chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nine children were evaluated after experiencing an allergic reaction to the first dose; This is a literature report.  A 10-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Allergic rhinitis" (unspecified if ongoing), notes: Atopic history. The patient's concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (medically significant), 120 min after the suspect product administration, outcome "recovered", described as "Nine children were evaluated after experiencing an allergic reaction to the first dose". The patient underwent the following laboratory tests and procedures: Brighton score: INS, notes: insufficient information to meet case definition. Therapeutic measures were taken as a result of hypersensitivity. Additional information: Age: 10; Sex: M; Atopic history: Allergic rhinitis; Anaphylaxis cause: No; Onset after receipt, min: 120; Signs and symptom: Itchy hives; Intervention: Diphenhydramine, steroids; Time to symptoms resolution, h: 6; Meet Resource criteria: INS; Brighton score: INS; Symptoms after second dose: None.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event hypersensitivity and the use of suspect product cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-PV202300015137 Same article/ drug and different patient/ event;
Information has been received from a physician concerning a 52 year old female with no past neurological history, who on 06/08/02 was vaccinated with one dose of rubella virus vaccine live (second generation) (lot # not given). On 06/28/02,the patient developed tingling and numbness of her fingers and toes. Unspecified medical attention was sought and no treatment or medications were ordered. Additional information has been requested.
at around 2am the day following vaccination, the patient noticed itching in her left arm. Around 2pm that same day (day after shot), the patient noticed swelling in the upper lip. She took 50 mg of Benadryl which cleared up symptoms after a couple hours.
This case was reported by a consumer via call center representative and described the occurrence of pain in upper extremities in a adult male patient who received BOOSTRIX for prophylaxis. The patient's past medical history included gallbladder removal (gallbladder had been removed in 1999). Previously administered products included Tetanus with an associated reaction of pain (received in his 40's and had slight pain). On 14th December 2018, the patient received BOOSTRIX (intramuscular) .5 ml. On 16th December 2018, 2 days after receiving BOOSTRIX, the patient experienced pain in upper extremities. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in upper extremities was not recovered/not resolved. It was unknown if the reporter considered the pain in upper extremities to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported, but the patient was in his 50's. The patient did not have any allergies. The patient received BOOSTRIX on upper left arm (left deltoid). The patient was experiencing excruciating pain in left arm and had continued to have the pain. The patient was experiencing severe excruciating pain in left arm and had continued to have the pain. It was reported that the patient was not able to sleep because he could not get his arm comfortable. He had tried multiple means, including ibuprofen, percussion massage, electronic simulation, exercise and nothing had helped him with the pain. The patient believed there was an issue with the lot of BOOSTRIX. There was no product available for return and no replacement of the product or reimbursement was requested at that time. The patient did not receive any other vaccines on the same day or 4 weeks prior to receiving BOOSTRIX. The patient's physician stated that he had a very high tolerance to pain. But this event was excruciating. He stated that he was overdosing on Ibuprofen trying to get relief.
On 8th day after vaccine patient reports she had swelling around injection site and red and itchy-she called her doctor and was told to put a cold compress on site and take benadryl for the itching.  It had cleared up and then came back on the 3/16 and was itching further down her arm. The next day looked red and swollen again. On 18th was red/swollen/hard. She states she took ibuprofen the night of 18th and helped her be able to sleep. Today 3/19 looking pink and slightly swollen.
LIGHTHEADEDNESS; SICK; PAIN IN ARM; TIREDNESS; INJECTION SITE PAIN/ INJECTION SITE TENDERNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 21-MAY-2021, the subject experienced lightheadedness. On 21-MAY-2021, the subject experienced sick. On 21-MAY-2021, the subject experienced pain in arm. On 21-MAY-2021, the subject experienced tiredness. On 21-MAY-2021, the subject experienced injection site pain/ injection site tenderness. The action taken with covid-19 vaccine was not applicable. The patient recovered from lightheadedness, sick, pain in arm, tiredness, and injection site pain/ injection site tenderness on 23-MAY-2021. This report was non-serious.
