chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (received the 1st dose on an unknown date. Refer case US2018089348). On 20th August 2018 20:00, the patient received the 2nd dose of SHINGRIX. On 20th August 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm. On 21st August 2018, the patient experienced fever. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the pain in arm and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received the 2nd dose of SHINGRIX on 20th August 2018 and experienced arm soreness in the arm where he received the shot. The soreness presented a few hours after the shot. He said his arm was a little more achy than it was the first time. On the day of reporting, in the morning he experienced a fever of 100 degrees F. The patient had denied permission to contact their physician.
17 hours post injection: tiredness chills muscle aches nausea diarrhea headache Sore arm at injection site continues since injection
temperature excursion due to the thermostat in the refrigerator being accidentally adjusted resulting in a low excursion, MENQUADFI, at a low of 33F out of range for a total of 21 hours with no reported adverse event; administered menquadfi post excursion with no reported adverse event; Initial information received on 09-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2023SA147112.  This case involves a 11 years old female patient who was administered Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] post temperature excursion due to the thermostat in the refrigerator being accidentally adjusted resulting in a low excursion, at a low of 33F out of range for a total of 21 hours with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine Toxoid, Pertussis vaccine Acellular, Tetanus vaccine Toxoid (TDAP) and Meningococcal vaccine B RFHBP/NADA/NHBA OMV (BEXSERO) both for Prophylactic vaccination.  On 04-May-2023, the patient received 0.5ml dose, total (strength: standard) of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection of lot U7595AC and expiry: 11-May-2025 via intramuscular route in the left arm for immunization.  From 02-May-2023 to 08-May-2023, the non-serious event of temperature excursion occurred due to the thermostat in the refrigerator being accidentally adjusted resulting in a low excursion, of Meningococcal A-C-Y-W135 (T CONJ) vaccine, at a low of 33F out of range for a total of 21 hours with no reported adverse event (product storage error)(latency: unknown).  On 04-May-2023, the patient developed a non-serious event administered Meningococcal A-C-Y-W135 (T CONJ) vaccine post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
The next day 10/19/22 I woke up very tired - could not seem to shake it. After lunch I began Vomiting then diarrhea I did not get out of the bathroom until 6 pm. I felt extremely cold - I could not warm up. Went to bed. Next morning woke up very tired still and had one more bout of diarrhea not bad though.
Patient received booster dose first instead of 3rd full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received booster dose first instead of 3rd full dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Immunocompromised. Concomitant products included MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) for Immunosuppressant drug therapy.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient received booster dose first instead of 3rd full dose). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received booster dose first instead of 3rd full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Patient developed a very fine sand paper like rash at the injection site (Left deltoid), 5 minutes after administration of the Hib vaccine. Rash then spread to rest of the left arm, face, and edges of both ears.
Called the patient about getting the second vaccine in the SHINGRIX series. Patient reported feeling fine after the injection but went to the urgent care a month later, 4/17/2018,  to get a cut and rash on his leg checked out. Patient has a history of MRSA and wanted to get the lesions under control as it seemed to be growing. The doctor identified the lesions as a rash consistent with zoster. At the time of the appointment, just under two weeks after the initial lesions, they appeared to be resolving papulovesicular lesions that are now crusted. Plan was to let the rash heal on its own as the course of shingles seemed to be resolving itself. Too late for VALTREX and was not prescribed. MD mentioned the rash being a lesser rash due to the immunization.
fever & fussiness x 3 days p/immun; 3rd day p/immun devel hives & taken to family MD; rx advil & tavist syrup;
Administered Afluria Quadrivalent around 5pm on September 4, 2020. Patient reported that around midnight that night she developed a severe rash, chest tightness, and fainting. She conducted a telehealth visit with doctor, who prescribed Prednisone 20mg, 2 tablets once daily (for 5 days).
tested positive for COVID via nasal swab; tested positive for COVID via nasal swab; This is a spontaneous report from a contactable healthcare professional. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ165), via an unspecified route of administration at left arm on 17Nov2020 18:45 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID via nasal swab on 27Dec2020. The outcome of the events was unknown.; Sender's Comments: The 51-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ165), on 17Nov2020 and tested positive for COVID via nasal swab on 27Dec2020. It was unknown whether he received second dose.   Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  Further information is needed for full meaningful medical assessment.
Gave Rotateq at 13 weeks of age.  No side effects noted.  Gave vaccination orally.  Client had normal infant behavior prior to and after the vaccination.
Nausea, vomiting, diarrhea, fever 101.4, lightheaded, body aches, chills, sore arm at injection site. Was told to take Tylenol to reduce fever and drink liquids.
