chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3/31/2021 Moderate Pain /soreness at injection site almost immediately after  vaccine. Used ice . 9p.m. Less pain.   2a.m, 4/1/2021-fever of 100.0 F,  640 mg Tylenol. 4/1-11a.m, Temp 99.0 F Continue with ice. 4/1/-5p.m. Temp 100.8,F, slight chills, moderate aches.  Tylenol 640 mg .Injection site reddened, slightly itchy            9 pm Tylenol 640 mg 4/2- Fever did not return. Slight muscle aches, itchy at site..Soreness improving 4/3-4/4 Very minimal tenderness, itching,soreness  4/5- no symptoms
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2009, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 23-DEC-2014, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
VACCINE WAS  REFROZEN; REFROZEN VACCINE ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 20-MAR-2022) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. Age at time of vaccination 40 years old. No concomitant medications were reported.  On 30-AUG-2021, the patient experienced refrozen vaccine administered to patient. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was refrozen and refrozen vaccine administered to patient was not reported. This report was non-serious.
Information has been received from a LPN concerning a 7 year old male who on 08/02/01 was vaccinated with a dose of varicella virus vaccine live (Lot # 638811/0498L). It was reported that the pt has had chickenpox twice since then, in March 2002 and in May 2003. Both cases were relatively mild. Unspecified medical attention was sought and no treatment was required. No product quality complaint was involved.  Additional information has been requested.
This spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. Patients' concurrent conditions and medical history were not reported. On an unknown dates, the patients received doses of improperly stored M-M-R II (lot# K000174, expiration date: 08-JAN-2016, lot# reported as 1002873, expiration date: 27-JAN-2017 or lot# J014876, expiration date: 21-NOV-2015), dose and route were not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
At 34 weeks, 4 days pregnant I was diagnosed with preeclampsia. As a result I had to deliver early at 34 weeks, 5 days via emergency csection. My son was born 5 weeks and 2 days early at 4 pounds, 8 ounces on 6/10/21.
received First Covid vaccine- a week later got a positive test; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration, on an unspecified date, as a single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient received her first COVID vaccine and a week later the patient got a positive test on unspecified date; the second dose will be rescheduled. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
kidney failure; This is a spontaneous report from a Pfizer Sponsored Program from a contactable nurse (patient's daughter). A 101-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 10Feb2021 for COVID-19 immunisation. Medical history and concomitant medication were not reported. Reporter was asking for her mom. Her mom got her first dose of the vaccine on 10Feb. Two weeks after receiving the first dose, her mom's kidney markers elevated leading to kidney failure on an unspecified date. She said that before the vaccine her mom's kidney markers were okay. The outcome of event was unknown.; Sender's Comments: The causal association of the event renal failure and suspected drug BNT162B2 cannot be totally excluded.  Case will be reassessed once new evidences and information are reported.  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
Large red, itchy, hard lump at injection site. Started about 4 hours after given the vaccination. Has continued to get larger and itch is worsening.
This case was reported by a pharmacist and described the occurrence of injection site pain in a 39-year-old female patient who received BOOSTRIX (batch number P39A2, expiry date 15th February 2015). On 29th October 2014, the patient received BOOSTRIX. On 30th October 2014, 1 days after receiving BOOSTRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unkonwn if the reporter considered the injection site pain to be related to BOOSTRIX. Additional information: The patient was vaccinated on 29 October 2014 and pain at injection site has not gone away yet. Hurts to move her arm.
Patient's report: About one week after the immunization, I noticed a burning sensation within an ~3 inch diameter region on my back near my right shoulder blade.  The pain was a constant 1 to 2 on a 10 point scale--tolerable but concerning.  My wife inspected the affected region every night for about a week and saw no sign of inflammation or bruising.  She applied lotion once per night for several nights and that might have slightly reduced the pain.  I tried Tylenol only once and it seemed to have no effect. The pain has persisted, but seems to be reducing in strength to barely perceptible now.
