chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu like symptoms. BIP machine used for breathing with oxygen. Take arthritis medicine. Follow up note states the lot number was not recorded. Follow-up report on 02/19/2003: PT states, "Lots of pain in body and fever. Fine a crue pain."  Annual follow up on 12/23/03: "Vaccine recipient has not recovered from adverse events that were reported for this vaccination.  Have a lot of pain, take lot of pain pill and have to use oxygen."
pt recv vax 1030AM;pt seen in hosp ER by MD T38.9, sz;in AM had another sz;
This case was reported by a nurse via call center representative and described the occurrence of arthralgia in a 56-year-old female patient who received FLUARIX QUADRIVALENT (batch number 92D9J, expiry date unknown). On 4th October 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 4th October 2016, several hours after receiving FLUARIX QUADRIVALENT, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was recovering/resolving. The reporter considered the arthralgia to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: Concurrent medical conditions included media allergy (details not provided). The patient received FLUARIX QUADRIVALENT in her left deltoid. On the same day of vaccination, in the night, after receiving the vaccine the patient developed severe arthralgia all over.
No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 38-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 29-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medication information provided. Patient age was 38 years 6 months. Before use date reported was 08-Sep-2022. Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30 day beyond use date. No treatment information provided.       This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Significant follow up received: Patient information and vaccination details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
The patient is a 67 y.o. with past and current medical history of ICM EF 15-20% chronic systolic heart failure, CAD with hx of anterior STEMI in 2016 with PCI LAD, with 70-80% RCA not intervened at the time, EF25% at that time. He has followed with Cardiology but was referred to another healthcare facility Feb 2022.    He presented to the ED 6/15 with edema, dyspnea, orthopnea, and PND for 1-2 weeks prior to admission. He had admitted weight gain about 20-25 lbs. In the ED, CXR with pulmonary congestion, BNP 5k. He was admitted to care service for diuresis. An echo was updated on admit that showed severely dilated LV with EF 15%. He was diuresed aggressively with a lasix drip. He threatened to leave AMA multiple times, but ended up staying, lasix gtt transitioned to PO torsemide 40mg bid. His fluid status and symptoms greatly improved with aggressive diuresis.   GDMT; his coreg was cotninued. Lisinopril was continued but later held and transitioned to entresto on discharge. He reported a hx of dizziness with aldactone but this was trailed while inpatient and tolerated well. SGLT2i cost was prohibitive, therefore not prescribed.    Patient reported that his wife recently testes positive for COVID, he took a home test and was positive, PCR was positive on admit 6/16. Internal medicine was consulted to help treat COVID. He was hypoxic, unclear how much was from COVID vs fluid overload. He was treated with remdesivir x5 doses. He was offered decadron but declined due to possible edema side effects.    He qualified for home oxygen, especially required it at night, he initially refused home O2 due to the copay, but later okay with a lower copay and was delivered oxygen tanks.
Dizziness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and NAUSEA (Nausea) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced DIZZINESS (Dizziness) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no treatment medication provided. no concomitant medication provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: patient disconnected call without providing any information
Arm sore; This is a spontaneous report received from contactable consumer for a Pfizer sponsored program. The reporter is the patient.  A 72-year-old female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Arm sore".  Additional Information: While assisting the patient with looking up the prescription, she stated that she got her COVID-19 shot and it made her arm sore, and it lasted for 3 days.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Reaction at the site of my injection (noticeable almost immediately upon injection); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Reaction at the site of my injection (noticeable almost immediately upon injection)) 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 SITE REACTION (Reaction at the site of my injection (noticeable almost immediately upon injection)). At the time of the report, VACCINATION SITE REACTION (Reaction at the site of my injection (noticeable almost immediately upon injection)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
The first adverse event occurred in June and involved stabbing pains in my heart and the feeling of glass shards going through my heart. The same event happened several more times in 2021, off and on, and still in 2022 but not as strong. I also had a heart event in November 2021 in which it felt that my heart might give out and this lasted for about 15 minutes until it could calm down. Although I did have tachycardia, This was not SVT.  Additional events include daily unusual pains or aches in my heart, sometimes all day. I ran a half marathon 2 months after the vaccines, and yet began having novel heart issues a month after the run. I had a second heart episode November 2022 which lasted about 30 minutes. Treatments included lying on my back, drinking extra water (I was not dehydrated when stabbing pains or episodes occurred), eating extra green foods, avoiding solutes. Outcome includes recurring occasional stabbing pains and aches. Outcome of episodes includes resolved and heart beating normally after 15-30 minutes. I am still able to run and have run two 10ks since and a 5k. I am wary of doing another half marathon.
hx of "anaphylaxis at 3yo due to pcn so patient was observed post covid vaccine for 30 min.   At about 40 min post vaccine she reported some itching in scalp only.    No chest pain, SOB, lightheadedness,  No  oral/facial swelling;  ;  hx of asthma on meds but no wheezing now. evaluated in emp health -   BP 122/70;  P80;  NAD;  Lungs clear;  Skin clear Given 50 mg Benadryl po ( has taken this "many times before") Mild scalp itching  at 10 am ;   back to work and rechecked at 11:50 am -   "only very mild scalp itch"     Advised ED if worse.
