chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; PEDVAX HIB and ROTATEQ administered after temperature excursion.; This spontaneous report has been received from a registered nurse concerning a unknown gender and age patient. No information regarding the patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 25-JUL-2022, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot number U039951 had been verified to be a valid number; expiration date reported as 22-JUN-2023, and upon internal validation established as the same date, administered as prophylaxis ((strength, dose, units, vaccination scheme, frequency, route of administration and anatomical site of injection were not provided); and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot number W004502 had been verified to be a valid number; expiration date reported as 09-OCT-2023, and upon internal validation established as the same date, administered as prophylaxis (strength, dose, units, vaccination scheme, frequency, route of administration and anatomical site of injection were not provided). Both vaccines were stored at a temperature of 23.8 degree Celsius (C) for the time frame of 9 hours and 45 minutes (product storage error). There was no previous temperature excursion and no additional adverse events were reported.
This case was reported by a other health professional and described the occurrence of acute pancreatitis in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced acute pancreatitis (serious criteria GSK medically significant). On an unknown date, the outcome of the acute pancreatitis was unknown. It was unknown if the reporter considered the acute pancreatitis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed acute pancreatitis 14 days after administration of SHINGRIX. The reporter was asking if there had been any reports of acute pancreatitis after SHINGRIX injection.
Fainting with clonic jerks, pale, woke almost immediately but pale/woozy x 20 mins.
Narrative:  PATIENT REPORTS ITCHINESS 2 DAYS POST SECOND DOWN, 10 DAYS LATER ARM IS STILL RED, SWOLLEN AND WARM.
Site: Redness at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Systemic: Nausea-Mild, Additional Details: Sharp pain in left shoulder once
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: face was pale---consiousness was on and off-Severe, Systemic: Nausea-Severe, Additional Details: after recieving 1 st dose of pfizer vaccine--patient was in the observation area for 15 minutes,during that time frame patient started feeling nauseous and then she felt dizzy..her skin was turning pale.. her consiousness was on and off.. she would respond one time and then another second she would freeze..at one point she lost consiousness. then we called 911 (EMS) right away...before even ems arrived patient regained consiousness. when EMS arrived patient was responsive & went to hospital.
This serious medically confirmed spontaneous report (initial receipt 03-Feb-2015) concerns a 59 year-old female patient who was taking concomitant medications of baby aspirin and propafenone for atrial fibrillation. She had received influenza vaccine in the past and unknown if she had received AFLURIA brand previously. She did not have a history of skin reactions or shingles. On 20-Nov-2014, the patient received intramuscular AFLURIA (batch number not provided) from her employer. On an unknown date in Nov-2014, a few days following the vaccination, the patient experienced the symptoms of pain, numbness, tingling, increased sensitivity in her left arm and hand. The pain eventually migrated towards her neck. She sought her primary care provider who ordered a cervical x-ray and prescribed methylprednisolone dose pack. This did not alleviate the neck pain, therefore, her prescription then changed to gabapentin. On the morning of 01-Dec-2014, she noticed blisters on her arm, hand (including palms), wrist and elbow when getting out of the bath tub. There was also a blister under her middle fingernail. On the same day, she revisited her primary care provider who diagnosed her with shingles. She was prescribed valacyclovir 1g daily, gabapentin was changed to pregabalin TID, and hydrocodone 7.5mg daily for pain which she used sparingly. On around 13-Jan-2015, she visited a dermatologist for itchy sores on her forearm. The sores were described as "pimples that keep popping up. Once they heal, they scab over look like craters that were the size of a pencil head". The dermatologist diagnosed her with post herpetic neuralgia and prescribed fluocinonide cream. On 03-Feb-2015, she still had numbness on her palm including her left pinky. The outcome was not recovered.
I didn't feel like myself. I felt lightheaded. I took my blood pressure, it was 86/66. I thought because I started the pravastatin drug that it may be that. I called my physician and she instructed me to stop the pravastatin. I only had 4-5 doses of it. The doctors office told as I was monitoring my blood pressure to make sure I was hydrated with electrolytes. I went in to see the physician on 4/5/2022. She ordered and echocardiogram and a full blood panel. The TSH and cortisol levels were elevated when the test came back. I have an appointment to see a cardiologist next week and an endocrinologist 5/25/2022. I also have a CAT scan scheduled for tomorrow.
