PRN if patient has pain.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 82-year-old female patient who received SHINGRIX (batch number 4FS5N, expiry date 8th March 2021) for prophylaxis. On 13th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, chills and localized erythema. On an unknown date, the outcome of the pain in arm, chills and localized erythema were recovered/resolved. It was unknown if the reporter considered the pain in arm, chills and localized erythema to be related to SHINGRIX. Additional details were provided as follows: The patient reported chills, arm soreness, and significant localized redness expanding up to the shoulder. The symptoms resolved after a few days. This case was linked to the case US2018184661, reported by the same reporter for the different patient who also experienced same symptoms with the same lot number.
Vaccine administration error.  It is suspected that a 1/2" needle syringe was used instead of a 1" needle syringe.
Initial information received on 04-Jun-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a patient (gender and age not reported) who experienced excessive redness at injection site and vomiting within 24 hour, after receiving vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect QUADRACEL (lot number and expiration date not reported) via unknown route in unknown administration site. On an unspecified date (latency not reported), following vaccination, the patient developed excessive redness at injection site and vomiting within 24 hour. No complementary investigations were reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for excessive redness at injection site and as unknown for vomiting within 24 hour. List of document held by sender: none.
Pt received Pneumovax on 09/22/03 called 09/24/03 with redness, swelling and tenderness at site of injection.  Pt came into clinic and evaluated by MD diagnosed with cellulitis and treated with ABX, Ice and Tylenol.
Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Medium, Systemic: Diarrhea-Medium, Systemic: Fever-Medium, Systemic: SLURRED SPEECH, INABILITY TO HOLD SELF UP IN CHAIR, INCONTINENCE-Medium, Additional Details: RN ADVISED PT HAD FEVER OF 101, DIARRHEA, WHOLE-BODY MUSCLE SORENESS, STROKE  LIKE SYMPTOMS INCLUDING SLURRED SPEECH, INABILITY TO HOLD SELF UP WHILE SITTING IN A CHAIR, INCONTINENCE, AND CONFUSION ABOUT HER SURROUNDINGS, DATE, TIME, AND SITUATION. ALSO ADVISED THAT PT IS A GREAT HISTORIAN & NORMALLY KNOWS CURRENT DATE, TIME, AND SITUATION. SYMPTOMS LASTED ROUGHLY 72 HOURS, AND PATIENT DID COMPLETELY RETURN TO BASELINE AFTER 72 HOURS HAD PASSED
Arthritis flared up; She was in bed for a month; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ARTHRITIS (Arthritis flared up) and BEDRIDDEN (She was in bed for a month) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Arthritis.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Arthritis flared up) and BEDRIDDEN (She was in bed for a month). At the time of the report, ARTHRITIS (Arthritis flared up) and BEDRIDDEN (She was in bed for a month) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  No treatment medication information was provided by the reporter.  Company comment.  This spontaneous case concerns an adult female patient, with current condition of arthritis, who received a dose of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine and experienced the unexpected, non  serious AESI of arthritis. Latency cannot be properly assessed since exact onset date and vaccination date were not provided. The report stated that the patient received an additional booster dose and experienced an arthritis flare up from which she was in bed for a month. No further clinical details were provided for medical reviewing. Patient´s mentioned medical history remains as risk factor for the event since is it could be part of the natural course.  The benefit-risk relationship of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
Large, sore, red, warm to touch welt at site of injection noted roughly 18 hours after 2nd shot of Pfizer.  The next day, welt grew larger, still warm to touch and sore.
I end up getting shingles; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number was not reported), via an unspecified route of administration on 05May2021 (at the age of 59-year-old) at a 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 for COVID-19 immunization. Patient stated, patient was just calling you know just to, report a side effect of the Pfizer vaccine that patient had done 05May2021, patient had second dose of it and this week patient end up getting shingles on 22May2021. Patient was almost 60-year-old woman and patient looked it up when its, sometime people do end up getting shingles after getting the Covid vaccine and patient just want you guys would be aware that, of course she was treating it right now, to aware research and just you know, take a quick look at the vaccine. Outcome of the event was unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.