This spontaneous report as received from a licensed practical nurse refers to an unspecified patient. The patient was vaccinated subcutaneously with a dose of 0.65 ml ZOSTAVAX (lot # 663197/1418X, expiration date 04-APR-2010) on 11-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Febrile sz simple fever x 4 days; normal CBC, LP, cultures blood, CSF, Urine;
Pt to ED via EMS for generalized weakness and chronic back pain on 2/3. COVID positive upon admission. On 2/5 Pt is a/ox4, RA,follows commands, pills whole, fever medicated with Tylenol. Fevers continue and 2/5 patient is sepsis is firing. Pt had to be placed on oxygen and by day of discharge, continued to require high-flow nasal cannula 45 L with an FiO2 75%.  Pt completed course of remdesivir and put on baricitinib.  He has been cleared by Pulmonary and Infectious Disease to go to hospital and as such pt transferred to hospital for pulmonary rehabilitation purposes 2/23.
Terrible itch and whelps on palm of hand and bottom of foot, then lip , tongue and throat , used epi pen to control. this is on going and keeps happening
After receiving Td vaccine client's arm became sore the next AM. On Friday arm began to swell from clavicular area to finger tips. Client unable to straighten arm, arm very shaky with tremors. Client to urgent care 8/2/02 to seek treatment.
Pt was admitted 27NOV91 to hosp w/dx of H. Haemophilus Influenzae-pt had fever 101.8 on 25NOV91;
2nd shot received 2/1/2021. Shingles seen 02/18/2021. Blisters broke 02/19/2021. Visited doc 02/20/2021. Rx Valacyclovir (7 days). Pain lasted 2 weeks. Fatigue since then has caused me to have to  nap almost every afternoon, 1.5-2 hours. Unable to concentrate for as long as I used to. Shortness of breath and inability to walk as far as normal (regular 1.5m walk now a challenge). Worsening tinnitus.
High blood pressure; Sweating; Lump in throat; Started seeing stars; Tingling in both hands; This is a spontaneous report from a contactable HCP (Pharmacy intern). An unspecified age male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Jun2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, the patient experienced high blood pressure, sweating, lump in throat, started seeing stars and tingling in both hands. The report was no related to a study or programme. The reporter's Pharmacist wanted to know if these have been reported and if there was any information on incidents of blood pressure increasing. Post-authorization safety reports: As of 31Dec2020, a search of our safety surveillance database for Pfizer-BioNTech COVID-19 vaccine revealed that we have received spontaneous reports of dental paresthesia, paresthesia, paresthesia oral, paresthesia mucosal, intranasal paresthesia, pharyngeal paresthesia, paresthesia ear and vaccination site paresthesia since the market introduction (including emergency use authorization) of Pfizer-BioNTech COVID-19 vaccine. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SkinRash, HYPERtension, Tachycardia, AND CHILLS AND SORENESS AT INJECTION SITE . was seen in local ED and treated with IVfluids and IV Benadryl and  released Narrative:   Employee stated she experienced chills, tachycardia,  hypertension nd skin/rash/mottling after her 2nd dose on  1/25/2021  Other Relevant History:
Vaccine was administered past the 30 day refrigerator expiration date by MA. Moderna and state health department were notified on day of administration. Patient notified today. No known adverse event.
devel tissue swelling,pain & hardness immed p/inj;site 6" diameter;sx stopped p/5 days
burning in her chest; cough; Currently Feet feel kind of numb; her vision was blurred; head ache; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on 05Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization and experienced rash and urinary tract infection. Patient received cipro [ciprofloxacin hydrochloride] for urinary tract infection, benadryl for rash. Caller was a consumer that was calling about the Covid-19 Vaccine and reported that she had her second dose on Friday 05Mar2021. She said that she may have done some thing wrong and reported that she was on an antibiotic for a urinary tract infection and took her last pill finished them on Friday morning. Caller was experiencing side effects, when the caller got the vaccine her vision was blurred for a little bit and had a headache, currently feet feel kind of numb. She clarified the rash was almost gone when she got her second vaccine. Her daughter, who was a nurse, sent her to get the Covid-19 vaccine and her daughter told her that she did not need to mention the rash. She said that the rash was just about gone and she did not think that the vaccine did anything to the rash. Caller mentioned that she did have some other side effects though. The caller clarified that as soon as she got the vaccine and was in the 15 minute holding area, she tried to look at her cellphone and the letters were blurry. Caller said that she had blurred vision. Then she had a headache. When she got in the car she relaxed the rest of the way home and went to bed. The next day she had a little bit of a headache, she had cough, and burning in her chest (on 06Mar2021). She said that she stayed in bed and put a heating pad on her chest. She said that she was getting better everyday. The outcome of all events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Extreme body aches; heavy legs; fatigue; severe headache; painful arm; knot on site of injection size greater than half dollar coin; extremely red; itching  occurred 24 hours after initial vaccine and lasted 48 hours
Urticaria. Treated with Zantac, Claritin, Benadryl, prednisone. Pt has referrals to dermatologist and allergist. Appropriate labs ordered.
