chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 12 hours post vax, pt developed 6X7 cm warm indurated area around injection site with no pain or fever. Presumed local allergic reaction. Pt treated with Claritin10 mg, close clinical follow up.  Event resolved within 48 hours.
Information has been received from a physician concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23v polyvalent. Within 24 hours of vaccination, the pt developed urticaria. The pt was seen over a thee week pd. None of the reactions were severe but appeared to be a type three allergic reaction. Unspecified medical attention was sought and no treatment was required. There was no product quality complaint involved. It was noted that the pt recovered. The physician also mentioned other patients who had a similar experience following exposure to pneumococcal vaccine 23 polyvalent. Additional information is expected.
Soldier presented to the Troop Medical Clinic on 5/25/08 with c/o red raised area at Anthrax vaccination site. Pain reported at an 8/10. Burning sensation radiating up arm. Papule measuring 3 by 8cm to the left upper arm noted. Area was erythematous and circular in shape. I&D done via needle aspiration. Orders given for Bactrim DS bid x 10 days, Augmentin 875mg bid times ten days, Methylprednisolone 4mg, Hydroxyzine 25mg, Ceftriaxone 2GM IM stat, Aerobic culture taken, Triamcinolone and Diphenhydramine were also ordered. Diagnosed with local infection following vaccination. Returned to clinic on 5/26/08 and given quarters x 72 hours, meds continued and soldier was provided with supplies for dressing changes. Seen again on 5/27/08 and given Ceftriaxone 2GM IM stat and Triamcinolone 60MG IM stat. Seen again on 5/28/08 with improvement in sx noted. Area measures 1cm by 1cm at this time. Orders given to return to full duty and follow up as needed.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 19Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included paxlovid from 25Jan2023 to 29Jan2023. The patient had received other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
RECEIVED CHICKENPOX VACCINE 2 DAYS AGO. NOTICED TODAY REDNESS AROUND THE SITE AND WARM TO THE TOUCH. REDNESS MEASURED 4.5CM X 5CM. ALSO COMPLAINED OF PAIN AT INJECTION SITE. ADVIDED SYMPTOMATIC TREATMENT.
What are the typical side effects; 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 VACCINATION COMPLICATION (What are the typical side effects) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (What are the typical side effects). At the time of the report, VACCINATION COMPLICATION (What are the typical side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. No concomitant medications reported.
Patient was passing out  right after 10 minutes later after the vaccine. He felt  dizzy, weak, and his  hands were numbed  for as short time.. He felt like he was sweating  and still feeling weak. EMS came to take care of him.
This initial spontaneous case, was received on 10-Oct-2017, from other health professional, concerning a 45-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 05-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195128, expiry date: Apr-2018). On the same day, few hours after shot, the patient had a raised, itchy welt. On 06-Oct-2017, the patient recovered from the events. It was reported that, the patient recovered from the events after 72 hours. The reporter assessed the event as non-serious. Significant follow-up received on 26-Oct-2017: The patient details were added (date of birth, age and gender). The event stop date was updated as 06-Oct-2017. Narrative amended accordingly. Significant case correction received 12-OCT-2017: event coding was changed for raised whelped and itchy.
Approximate 5 min after receiving H1N1 injection child reportedly fainted and had seizure like activity was incontinent of urine. Remained pale, cold and some confusion. Applied O2 and was transported to ER. He was observed and released. Questions of hx of seizures in the past.
Initial and follow up info has been received from a medical assistant and a physician concerning a 51 year old female teacher with a fear of injections and allergies to morphine and codeine with hallucinations and a history of migraines who on 10/17/2002, was vaccinated with her 1st dose of pneumococcal vaccine 23 polyvalent (Lot #640578/0996L), injection administered in the left hip at the pt's request. Concomitant therapy included loratadine (CLARITIN), zolmitriptan (ZOMIG) and valdecoxib (BEXTRA). On the day of the vaccination, the pt was started on therapy with valdecoxib (BEXTRA) for inflammation not related to the vaccination. On 10/18/2002 at 10:30 AM for the next week the pt experienced a headache, slept for 2 days, had pain all over including her hair and skin/ached all over for 3-4 days. The pt's developed injection site (left hip) inflammation and tenderness. The injection site was red, hot, hard to touch and the size of her hand. Subsequently, the symptoms subsided. On 10/31/2002, the pt recovered from her injection site inflammation and tenderness. The pt did not notify her physician until 11/07/2002, during an unrelated office visit. The pt did not state what or if treatment was used. Unspecified medical attention was sought. No further info is available.