This case was reported by a healthcare professional (a nurse, also the subject) and described the occurrence of bloody diarrhea in a 51-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included gastroesophageal reflux disease, high blood pressure and irritable bowel syndrome. Concurrent medications included PRILOSEC and lisinopril. On 1 December 2008 at 11:20 the subject received unspecified dose of FLULAVAL at 0.5 ml in the right arm. On 2 December 2008, at 18:00, the subject experienced bloody diarrhea. Also on 02 December 2008, the subject's injection site was very swollen and red due to the medical assistant not properly administering the vaccine into the deltoid muscle. This was considered to be an incorrect route of drug administration. On 03 December 2008, the subject experienced very loud ringing in both ears which she never experienced before. This persisted constantly and was still continuing at the time of reporting. Following the next several days, the subject experienced excruciating pain (even hurt her ears to talk) and pressure in the left ear with sensitivity to noise and sound. She reported that "even her own voice sounded strange." It was reported that her left ear was slightly worse than her right. The subject was hospitalised and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). She visited an otolaryngologist who placed a slit in her tympanic membrane which did not help. She was placed on low dose course of prednisone with no change. Then she was placed on a 14 day high dose of steroid course and 10 day course of AUGMENTIN with no relief. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. In January 2009 and MRI was normal. A CT scan showed bilateral semicircular canal dehiscence which she had a plugging surgery  on 31 July 2009. This resulted in no symptom improvement except she no longer felt eye movement. It hurt to talk or to listen and hear. In December 2009, she stopped producing saliva and tears due to damage to her salivary glands. This resulted in dry gritty eyes and she was only able to produce 5 ml of tears in five minutes. She also experienced gum recession and sores in her mouth due to this affect on salivary glands. Attribution of these later events to treatment with FLULAVAL was not reported.
Fever, fussy all night especially at 1am. Tylenol given before vaccination, 4pm and again at 1am. Seizure at 5am. Taken to ER. Temp 102 degrees per ear. Motrin given. Stayed in hospital for observation until 4pm 10/4/02.
sick; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP), Program ID: A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, booster (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick". Follow-up attempts are not needed. No further information is expected.
cardiac arrest; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp.  This case involves a 16 years old and unknown gender patient who suffers cardiac arrest while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (formulation, strength: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient suffers cardiac arrest (cardiac arrest) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (cardiac arrest).  At time of reporting, the outcome was Unknown for the event cardiac arrest.; Sender's Comments: Sanofi Company Comment dated 04-Feb-2022.This case involves a 16 years old and unknown gender patient who suffers cardiac arrest after receiving INFLUENZA VACCINE. The time to onset is not reported with the role of the vaccine. Patient's past medical history was unknown. Additional information regarding condition at the time of vaccination, lab data excluding other predisposing etiologies, lifestyle/dietary history/habits, pre-existing risk factors, family history for cardiac disease(s), corrective treatment and clinical course details would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Consistent numbness in right side of face, left fingers, both legs, left arm.  Symptoms started 2-3 days after vaccination and symptoms have not subsided and continue to be of concern.
This spontaneous report as received from a pharmacist (R.Ph.) refers to a 63 year old male patient. On 03-JUN-2013 the patient was vaccinated with 0.65 ml dose of ZOSTAVAX (lot # J001003, expiry date 25-APR-2014), subcutaneous. There was no concomitant medication. And no pertinent medical history and drug reactions/allergies were reported. On 13-JUN-2013, (10 days after receiving ZOSTAVAX) the patient developed an unspecified rash on his face and the lids of his eyes as well as "localized" pain on his hand and an unspecified side of his face after receiving ZOSTAVAX. The pharmacist reported that the patient was seen by his physician on 14-JUN-2013 and the physician diagnosed the patient with shingles. No lab test was performed. The physician prescribed diclofenac (75 mg twice a day) as well as VALTREX (1 gram three times a day for a week). The outcome of shingles was reported as not recovered. This is one of several reports reporting from same source. Additional information has been requested.
Within 24 hour, high fever 102 and body aches that lasted for 6 days. On Jan 12, 2021 contacted COVID line, recommend rest and fluids, no recommended to Test for COVID. After fever reduced, rash on both legs appeared approx Jan 18th. On Feb 2nd Went to Express care after this rash didn't go away. Was told it was exzcema given Kenalog cream and Atarax and to follow up with PCP if not better in 10 days. Sent message to PCP with photos of rash and recommendation. Referal completed for Dermatology. Had appt on Feb 22 but rash had cleared up prior to appt. Was advised to call if reappeared. Approx April 13 rash reappeared. Used Kenalog as before but no difference. On April 20, 2021 Contacted Dermatologist was advised to continue using kenalog. On April 22 contacted Dermatologist again to advise that rash is getting worse and had spread more to thighs rather than just lower leg area. Was prescribed betamethasone dipropionate .05% ointment. April 23 rash remained the same, experienced swelling in lower extremities. towards evening lower calves were swollen to same size as thighs. Asked husband to take me to express care. On the way to express care, i began experiencing numbness on the right side of my body and was taken to Emergency Room. At the emergency room, began having trouble formulating words. Was worked up for possible stroke. Stroke was ruled out but no answers as to why i experienced the stroke like symptoms. Rash was examined and prescribed prednisone and follow up with Dermatology on April 26. Met with Dermatology on April 26 and a biopsy was performed resulting in diagnosis of dermal hypersensitivity reaction. Over the course of the next few weeks, I had swelling off and on in my legs like what lead me to the emergency room on April 23 but no rash was present. I made contact with PCP on May 19th to advise of the swelling and was requested to come to the office.  As a result of the office visit, an ultrasound was requested of my right leg which indicated a DVT. I have since started blood thinners and continue to follow up with providers as necessary.