12/8/2021 - Arrive to ER with c/o weakness/urinary problem. UTI diagnosed 2 weeks prior and treated with full course antibiotics but never bounced back. UA normal, Temp 97.6 (100.2 at home), RR 18, Pulse 103, O2 sat 95% on room air. WBC 10.9 12/9/2021 - Covid + test, Monoclonal antibodies given along with Ceftriaxone, Decadron, Doxy, and therapeutic Lovenox.  12/10/2021 - Now requiring supplemental O2-2L to keep saturation >93%. CXR shows no acute disease. Febrile with Temp max 103.7, Pulse 110. Treatments continued. 12/12 - Urine culture unrevealing, now Afebrile. 12/15 - Antibiotics complete, continuing dexamethasone, and weaning from O2. Covid infection resolving. SNF placement following negative Covid swab.  12/16/2022- Respiratory distress, o2 sat dropped to 88%, BP elevated 177/94, O2 via NC placed 1L, o2 rose to 95%. Lasix ordered. 12/17/2022- Down to 0.5L  of o2. Continue current medications.  12/20 - Patient discharged to Ideal for rehab.
Injection site was sore the first week. Starting the second week, upper arm became more sore, and pain extended down biceps to elbow. She has pain when lifting or using that arm and it feels weaker. It is still hurting just as severely as the 2nd week after the injection
Severe Abdominal pain; A spontaneous report, was received from a consumer, concerning a female patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced severe abdominal pain (abdominal pain).  The patient's medical history was not provided. Concomitant medication was not reported.    On 12 Feb 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscular for the prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced severe abdominal pain and visited emergency room (ER) and stayed there for 7 hours. On 18 Feb 2021, the patient was re-hospitalized and stayed for 25 hours. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not provided.  The outcome of the event, severe abdominal pain, was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
exp w/in 24hr chills, general achiness, nausea & very sore rt arm;T100, started w/both arms being very sore, heaviness & pain;sx resolved w/in 72hr;
Approximately 2.5 years post vax the pt developed chickenpox on his body; red pustulant. Three days later the pt recovered.
pt said they had terrible arm pain after the shot for 7 months, specially when raising arm, did not follow up with md. feels perfect now
I had the first round of vaccine end of December (27th?) and had a bad reaction to it - fever, aches, chills for one day immediately after vaccine, and then general malaise for a couple of days afterward.  When I got the vaccine yesterday I had hoped it wouldn't be as bad but honestly the symptoms were worse.  I got the shot at 4PM, came home, had the normal arm pain at about 6:30/7PM.  It hurt to lift my arm and traveled around to underneath my armpit.  The fever and chills and aches started at 2AM.  I woke up to use bathroom and was shivering so bad and had aches EVERYWHERE.  Literally every part of my body was achy.  Right now as I'm typing this it's about 12:30 in the afternoon the next day.  I had fever this morning of 100 and that was with  tylenol.  Right now I'm on an Advil and have no temperature but I'm literally freezing and achy everywhere.
This spontaneous report as received from a registered nurse (R.N.) refers to unspecified number of patients. No medical history was reported. Since 21-APR-2015, the unknown number of patients (names unspecified) have been vaccinated with ROTATEQ, orally (lot number, dose and frequency not reported) and GARDASIL intramuscularly (lot number, dose and frequency not reported. No concomitant medications were reported. The group of patients underwent supported temperature excursion (incorrect product storage) and did not experience any adverse event. The outcome of the reported events were unknown. The reporter considered the events to be not related to GARDASIL and ROTATEQ. No product quality complaint (PQC) was filed. No further information was provided. Additional information has been requested.
I started my period on Monday, September 20.  My flow was heavy at the beginning of my cycle, which is normal for me.  I received my Johnson and Johnson vaccine at 2:00 p.m. on Tuesday, September 21.  I changed my tampon at 8:00 p.m. that evening.  Upon changing my tampon in the middle of the night, there was no blood on the tampon.  I had no bleeding or spotting from that point until approximately 2:00 p.m. on Wednesday, September 22nd when my period resumed.  Additionally, on the evening of Tuesday, September 21st, at 11:00 p.m., I was experiencing chills, and sweats and had a temperature of 100.6 degrees.
