chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shot was Monday at 5p. On Wednesday morning she woke up very thirsty and complaining of stomach cramps. She could not hold down any food or water and threw up about 6 times throughout Wed morning. She then slept for 3 hrs., woke around lunch and was able to hold down some Gatorade and toast. Note: She got a flu shot (not sure which one) at the same time as dose 1 of COVID shot.
Information has been received from a physician concerning a 62 year old female with no pertinent medical history, and an allergy to penicillin who on 30-AUG-2007 was vaccinated subcutaneously with ZOSTAVAX (Lot # 658086/0761U).  There was no concomitant medication.  On 30-AUG-2007 the patient developed redness, itching, swelling and pain at the injection site.  The patient was treated with Benadryl.  The event lasted two weeks, and the patient recovered on an unspecified date (approximately 12-Sep-2007).  There were no lab diagnostic studies performed.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
administered only the liquid component of Menveo; administered only the liquid component of Menveo; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amxa419a, expiry date 30th August 2022) for prophylaxis.   On 21st June 2021, the patient received Menveo. On 21st June 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The registered pharmacist stated the patient was administered only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The call center representative did not obtain consent to follow up from the reporter. This case has been linked to US2021151045, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151045:Same reporter
Approximately 9pm on evening of the shot started with body aches, them it moved to freezing chills, fever, very hot sweats, nausea, vomiting, then it all settled down  around 2am but a lingering mild headache sticking around.  Taking tylenol but feel better overall.
8/12/05 Was in on 7/11/05 for TD vaccine, states since the TD injection left arm has been very tender. States has no insurance. Nurse looked at arm no redness or drainage, open wound noted. Recommended seeing a physician but client states no insurance. Told him no sign of infection and that it is very unusual for the arm to be sore for over a month. Called nursing supervisor to speak with client. Client states he does concrete work, suggested perhaps he injured or pulled a muscle at work. Client also complained of dry mouth and wonders if due to vaccine. Told client not one of the symptoms of that vaccine. Client states that he did not notice any redness, swelling or drainage. After the vaccine only noticed a "small quarter size knot". Referred to health center. Client complained of weakness to left upper arm, says he can't even open a door very well with this arm. No muscle atrophy noted, moves arm when describing problems, no obvious alterations in ROM noted, no redness, swelling, or drainage noted. Concur with RN referred to follow up with doctor and report to Health Department as needed.
REDNESS AND SWELLING AT INJECTION SITE AS WELL AS OVER RIGHT SHOULDER (CLAVICLE)
Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received Shingles vaccine many years ago).   On 10th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th February 2020, 1 days after receiving Shingrix, the patient experienced injection site pain. On 12th February 2020, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The reporter stated that his wife experienced pain at injection site after getting the first dose of Shingrix vaccine. The pain started the next day after vaccination and it lasted for total of one day. She has had the original Shingles vaccine many years ago. The reporter did not consent to follow-up. The case has been linked with the case US2020080763 reported by same reporter.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 23-OCT-2013 at 17:30, ZOSTAVAX lot # J004268 was exposed to -14C for an estimated total time out of range of 10.0 hours. On 25-OCT-2013 at 18:30, ZOSTAVAX lot # J004268 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 10.5 hours. On 18-NOV-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J004268, Exp. Date: 12-JUL-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
While giving vaccine the syringe malfunctioned causing the vaccine to spill out and run down the arm. Patient was administered another vaccine.
States IZ given in late AM. He was sitting in a chair talking to someone, when his head "fell to his shoulder". He became extremely dizzy and vomited X 3 and then had a "hot Flash". He then perspired profusely and was not feeling well. He went to bed. He felt better in the AM.
This spontaneous report as received from a consumer refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions were not reported. On an unknown date the patient was vaccinated with MMR II (dose, route of administration were not reported). The concomitant therapy included unspecified medication "A". The reporter stated that the patient, who she knew, acted differently after receiving a dose of MMR II. The outcome of the event was unknown. The causality between the event and MMR II was not reported. Additional information has been requested.
On 20th I had a runny nose that was constant. It was not stuffiness, but it was continuous. It continued into the next day. On Sunday I took a COVID-19 home test and, I was positive. I went to the clinic and had a PCR test which also came back positive. I was prescribed Paxlovid and began taking it the same days. I was fatigued for about 12 or 13 days. I just stayed in the bed. I felt better about 2 days after taking the medication but then the fatigue returned on a Thursday and continued. I continued to quarantine for 10 and remained fatigued for an additional 3 or 4 days. I did eventually recover from all the symptoms. I measured my oxygen levels as I also has some shortness of breath. My oxygen levels remained in the lower 90's.
muscle ache, head ache, erratic and rapid heart rate, fatigue, feeling sick, eyes bloodshot; usual minor maladies flared
Pt recvd 3 doses of Hep B & booster dose & lab eval showed lack of seroconversion; dx w/carcinoma of the colon & it was felt that pt's carcinoma was the reason had not responded to the series of vax;
Patient received first dose on January 27th 2022 then received second dose on February 17th, 2022. Recieved second dose 22 days after first dose.