Pain, itchiness, rash - inner ( L ) thigh & mid abdomen, no hives, no joint issues. Treatment ~ 1% hydrocortisone cream to affected area.
kidneys weren't working; erythematous; Thigh pain reaction; Slight sore throat; Fizzing at the site; had trouble with my eyes and stuff; elevated creatinine; ocular issues; rash,; very red; erythematous; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN B COMPLEX; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization. The following information was reported: RENAL DISORDER (non-serious), outcome "unknown", described as "kidneys weren't working"; RASH ERYTHEMATOUS (non-serious), RASH ERYTHEMATOUS (non-serious), outcome "unknown" and all described as "erythematous"; PAIN (non-serious), outcome "unknown", described as "Thigh pain reaction"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Slight sore throat"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Fizzing at the site"; EYE DISORDER (non-serious), outcome "unknown", described as "had trouble with my eyes and stuff"; BLOOD CREATININE INCREASED (non-serious), outcome "unknown", described as "elevated creatinine"; OCULAR DISCOMFORT (non-serious), outcome "unknown", described as "ocular issues"; RASH (non-serious), outcome "unknown", described as "rash,"; OCULAR HYPERAEMIA (non-serious), outcome "unknown", described as "very red". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Adverse Event(S)/Product Complaint Details: PT experienced side effects after COVID vaccine. PT: I don't think so. I know I wanted to ask about the test strips and, um, I think that's probably, was there something else? Um, just with the, I think with the, with the COVID vaccine, I came in a couple three days afterwards, remember, and my kidneys weren't working. DR: Yeah. PT: And I had turned like this red afterwards and, um, then I had trouble with my eyes and stuff. And I've been taking some vitamins like the B complex which they told me when I had chemo that that helps with nerves and like that and so I've been taking that and so I'm feeling better. I, I'm you know, my kidneys have come back. They're great. DR: Yep. PT: I'm on the lisinopril but I'm hesitant about the booster. DR: Um, come on in. Cap, patient was [DEIDENTIFIED] reaction, period. Thigh pain reaction, period. Thigh pain, period. Fizzing at the site, period. Slight sore throat, period. So which vaccine was it that you got? PT: It was the Pfizer. DR: Cap, problems or concerns. New line, patient had a reaction to the Pfizer vaccine, period.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Atrial fibrillation; 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.  An elderly male patient received bnt162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (Dose 1, single), administration date: 19Jan2021, for COVID-19 immunization, reaction(s): "Atrial fibrillation"; bnt162b2 (Dose 2, single), administration date: 05Feb2021, for COVID-19 immunization, reaction(s): "Atrial fibrillation", "Inappropriate schedule of vaccine administered". The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown". Clinical course: Caller stated that he received 3 doses of the Pfizer BioNTech COVID-19 vaccines on 19Jan2021, 05Feb2021 and 06Oct2021 all from Pfizer. Caller mentioned that he had atrial fibrillation and would like to know if he could get another shot of the vaccine. Caller was over 75.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300317384 Same patient/same product, different dose/event;US-PFIZER INC-202300317383 Same patient/same product, different dose/event;
Difficultly taking a full breath and constant yawning.  I had to push my shoulders back and lift my arms to take a deep/full breath for 2 weeks.  I also had nausea, fatigue, muscle aches, diarrhea for one week.
Sat 15 minutes; was required to sit for 30 minutes; after 15 minutes developed hives along arms, chest and neck. Also had redness and itching.  She took 50 mg of Benadryl and sat another 15-20 minutes. Code called for monitoring.  She refused treatment.
