chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Janssen COVID-19 Vaccine given in Lt-deltoid without incident. Patient placed in observation room for 15 minutes without incident. 5 minutes later patient return to observation room from the waiting room c/o numbness and swelling of Top Lt upper lip. Evaluated by Dr and instructed to give Benadryl 50 mg IM and given in Rt deltoid. Patient observed for 30 min., no further swelling or numbness noted. Previous reaction subsided Reviewed all possible side effects with patient and husband. V-safe instructions also reviewed again. All questions answered. Patient to call with any further concerns. Contact information provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 84-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 84 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) 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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive, notes: positive test 9 days after completion of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information : The patient received paxlovid for COVID 19 treatment from 21Jan2023 to 25Jan2023. Vaccine was received. Other medication in 2 weeks recived (Warfarin, Potassium, Atenolol and Thyroxine).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Approx 2 minutes after administration of PPV, pt experienced anaphylaxis. Epi Pen 0.3 mg administered with recovery of air way within 1 minute. Pt transported to hospital, recovered completely.  Received MR. HPI: 54 yr. old who developed facial swelling, SOB and wheezing within 1 minute of Pneumovax.  Patient was treated with an Epi-pen and given several Duo-nebs, then transported to the ER via ambulance.   PE WNL with the exception of diffuse, faint breath sounds with expiratory wheezes and a prolonged expiratory phase. Txed with Benadryl po, pepcid, and prednisone.  Duo-nebs given x2.  Condition improved and discharged home same day. Impression: Adverse Drug Reaction to Pneumovax
This is a spontaneous report from a contactable pediatrician. A 17 year-old male patient of an unspecified ethnicity received a single dose of TRUMENBA via a unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date for 48 to 72 hours after having received the vaccine the patient experienced significant muscle soreness and he did not want to flex his deltoid due to this. Outcome was unknown.
This case was reported by a consumer via call center representative and described the occurrence of visual impairment in a adult male patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) and (batch number 4F7K7, expiry date 5th December 2020) for prophylaxis.  Co-suspect products included SHINGRIX (batch number G933B, expiry date 22nd September 2020) and (batch number 4F7K7, expiry date 5th December 2020) for prophylaxis. On 21st September 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, the dose was an unknown dose. On 3rd December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 21st September 2018, less than a day after receiving SHINGRIX and less than a month after receiving SHINGRIX, the patient experienced chills (serious criteria hospitalization) and fever (serious criteria hospitalization). On 23rd September 2018, the patient experienced visual impairment (serious criteria hospitalization), shingles (serious criteria hospitalization), balance difficulty (serious criteria hospitalization), dizziness (serious criteria hospitalization), confusion (serious criteria hospitalization) and leg pain (serious criteria hospitalization). On an unknown date, the patient experienced activities of daily living impaired and condition aggravated. On an unknown date, the outcome of the visual impairment, balance difficulty, dizziness, confusion and leg pain were recovering/resolving and the outcome of the shingles, chills and fever were recovered/resolved and the outcome of the activities of daily living impaired and condition aggravated were unknown. It was unknown if the reporter considered the visual impairment, shingles, balance difficulty, dizziness, chills, fever, confusion, leg pain and activities of daily living impaired to be related to SHINGRIX and SHINGRIX. It was unknown if the reporter considered the condition aggravated to be related to SHINGRIX. Additional details were reported as follows: On the same day of vaccination, the patient experienced chills and fever that was lasted for 24 hours. The patient vision was impaired like the patient was looking through a kaleidoscope and the patient's balance was off. The patient had dizziness and pain in his left leg. The patient had shingles on head, down the face and in the right eye. On 24th September 2018, the patient was hospitalized for 4 days. The patient had testing for a stroke but the tests came back negative for a stroke. All of the symptoms improved but did not resolve. After received of a 2nd dose of SHINGRIX, the patient experienced the symptoms worsened again. In early January 2019, the patient went to the emergency room but was not admitted into the hospital. The patient was referred back to his neurologist. The reporter stated that, the vaccine was ruined the patient's life. The patient lost his job and was a shell of the man he was prior to getting SHINGRIX. The reporter consented to follow up.
no AE; administration of improperly stored vaccines; This spontaneous report as received from a certified medical assistant refers to a 5-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapy was not reported.  On 27-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella virus vaccine live rHA (PROQUAD) (dose and route of administration were not reported, lot # S021326, expiration date 05-JAN-2021), for prophylaxis. The vaccine was reconstituted with a sterile diluent (STERILE DILUENT). Previously, the vaccine had experienced temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (8.47 Fahrenheit degrees) for 30 minutes.  The current temperature excursion was from 4 Fahrenheit degrees to 14 Fahrenheit degrees (10.56 Fahrenheit degrees) for 50 minutes. Digital data logger was used. No adverse event was reported.
