chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 66 year old female patient, regarding herself. No relevant medical history was reported. Drug reactions or allergies were reported as none. The patient was awaiting heart transplant. On an unknown date in 2014 (also reported as couple weeks before reaction) the patient was vaccinated with ZOSTAVAX. Concomitant medication was reported as none. On 29-JUL-2014 the patient experienced swelling of her lips and tongue (hospitalization) as well as hives throughout her body after taking ZOSTAVAX (hospitalization). The patient was hospitalised overnight. She also reported that she was given anti-viral medications for ten days and prednisolone that did not help her condition. The patient sought medical attention by visiting physician. On an unknown date, unspecified lab work and blood test were performed and the results were not provided. The adverse events did not improve. Outcome of the events were reported as not recovered. Therapy with ZOSTAVAX was not reintroduced. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Information has been received from a receptionist at a physician's office concerning her 12 year old granddaughter who on 09-JUL-2007 was vaccinated with a first dose of Gardasil (lot# unknown) IM injection. On 11-JUL-2007, 2 days post vaccination the patient had experienced nausea, headache and dizziness. Medical attention was sought. At the time of reporting the patient recovered from nausea, headache and dizziness. No further information was provided. Additional information has been requested.
Information has been received from a 61 year old female with an iodine allergy and no medical history who on 02 Dec 2006 was vaccinated SC with a dose of Zostavax. Concomitinat therapy included Effecor. On 05 Dec 2006, the patient developed redness and swelling at the site of injection. She also had a fever. No medical attention was sought and no diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. No further information is available.
pt recv vax 12FEB96 & the same day became irritable,sleepy & sl fever,given APAP;sx cont & 19FEB96 pt was found in crib w/SOB;pt died on 13MAR96;hosp x 3 wk;pt had numerous episodes of sz,edema,blood in brian-declared brain dead 22FE;
arm was sore; red and warm arm; red and warm arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), ERYTHEMA (red and warm arm) and FEELING HOT (red and warm arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A..A (illegible) and 031A21B) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included ATORVASTATIN, METOPROLOL TARTRATE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ), DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) and SEMAGLUTIDE (OZEMPIC) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), ERYTHEMA (red and warm arm) and FEELING HOT (red and warm arm). At the time of the report, PAIN IN EXTREMITY (arm was sore), ERYTHEMA (red and warm arm) and FEELING HOT (red and warm arm) outcome was unknown.            Treatment details were not provided.   This case was linked to MOD-2021-231407 (Patient Link).
This spontaneous report as received from a pharmacist refers to a 61 year old female patient. On 07-SEP-2013 the patient was vaccinated with ZOSTAVAX lot # J003723, subcutaneous. On 07-SEP-2013 the patient stated that the injection site was getting warm and she was feeling discomfort in the local area. The patient went back to the pharmacy on 08-SEP-2013 and was still experiencing the warmth and redness was about 1.5 inches around the injection site. No rash present. The outcome and relatedness were not provided. Additional information has been requested.
The tachycardia started around 7:30 pm/8 pm at night.  My first dose of the Pfizer vaccine was administered around 2:10 pm. When I noticed a pounding heart rate I started taking it frequently and it was noted to be anywhere from 104 beats perminute to 112 beats per minute while at rest and without activity.  It felt like my heart was constantly pounding during this period and this tachycardia continued until around 8:00 pm the next night, which was Saturday, 08/28.  Around that time I noticed my heart rate to be decreasing but it was still in the 90's at rest consistently.   Also, during this 24 hour period while I had tachycardia my heart rate was not irregular and remained regular but very fast.  I did call the pharmacist on Saturday, 08/28 in the afternoon to ask him about this as this was noted to be a documented severe allergic reaction symptom but he instructed me that it was my call as to whether or not to seek medical care.  Since my heart rate was fast but regular and I was not feeling short of breath or having chest pains I decided to rest since I was feeling very unwell I'm general from this first vaccine and that I would make an appointment this week to speak to my healthcare provider about it then as her office if closed on the weekends.  Also, upon waking up on Sunday, 08/29 and shortly after waking up I did have some intermittent dizziness but it resolved within a couple of hours  after waking and neither tachycardia or dizziness was noted after that.
pt recieved undiluted pediatric dose 0.3 ML of vaccine-instead of pfizer 12 + dose. pt reports soreness to arm where injection was given
Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of (privacy) The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Fever developed about 4 hours after vaccination, as high as 104 rectally. Twitching lasting only about 15 seconds, not repeated. Fever not controlled with Acetaminophen. Now on Ibuprofen and Acetaminophen alternating. History of pertussis exposure 4 weeks ago. Coughing and vomiting lasting only a few days; not cultured. No treatment.