This spontaneous report has been received from an office manager refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of ROTATEQ (lot # K023537, exp. date on 22-JUN-2016), orally, (strength and dose were not provided). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
30 minutes after shot, 10:30, had extreme fatigue. 7:30 not feeling well, went to be bed. Woke at 11:00 with extreme pain lower brain, neck, shoulders, upper back and arms.  Vomited. I was very cold and felt chills started shaking and trembling. Placed 5 blankets on me. I started my breathing exercise to try to relax my muscles to see if I could lesson the pain that I thought was causing the nausea so I could go back to sleep. Slept off and on and finally woke to a fever of 100.4 at 5:00am. Stayed in bed the rest of the day 3/3. Fever broke at 10:00pm
Within about five minutes I started to feel a bit dizzy and disoriented.  Reported to pharmacist who indicated to monitor and not be left alone, contact if got worse and also advised two extra strength Tylenol in case of fever. Took two extra strength tylenol to try to avert pain and fever when I got home and before bed.  Next day woke with low grade fever, slight headache, and felt very achy all over  - like the flu.  Continued with tylenol.  Feel better next day (today), but sill a bit under the  weather.  Arm is also quite sore.
The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 before the administration date; Administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 before the administration date) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     It was reported that the patient had no known drug allergies.     On 30-Mar-2022 at 11:12 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 30-Mar-2022 at 11:12 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 before the administration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 before the administration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had never been diagnosed or tested positive for COVID-19. No concomitant medications were reported. The date the vial was initially stored in the refrigerator was on 01-Mar-2022. The nurse (healthcare provider) at a local county health department that they inadvertently administered the expired Moderna COVID-19 vaccines to 17 patients on 30-Mar-2022 with expiration date was 19-Mar-2022. No patients had reported any adverse events for now. The adverse event had not caused the patient to seek the medical care. The vial had not undergone any temperature excursions. No treatment medications were reported.
I had a baby. My second dose of the vaccine made me have abnormal spotting. I?m exclusively breastfeeding so should not have a period just yet. It could be a coincidence but the spotting started around 10 hours after the vaccine
No other AE reported; ROTATEQ has been administered once since the temperature excursion; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 23-DEC-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 1 dosage form, oral, lot number 1688504, expiration date 19-NOV-2021 for prophylaxis. No other adverse event reported  The vaccines experienced a temperature excursion of 32.9 degrees Fahrenheit (°F) and 34°F for 24 minutes and 16 hours respectively. There were no previous temperature excursions. The call was due to digital data logger.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Mild, Additional Details: Patient reported to RPH on duty on 6/28/2021 that there was a small bump and severe pain at injection.  Rph on duty recommended tylenol and compresses and to see MD or hospital if worsening.
A physician reported that a 61 year old female with a history of asthma received an injection of Pnu-Imune 23 on 10/22/01. Concomitant therapy included Theo-dur (theophylline), Ventolin, (salbutamol), and Serevent (salmeterol xinafoate). One minute post-immunization, she developed labored breathing and cyanosis. a diagnosis of anaphylaxis reaction was made and she was taken to the ER. She was stabilized in the ER and was sent home that evening. This event was considered medically important. FOLLOW-UP information received on 11/14/02 provided the county of vaccine administration.
SWOLLEN LIPS, HIVES ON ARMS AND BODY, ITCHING ON ARMS AND BODY
Patient has history of low level tinnitus since childhood. Within a few days of receiving the second Pfizer COVID19 vaccination patient reported experiencing a significant increase in the level of "ringing" in both ears. There were no other proximate causes to this change, reported as going from a level 1 to variating between a level 3 - 4 on a scale of 5. Over the counter medications to alleviate potential allergy and ear wax issues had no positive effect, nor did prescribed medications taken about two months later. Five months later an ear examination at the clinic showed no ear wax build up or eustachian tube issues, but did reveal high frequency hearing loss. Uncertain whether the hearing loss is causing the elevated tinnitus, or the elevated tinnitus is in frequency range of hearing loss and simply masking these low level sounds.