pt recv vax 13FEB96 & right away hair came out in clumps;pt ponytail one-half as big as formerly;
experienced loss of smell, taste and a headache/she came down with signs and symptoms/she got tested and got the results on Thursday that she was positive for covid 19 virus; experienced loss of smell, taste and a headache/she came down with signs and symptoms/she got tested and got the results on Thursday that she was positive for covid 19 virus; This is a spontaneous report from a contactable Other Health Professional (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection, lot number, via an unspecified route of administration from 14Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first dose of COVID vaccine on 14Dec2020. Eleven days following first dose, she experienced loss of smell, taste and a headache. She stated that she came down with signs and symptoms on 25Dec2020 and she got tested and got the results on Thursday that she was positive for Covid 19 virus. She was due for the 2nd dose of the COVID vaccine on the 6th of January. She asked what she should do about the second dose. She mentioned that her symptoms and positive test results were reported where she works in (State name). She wanted to know information as to whether she should get the second dose. Her second dose's scheduled was 6Jan2021. The event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of suspected LOE and COVID 19 infection due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available. 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.
Information has been received from a licensed practical nurse concerning a female who on 09-AUG-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). No problems were reported. The nurse confirms this was not a case of product confusion. There was no product quality complaint. Additional information has been requested.
Patient said he was of age to receive the vaccine but after clinic was over, it was verified that he was actually 17 and under the approved age to receive the Janssen covid vaccine. no side effects were reported from the vaccine.
Itching and bright red blotches on both arms + legs starting Friday morning.  Has not fully resolved yet as of Sunday afternoon.  Patient was in the sun at the beach Wednesday afternoon.  She has been taking CHLORTRIMETON and is better.
Fever in evening >100-101. Swelling injection site to elbow. Increased erythema and warmth injection site to most arm; slight tenderness.
Patient state he was not feeling sick at time shot was administered. Patient woke up in the middle of the night with chills & fever and could hardly walk - went to the ER - given a nebulizer to help with breathing
8 days after getting the first dose of the Moderna vaccine (April 12th) my arm was itchy. By the following morning, there was a hot and red rash. Over the next few days it turned into a bullseye and was achey. I took claritin, and applied ice and a steroid topical OTC cream. It resolved in 6 days.
Fever of 101 deg F at 9pm, given 2.5mL Infant TYLENOL. No fever when rechecked at 6am the next day.
Initially was thought to have developed  pneumonia but without much in the way of clinical signs - little improvement and moved from local MD to Hospital for further work up.    Developed Rapidly Progressive Glomerulonephritis and vasculitis.  The subsequent acute kidney failure necessitated renal dialysis - which remains ongoing.
Brief syncopal episode, lasted 5-10 seconds then slowly awakened and returned to baseline within a few minutes.  Provided a bottle of water and Jolly Rancher once he was fully awake and drinking well.  He did not remember passing out and thought he was coherent the whole time.  He was held up by his mother and lowered to a chair by myself and his mother at which point he began awakening.  By 15 minutes he had completed drinking his bottle of water and was feeling normal, no residual effects.
fatigue, no treatment, mostly resolved at 14 days from vaccine date sore throat, started bilateral but shifted to left side tonsil/throat (same side as vaccine). Pain mostly resolved at 14 days from vaccine date. swollen left axillary lymph node, discovered at day 13 from vaccine date. No treatment or diagnosis other than self-administered manual exam. As of morning of day 14, swelling is reduced but not gone.
This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a male patient who received Shingrix for prophylaxis. On 6th May 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced diarrhea, chills and influenza-like symptoms. On an unknown date, the outcome of the diarrhea, chills and influenza-like symptoms were unknown. It was unknown if the reporter considered the diarrhea, chills and influenza-like symptoms to be related to Shingrix. Additional details reported as follows: The age at vaccination was not reported. The reporter's husband received vaccination and experienced shivers. This case has been linked with US2018151935, reported by same reporter for herself (patient's wife).
One minute  following vaccination, patient hunched over and fainted. Nursing staff lowered patient off chair and onto floor, raised patient feet above heart level. Patient woke 15 sec later and sat up slowly. Patient given juice and granola bar. Patient observed for total of 50 minutes. Patient vitals remained within normal limits throughout observation period. Patient released after reporting feeling better and all symptoms diminished. No other severe symptoms or concerns noted during observation period noted.
I contracted COVID. I have a slight cough and a sore throat. It progressed to a fever and congestion. I had fatigue also. I called my doctor because I am a transplant patient and was given oral medication and after 5 or 6 days I felt normal again. Molnupiravir was the name of the medication.
