chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very sore arm not move it or lift for 3 days.; very sore arm not move it or lift for 3 days.; Hurt so bad trouble sleeping; Hurt so bad trouble sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 09:00 (Lot number: ER8727) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Cefaclor, reaction(s): "known allergies: Cefaclor". The following information was reported: PAIN IN EXTREMITY (non-serious), MOVEMENT DISORDER (non-serious) all with onset 25Mar2021, outcome "unknown" and all described as "very sore arm not move it or lift for 3 days."; INSOMNIA (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 25Mar2021, outcome "unknown" and all described as "Hurt so bad trouble sleeping". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, movement disorder, insomnia, condition aggravated.  No follow-up attempts are possible. No further information is expected.
fainted; weak; tired; dizziness, light headed; nausea; soreness and aches in upper legs; ear pain; swollen throat; joint pain; fever 101; chills; shortness of breath; elevated heart rate; sinus drainage; entire body pain; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the right arm on 05Apr2021 at 09:00 (Batch/Lot Number: ER8734) at 35-years-old as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks of the suspect vaccine.  The patient medical history was not reported. It was unknown if the patient had COVID prior to the vaccination.  There were no concomitant medications. On 09Apr2021 (as reported), the patient experienced: fainted (medically significant; also reported as 4 days after vaccine), weak (non-serious; also reported as 1-2 days after vaccine), tired (non-serious; also reported as 1-2 days after vaccine), dizziness, light headed (non-serious; also reported as 4 days after vaccine/ 7 days after vaccine), nausea (non-serious; also reported as 4 days after vaccine), soreness and aches in upper legs (non-serious; also reported as 4-7 days after vaccine), sinus drainage (non-serious; also reported as 4-7 days after vaccine), ear pain (non-serious; also reported as 4-7 days after vaccine), swollen throat (non-serious; also reported as 4-7 days after vaccine), joint pain (non-serious; also reported as 4-7 days after vaccine), fever 101 (non-serious; also reported as 7 days after vaccine), chills (non-serious; also reported as 7 days after vaccine), entire body pain (non-serious; also reported as 7 days after vaccine) shortness of breath (non-serious; also reported as 7 days after vaccine), and elevated heart rate (non-serious; also reported as 7 days after vaccine).  The patient underwent lab tests and procedures which included body temperature: 101 on 09Apr2021, heart rate: 118-125 beats per minute (bpm) on 09Apr2021. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events was not recovered. The patient was not tested for COVID post vaccination.
This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns an 82-year-old, elderly, female patient. On 16-Oct-2018, temperature excursion of the vaccine occurred. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019) that underwent temperature excursion. The patient did not experience any adverse events after vaccination. The reporter assessed this as non-serious. This case (201805006) was cross-linked to the case: 201805002 reported by the same reporter. Follow-up report received on 13-Nov-2018: The reporter refused to provide the patient's initials. The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The narrative and case comment were amended accordingly.
Information has been received from a nurse practitioner concerning a 37 year old female with no pertinent medical history who in September 2009, was vaccinated with the second dose of GARDASIL. Nurse practitioner stated the new patient to her practice, was vaccinated with first 2 doses of GARDASIL at another health care facility. In the meantime, patient had tested positive for human papilloma virus (HPV) type unknown. The patient sought unspecified medical attention. No further information is available.
Tingling to left site of tongue and tingling around the injection site. Nausea. Tingling is throat area.
One day post vax, mother noticed red, raised, hot, hardened are where DTaP was administered. Presented to the Health Department on 04/19 where same was observed and temperature was 100.1. Consulted primary care physician.
No additional AE reported; HCP reported that PROQUAD was administered to a patient accidently via IM route instead of SC route.; This spontaneous report has been received from a licensed practical nurse referring to a 5-year-old patient. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were unknown by the reporter  On 17-JUN-2022, the patient was accidentally vaccinated with measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) 0.5 milliliter intramuscular (lot number U039955 has been verified to be a valid lot number, expiry date 14-JUN-2023) (strength, frequency, anatomical location, and vaccination scheme were not provided) instead of subcutaneously (incorrect route of product administration) for prophylaxis. No additional adverse event reported.      The outcome of the events was not reported.
Rach, tachycardia, palpitations, shortness of breath shortly after receiving vaccine - given epi, solumedrol, Benadryl.  persistent symptoms the following day.
Large area of erythema covering site (left upper arm). Consistent with allergic reaction. Well demarcated.