Raised site of erythema and tenderness approx. 2-3 inches in diameter. Pruritic rash - day 3.
This spontaneous report was received from a pharmacist refers to an unspecified number of unspecified patients of unknown age. Concurrent conditions, medical history and concomitant medications were not reported. On an unspecified dates since 26-JUN-2015, the patients were vaccinated with an unspecified number of improperly stored doses of ZOSTAVAX (lot # K020186, expiry date 2 2-JAN-2016 (dose, frequency and route of administration not reported). No adverse effect reported. No product quality complaint (PQC) was involved. No additional information provided.  Additional information has been requested.
Pt saw pediatrician 29April04-09:15 for preschool physical. Had "runny nose" clear. No fever. Immunization 4-6 yr old ordered by MD. Pt came to Imm 30Apr04 for shots. Still "running nose" . No fever for over 10days. Immunizations given at 09:30. Pt tolerated well. Sent home. Parent states approximately 18:30 -child complained of itching. Parent noted hives-called Peds 24hour line. Pt sent to doctor. No respiratory difficulties. Child placed on benedryl 15mgm po q 12hours for 5 days and prednisone x 10days. Child doing well on 5/3/04. Mother had given child Children's ibuprofen post vaccination.
After the vaccine, I had excruciating back pain.  I am 26 weeks pregnant. I had a massage the day before and only mild back pain and tightness.   After the vaccine the pain has been excruciating and it has continued. I have a history of back pain but I?ve been pain free for over a year.
I had little to no reaction to the first two Pfizer injections I received, but booster shot caused fever, chills, body pain, and elevated heart rate for 3 days post injection.  The elevated heart rate is what I would consider adverse.   My heart rate was anywhere from 50-100% higher than normal
Body aches, high fever, headache and sore arm. Ibuprofen helped a little. Tylenol did nothing for any symptoms . At the 24 hours mark, the fever is gone but still have body aches.
Moderna COVID-19 Vaccine  Noticed a slightly raised warm red rash at area of injection site that expanded with a central clearing the next day then on the following day began to improve based on the marked area.
pt seen in ofc 1 day p/DPT w/T 102 & irritability & did not fit adverse rxns but later reported high pitched unusual cry later that night
Initial report received from a consumer on 25 Feb 2010: This patient, with an unknown medical history was vaccinated with FLUVIRIN (batch no. unknown), 0.5 ml, intramuscularly on 21 Jan 2010. On 22 Jan 2010, the patient experienced abscessed tooth, numbness in hands, developed stomach flu and red, itchy rash over most of body that produced blisters. It was also reported that, about a week after the blisters began to appeared. The outcome of events stomach flu and abscessed tooth was reported as completely recovered and the outcome of events red, itchy rash, blisters and numbness in hands was reported as condition unchanged.
Low grade fever, severe fatigue/malaise, cough, severe vertigo, loss of appetite,
103 temperature. Muscle aches. Joint pain. Severe headache. Fatigue. Nausea. Chills
1st moderna covid vaccine 4/20 /21 4/23/21 period was 1 week early  and "intense" which was unusual for her as she is always regular  Conceived in between 1st and 2nd doses  2nd vaccine 5/18,  First positive HPT on 5/21 and again on 5/22 and 5/23.  5/24 Started spotting lightly  5/25 Bleeding heavily and cramping badly
Admitted on 2/15 with complaint of generalized weakness only sitting in recliner for about 4 weeks. CT showed pulmonary embolism that was subacute with no infarct and multifocal pneumonia. Evidence of severe distal diverticulosis COVID +. Was anemic and hypotensive. Heme positive stool. Also large sacral decubitus ulcer/deep tissued injury. Started broad spectrum antibiotics and heparin after H/H stabilized. Several days later noted drop in H/H. Heparin stopped. CT of Abdomen revealed acute extravasation from the distal duodenum. Poor respiratory status necessitated intubation with cardiac arrest. Started a vasopressor and resuscitated with blood products. Emergent EGD revealed blood clot attached to duodenal ulcer. Areas injected and clipped. Second vasopressor added. Continued with anemia, thrombocytopenia and coagulopathy noted to have DIC. Continued to decline despite aggressive interventions requested by family.