presented to the emergency department for evaluation of fevers and chills and was eventually admitted to the hospital with concern for COVID-19 pneumonia with acute hypoxic respiratory insufficiency with exertion
Armpit very sore; lymph nodes very sore; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6208) via an unspecified route of administration in the arm left on 15Mar2021 at 16:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not have any allergies to medications, food, or other products. Concomitant medication included birth control , unspecified (MANUFACTURER UNKNOWN) on unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 at 12:00, the patient experienced arm pit and lymph nodes were very sore post vaccination. This occurred in her vaccination arm a week after the first dose. It was so painful it kept her awake at night . On 5Apr2021, the patient underwent lab test and procedures which included PCR test ( Sars cov-2 test)( test type: nasal swab)and the result was pending. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event.  The clinical outcome of the event lymph nodes very sore and armpit very sore were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient presented to our clinic on 10/24/19 with complaints of soreness, redness, and tenderness to right arm.  Patient reported she received her flu shot 2 days ago on her right arm. Patient showed our PA where the Pharmacist gave her the shot. The PA prescribed Keflex 500mg BID x 7 days for treatment of cellulitis.   We received documentation from the pharmacy who administered the vaccine, there documentation indicates the flu vaccine was given in the left arm, however patient insists it was right arm.  When I spoke to the RPH she reports it is possible the documentation on their end could be wrong as sometimes they give multiple flu shots back to back right now and could have not circled the correct location on their consent.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A female patient received bnt162b2 (COMIRNATY), administration date 14Sep2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "During the call he mentioned that neither he nor his wife can walk well and because of that he cannot go away from the site where he received his first two doses". Additional information: When he will be called to receive his third dose of Pfizer COVID-19 vaccine, he received his second dose on 14Sep, he also calls on behalf of his wife: who also wants to receive the third dose of the vaccine. During the call he mentioned that neither he nor his wife can walk well and because of that he cannot go away from the site where he received his first two doses. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 06-Jan-2021, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Pt vaccinated with Engerix-B developed itching, rash , sores.
unusual and pronounced panic attacks and depression; unusual and pronounced panic attacks and depression; fatigue; fever; sweats; pain in my arm and neck; pain in my arm and neck; swollen lymph nodes; I nearly passed out from an anxiety attack; I nearly passed out from an anxiety attack; This is a spontaneous report from a contactable consumer reporting for herself. A 34-year-old female consumer reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in arm left on 09Apr2021 01:15PM (at the age of 34-year-old) for COVID-19 immunisation. Relevant medical history included COVID prior vaccination. Past drug history included known allergy to cefaclor (CECLOR) and morphine. Concomitant medications were not reported. The patient nearly passed out from an anxiety attach 15 minutes after the vaccine was administered, on 09Apr2021 01:30PM: this had never happened before. For a week after, she experienced fatigue, fever, sweats, pain in arm and neck, and swollen lymph nodes. She had also experienced unusual and pronounced panic attacks and depression since receiving the vaccine and would be seeking medical attention for those issues. Events resulted in physician or other healthcare professional office/clinic visit. No treatment was received. The patient had not tested for COVID post vaccination. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Fatigue from 10 am until 6 pm 2/19/2021 Chills, fever, body aches, nausea from 6 pm 2/19/2021 until noon 2/20/2021 Fatigue and body aches from noon 2/20/2021 until 9 pm 2/20/2021
2006 flu shot mistakenly administered (instead of 2007 shot). Lips, eyes, face swelled. Required adult dose of antihistamine. Mild swelling of eyelids continued into next day.
Temp 101-102 rash on 6-3-09 seen in office.
Urticarial rash spreading from July 27 until 8/1 Treated with prednisone and atarax
It started with muscle aches and stiffness. Couldn't move my head from side to side. I then got hot and cold flashes, nausea, extreme fatigue and nausea. All of those symptoms lasted about 5 days. I had absolutely no symptoms after Dose 2 besides a headache.
Severe localized arm reaction with swelling, redness, edema; onset within 12 hours of injection.
Information has been received from a office manager concerning a female who did not eat the day of the vaccination and a history of passing out who was vaccinated with a first dose of Gardasil. Within 5 minutes of the vaccination the patient's arm went rigid, she "shook a little", and passed out. After she came to she was nauseated. Unspecified medical attention was sought. On the day of the vaccination, the patient recovered. Additional information has been requested.
Received expired dose of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medications were reported.    .   This case was linked to MOD-2021-342712 (Patient Link).
This spontaneous report was received from a 39 year old male patient, who is also a pharmacist reporting on himself. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were reported as none. The patient's concurrent conditions were not reported. On unspecified dates, the patient administered an unspecified number of doses ZOSTAVAX to an unspecified number of patients, for prophylaxis. The reporting pharmacist stated that he never had ZOSTAVAX administered to him but he administered a lot of ZOSTAVAX doses to his patients. On 01-FEB-2017, the patient began experiencing the feeling of a bad sunburn on his back and side and at times it felt like someone punched me in the side about 10 times for the first couple nights". On an unspecified date in February 2017 (reported as after a couple of days), the patient started to develop a rash so he went to his physician and was diagnosed with shingles. It was reported that the patient received an unspecified treatment for the adverse events. At the time of reporting, the outcome of the events was unknown. A product quality complaint was not involved. The causality assessment between the events and ZOSTAVAX was not provided. Additional information is not expected because the reporter refused additional contact.
on 29MAY92 pt recvd DTP/OPV/HIB & cried unconsolably for 6 hrs despite rocking, holding & APAP;