Awhile back I broke some ribs, I have osteoporosis and I went to the ER, and they did a x-ray and they saw spots on my lungs.  They called it Ground Glass Opacites. It is in my lungs they said they have seen that with people that have had COVID. They also mentioned my heart is enlarged which could be from COVID as well.   They have referred me to a pulmonologist.    I do not think it has to do with the vaccine it is from COVID.
chills; sweats; nausea; This is a spontaneous report received from a contactable consumer. A 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and Lot Number: EN6198), via an unspecified route of administration in left arm on 22Feb2021 15:15 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Feb2021, the patient experienced chills, sweats, and nausea. The outcome of the events was reported as recovered on an unspecified date.
Only 1st dose was administrated; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on 19th June 2021, Lot number: k2c04, Expiry date: 11 November 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable. Till the time of reporting the patient had not received her 2nd dose, which led to incomplete course of vaccination. The patient was late for the second dose of Shingrix as only the first dose was administered. No adverse event was reported.  The reporter did not consent to follow up.
I woke up with a sore throat and I thought it was a cold. I felt fine the night before. I wasn't sure what was going on so I stayed home just in case it was COVID-19. I then developed a cough and so I called my doctor on the 16th. I told the doctor the issues I was having with the cough and asked for some medicine that would treat that. The doctor advises me to come in because she thought it may be COVID-19. I went in and it was confirmed to be COVID-19. I was given Paxlovid and Benzonatate. which both helped so much. I isolated for 10 days as I was told, and my husband just stayed away from me but the symptoms only lasted for about 5-6 days total.
Here for 4 y/o physical on 7/30/13. Given IZ's and (L) upper outer arm swollen, hot, red 5 cm x 8 cm area when here. KINRIX and Varicella given on (L) arm.
Expired vaccine used; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and 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.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), 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 medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Headache, generally not feeling well, took 1 ALEVE chills, no fever, slept most of the day pain at injection site (ice not needed) symptoms lasted 1 day; injection site pain 3 days.
had Shingrix vaccine and have Shingles/ suspected vaccination failure; have Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had Shingrix vaccine and had Shingles at the time of reporting. The patient asked how often this happens. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
This consumer report (initial receipt 07-Aug-2012) concerns a 55-year-old male patient who had a medical history of high blood pressure and high cholesterol. Concomitant medications included unspecified high blood pressure medication and neomycin. The patient had previously experienced drug reactions/allergies to sulfa drugs and neomycin. The patient received flu vaccination (manufacturer and batch number unspecified) and afterwards cut himself. The patient visited his doctor, unspecified blood tests were performed. The patient recovered on an unspecified date after stopping therapy. No further information was available.
Baby had a very high fever for 24 hours and then had a febrile seizure lasting 30 seconds where his whole body was tense and shaking. He stopped breathing. Lips were blue etc.
Fever; chills; Based on information previously received, the following information [suspect was updated from Sanofi product NOS to influenza vaccine (unknown manufacturer) and classification was delete non-valid] has/have been amended.   Initial information received on 16-Nov-2020 regarding an unsolicited valid non-serious case received from a media  consumer (patient).  This case involves patient (unknown demographics) who experienced fever (pyrexia) and chills, while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious fever (pyrexia) and chills (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was not reported.  There will be no information available on the batch number for this case.
Information has been received from a consumer, for GARDASIL, a Pregnancy Registry product, concerning a 26 years old female patient with no pertinent medical history and no drug reactions or allergies who was vaccinated with a dose of GARDASIL on 08-SEP-2012 (lot #, dose and site of administration were not provided). No other co-suspects were reported. No concomitant medications were reported. On 09-SEP-2012, the consumer stated that after the administration of GARDASIL, she experienced soreness in her arm, short term memory, fatigue, and not able to eat. She has also really sick for 2 to 3 months. No treatment was given for the adverse events. No lab diagnostic test was performed. The patient did not seek medical attention. The patient LMP and EDD were not provided. At the time of the report, the patient outcome was unknown. Additional information has been requested.
I was covid positive Feb 2, went to get shot and had fever, chills, tiredness. Arm sore, limp node under arm swollen.