Pt recvd HIB vax & 2 months following vax it was nted that pt had devel a small nodule @ inject site;
Patient calls to say she finished her oral typhoid vaccine on Saturday, 3/22/08. Soon after starting to take it she noted some dizziness, headache and heart palpitations. She also noted upset stomach during course of taking medication. Patient has previous hx of AFIB but this has not troubled her for several years. She contacted both her PCP and her cardiologist who advised her to come in only if palpitations should continue. Patient notes her symptoms have subsided since she finished the vaccine. I advised her that the headache and GI symptoms are certainly possible side effects of Vivotif, but no direct cardiac ADR's are listed for the drug. Advised her to see PCP or go to ER or urgent care if she continues to have palpitations or develops chest pain, or if her headache or GI symptoms do not continue to improve.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. An elderly female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Oct2021 13:30 (Lot number: FF2589) as dose 3 (booster), single, administered in arm right, administration date 13Feb2021 11:30 (Lot number: EL9266) as dose 2, single and administered in arm right, administration date 23Jan2021 12:00 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Known allergy: Parabens" (unspecified if ongoing); "known allergy: several antibiotics" (unspecified if ongoing); "known allergy: garlic/onions" (unspecified if ongoing); "known allergy: rosemary" (unspecified if ongoing); "known allergy: Nut" (unspecified if ongoing); "known allergy: Sulfa" (unspecified if ongoing); "known allergy: raisins" (unspecified if ongoing); "known allergy: citrus" (unspecified if ongoing). Concomitant medication(s) included: THYROID. Past drug history included: Tylenol, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Office visit too late to ID Covid as cause"; PAIN (non-serious) with onset 03Oct2021 08:00, outcome "recovering", described as "body ache". The event "body ache" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: investigation: (unspecified date) unknown results; sars-cov-2 test: (04Oct2021) negative, notes: Nasal Swab; thyroid function test: (unspecified date) abnormal thyroid results. Therapeutic measures were taken as a result of pain. Facility type vaccine reported as pharmacy or Drug Store. If other vaccine in four weeks reported as no and other medications in two weeks reported as thyroid. After the 2nd vaccination had marked shortness of breath, headache, tiredness & body ache. Office visit too late to ID Covid as cause and had abnormal thyroid results which complicated diagnosis. Symptoms almost gone Sep2021. After 3rd shot all symptoms immediately returned and have decreased as of now, but only the headache is totally gone. Employer required Covid testing every 2 weeks--routinely tested between mid Aug and Dec. 2021--all tests were negative. Reporter was very interested to know if there is a test for allergy to some or all components of the vaccine. Reporter don't want to go through the symptoms a 3rd time. A treatment reported as inhaler to help with shortness of breath. Covid prior vaccination reported as no. Treatment ae reported as yes. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Based on the information in the case report, a causal association between reported events and suspect BNT162B2 cannot be excluded. Linked Report(s): US-PFIZER INC-202200461578 similar report from same reporter.
Very sore left arm, 101º fever, body aches, fatigue, mild headache 2nd day: Fever and headache gone, other symptoms much milder 3rd day: Symptoms very mild early, arm still a little sore for a few days
rash all over stomach; 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 RASH (rash all over stomach) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash all over stomach). At the time of the report, RASH (rash all over stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
From 27OCT90-31OCT90 irritable & seemed tired but didn't wish to sleep, wished to be held. Temps were 98.8-99.6. 28OCT90 child woke w/a shrill, loud scream. 29OCT90 diarrhea w/severe irritation; 9NOV90/w rhinorrhea x 3-4 days; Dx OMedia,PR.
Nothing first night, woke up following day with a negligible tenderness at left shoulder.  No issues until 10am, had a smoothie, first sip agony left side maxilla from front incisor to 3rd molar. Pain radiated through my jaw up to my ear for about 30 minutes.  Once subsided no further issues at this location. Worked around the house all day (moderate activity, painting walls cleaning etc) after dinner took a shower and while my body was cooling down and starting to rest my right shoulder (not injection side)  (have bursitis on my right side joints from over use) started to spasm in spurts of 5-10 minutes. Went to bed around 10pm and spasms continued to increase in duration. Woke up around 2am with spasms in my right forearm and hand. They were mild but enough to wake me. Finally went back to sleep around 6am, woke up around 830am with mild numbness at both knees and feet. Dissipated within a few hours. Muscle spasms in forearm and hands decreased activity, but right calf started firing through the next night when at rest (lasted 2 days and were mild). Right shoulder spasms continually reduced duration  through out the next few weeks. Took about 6 weeks for them to completely subside. Always activated most intensely after resting ( increasing in the evening) following moderate to intense activity through out the day.