I started having a racing heart that lasted for days at a time . I went to my heart doctor 2 weeks after symptoms started. she put me on a heart monitor for 30 days. I briefly mentioned having had the covid vaccination at my appt, but she said it didnt have anything  to do with it. I was one of the first in my community to have gotten the shot. So the racing and palpations lasted on and off for 2+ months. They have since subsided. We never did any type of ultrasound at the time because we didnt know about the correlation between shot and myocarditis. my halter monitor did show episodes of tachycardia and bradycardia.
I contracted COVID-19 on 06/19/2022 with symptoms of congestion, headache, and cough. I was prescribed PAXLOVID on 06/20/2022. I was ill for 4 days before my symptoms began to resolve. I am fully recovered with no lingering symptoms.
11x7cm area of induration;cellulitis lt upper arm;pt put on Duricef;
Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, ARTHRALGIA (Joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided\
Patient received the COVID-19 booster dose too early. The 2nd dose given Nov 15, 2021. The new recommended spacing between the 2nd and booster dose: 5 months. The booster given Mar 8, 2022 (about 1 month and 1 week too early).
Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 35 years old female patient who experienced leg numbness, tingling, altered gait and weakness, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Details of concomitant medication was not provided. On 07-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ005AC via unknown route in the no information. On 09 October 2018, The patient developed a non-serious event of leg numbness (Hypoaesthesia), tingling (paraesthesia), altered gait (gait disturbance) and weakness (asthenia), 2 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was mention that the patient reported to the ER on Wednesday for complaining of leg numbness, tingling, altered gait and weakness. Other relevant tests included no lab data was provided. Final diagnosis was complaining of leg numbness, tingling, altered gait and weakness. It was not reported if the patient received a corrective treatment. The patient outcome was reported as Unknown for complaining of leg numbness, tingling, altered gait and weakness. Documents held by the sender: none.
Subsequent to receiving the third dose of Engerix B, the pt experienced a headache. A doctor visit was required and the pt was referred to a neurologist. The most recent information received reports the condition of the pt is ongoing.
LITTLE SLUGGISH TODAY, BUT NOTHING MAJOR; COLD CHILLS; BODY ACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 09:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-MAR-2021 20:00, the subject experienced cold chills. On 13-MAR-2021 20:00, the subject experienced body aches. On 14-MAR-2021, the subject experienced little sluggish today, but nothing major. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold chills, and body aches on 14-MAR-2021 01:00, and the outcome of little sluggish today, but nothing major was not reported. This report was non-serious.
grandma called nurse to report that pt had rxn to vax required ER visit on 20JUL96;pt still sick per grandma;PHN referred family to community benefits program;
1/25/21: Fever 102.6*F, joint pain: hips, back. Palms of hands and bottom of feet on "fire." Body aches. Shortness of breathe, "Can't take a deep breathe." Fatigue.
No additional AE's; underwent multiple temperature excursions; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 12-MAY-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), (lot # T020652 was verified to be valid, expiration date was not reported, however upon internal validation established to be 16-JUN-2022), and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot # S035352 was verified to be valid, expiration date was not reported, however upon internal validation established to be 05-NOV-2021), both for prophylaxis, (dose, route of administration and vaccination site were not provided for both).  The administered doses of vaccines experienced a temperature excursion of -14.03 Celsius degrees for 1 hour 15 minutes, -14.09 Celsius degrees for 9 minutes and -6.3 Celsius degrees for 2 hours. Data Logger was involved. The patient did not experience any additional adverse reactions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA003718: US-009507513-2105USA003706: US-009507513-2105USA003698: US-009507513-2105USA003695: US-009507513-2105USA003680: US-009507513-2105USA003672: US-009507513-2105USA003596: US-009507513-2105USA003554: US-009507513-2105USA003472:
Within 5 mins patient experienced dizziness and hearing which she states like it was far away and also had crackling sounds noted. The episode lasted about 5 minutes and she was fine.
Had 1st dose of Moderna Vaccine 3/15/2021.  Has severe body aches and Severe pain in the entire body for 3 weeks.  Developed a sore throat at that time that has persisted.  She reported to this to me in a recent visit and stated that it was not reported.
Initial information received on 26-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a 4 years old patient who received 0.25 ml dose, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included influenza vaccine from JUN-2015 to JUN-2016. The patient's past medical history, medical treatment(s) and family history were not provided. On 08-Feb-2019, the patient received a 0.25 dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. It was a case of medication error due to vaccine underdose. 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 Directive 2001/83/EC 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.
Large area of redness?sore and hot which is getting more inflamed on day 3+. Also tender lymph nodes in neck on same side as injection arm.