Information has been received from a registered pharmacist concerning a female who's husband was vaccinated with a dose of ZOSTAVAX (Oka/Merck) on 20-NOV-2007. On an unspecified date the patient subsequently developed shingles. The patient sought medical attention via her physician. At the time of the report the patient's status was  unknown. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/26/2008. Information has been received from a registered pharmacist concerning a female (235 lbs., 69 in.) physician who's 66 year old husband was vaccinated with a dose of ZOSTAVAX (Merck) subcutaneous (lot 658395/0966U) on 20-NOV-2007 at 13:00. On 27-NOV-2007, one week later, the patient developed shingles. The patient sought medical attention via her physician and subsequently recovered. A product quality complaint was not involved. Additional information is not expected.
Arm very swollen, size of softball, hard and very painful. Muscle pain and complaining of pain.
cardiac arrest; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced cardiac arrest 20 hours after receiving BNT162B2 on an unspecified date. The patient passed away due to cardiac arrest. The patient died on an unspecified date. It was unknown if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: cardiac arrest
Began 1/19 at 2am. Fever 102.2 lasted 2 days, extreme fatigue and muscles wouldn't work, severe migraine, 1/21-1/22: cough, congestion, diarrhea, slight fever, headaches
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an adult female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2010, the patient was inoculated with ZOSTAVAX at a medical office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unspecified date, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Had a stricture; 1st dose received on 03-Mar-2021, 2nd dose received on 21-Mar-2021; Tiredness; throwing up; High fever; This spontaneous case was reported by a consumer and describes the occurrence of STENOSIS (Had a stricture), FATIGUE (Tiredness), VOMITING (throwing up), PYREXIA (High fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 03-Mar-2021, 2nd dose received on 21-Mar-2021) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 14-Apr-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced FATIGUE (Tiredness), VOMITING (throwing up) and PYREXIA (High fever). On 21-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 03-Mar-2021, 2nd dose received on 21-Mar-2021). On an unknown date, the patient experienced STENOSIS (Had a stricture). At the time of the report, STENOSIS (Had a stricture), FATIGUE (Tiredness), VOMITING (throwing up) and PYREXIA (High fever) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 03-Mar-2021, 2nd dose received on 21-Mar-2021) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of TIREDNESS/THROWING UP onset in March 2021, TIREDNESS/THROWING UP onset in March 2021 and HIGH FEVER was not provided. The reporter's causality for the event(s) of HAD A STRICTURE with HUMIRA(ADALIMUMAB) was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Both vaccines were given simultaneously, patient fainted following administration of vaccines. She was unconscious for 15 seconds; she was lowered to the ground from chair. Reports she had only eaten "a little yogurt this morning". She was given juice, refused anything to eat. She remained with nursing staff for 1 hour then we taken to the school nurse.
This spontaneous report as received from a registered nurse refers to a 12 month old female patient. There were no patient's concurrent conditions. The patient's historical condition was not reported. Moreover, there was no illness at time of vaccination. Concomitant therapies included HAVRIX, M-M-R II by "RL" as site of administration and sterile diluent. On 11-OCT-2017, the patient was vaccinated with an improperly stored first dose of VARIVAX with lot #  L050561 and expiration date of 14-DEC-2017, subcutaneously (SQ) in the "LL" as site of administration (strength and dose were unknown) for prophylaxis, which was stored from -9 Celsius degrees (°C) to 8°C (-3.3°C) for 5 hours and 45 minutes. There was no previous temperature excursion. Moreover, it was reported that the temperature excursions were detected by a data logger. No adverse effects were reported.  This is one of two cases received from the same reporter.; Sender's Comments: US-009507513-1710USA007032:
This spontaneous report as received from a pharmacist via a company representative refers to a male patient of unknown age. On an unknown date in August 2013 (reported as some time last week) the patient was vaccinated with a "standard dose" of ZOSTAVAX (lot # not reported), subcutaneously. Patient developed a severe gout attack later in the day on the day of the vaccination. Patient sought medical attention by talking to the doctor. Prednisone was given to patient as treatment, 40 mg once daily. The outcome of severe gout attack was unknown. Additional information has been requested.
Patient reported to student health services 2 days after receiving his Varicella Vaccine (04/08/2009). He present with right upper arm mild swelling and tenderness with a mild induration that was palpable at the injection site and approximately 2 cm diameter outwards/ He was treated with a 7 day course of Keflex 500 mg every 12 and instructed to use ice to reduce the swelling/ He returned to student health on 04/11/2009  for a recheck of his arm and there was great improvement