Information has been received from a 24 year old female with citric allergy who on an unspecified date was vaccinated with a single dose of MMR II . Consumer who is now 38 year old, reported that she received MMR II when she was young and then when she was 24 years old she went to the hospital for 2 days because of a stomach virus and while she was in the hospital she had some upper and lower gastrointestinal tests done and was diagnosed with Crohn's disease. At the time of reporting the patient had not recovered. This is one of several reports received from the same source. Additional information is not expected.
reporting the patient was inadvertently administered a dose ofROTATEQ that had been improperly stored.; No adverse effect; This spontaneous report was received from a Medical Assistant who referred to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not provided.   On an unknown date, the patient was inadvertently administered with  an improperly stored dose (product storage error) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally for prophylaxis (strength, frequency not provided)(lot number S000961 and R033255 have been verified to be valid lot numbers; expiration dates: 19-OCT-2020 and 26-JUN-2020, respectively). The  temperature  excursion was at 48.5 degrees Fahrenheit (F) , for a time frame of 15 minutes, and  the previous temperature excursion was at 46.9 F for a timeframe of 5 minutes. It was reported that the call was due to data logger. No adverse effects were reported.
was vaccinated and had a shingles outbreak/ suspected vaccination failure; shingles outbreak, close to 4 months; pulsating pain; burning; itching; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, burning sensation and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain, burning sensation and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, burning sensation and pruritus to be related to Shingles vaccine.     Additional Information: GSK receipt date: 23-AUG-2022 Reporter's Comments: The reporter reported the case via interactive digital media.. Patient was vaccinated and had a shingles outbreak, close to 4 months and was still experiencing pulsating pain and burning and itching. In 2022, the patient experienced vaccination failure, shingles, pain, burning sensation and itching.  Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding time to onset, dose number and laboratory test confirming shingles were unknown at the time of reporting.
Narrative:  COVID infection following COVID vaccine series 12/16/2020 Pfizer, dose #1 01/06/2021, Pfizer, dose #2 10/01/2021 Pfizer, dose #3 08/18 CXR impression: Suspected residual bronchovascular crowding and atelectasis rather than residual/recurrent infiltrate right lung base, otherwise no radiographic evidence of acute cardiopulmonary disease. 08/23 COVID swab, result: not detected 08/27 COVID swab, result: detected 08/27 pt cc: exposure:  unknown 08/30 CXR: FINDINGS AND IMPRESSION: Support devices: None identified Mediastinum: Normal cardiac size. No central pulmonary vascular enlargement. Lungs and pleura: no dense consolidation or pleural effusion is identified. Bones: Unchanged 09/02 pt cognitively impaired admitted to  COVID unit 09/07 clinically resolved 09/16 COVID swab, result: not detected
pt recvd vax; mom states w/ last immun,pt inconsolable crying for 3 hrs; had fever,but mom did not take t; p/ 3 hrs,pt did settle down & had no further problems;
6 mo old w/fussiness. Crying assoc w/BM on and off for past few weeks. Increased in frequency over past 2 days - Episodes in sleep, not associated w/BM's. No fever, no sig. labs. (ED note 5/6/17).
No additional AE information reported; A patient was adminstered PEDVAX HIB (expiration date 10/17/2021) on 1/21/2022; This spontaneous report was received from a medical assistant, concerning an 11-month-old patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 21-JAN-2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number S000356, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 17-OCT-2021), as prophylaxis (dose, frequency, route of administration, anatomical location and vaccination scheme were not reported) (expired product administered). No additional adverse events were reported.
Epigastric and should pain on 3/31/21. Patient hospitalized on 4/6/21 and found to have pneumonia. Unusual appearance on imaging - cryptogenic organizing pneumonia. BAL positive for SARS-CoV2 PCR. Of note, initial Np swab on 4/5/21 was negative.