A few hours post vax, the pt presented to the ER with swelling, pain, redness, itching, and warmth in the right arm for 2 days after the shot. Swelling of 14 cm in diameter. Treated with cold compression pack and Motrin.
Three days post immunization patient developed diffuse body aches, headaches, fever and joint stiffness. Four days post vaccine she noticed a rash on her feet, knees and hands. She tried over-the-counter ibuprofen without much significant improvement. She developed a sore throat. Pharynx was erythematous. Skin showed clusters of erythematous papules on the feet, knees and hands. Impression was arthralgias and rash secondary to MMR reaction. Patient was given Demerol and Vistaril in the emergency department. She was prescribed Naprosyn and
This spontaneous report as received from a certified medical assistant refers to a multiple unspecified patients of unknown demographics. On 30-SEP-2016, the patients were vaccinated with an improperly stored doses of GARDASIL 9 lot # M009378 and expiration date: 23-APR-2018, (strength, dosage and route unspecified). The vaccine was exposed to temperature of 34.6F for the timeframe of 7 hours. The call was because of a data logger. No previous temperature excursion involved. No adverse effect reported. No product quality complaint involved. No further details provided. This is one of several reports received from the same reporter. Additional information has been requested.
COVID-19 Breakthrough. I woke up in the middle of the night thinking it was my allergies. I had scratchy eyes, congestion, sore throat, and, sinus headache. I didn't have a fever or chills. I am so tired, I've been having a lot of fatigue. I've also been experiencing muscle aches.
Intense vertigo and nausea interrupting ability to work. Patient has never experienced this before. 5 days since onset of symptoms and they have not subsided.
This pt received first and second doses of varicella vax. Lab results indicated a lack of seroconversion.
Gave ob patient Tdap per OBGYN, ordering provider, instruction, then realized patient received Tdap the day before already from PCP. Consulted Dr. stated no risk to receive an additional Tdap. Informed patient regarding error and Dr. consultation.  Patient's EDC is 02/28/2023.
Severe muscle pain in the left side upper.  Severe muscular pain upper back to shoulders.
DTAP/IPV administered HIB was excluded, child was not due for HIB, box contains 2 separate vials to be reconstituted to make full combo. Med error due to confusing dosing-education given.
The day following vaccination, client experienced soreness at injection site on arms (both), began with shooting back pain, leg cramps and numbness x 2 1.2 weeks. Week after vaccination, began with fever, sweating and rash over entire body, itching sore tongue and enlargement and sores on tongue. Went to MD at this time. Rash, tongue sores resolved after 4-5 days.
Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body Aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body Aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain management, at an unspecified dose and frequency. At the time of the report, MYALGIA (Body Aches) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up was received on 24 May 2021 included event outcome and treatment was updated.
body aches vomiting diarrhea temp 101 chills flat, red, splotchy rash
Both pt and her husband were sitting in observation after receiving their COVID19 vaccination. They both reported feeling tingling in their throats and a strange taste in their mouths. Trinity EMS was already available in clinic. They evaluated both recipients who then reported feeling better. Both recipients signed refusal for transport to the hospital.
This spontaneous report was received from an online news article (on 21-JUL-2017). The article refers to 18 unspecified patients (ages and genders not specified) who received ZOSTAVAX (Dates of vaccinations, doses, routes of administration, sites of administration, Lot numbers and expiration dates were not reported.) MARRS # 1708USA003597 refers to 16 of the 18 patients). Current conditions, medical history, allergies, and concomitant medications of the patients were not specified. The article stated the following: Eighteen patients have filed a liability lawsuit against Merck, alleging the company produced and sold an "unreasonably dangerous vaccine" that caused serious injuries after vaccination.  The plaintiffs were from 5 different states. Instead of preventing shingles, ZOSTAVAX caused the plaintiffs to "contract a persistent strain of herpes zoster," according to the suit, resulting in painful outbreaks, hospital visits and post-herpetic neuralgia in two cases." (Reference MARRS # 1708USA003624 for the 2 patients with post-herpetic neuralgia.) The treatment and outcome of the Instead of preventing shingles, ZOSTAVAX caused the plaintiffs to "contract a persistent strain of herpes zoster", resulting in painful outbreaks was not reported. Additional information is not expected as there were no contact details. Sender's Comments: GB-009507513-1703GBR007969: US-009507513-1708USA003624.