2 days after my first shot, "Covid Arm" developed.  A large spot, about the size of 1 and 1/2 tennis balls developed.  It was red, hard, hot and was extremely itchy.  These side effects lasted for 10 days to 2 weeks.  I treated my arm by using Advil, hydrocortizone and neosporin with ice packs.
numbness in my mouth and around my lips. Numb for 3 days now experiencing numbness on left side of face, felt like druelling sensation
Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 47 years old male patient who received 0.25 ml dose of vaccine ADACEL intradermaly in the forearm. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy received. On 22-Feb-2019, the patient received a 0.25 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5128AA via unknown route in the arm nos. It was a medication error case due to Incorrect route of product administration and vaccine underdose. It was unknown if adverse event was there. 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.
A student  complaining that he started having vision problems the night of receiving flu and COVID shots on 9/25/23.  He has already been checked out in the ER and by an eye doctor. Outcome unknown.
Itchy throat experience 30 minutes after vaccination. 1 capsule of banophen 25mg was given to patient. 20 minutes after banophen administered, patient vomited. Patient stated she had not eaten all day. Throat continued to feel itchy. EMT's arrived and evaluated patient. Patient chose not to go with EMT's to hospital, left immediately after evaluated.
Pt vomited, temp, decreased feeding x 24 hrs. Still had temp 9/10/14.
Vertigo - in spring 07 worse since Gardasil 6/22/07 8/31/07
NEUROPATHY  11/4/2022 -- RECURRENCE OF SAME SYMPTOMS
PT states her whole arm became "Hard as stone" and she was unable to bend her elbow or flex her wrist. Her arm was extremely painful all night long like a "cold burn." The next morning the muscles felt weak and fatigued but "she did have some joint movement. Was seen in off and prescribed prednisone.
Patient was seated, fainted and fell onto the floor. Recovered consciousness within about 30 seconds, was breathing normally and oriented x3
L upper arm sore, swollen and hard. Keflex 500mg TID.
As soon as the injection began I felt a rush of tingling and almost blacked out/fainted. Felt like I had a gray static cloud wash over my eyes/vision. I couldn't really explain what I felt other than a woozy faint feeling like when you're about to faint and begin to lose control over your vision. Felt a little wobbly walking afterwards as well. Just sat and waited in the waiting area but nothing else presented itself immediately after.  About an hour later, I felt like my heart was racing and I kept trying to calm my breathing. It was a conscious effort to slow it down.  About two weeks later, I got my period two weeks early and it was very bright red and not typical bleeding. Very heavy bleeding that lasted approximately four days.  A year later and I still feel an uncomfortable heart fluttering feeling like my heart is pumping or working harder. I can describe the feeling as that post workout high where you're trying to catch your breath afterwards. Except this feeling happens to me when I'm not in active exercise.
deliberately missed her second dose which was slated for yesterday 12Apr2021; vomiting; fever; severe headache; chest pain; sweating; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), HYPERHIDROSIS (sweating), DIARRHOEA (diarrhea), PRODUCT DOSE OMISSION ISSUE (deliberately missed her second dose which was slated for yesterday 12Apr2021) and VOMITING (vomiting) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M02A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pulmonary embolism. Concurrent medical conditions included Immunosuppression (immunosuppressed (low IgG)). Concomitant products included GAMMA GLOBULIN, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) and PROPRANOLOL HYDROCHLORIDE (INDERAL) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced CHEST PAIN (chest pain), HYPERHIDROSIS (sweating), DIARRHOEA (diarrhea), VOMITING (vomiting), PYREXIA (fever) and HEADACHE (severe headache). On 12-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (deliberately missed her second dose which was slated for yesterday 12Apr2021). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) ongoing since an unknown date at an unspecified dose and frequency; PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. On 19-Mar-2021, CHEST PAIN (chest pain), HYPERHIDROSIS (sweating), DIARRHOEA (diarrhea), VOMITING (vomiting), PYREXIA (fever) and HEADACHE (severe headache) had resolved. On 12-Apr-2021, PRODUCT DOSE OMISSION ISSUE (deliberately missed her second dose which was slated for yesterday 12Apr2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Client has a history of pulmonary embolism and is immunosuppress (low IgG) that requires occasional gamma globulin therapy. She took first shot of Moderna COVID-19 vaccine on 15Mar2021 and about 12 hour later, she developed vomiting, diarrhea, fever, sweating, severe headache, chest pain which made her to rush to the emergency room for a visit that lasted about 6 hours with no clear diagnosis made. Symptoms lasted for about 4 days then gradually resolved. She is aware that AE from second shot is worse than first shot and wanted more information to encourage her take the second dose given these severe adverse effects that she had after the first dose of the Moderna. She deliberately missed her second dose which was slated for yesterday 12Apr2021.