This spontaneous report was received from a consumer's wife regarding her husband, a 71 year old patient with no pertinent medical history reported. On 29-MAY-2013 (reported as two weeks ago) the patient was vaccinated with ZOSTAVAX (lot number and expiration date not provided) (dose and route not provided) as a prescription from primary physician for ZOSTAVAX. No other suspect therapies were reported. Concomitant medications included aspirin. On an unspecified date in 2013 (reported as a few days later) the patient's arm showed bruising down his elbow to his shoulders. The reporter stated that from their own Internet research it appeared like cellulitis. The reporter was encouraged to consult their healthcare provider. It was reported that the patient still has the bruising on his arm (which arm information was not distinguished). No treatment information was reported. Additional information has been requested.
Received High Dose Flu and PREVNAR 13 vaccines October 8th. On October 9th onset difficulty focusing eyes, weakness, insomnia, mild rashes, ataxia. On Oct 10th medic transport to hosp ER. No acute findings, vitals wnl.
Patient called the pharmacy on 9/17/2020 at 5:00 pm to tell me he has had soreness and swelling  at the injection site for 2 weeks now. He stated the area is not red but it is swollen. He is coming in to show me this weekend. In the meantime I told him to use benadryl at night and cold compress throughout the day. He gets the flu shot every year and has never had a reaction. His wife got hers at the same time and was fine.
Patient presented on 12/27/2021 with right facial droop and right sided weakness. He also reports numbness in his lips with blurry vision. He had further complaints of chest pain and shortness of breath.  Patient was admitted for closer monitoring. Infectious work up completed when patient was noted to be febrile 101.8F. IV ABX initiated vancomycin and Zosyn, and patient tested positive for COVID-19. During this hospitalization he was also noted to have afib. Neurology was consulted who recommended repeat MRI however could not be completed due to patient's underlying respiratory status  Went into AFib RVR on 01/08 and was started on amiodarone drip, amiodarone drip was subsequently stopped due to bradycardia   January 13, WBC is 23 which is improved from 27. He is on HFNC 50L 70%. BP is elevated; restarted hydralazine and minoxidil. He continues on meropenem.  January 15, patient has requested discontinuation of HD and oxygen support and requests comfort measures only.   Patient was pronounced expired at 16:25.
Anaphylactic reaction; Throat block; RASH; SWELLING; CHILLS; A spontaneous report was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction, throat block, chills, rash and swelling.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) Intramuscularly for prophylaxis of COVID-19 infection.  On 12 Mar 2021, the patient experienced the events, anaphylactic reaction, throat block, chills, rash and swelling.  Treatment details included hydrocortisone shot, IV diphenhydramine as oral diphenhydramine was not working - 1st visit to emergency, IV diphenhydramine, epinephrine injection pen (had anaphylactic reaction for this drug also) and prednisone was given to, decrease itching and swelling at the 2nd visit to emergency.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, anaphylactic reaction, throat block, chills, rash, swelling was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
expiration date was yesterday and four shots were accidentally given out; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expiration date was yesterday and four shots were accidentally given out) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expiration date was yesterday and four shots were accidentally given out). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expiration date was yesterday and four shots were accidentally given out) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   Vial did not underwent any temperature excursions.  The vial was initially stored in the refrigerator on 26-Apr-l2022. The patient was administered with booster dose.  No treatment drug were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow-up received contains no additional information.
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old male patient who received inadvertently an expired 0.5 ml dose of vaccine FLUZONE QUADRIVALENT (lot UI865AA  and expiration date 30-Jun-2018) via intramuscular route in the right thigh on 11-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was not reported if patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
facial swelling; including his eyes which were "swollen shit." / Swollen eyes; Red rash on face/ had rash around both eyes; had a rash on his thighs; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; batch/lot number EN6200, NDC number, UPC number and expiry date: unknown) via an unspecified route of administration on 10Mar2021 at 11:00 (age at vaccination: 73-years-old) in right arm as dose 1, single for covid-19 immunisation. Medical history (including any illness at time of vaccination) included ongoing hypothyroidism, ongoing hypertension, ongoing blood cholesterol increased for years and ongoing eczema for 10-20 years. This report was not related to a study or programme. The patient is a veteran and received the covid 19 vaccine. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid-19. No adverse events following prior vaccinations. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. No additional administered vaccines and no other vaccines administered on same date with the Pfizer vaccine considered as suspect. It was reported that the patient was fine on 11Mar2021 but on 12Mar2021, his face blew up, clarified face swelled, had rash on thighs and around both eyes, eyes were swollen shut. The reporter had him take his blood pressure and that was fine and everything else was fine. He had red rash on face. This lasted for about 5 days. The reporter didn't know if that was one of the allergic reaction's symptoms or not, but he had swollen eyes and all red on face. He had swelling that lasted about 5 days but finally subsided. The events required visit to physician office. Patient was taking an antihistamine for swelling and swollen eyes. The doctor did mention to the nurse to tell patient to continue with antihistamine. The rash and swelling finally really went away on 18Mar2021 and he was fine. Patient had no problem in breathing, blood pressure was normal. She wanted to know if he should get the second dose. His MD instructed him to get the second dose but the covid line directed him to not get the second dose. Patient was due for second covid 19 vaccine on 30Mar2021. The reporter was afraid because she had heard that the second covid 19 vaccine might give him a reaction. He had a reaction with the first covid 19 vaccine. The reporter's concern was, should he go and get the second covid 19 vaccine. The reporter wonders if his immune system was affected. The patient underwent lab tests and procedures which included blood pressure measurement: normal (fine) on an unknown date in Mar2021. The outcome of all the events was resolved on 18Mar2021.  No follow-up attempts are possible. No further information is expected.