I have not gotten my period since I received the second dose of Moderna in February of 2021.
Very achy, would not want no one to touch her; Sore arm after every shot; body was hurting; light chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Nov-2021 and was forwarded to Moderna on 17-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Very achy, would not want no one to touch her), PAIN IN EXTREMITY (Sore arm after every shot), MYALGIA (body was hurting) and CHILLS (light chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), ESCITALOPRAM OXALATE (LEXAPRO), IBUPROFEN, PARACETAMOL (TYLENOL [PARACETAMOL]) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Very achy, would not want no one to touch her), PAIN IN EXTREMITY (Sore arm after every shot), MYALGIA (body was hurting) and CHILLS (light chills). At the time of the report, PAIN (Very achy, would not want no one to touch her), PAIN IN EXTREMITY (Sore arm after every shot), MYALGIA (body was hurting) and CHILLS (light chills) had resolved.        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.   Treatment medication was not provided.  Patient forgot the concomitant medication Flonase sometimes and had regular pain, so she takes a combination of pain killers. She was dosage sensitive.  Patient sometimes replaces Ibuprofen with aspirin, does not take aspirin everyday.   This case was linked to MOD-2021-390091, MOD-2021-390090 (Patient Link).
Fever started March 10th and continued until March 12th.  Along with the 101.5 fever came chills, weakness, fatigue, and headache. Tested for COVID-19 and was negative. Also tested for FLU and was negative. No other symptoms.
Listlessness, mild temperature.   Armpit area under right shoulder where shot was administered tender and swollen.  Continued to 11/14/2021.
It was reported, that a female pt received a Yellow Fever and a Hepatitis A (unspecified) vaccination on October 8, 1999. Reportedly, on 10/16/1999, the pt developed urticaria and was evaluated by physician, and dermatologist. Pt was treated with Prednisone and Benadryl. Reportedly, the dermatologist feels it is an allergic reaction to a preservative. Pt stated, the only thing I did differently was eat sheeps cheese the day before I broke out in hives. Pt denies egg allergy.
ITCHY RASH ON BOTH ARMS, THIGHS,  CHEST, AND UPPER BACK; 2 ITCHY BUMPS EITHER SIDE OF  INJECTION SITE; HEADACHE; BODY ACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy. The patient was previously treated with loratadine for pollen allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included ergocalciferol. On 12-MAR-2021, the subject experienced body aches. On 12-MAR-2021, the subject experienced 2 itchy bumps either side of injection site. On 12-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced itchy rash on both arms, thighs, chest, and upper back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and headache on 13-MAR-2021, was recovering from 2 itchy bumps either side of injection site, and had not recovered from itchy rash on both arms, thighs, chest, and upper back. This report was non-serious.
Patient seen in office 3 days after vaccination for redness and swelling of extremity where vaccine was given. Arm circumference on non-affected arm = 18.5 cm. On affected arm circumference was 21.5 cm. Recommended antihistamine once per day until resolved, and to follow-up with the allergist to evaluate for possible allergy to flu vaccine.
Myalgia, Arthralgia, Fever,  CHILLS, FATIGUE, CLOUDY MENTALLY, PULSE OX 95% Narrative:
This spontaneous report as received from a healthcare worker refers to an unspecified patient of unknown age and gender. On an unknown date the patient was vaccinated with an improperly stored VARIVAX (Merck) (subcutaneously, 0.5 ml, lot # and expiration date not reported). No adverse events were reported after improperly stored VARIVAX (Merck) was administered. No further information was provided. Additional information has been requested.
I had my first booster shot of Pfizer covid 19 vaccine Nov2021 then. I got infected with covid 19 Dec2021; I had my first booster shot of Pfizer covid 19 vaccine Nov2021 then. I got infected with covid 19 Dec2021; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A female patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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) all with onset Dec2021, outcome "unknown" and all described as "I had my first booster shot of Pfizer covid 19 vaccine Nov2021 then. I got infected with covid 19 Dec2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2021) infected with covid, notes: I got infected with covid 19 Dec2021. Clinical course: The patient wanted to know whether she can take her second covid 19 vaccine now or do she need to check her antibodies first.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.