The patient developed a fever of 102F; Caller explained a patient was inadvertently administered PROQUAD and VARIVAX at the same time.; This spontaneous report was received from  a nurse regarding a male patient of an unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 13-SEP-2022, the patient was inadvertently vaccinated at the same time with measles, mumps, rubella and varicella (rHA) (oka-merck) virus vaccine live (PROQUAD) lot #W016355, expiration date: 29-OCT-2023, (dosage regimen, strength, anatomical location, and route of administration were not provided) as prophylaxis; and  varicella virus vaccine live (oka/merck) (VARIVAX) lot #W002596, expiration date: 24-JAN-2024, (dosage regimen, strength, anatomical location, and route of administration were not provided) as prophylaxis (Accidental overdose). On the same day, he developed fever of 102 Fahrenheit (F). It was unknown whether the patient received treatment. At the time of reporting, the outcome of fever was not provided.  The causal relationship between fever and measles, mumps, rubella, varicella (oka-merck) virus vaccine live (PROQUAD), and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
The pt experienced red papules with vesicles and excouatrons of various sizes. Treated with Benadryl.
full blown torso front and back; body rash; shingles; very achy; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in right arm on 16Apr2021 at 03:30 AM (at the age of 48 years old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included post-traumatic stress disorder, neoplasm malignant, anxiety. The patient did not have any known allergies. Concomitant medications in two weeks included ciprofloxacin (CIPROFLOXACIN) for herpes zoster; ethinylestradiol, norgestimate (SPRINTEC); oxcarbazepine (OXCARBAZEPINE); lorazepam (LORAZEPAM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of unspecified vaccine on 16Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 18Apr2021 at 21:30 patient experienced very achy sat. Sun. She woke up with a questionable patch on her abdomen sat. She didn't think related. Sore rash like. She had a full blown torso front and back body rash on sun night. She got cream. Later in the week diagnosed with shingles. She have cancer so not sure what to attribute the shingles to. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of very achy, cream for body rash, valacyclovir for shingles. The outcome of events was recovering.
4 days later, she fell and hurt herself; she had a big bruise on right leg; She had open cut on her right leg; term 4 days later, she fell and hurt herself; She had a sore arm after receiving 2nd dose; She had little fever; This spontaneous case was reported by a consumer and describes the occurrence of FALL (4 days later, she fell and hurt herself), CONTUSION (she had a big bruise on right leg), WOUND (She had open cut on her right leg), PAIN (term 4 days later, she fell and hurt herself) and PAIN IN EXTREMITY (She had a sore arm after receiving 2nd dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (She had a sore arm after receiving 2nd dose) and PYREXIA (She had little fever). On 14-Mar-2021, the patient experienced FALL (4 days later, she fell and hurt herself), CONTUSION (she had a big bruise on right leg), WOUND (She had open cut on her right leg) and PAIN (term 4 days later, she fell and hurt herself). At the time of the report, FALL (4 days later, she fell and hurt herself), CONTUSION (she had a big bruise on right leg), WOUND (She had open cut on her right leg), PAIN (term 4 days later, she fell and hurt herself), PAIN IN EXTREMITY (She had a sore arm after receiving 2nd dose) and PYREXIA (She had little fever) outcome was unknown.            No concomitant medication reported   No treatment medication reported  Action taken with mRNA-1273 was not applicable
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Endolymphic Hydrops or MD" (unspecified if ongoing). Concomitant medication(s) included: HCTZ, start date: 01Apr2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Negative, notes: PCR test, got better and tested at home negative; (unspecified date) Positive; (Aug2022) Positive, notes: Tested positive at home a day after symptoms restarted. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid rebound Took Paxlovid 2 days after + PCR test, got better and tested at home negative. 3 days after stopping Paxlovid got sick again. Tested positive at home a day after symptoms restarted. Symptoms were similar but rebound did not have a fever.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On the evening of 3/21 I started to feel like I had a sore throat.  Morning of 3/22 it felt like a full blow cold with soar throat, swollen glands.  Symptoms became worse throughout the day.  Reported sick at work on 3/23 because symptoms were worse.  (measured temperature 98.9 to 99.9 throughout the say, normal temperature for me is 97.5)  Had covid test that came back negative.  Started taking cold relief medications.  Conditions slowly improved over next few days but still don't feel 100% as of this report.
Fever, Chills, extreme muscle pain all over body, pain in the arm of infection, headache, blocked ear (right)  All started around 10 hours after injection and are continuing 48 hours later.
Presented to ED as per MD for infected left great toe which has not improved after 10 days of antibiotic treatment.  had fever in ED. Acute osteomyelitis of toe. from bone scan.  Admitted with infected toe, from pressure ulcer on plantar aspect.  Was placed on vancomycin.  Acute hypoxemic respiratory failure due to COVID-19 on O2 2L nasal cannula on Nov 19/2021