VERY tired. don't feel right ever since this shot.  Never fully feel rested after sleep.  Body/joint pain that never goes away.  Right shoulder above injection site has a painful spot that has not gone away and there is pain in my right deltoid/shoulder area from using my right arm in any way - picking up anything light, reaching or stretching right arm in any way causes pain to this one spot on right shoulder.  Have a hard time being task oriented and getting anything done. Need to do nothing when off work to recover from normal working days.  Had several instances of having high heart rate and went to hospital for chest xray and EKG. was treated as if i was there for no reason.  no acknowledgement that this was actually happening. treated like a psych patient.  it is not normal to suddenly have tachycardia when doing nothing.  None of the items in this list existed prior to these shots.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Patient was seatd at the pharmacy area after vaccine adminstration. We are made aware of a possible reaction, she states she was feeling a little shaky. I advised her to sit in a head down position for a few mins after I give her 1 dose of oral benadryl 25 mg. She states she is breathing a little fast  and wants us to call EMS. Staff called EMS and dispatcher instructed me to give her a dose of epinephrine (right thigh). Then EMS arrived and transport her after taking her vitals.
was recently diagnosed Covid positive; was recently diagnosed Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 73-year-old patient received BNT162b2 (BNT162B2), 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 "unknown" and all described as "was recently diagnosed Covid positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (12Jun2022) Positive.  Clinical course- The patient Primary Care Physician recommended  take the 5-day PAXLOVID medication. The patient just took first set of morning pills. Sunday tested positive and felt terrible (a 10 on the feeling bad chart). Today, Wednesday, the patient feeling better and am at a level 7 on the feeling bad chart.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a nurse refers to a female patient (also a hospital employee), who was currently in her 40's. The patient had no pertinent medical history or drug reactions/allergies. There was no concomitant medication. The patient stated that she had been vaccinated with a dose of M-M-R II (injection, lot #, dose and frequency were not provided) intramuscularly on an unspecified date as a child. The patient had titers for measles, mumps and rubella drawn on either 04-AUG-2014 or 05-AUG-2014 and the results were negative (also reported as no lab diagnostics study was performed). As treatment, the nurse reported that she administered a dose of M-M-R II (dose and lot # were not provided) to the patient on 19-AUG-2014 intramuscularly rather than subcutaneously (also reported as no treatment was given for the adverse events). The patient stated that the injection "burned" as it was administered. Patient's present status was reported as recovered on 19-AUG-2014. Additional information has been requested.
1. Facial numbness 2. Nausea 3. Pain in back of neck 4. Headache
itching lips started the third day after taking chickenpox vaccine. small water bubble on lips look like chickenpox. Liquid came out of lips.
Extreme fatigue, severe headache with pressure in ears, body aches, and anxiety- all symptoms were expected but have now lasted for 6 days. I have seen my PCP and rheumatologist. I was instructed to rest and if not improved in one week, I should see a neurologist.
pt recvd vax & was on floor unconscious from syncope; RN turned pt on back; pt pulse was strong & regular but was cool, clammy & pale; pt awoke w/in 30 seconds; pt struck lt periatal head on the floor; no bleeding;
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Medium, Additional Details: At the 15 minute mark of the observation period, patient dropped cell phone and slid to the floor.  Pharmacist and Pharmacy Student went over to see if he was okay, patient was unresponsive for 30 seconds.  Patient was breathing throughout.  911 was called and the paramedics arrived in under 5 minutes to do a full workup.  All vitals were normal when they got there.  Patient reports feeling \"blacked out\", but felt fine after about 5 minutes.  Paramedics walked with the patient outside.
Chills; Headache; Body aches; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body aches) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body aches). At the time of the report, CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body aches) outcome was unknown. Not Provided          No concomitant and treatment medication reported.