COVID-19; This is a spontaneous report from a contactable consumer. A 55-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 23-FEB-2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications wee not reported. Subsequently began feeling ill on Sunday and went in on Monday 01Mar2021 tested positive to COVID-19 and the patient was scheduled for second dose on 16 Mar 2021 and caller asked what should he do about second dose. The outcome of the events were unknown.   Follow-up attempts are completed. No further information is expected.
angioedema; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: ANGIOEDEMA (medically significant), outcome "unknown". The event "angioedema" required physician office visit. The patient was seeing an allergist. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and known product profile, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the reported event "angioedema". 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.
Localized erythema and edema to right arm. Tenderness to touch. Abdominal pain.
7 DAYS AFTER VACCINATION 3-29-2020 PATIENT PRESENTED WITH 4X6 RAISED, RED AREA. THE AREA AFFECTED IS TO THE SIDE OF THE VACCINATION POINT.  DR SAYS THAT THE ARM IS WARM TO TOUCH,BUT NO PAIN ASSOCIATED WITH AFFECTED AREA. IMMEDIATELY AFTER VACCINATION ON 3-22-2020 - THERE WAS NO ILL EVENT EXCEPT FOR THE FACT THAT THERE WAS SLIGHT BLEEDING AFTER THE VACCINATION WHICH PRESENTED AS A BRUISE THE NEXT DAY.
Since injections had 3 separate episodes when areas on leg became erythemetous, swollen, and warm.  Mother administered benadryl and patient improved.  Swelling went down.  Patient examined on 04/01/2003 after the 3rd episode.  Adn small nodular areas were palpable along left wastus muscle area.
This spontaneous report as received from a healthcare worker refers to a 24 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 31-JUL-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (Lot#L000610, expiration date 31-JAN-2017) (Strength, dose and route were not provided). Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
About 8-9 hours after getting shot I started feeling tingling in left thigh. A sensation of itchiness, pricklyness, tingling spread to different areas of my body, throughout my body. This is day 5 after the vaccination and these sensations have continued, they are less in the morning but worsen as the day progresses. The sensations move, sometimes in my face, arms, legs, feet, trunk. Sometimes my face feels sort of numb. There is no visible rash.  These sensations and reaction are what I experienced in 2018 after taking several doses of malarone a second time (no reaction the first time 2 years earlier)
Localized redness @ injection site- esp with VARICELLA.  0 Rx except for observation for 30 mins Pt. advised to give BENADRYL @ home no sob, wheezing
Running fever 99+ by 6pm.  By 8pm started aching like flu.  Condition was worse with chills and continued through Monday and started to subside around 7pm 3/15/2021.   Slightly achy on Tuesday will low grade fever.
Client had inconsolable crying and high-pitched within the 1st 24 hours of administration of DTAP #2. Also received IPV #2, HIB #2, HEP-B #2 and Prevnar #2.
That night she had a sore arm; molar hurt; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced that night she had a sore arm leading to pain in extremity and her molar hurt leading to toothache on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of this with Tylenol. She also wants to know if she can go on an antibiotic for her toothache.   Follow-up (11Feb2021): This is a follow up spontaneous report from a Pfizer sponsored program. A contactable consumer reported that:She had eaten popcorn and tooth had cracked. Was reading online and it said not to take Tylenol, Advil or anything. Wasn't sure about Benadryl. Said had to get up in middle of night and took 1 extra strength Tylenol. It did help but worried it will affect vaccine. Wanted to know what is suggested.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Swelling and erythema in the thighs, thighs warm to touch, pain to touch, Pain and tenderness in thighs, Cried for 3 hrs.