This retrospective pregnancy case was reported in a literature article and described the occurrence of laryngotracheomalacia in a 3-month-old subject of unspecified gender whose mother was vaccinated with DTPa (with small D + P), manufacturer unspecified) during pregnancy. On an unspecified date, the mother of the subject received unspecified dose of DTPa (with small D + P) (unknown route and injection site). The mother's last menstrual period was on an unspecified date and estimated date of delivery was not provided. The neonate was exposed to the vaccine during unspecified trimester. On an unspecified date, after unspecified weeks of gestation, the neonate was delivered by unspecified method. Birth defects were noted. The neonate experienced laryngotracheomalacia which was assessed as a congenital anomaly by GlaxoSmithKline. The subject was hospitalised. At the time of reporting the outcome of laryngotracheomalacia was unspecified.
MEDICATION ERROR.   PEDIATRIC PFIZER WAS NOT DILLUTED AT THE TIME OF THE ADMINISTRATION.  PATIENT RECEIVED CONCENTRATED DOSE..
When patient came in on 12/17/2019 to receive Shingrix #2, patient told the nurse that was administering the shot that he had an adverse reaction after the first shot.  Patient stated that about a week and half after he got the first vaccine of Shingrix, he got shingles on his back, spine and around his side.  He said he had pustules, but that he didn't have any pain.  They stayed for a few days and then went away.
tiredness, headache, chills, fever, muscle pain, and basically feeling like crap for 24 hours after receiving vaccination
Very heavy bleeding with my period happened just a few days after my shot. My periods are always regular with about a 28 day cycle, and last about 5 days. This one was 8 days and heavier bleeding.  Then, 10 days after I was done bleeding with that period, I started ANOTHER period. This one was heavier than the last one, and lasted 7 days.  2 periods within 10 days apart. Normal effects after both shots included fever, fatigue, head ache and body aches. The first shot was worse and lasted about 4 days, and the 2nd shot was more mild, lasting about 2 days.
RIGHT ARM BEGAN TURNING BLUE, PURPLE AND SOME SWELLING WITHIN 48 HOURS. PT PUT ICE ON IT. WENT TO ER, HAD SCAN TO DETERMINE ANY CLOTTING. RESULTS NEGATIVE. STILL HAD SOME DISCOLORATION AFTER 8 DAYS ON ABOUT A THIRD OF HIS ARM. SWELLING WAS NOT EVIDENT.
No adverse event; Patient received a monovalent vaccine instead of a bivalent vaccine; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a monovalent vaccine instead of a bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 9-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     Patient does not have any allergies.  The patient's past medical history included Cat scratch fever. Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, lot number-FK5127, Dose as 0.2 ml, route of administration as : Left deltoid.) on 08-Nov-2021, Pfizer (Dose 2, lot number-FL0007, Dose as 0.2 ml and route of administration as Right deltoid.) on 30-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Alpha thalassemia trait. Concomitant products included AZITHROMYCIN and INFLUENZA VACCINE for an unknown indication.    On 26-Oct-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a monovalent vaccine instead of a bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a monovalent vaccine instead of a bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received a monovalent vaccine instead of a bivalent vaccine).    It was reported that patient had received the vaccine for 6 to 11 year monovalent vaccine at 0.5ml dose. The patient was supposed to receive a bivalent dose. The dose patient received on 26-Oct-2022 was first booster.  No treatment medications were provided by the reporter.
