chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got 3 injections, still get shingles/ suspected vaccination failure; shingles; it doesn't hurt so bad; makes me miserable; got 3 injections; blisters; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, blister, feeling miserable and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles, pain, feeling miserable and extra dose administered were unknown and the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, blister and feeling miserable to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient got 3 injections of Shingles vaccine, which led to extra dose administered. The patient still get shingles at least once a year it did not hurt so bad and the blisters go away in about 2 weeks, so it was better.  It still makes patient miserable. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Onset of left shoulder pain and limited range of motion within 24 hours of vaccine. Difficulty with shoulder flexion and abduction beyond 90 degrees. Not responsive to ibuprofen. Symptoms persisting at 6 weeks out from vaccine, with mild improvement over most recent 2 weeks.
I had tender, very painful lymph node on the right side of my neck (8 out of 10 pain scale). It cleared about  a day and half later.
calf swelling; the back of her knees felt very tight/back of her knees were tight and her calves were tight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 13:00 (Batch/Lot number: unknown) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Dry eyes" (unspecified if ongoing). Concomitant medication(s) included: PROLIA taken for osteoporosis (ongoing); XIIDRA taken for dry eye (ongoing). Vaccination history included: Bnt162b2 (First Dose, lot number ER8729, administered in left arm), administration date: 09Apr2021, when the patient was 63 years old, for Covid-19 Immunisation; Bnt162b2 (Second Dose , Lot: EW0164, administered in left arm Reaction/event as reported by primary source: Fever, Date of start of reaction/event: Apr2021, Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED), administration date: 30Apr2021, when the patient was 63 years old, for Covid-19 Immunisation, reaction(s): "Fever", "Chills", "Headache". The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 23Nov2021 17:00, outcome "recovering", described as "calf swelling"; MUSCLE TIGHTNESS (non-serious) with onset 23Nov2021 17:00, outcome "recovering", described as "the back of her knees felt very tight/back of her knees were tight and her calves were tight".  The lot number for [BNT162B2], was not provided and will be requested during follow up. The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a consumer concerning her grandfather with no reported allergies and no pertinent medical history, who in November 2006, was vaccinated with one dose of Pneumovax 23.  It was reported the patient received the Pneumovax 23 by "oral" route.  It was reported that "soon after the vaccination" was given, the patient's arm swelled and he had a rash on most of the arm.  The reporter thought that the patient may have been diagnosed with pneumonia a few days ago.  The patient sought unspecified medical attention.  At the time of the report, it was unknown if the patient recovered.  Additional information has been requested.
Patient presented to the ED and was subsequently hospitalized for Cerebrovascular accident (CVA) due to occlusion of left middle cerebral artery within 6 weeks of receiving COVID vaccination.
Immediately after getting the vaccine on February 19,  I had prickling and burning in the top back of my head.  I was sent to the emergency room where I was given an injection of Decadron and Pepcid and sent home with a prescription to take Prednisone for four days and Pepcid twice a day for 7 days.  The prickling decreased a little but has returned with tingling in the face, feet, legs and arms.
nausea for 7 days, headache, backache and neck pain for 7 days -no treatment requested, advised if it continues past today to report to the doctor
left COVID arm; discolored itchy hot rash in the left arm; swelling in the left arm; lump in the left arm; discolored itchy hot rash in the left arm; soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (left COVID arm), RASH PRURITIC (discolored itchy hot rash in the left arm), SWELLING (swelling in the left arm), MASS (lump in the left arm) and SKIN DISCOLOURATION (discolored itchy hot rash in the left arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (left COVID arm), RASH PRURITIC (discolored itchy hot rash in the left arm), SWELLING (swelling in the left arm), MASS (lump in the left arm), SKIN DISCOLOURATION (discolored itchy hot rash in the left arm) and PAIN IN EXTREMITY (soreness in the left arm). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (left COVID arm), RASH PRURITIC (discolored itchy hot rash in the left arm), SWELLING (swelling in the left arm), MASS (lump in the left arm), SKIN DISCOLOURATION (discolored itchy hot rash in the left arm) and PAIN IN EXTREMITY (soreness in the left arm) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Pt to hospital with AMS and worsening lethargy; positive for COVID; O2 supplementation; AKI; hypernatremia; pt's condition worsened; refused artificial nutrition tube placement; comfort measures and hospice; pt passed away in the hospital.