No additional adverse events; patient received VAQTA pediatric dose instead of adult dose.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender.  Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.    On 23-SEP-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot # S021092, expiration date 18-MAY-2020; strength and route were not reported) pediatric dose instead of adult dose for prophylaxis (incorrect dose administered). No adverse events were reported.
Information has been received from a Doctor of Pharmacy concerning a 68 year old female who on Oct 11 2004 was vaccinated in the left arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 649693/0486P). Subsequently, in October 2004, the patient developed severe muscle pain, swelling of arm and did not feel well. The patient sought unspecified medical attention. The Doctor of Pharmacy also reported another patient who had a similar reaction post vaccination with pneumococcal 23v polysaccharide vaccine (lot # 649693/0486P). Additional information has been requested.
Hospitalization: 4/12/2022 - 9/14/2022 (155 days) Presentation to the ED: HYPERTENSION. COVID-19 + date: 7/23/22 Treatment: PATIENT DEVELOPED COVID ON 7/23/22. ANTIBIOTICS. NO PROPHALYXIS OR STEROIDS. Discharge to: PRIVATE
Patient to health department 9/13/06 states neck right side starting hurting 9/12/06 pm, no redness at site of injection in right arm but has supraclavicular node, right chest and tenderness. Patient stated muscles very sore top of right shoulder, clavicle area and tropes versus muscle back of right shoulder.  Sent to private medical doctor give to note- patient did not keep appointment.
This spontaneous report was received from a physician refers to a female patient of unknown age. On an unknown date, the patient received ZOSTAVAX (dose, route and lot not reported) and developed shingles. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was unknown. This is one report of several reports from the same source. Additional information has been requested.
mom states baby was staring, upper & lower extremities were trembling & resp were rapid;mom states pt did not have a fever;
2hr p/vax mom reported hives all over & child face & lips extremely swollen-eyes swollen shut;pt taken to ER had also devel a runny nose & croupy cough;seen by MD;placed on Zyrtec & pediapred;
Patient reported having pain and swelling at the injection site. Uncomfortable feeling at night when sleeping on the side of the injection.
developed Covid; developed Covid; This is a spontaneous report from a contactable pharmacist. A 55-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on Oct2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Pharmacist is calling about a patient, male, aged 55, who received his first dose of the Pfizer BioNTech Covid 19 vaccine 21 days ago (not specified) and then developed Covid on an unspecified date. He is due to receive his second dose of the vaccine today. The outcome of the events was unknown. The events were considered as serious (medically significant).  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events  Drug ineffective, COVID-19  cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
About 3:30 in the morning, I had terrible side effects. I got up to go to the bathroom, felt fine, went to the bathroom, stood up, suddenly felt very dizzy, and then ... I woke up on the floor, my head and shoulders in my shower. The dizziness was gone, but I had a lump on the back of my head. For a short while there was a buzzing in my ears. I felt feverish and stayed where I was because the floor was cool. When I finally felt able to get up, I walked to the kitchen for a bowl in case I vomited. I started writing a note about what happened in case I didn't make it through the night. As I was writing, I started vomiting, which lasted for several minutes. When I went back to bed, I had the chills for a while.
Patient came back to the pharmacy 3 days after getting the vaccine to report side effects of soreness on the injection site and she could not lift or move her left arm.
Patient received a flu and pneumonia shot on 12/19/06. The patient has lupus. The patient developed left hand and right leg numbness immediately after the injections were given. 02/23/07-records received and reviewed for DOS 12/18-12/26/06 DC DX: meningitis, staphylococcus coagulase negative lupus induced monoeuritis multiplex congestive heart failure exacerbation; two dimensional echo showed global hypokinesia with concentric left ventricular hypertrophy pulmonary hypertension chronic anemia and B12 deficiency diabetes mellitus hypertension SLE Presented with shortness of breath and bilateral lower extremity swelling for three days.  PE: CNS:generalized decrease in strength 4/5 all extremities. Sensation decreased in left lower extremity. Plantars are downgoing.