This is a spontaneous report received from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1283, expiry date: unknown), via an unspecified route of administration, on 04Feb2021, at single dose, for COVID-19 immunization. Medical history included COVID-19 on Mar2020 (reported as "had the virus"). The patient's concomitant medications were not reported. The patient had a temperature, chills and headache on an unspecified date in Feb2021. The patient thought that it is because she had the virus back in Mar2020. She heard that if you had the virus that the side effects from the vaccine are worse. She wanted to know if that was true. She also wanted to know if she can take Tylenol. She reported that she does not think she will get the second one if it was like this. The outcome of the events was unknown.
Side effects of the moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects of the moderna shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects of the moderna shot). At the time of the report, VACCINATION COMPLICATION (Side effects of the moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication information was provided.   Reporter did not allow further contact
Face is extremely swollen with her lips; Felt like all bone was hurting; High Fever; Rash on her chest and stomach; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face is extremely swollen with her lips), BONE PAIN (Felt like all bone was hurting), PYREXIA (High Fever), RASH (Rash on her chest and stomach) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032LL20A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced SWELLING FACE (Face is extremely swollen with her lips), BONE PAIN (Felt like all bone was hurting), PYREXIA (High Fever), RASH (Rash on her chest and stomach) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (Face is extremely swollen with her lips), BONE PAIN (Felt like all bone was hurting), PYREXIA (High Fever), RASH (Rash on her chest and stomach) and HEADACHE (Headache) outcome was unknown.
Informaton has been received from a health professional concerning a 63 year old female who on 12/13/01 was vaccinated with one dose of pneumococcal vaccine 23 polyvalent. Eight hours post vaccination, the patient experienced severe local reaction. According to the reporter, the reaction began as pain and swelling and progressed to cellulitis. On 12/17/01, the patient was seen by her physician and was trated with an antibiotic. The patient again saw her physician on 12/24/01 for a follow up visit and the reaction was reported as resolving. Additional information has been requested.
Pt recvd vax 3JUL91 @ 810Am; @ 845AM t103.2 AX pt given Pedaprofin x 24 hrs then APAP x 24 hrs; Lethargic, pale, fussy, & wouldn't eat; Seen by MD 4JUL91 placed on ATB as one ear maybe slight pink; 3 days later devel diarrhea;
On 12/04/2022 in the late evening around 8:00PM. I had a sore throat. I tested with a home test which was negative. On Monday night I was experiencing difficulty breathing. On 11/28/2022 I was taking amoxicillin for a bone graph that was done. I thought It was a reaction I was having from the antibiotics. I tested 2 times negative and the 3rd time on 12/05/2022 I tested positive. I called my doctor on 12/06/2022 she prescribed me with PAXLOVID for 5 days. She also called me to inform me not to take atorvastatin. Today 12/08/2022 is the third day I am on the PAXLOVID.
This spontaneous report as received from a pharmacist refers to a 64 year old female patient with edema/swelling and no drug reactions or allergies. on 07-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number # J000446, expiry date was 11-APR-2014 and dose was not reported), subcutaneous in the right arm. Concomitant therapies included gabapentin, prednisone, furosemide, and simvastatin. On 10-APR-2013, the patient felt tired, and had chills and a high fever and also had a "dime injection site reaction". On 13-APR-2013, the patient woke up with "post nasal drip and a sore throat with headache". Approximately on an unknown date in May 2013 (reported as currently) the patient has a raspy throat. Diagnostic test was unknown. The patient sought no medical attention and no treatment was provided. Raspy throat was not recovered/not resolved. The outcome of felt tired, had chills and a high fever, had a "dime injection site reaction" and "post nasal drip and a sore throat with headache" was reported as recovering/resolving. Additional information has been requested.
This spontaneous report received from a pharmacy intern refers to a 65 year old patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date in June 2018, the patient was vaccinated with a dose of PREVNAR 13 and on 10-SEP-2018 the patient was vaccinated with PNEUMOVAX 23 (dose, frequency and route were not reported) (lot # R006465, expiry date: 24-OCT-2019) for prophylaxis. No adverse effects were reported. No product quality complaint was involved.