Caller have received first dose of the vaccine and 10 days later tested positive for Covid; This is a spontaneous report received from Pfizer sponsored program. A contactable female consumer(patient) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  Patient have received first dose of the vaccine and 10 days later tested positive for Covid and wanted to know if they can still get second dose. The outcome of the event was unknown.  Follow up activities are possible; Further information is expected.
Onset before sore throat; next day "high fever" (no thermometer) which continued until 04/25 AM at about 103 degrees F (temperature first taken 04/24 at 20:00-was 103).  Then late 04/25 fever back up to 103.4 degrees F.  Seen at hospital.  Diagnosis probable influenza with dehydration.  Patient has a cough since 04/21 and severe muscle aches; also 3 spots rash on left arm, on near injection site, size of dime; others smaller.  Now temperature normal, still with much coughing.
asthma attack; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (asthma attack) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced ASTHMA (asthma attack). On 31-Mar-2021, ASTHMA (asthma attack) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided Treatment medication include inhaler.
Vaccine injuries; Got the shingles vaxx and within 2 weeks I developed a skin problems that hasn't gotten any better; This case was reported by a consumer and described the occurrence of injury in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced injury and skin disorder. On an unknown date, the outcome of the injury was unknown and the outcome of the skin disorder was not recovered/not resolved.   It was unknown if the reporter considered the injury and skin disorder to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient got the shingles vaccine and within 2 weeks developed a skin problems that had not gotten any better. Also stated vaccine injuries.
About 10 hours after receiving immunization severe arm pain, neck and spine pain. About 24 hours after fatigue, 102 degree fever, and chills.
Pt vaccinated with DTP/OPV developed temp of 104.2 axillary; rash on back of neck, wheezing. Pain in joints; Nausea/vomiting; weakness & shakiness. Placed on Keftab. Dx with Pediculos captis.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age. On 18-OCT-2013, the patient was vaccinated with an expired dose of GARDASIL (lot # 669313/0692AA, expiration date 13-AUG-2013) intramuscularly. It was unspecified what dose in GARDASIL vaccination series that dose was. No adverse effect reported. Additional information has been requested.
tested positive for COVID; tested positive for COVID; This is a spontaneous report from the Pfizer-sponsored program. A contactable consumer (patient), reported a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number was not reported), dose 1, via an unspecified route of administration on 01Apr2021 as 1st DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date (reported as "this weekend"), the patient tested positive for covid. The patient was scheduled to receive the 2nd dose on 29Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test (Apr2021): positive. Clinical outcome of the events tested positive for covid was unknown.   Information about lot/batch number has been requested.
Redness, swelling, hard lump 6.5 cm X 2.5 cm left thigh.  Hematoma; apply heat, observation.
Moderate to severe Chills; body and head aches; head aches; Fever (99.6 F); This is a spontaneous report from a non-contactable other hcp.  A 32-year-old male patient received BNT162b2 (COVID 19, Lot number: EK9231, dose number was 1), intramuscular at right arm on 28Dec2020 08:00 AM at single dose for COVID-19 immunization in hospital.  Medical history was none. There was no known allergies to medications, food, or other products. The patient's concomitant medications were not reported. There was no other vaccine in four weeks.   The patient experienced Moderate to severe Chills, body and head aches, and Fever (99.6 F) on 28Dec2020 20:30(08:30 P.M). There was no treatment. There was no COVID prior vaccination nor COVID tested post vaccination. Outcome was recovering.  Events were assessed as non-serious by the reporter.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported event chills cannot be excluded based on known safety profile of suspect drug and compatible temporal relation.