Lot number of doses not reported.  Hospitalized; supplemental O2; dexamethasone
Headache, Diarrhea, NauseaVomiting, chills, fatigue Narrative:  Headache, chills, nausea, diarrhea, fatigue; advil; recovered in 48 hours.
Patient is a 63 y.o. female who presents to the ED with throat swelling and a facial rash. She had a vaccination for Hepatitis at 11:30 AM and her symptoms began at 12:00 PM. She is allergic to beef, pork and lamb and thinks one of the vaccines has bovine protein. States her symptoms feel improved after taking 50 mg Benadryl. Denies shortness of breath. She did not have any side effects to the COVID vaccination.
Small cut on foot would not stop bleeding  For 2 days. Doctor used Dermabond to stop bleeding. Usually  small cuts stop quickly. Doctor thought I was using a blood thinner.
3/5 painful cyst inside left nostril 3/6 painful swelling under & on sides of tongue 3/7 painful blisters started to form on tongue 3/8 painful blisters started forming on inside of lower lip 3/9 lip started to swell up to the point of interfering with my speech 3/10 chin started to swell up so I went to Urgent Care. They injected me with Benedryl & Toradol. I felt better but when I woke up the next morning, I was worse. 3/11 painful hard lump in chin was growing larger & pain was moving up the left side of my face toward my ear, so I went to the ER. Doctor did CT scan and blood work. CT showed inflammation in my chin. Blood work showed high white blood cells. I think they were eosinophils. Prescribed Keflex & sent me home.
Patient returned to her home and called back to report a strange feeling in her lips and a bad taste in her mouth. She described feeling as if she had eaten menthol. Upon speaking to her a 2nd time, she also reported tingling on her tongue. She denied trouble swallowing, trouble breathing, or swelling of any kind.
I started to experience a problem with my left eye about 6 hours after I received the vaccine. I could see small bolts of white light is the far outside corner of my eye. I first attributed it to an ocular migraine, but those usually only last maybe an hour. The next morning I could still see the bolts of light which were very distracting. I called in sick to work and went to see an eye doctor. He diagnosed me with a PVD (posterior vitreous detachment). It may have been coincidental, however since it occurred on the same day I received the first vaccine, I was advised to report it by V-safe who was doing periodic follow up through texts.
DIZZINESS; WARMTH; SIDE-EFFECTS; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced side-effects. On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced warmth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from side-effects on 10-APR-2021, had not recovered from dizziness, and the outcome of warmth was not reported. This report was non-serious.
Pain noted at injection site within 2 hrs after receiving vaccine. Swelling increased throughout night. Fever noted next AM. Pt reports missing 2 days of work due to being unable to lift (R) arm. Pt given antibiotic by family friend who is Nurse Practitioner. By 3/23/12 symptoms had resolved.
Pt called pharmacy back the following day to report he wasn't told his arm would hurt after getting the vaccine. He reported his arm was very sore and he wasn't even able to use it. I (pharmacist) apologized that the administering pharmacist had not counseled him on this potential side effect beforehand. I let him know that this vaccine can cause some pain at the injection site but that it should be relieved by taking acetaminophen or ibuprofen (whichever his doctor has said he is okay to take) and applying a warm compress. Pt came in on Wednesday (3 days later) to report he still could not use his arm and it was still store. He mentioned he is used to getting vaccines in his shoulder muscle (pointing to his deltoid) but said this shot was given higher up, in his shoulder joint area (pointed to that area). The pharmacist who spoke with him the second time said it may take few more days to heal and that we will be contacting him to follow up on this progress.
This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 7-year-old patient who received FLUARIX QUADRIVALENT (batch number UNKNOWN, expiry date unknown). On 2nd December 2014, the patient received the 2nd dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 2nd December 2014, an unknown time after receiving FUARIX QUADRIVALENT, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional information received: Caller reports that 7 year old received second dose of FLUARIX QUADRIVALENT three weeks after initial dose instead of 4 weeks. No adverse events were stated.