Chest pain post 5th day of second shot - pain worse with deep breaths - started late afternoon, went on until I went to bed and resolved next day- Pain level of 4/10 - I did not seek medical attention
Was in close contact with my 22 month old who had been exposed to a positive Covid 19 case. I developed symptoms 8/23/21 of aches, malaise, fatigue, nasal congestion, sore throat. Only ran a temp of 101 once. Was taking all my medicines/supplements as listed in beginning of this form. Tested positive 8/26/21. I do feel the vaccine prevented me from getting sicker.
profuse sweating, neck pain, leg pain, exhaustion, fussy, nausea, and vomiting
PULMONARY EMBOLISM; PAIN IN CALVES; TIRED; This spontaneous report received from a patient and patient's mother and  concerned a white, not Hispanic/Latino female of unspecified age. 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 in the right arm for prophylactic vaccination.  No concomitant medications were reported.  On 12-APR-2021, 7 days after receiving the injection, the patient experienced pain in calves, felt tired and had hard time breathing. She went to the doctor, and unspecified tests were run.  On 20-APR-2021, the physician called and told her to go to the ER  (Emergency Room) right away, which is when the patient was diagnosed with pulmonary embolism, further described as right below the right lung. The patient's mother took the patient back to the ER a few days later.  The patient now "seems better", and is able to breathe better again, but was still having a hard time breathing. Treatment medications (dates unspecified) included: XARELTO (rivaroxaban). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tired, and had not recovered from pulmonary embolism and pain in calves. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210505298-covid-19 vaccine ad26.cov2.s -Pulmonary embolism. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient reports he had a reaction to the flu shot. Nausea, vomiting, and confusion.
On 10/6/2022 I had mild neuropathy in hands and feet and mild muscle aches. Intermittently for about 10 days. Diverticulitis began Saturday, 10/15/2022. I saw medical care for the diverticulitis. I had a tele visit on 10/19/2022 when the symptoms got bad. The doctor advised me to get labs and a CT scan. It does not seem like the neuropathy is directly related to the vaccine because I was recovering from muscle soreness from the vaccine the next day, I had muscle soreness that resolved a day or two. It was not anything that was debilitating.  The neuropathy was at least 2 to 3 weeks after the vaccine. The diverticulitis is a known condition that I have had for over a decade with occasional flares.
No addtional AE; The office manager is reporting that a patient received improperly stored vaccine.; This spontaneous report has been received from office manager, regarding to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 01-FEB-2023, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), oral liquid, orally administered, for prophylaxis (lot number: 1892788, which was determined to be valid, with an expiration date on 02-DEC-2023) (strength, dose, and vaccination scheme were not reported).   Administered doses were stored at a temperature of 9.5 degrees Celsius (C), during a time frame of 30 minutes and 0. 28 C for 5 hours and 30 minutes (product storage error). There was no previous temperature excursion.   No additional adverse events were reported in the patient.
Information has been received from a physician via a company representative concerning a 12 month old female patient with no known allergies or reported medical history who on 1/23/04 was vaccinated SC into the right deltoid at 11:30am with a first dose of MMR (lot # 641627/0666N). There was no illness at the time of vaccination. On 1/31/04 the patient developed a significant prolonged afebrile seizure without warning that lasted about 15 minutes. The patient was hospitalized that day and required intubation. On 2/1/04 the patient spiked a fever without sequelae. On 2/2/04 the patient was reportedly doing well and had recovered relatively rapidly. It was reported that the patient would be discharged on 2/3/04. According to the reporter, a neurologist at the hospital told the patient's mother that the event was directly related to the MMR. The reporting physician was not sure that the MMR was the cause of the seizure if the patient did not have a fever. No further information reported. In follow up information the physician reported that a neurologist had diagnosed the patient with an MMR reaction. An EEG and CT of the head were within normal limits. She was hospitalized for four days and no other problems had arisen per the physician. Subsequently, the patient recovered on 2/2/04. Additional information is not expected.
Since the second dose of the Moderna vaccine for SARS-CoV-2, I have had a very swollen lymph node (supraclavicular) on the same side of the body as the injection. It is visibly swollen and can be palpated, and is just over dime-sized in diameter.  I've now had it for 3 weeks with no reduction in size.  There is no pain.  (Please note that this same side effect has occurred to me in the past following administration of the influenza vaccine. It was not unusual for me, but I thought it should be reported. )
Fever, chills, weakness, nausea, further progressed. Ended up with pneumonia, metabolic encephalitis of unknown cause. Hearing loss and vision changes. Vasculitis. Ended up on life support for the mucous plugs. Peg tube placement for inability to swallow.