10 hours after vaccine, developed foot and ankle swelling, redness, warmth and pain. Fever up to 101 the next day. Foot and ankle swelling and pain persists for 9 days and counting.
This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a 16-year-old female patient who received BEXSERO. Concurrent medical conditions included penicillin allergy. On 15th December 2015, the patient received BEXSERO .5 ml. In December 2015, less than a week after receiving BEXSERO, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site swelling to be related to BEXSERO. Additional details were received as follows: In December 2015, less than a week (it was unsure whether injection site swelling occurred on same day of vaccination or next day) after receiving BEXSERO the patient experienced severe swelling at the injection site of the size of a baseball (swelled up into a knot) fro about 5 days and was still ongoing at the time of reporting. The patient was allergic to penicillin but did not have any latex allergy. The patient initials, date of birth, vaccine batch number and expiry date of vaccine were unknown. The call was escalated to medical information system.
nephrotic syndrome (protein in urine, swollen ankles); current treatment is Lisinopril 10 mg daily and Atorvastatin 20 mg daily
PT WAS ADMITTED TO HOSPITAL FOR THE FOLLOWING SX'S; FEVER, CHILLS, NAUSEA, SWELLING, REDNESS AND WARMTH AT INJECTION SITE. 03/12/07-records received from facility- Admitted with fevers and cough, decreased appetite and nausea. No shortness of breath.
The patient received her vaccine on 10/11/17 and returned to the clinic on 10/12/17. She reported waking up on the morning of 10/12/17 with swollen eye lids, drainage from the left eye and swelling/redness at the site of the injection. Her eyes were not red, itchy or painful. The swelling resolved throughout the day and was almost completely gone at the time of her appointment (4:45 PM) on 10/12.
About 2 min after injection patient was seated in the waiting and passed out. his friend called for help and as he slip out of his chair to the floor he began to have seizure like activity (mild convulsions). Once he hit the floor he woke up and began to sweat profusely. Paramedics came and checked his vitals and as he seemed to be ok let him go home with his father.
She still got the second shot and now she feels even worse; still with low energy; occasional headaches; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (She still got the second shot and now she feels even worse), ASTHENIA (still with low energy) and HEADACHE (occasional headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021, the patient experienced CONDITION AGGRAVATED (She still got the second shot and now she feels even worse), ASTHENIA (still with low energy) and HEADACHE (occasional headaches). At the time of the report, CONDITION AGGRAVATED (She still got the second shot and now she feels even worse), ASTHENIA (still with low energy) and HEADACHE (occasional headaches) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-307139 (Patient Link).
Severe arm pain, swelling at site of vaccination, overall malaise. All symptoms began 10 days after vaccine
Bump in shot, red, hot and swollen skin. It was painful and lasted a week.
On 2/2/21, the patient started to show redness and swelling at the injection site- about 2 inches in diameter. The nursing staff applied ice and monitored the patient's condition.  By 2/4/21, the reaction was improving and resolved by 2/8/21.  No additional medical attention was necessary.
Patient first experienced and itch arm at the site of injection.  She was given 25 mg of benedryl.  She left and came back after saying she felt okay. She was now experiencing chest tightness which eased when sitting down. We watched for 15 minutes more. with no change in status.  At this point I was going to call 911 but she did not want that. She called her mother who came down to the store.  We were monitoring her for any changes. She did mention that her tongue felt tingly but for only a short time.  Her mother came shortly and her mother took her to the hospital  Patient was talking normally and having normal conversation with out stall.
This case was reported by a nurse practitioner to a sales representative and described the occurrence of fever in a 2 month old subject of unspecified gender who was vaccinated with Pediarix. On an unspecified date before 5/3/05, the subject received first dose of Pediarix. On an unspecified time following the administration of the first dose of Pediarix, on an unspecified date before 5/3/05, the subject experienced "a high fever of 102.6 F". The pt was hospitalized for an unspecified period of time. The fever resolved and the pt was discharged from the hospital on an unspecified date on or before 5/3/05. The vaccination course with Pediarix was discontinued. The NP considered the fever was possibly related to vaccination with Pediarix.