Cough; Stuffed nose; 12 hours after the vaccine I had a fever of 100 degrees which lasted for 16 hours until I took tylenol; Aches; Chills; Tiredness and exhaustion; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 05Apr2021 at 08:30 (at the age of 33-yeasr-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have allergies to medications, food, or other products. The patient received birth control medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 20:30, 12 hours after the vaccination, the patient experienced fever of 100 degrees which lasted for 16 hours until the patient took tylenol. During that time patient had aches, chills, tiredness and exhaustion. The fever subsided after a day but the aches lasted about 2 days. On 07Apr2021, on the third day, the patient developed cough and stuffed nose which continued to the day of reporting. The patient underwent lab tests and procedures which included body temperature on 05Apr2021 at 20:30 and the result was 100 degrees (unspecified units). The events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events fever, aches, chills, tiredness and exhaustion and included treatment with Tylenol. The clinical outcome of the event fever was recovered on 06Apr2021 at 12:30, the event aches was recovered on 07Apr2021 and the events chills, tiredness and exhaustion were recovered with lasting effects on an unknown date in Apr2021 and the events cough and stuffed nose were not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Pt is s/p liver transplant in May 2012 on chronic immunosuppression medication. He received first dose of Covid vaccine on 1/29/2021. On routine labs on 2/5/2021, LFTs were significantly elevated from baseline -  ALT 123 (27), AST 66 (21), Alkaline Phosphate 242 (127), Total bilirubin 2.8 (0.3), Direct bilirubin 1.9 (<0.2). He did report new full body itching the day before. As a result of elevated labs, the patient presented to the emergency room due to concerns for biliary obstruction versus graft rejection. Repeat liver function tests were still elevated, although slightly better. Abdominal US was normal, no signs of dilatation or obstruction with patent vasculature. Pt was admitted to the inpatient transplant unit overnight and labs repeated on 2/6 showed continued improvement. With this, pt was continued on the same immunosuppressive med regimen and discharged home with close outpatient transplant follow-up.
11/30/21 patient presents to ED for "severe left hip pain". PMHx of "bilateral sciatica s/p MVC" "hyperlipidemia without myalgias"
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Additional Details: 156/82 was bp when paramedics arrived, pulse 67
FELT LIKE HIT BY A TRUCK; SORE THROAT; BODY ACHES; HEADACHE; FEVER; FEELING REALLY BAD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021, the patient experienced feeling really bad. On 16-SEP-2021, the patient experienced felt like hit by a truck. On 16-SEP-2021, the patient experienced sore throat. On 16-SEP-2021, the patient experienced body aches. On 16-SEP-2021, the patient experienced headache. On 16-SEP-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt like hit by a truck, sore throat, headache, fever, body aches, and feeling really bad. This report was non-serious. This case, from the same reporter is linked to 20210936144.
Reported local reaction following influenza vaccination on 09/26/2013. Left deltoid injection site swollen, red, tender, warm and itchy; symptoms began 09/26/2013 following the injection; site measures about 3" in diameter. She treated with Benadryl 25mg po at HS last night with no relief. Diphenhydramine cream applied. Administered Ibuprofen 400mg po. Advised to continue with OTC Diphenhydramine cream if helpful. Recommended regular Ibuprofen therapy, Benadryl po at HS and ice therapy. Provided ice bag. Advised to monitor for increased size and severity of local reaction and if symptoms worsen or do not improve to seek medical care, i.e. Urgent Care.
developed shingles outbreak the following day; stress; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced shingles (Verbatim: developed shingles outbreak the following day) and stress (Verbatim: stress).  The outcome of the shingles was not reported and the outcome of the stress was not resolved.   It was unknown if the reporter considered the shingles and stress to be related to Shingrix.     It was unknown if the company considered the shingles and stress to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-SEP-2023 The patient got her first shingles vaccine and developed shingles outbreak the following day. Doctor thought it was weird because it was not a live vaccine. She thought the outbreak could also be related to stress the patient was currently experiencing. The reporter agrees to follow up from GSK.