pt recvd vax; ex during few days after vax,noticed eyes roll back & became unresponsive on the 25th;called ems; had sz;spent wk in hosp;they could not find anything wrong;gave meds & sent home;cont to have sz on 4 different meds & more test
felt very tired; Headache; chills; flu like symptoms; deep breath "tickled a little"/intensified/feels fine; Right arm injection site soreness (booster)/right arm still slightly sore; other arm was achy/limbs were achy; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (other arm was achy/limbs were achy), DYSPNOEA (deep breath "tickled a little"/intensified/feels fine), VACCINATION SITE PAIN (Right arm injection site soreness (booster)/right arm still slightly sore) and CHILLS (chills) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Verapamil). Concomitant products included ARIPIPRAZOLE (ABILIFY) for an unknown indication.    On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Dec-2021, the patient experienced PAIN IN EXTREMITY (other arm was achy/limbs were achy) and VACCINATION SITE PAIN (Right arm injection site soreness (booster)/right arm still slightly sore). On 05-Dec-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (deep breath "tickled a little"/intensified/feels fine), CHILLS (chills) and HEADACHE (Headache). On an unknown date, the patient experienced FATIGUE (felt very tired). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (other arm was achy/limbs were achy), DYSPNOEA (deep breath "tickled a little"/intensified/feels fine), CHILLS (chills) and HEADACHE (Headache) had resolved, VACCINATION SITE PAIN (Right arm injection site soreness (booster)/right arm still slightly sore) had not resolved and FATIGUE (felt very tired) outcome was unknown.            Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Significant follow up appended Event added Felt very tired.
Case previously recorded as MA2009-5503. Received the following information from a health care professional via MedCom on 21 NOV 2009: A female adult patient was vaccinated with S-OIV FLUVIRIN (batch no. 102040P1) on an unknown date in 2009. Vaccine ran down arm and hand. No adverse event was reported. MedCom Ref. no.: NA09-008339.
Patient presented with redness and swelling around injection site. Area also swelling in elbow joint. Warm to touch. Required oral antibiotic.
24 hours after the vaccine administration, patient began experiencing respiratory (asthma) symptoms.   She was treated with nubulizer treatment and albuterol HFA inhaler.
pt recv vax 19JUL95 & JUL96 pt exp a failure to seroconvert based on lab values;
11/15/2021 - patient presented to the emergency department via EMS. Pt states today he was unable to get out his recliner d/t generalized weakness, vomited x2. Mildly tachycardic upon presentation at 110bpm, temperature 99.4F. Patient admitted to hospital for observation and close monitoring for significant weakness. Patient's signs/symptoms were improved the next day - he was able to walk and was discharged home 11/16/2021.
02/03/2016 - PREVNAR 13 given IM left deltoid. VIS given. 2/5/2016 - Patient call back stating thinks has had side effect - states after she left clinic B.P 90s/50s - site of injection slightly swollen. 2/8/2016 - Patient comes to clinic arm swollen extending towards the elbow PCP informed patient seen. 2/11/16 - Called patient states arm swelling almost gone. PCP gave her BENADRYL she was on Amoxicillin given at time shot given and this continue as per PCP.
Left axillary lymph node swelling and pain lasting 3+ days, deltoid pain at injection site (2 days),  general body aches, fatigue (3+ days).
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient fainting in waiting area chair after 1st dose of Moderna Covid vaccine. She did not fall from chair. She did rouse when touched and spoken to. She was pale, hot and sweating. She was able to drink water. She was leaning against her boyfriend and possibly went unresponsive again for a second. BP was 118/95; erteam took again : 120/80. She reported abdominal cramping to paramedic. She did choose to transport to local ER. (Of note: there was not pain at injection site.
Information has been received on 23-MAR-2018 from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-OCT-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the patient was treated at a medical center, and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
2 weeks after receiving the Moderna booster shot I woke up with hives and itchy rashes all over the body. These hives have continued for the last few days. I am taking OTC antihistamines and cortisone creams. This is a reaction that I have never had from any other vaccine. had never had this issue ever in my life.
asked me to reach out to you in regards to a COVID Vaccine Reaction I had yesterday. I received my first shot on Tuesday around noon and yesterday I experienced shortness of breath, headache and muscle pain. I ended up in the ER. The ER doctor advised for me to stay home for a few days to make sure everything calms down.
Information has been received from a physician assistant concerning a 12-month-old female who was vaccinated with 0.65 ml dose of zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck). No adverse experience reported. A product quality complaint was not involved. Additional information has been requested.
Child came into office with suspected case of chicken pox, had varicella vaccine 04/21/03. Drew varicella zoster IgG AB which was neg.