Child seen 8/29/13 by CNP for lingering hives on R upper arm. Reaction began 8/24/13 by mom's report as redness and swelling from shoulder to elbow. Now no swelling but scattered welts. No signs of infection.
patients caregiver has described pain at injection site -7 days past injection. pain at injection site started morning after injection. patient informed me that they will seek medical evaluation. no other details given.
Fever, chills, headache, complete fatigue resulting in spending the whole next day in bed.
I received my 1st dose on 01/15/2021. After 1 and half hour later I started experiencing shortness of breath. As of today 12/16/2022 I am still experiencing shortness of breath. I contacted my doctor 2 weeks ago regarding this problem. He referred me to see a Cardiologist. They did a stress test on 12/14/2022. I did receive the result yet. When I try to walk or do something I ran out of breath. It happens suddenly. It comes and goes. If I try to for a longer period of time I ran out of breath. It never happened to me like this before but after getting the dose 1 It started happening. When I was getting my 2nd dose since I've experienced shortness of breath after my 1st dose they made me wait at least 2 hours to see If I have any reactions which I didn't had any except for the shortness of breath. At the time of my dose 1 I didn't see my doctor because I was in a different state. I just contacted my doctor recently.
Started on November 9th 2022, sweating, heartrate 148, Went to ER and put on Cardizem IV from morning to next morning as admitted to hospital.  Did Defibrillation next morning and able to be discharged that afternoon on Cardizem oral
expired vaccines was inadvertently left in the refrigerator and was administered to 2 children, no AE; Initial information received on 17-Sep-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to case 2019SA262365 (same reporter).  This case involves a seven years old female patient who received 0.5 ml dose of expired vaccine QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) (lot UT6375LA, Exp. Date 30-Jun-2019) via intramuscular route in left deltoid on 13-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  It was reported that a box of expired vaccines was inadvertently left in the refrigerator and was administered to 2 children on 9/13/2019.  At the time of reporting, no adverse reactions were 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.  List of documents held by sender: none.
Raised red rash across face with one vesicle. Started on Valtrex but came back negative for shingles.
Accute appendicitis... during laparoscopic appendectomy it was found that the appendix was gangrenous and perforated
Severe body ache, fever , toothache, insomnia, runny nose, nausea  Treated with Tylenol - no change in symptoms
This spontaneous report as received from a pharmacist refers to a 66 year old male patient with drug reaction/allergies to penicillin. On 08-NOV-2013 the patient was vaccinated with PNEUMOVAX 23, dose 0.5 ml, route intramuscular. Dose, lot and expiry date were not reported. Concomitant therapies included unspecified flu shots (manufacturer unknown) and blood pressure medication. On 09-NOV-2013, one day after receiving the first dose of PNEUMOVAX 23, the patient experienced severe swelling of the hand and arm. The patient was seen at the hospital emergency room but not admitted. The patient was diagnosed with cellulitis and was started on BACTRIM and cephalexin. The patient had fully recovered from events on an unknown date. Additional information has been requested.
15DEC93 parents report pt fussy & irritable around 5PM; parents gave pt a bath, p/bath pt face (cheeks) started to swell & became very reddened, elevated temp; pt holding self stiff; vomited;
HYPOTENSION  9/10/2022  --  RECURRENCE OF SAME SYMPTOMS
Throat tightening & pain with swallowing, itching, irritable/aggitated, hot.  Purposefully tried to avoid EPI this time.  Took oral hydroxyzine and decade in. Waited 1hr in observation. No changes, willing to send me home.Developed vomiting & diarrhea in the night,  still itchy,  throat still hurts.
PATIENT EXPERIENCED HIVES (RAISED WHELPS) FROM INJECTION SITE TO ELBOW AREA WAS HOT TO TOUCH AND ALSO SORE FOR SEVERAL DAYS AFTER INJECTION