chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning her college aged son who 2-4 years ago was vaccinated with a dose of Varivax. A recent varicella titer was equivical with an IgG of 0.98, did not show seroconversion. Unspecified medical attention was sought. It was noted that no other symptoms were noted. No product quality complaint was involved. Additional information has been requested.
After getting my second COVID vaccine I again had a bad RA and Fybromialgia flare.  Then I noticed that I started have trouble understand people when they talked to me and many times had to ask them to repeat themselves.  I then noticed that I had difficulty hearing what people on the TV were saying, especially if there was music playing at the same time that the people were talking.  I also started having to turn the TV up much louder to be able to hear is even a little clearly.  I had an appointment with my otolaryngologist and discussed this issue with her.  She had a hearing test done and found that I have hearing loss severe enough that I need to have hearing aids.  I have never had these issues before.  Before taking the COVID vaccine my hearing was fine and I had no issues hearing and understand even when someone was whispering.
Moderna Covid 19 Vaccine EAU  Sore Arm- within 6hrs  The following within 8hrs after injection. Lasted for 24-30 hrs. Relieved with Motrin and Tylenol. Dizzines Fatigue Nausea Stomach pain Sluggishness Lymph node formation in left neck.
Information has been received from a 64 year old female patient via a company representative referring to herself. The pertinent medical history and concomitant therapy of the patient were unspecified. On an unknown date, when the patient was 63 year old, she was vaccinated with a dose of ZOSTAVAX (lot # and expiration date unspecified), 0.65 ml, subcutaneously. An unspecified time after the vaccination, the patient developed shingles. The outcome of the event was reported as recovered/resolved on an unknown date. Additional information has been requested.
SHINGLE VACCINATION - SWELLING IN LOCATION WHERE INJECTION WAS INSERTED ON LEFT ARM - REACTION ONSET A WEEK LATER.  THE SIZE OF A PALM. oN. DEC. 18TH - A SMALL BUMP ON RIGHT SIDE OF STOMACH AND NOW IS THE SIZE OF A HALF DOLLAR. ITCHING AND REDNESS.- SEEING PHYSICIAN ON DEC. 29TH.
Vasovagal: 4/28/21  At 5 minutes post vaccine, while in the observation area, patient had a vasovagal episode at approximately 2:40pm.  While patient was scheduling his second dose appointment, patient reported he was feeling unwell to flow monitor. Flow monitor informed PA, while PA was assessing patient, his head tipped back and his eyes rolled back.   A cot was placed next to the patient, and while patient was assisted onto the cot, he came to.   Patient was wearing several layers of clothing, a mask and disclosed he hadn?t eaten yet today.  Patient was given water, cookies and crackers and was observed for an additional 20 minutes before PA released him.
This spontaneous report was received from a licensed vocational nurse referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, or concomitant medications. On unspecified dates, the patients were vaccinated with an improperly stored dose of VAQTA (lot number M033611, expiration date 02-MAR-2018) for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion 57 degrees Farenheit for 15 minutes. A previous temperature excursion of 48 degrees Farenheit for 15 minutes was also reported. The temperature excursions were recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports from the same reported (MARRS No. 1703USA013299, 1704USA001638 and 1704USA001639). Additional information has been requested. Sender's Comments: US-009507513-1704USA001639: US-009507513-1703USA013299: US-009507513-1704USA001638.
Sore arm; Progressive and gradual pain at the neck; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NECK PAIN (Progressive and gradual pain at the neck) and HEADACHE (Bad headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, 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 experienced PAIN IN EXTREMITY (Sore arm), NECK PAIN (Progressive and gradual pain at the neck) and HEADACHE (Bad headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), NECK PAIN (Progressive and gradual pain at the neck) and HEADACHE (Bad headache) had resolved.            No concomitant medications and treatment information was provided. Patient reported that "progressive and gradual pain at the neck, sore arm and bad headache that lasted for about 48 hours and it subsided the next day."   This case was linked to MOD-2021-018463 (Patient Link).
2 1/2" x 1 1/2" area of redness & elevated skin temp lt deltoid area; redness-swelling; dx local rxn to vax;
I had a spot on my right breast because it was itchy and felt a lump. I had chemo and will be starting radiation and will be on medication for the next five years.
Developed lung congestion so I contacted my doctor who gave me prednisone and an antiviral. Still congested and taking antiviral as of today.
The evening of 01/02/2023 I noticed that I  had sore throat.  The next day I had fatigue, cough, chills, low grade fever that never got over 101.0 that lasted another two days. Saw my doctor on the 5th he prescribed a z-pak and prednisone it took around 11 days after medication before it went away.
Received call from client on 10/5/2020. Has been having lower back pain with legs painful to touch since 1/01/2020. Verbalized it hurts to shave my legs. Has been taking Ibuprofen every 6 hours. Advised to call PCP who ordered cortisone 20 mg tablets daily x10 days and Ibuprofen 600mg every 6 hours. Client also tested for COVID. 10/6/2020 Client now reports severe headaches. 10/07/2020 Client called that she continues with severe headaches. Tested negative for COVID. 10/08/2020 Called client who continues with headaches and developed temp of 100.8 last night. Took Aleve tablets with some relief of headache. Verbalized back and legs have been better since 10/07/2020.
awful, very hard on the body; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and felt awful. The patient also stated that be careful of these shots, they were very hard on the body. The follow-up would not possible as no contact details were available. This is one of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR215057:same patient diferent dose US-GLAXOSMITHKLINE-US2021AMR215055:same reporter
This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain and rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site swelling, injection site pain and rash were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site pain and rash to be related to SHINGRIX. Additional details were reported as follows: The lot number and expiration date and administration site unknown. The reporter spoke to HCP this morning and the physician later in the day. The reporter learned the patient was a female but no other patient information provided. The adverse event reported was minor injection site swelling and pain. Following administration the patient had a rash on the upper torso which appeared 2 days following administration. According to the physician, patient was not concerned about the swelling or pain, these resolved without additional treatment.  For the rash, the patient took Benadryl that evening and the rash resolved. The patient called the physician on the following day. The physician wanted to make sure the patient was ok to receive the second vaccine. The physician stated it was office policy not to share patient information with reporter to complete this adverse event report. The physician had a copy of a VAERS report that she would complete herself. Health care professional declined further follow up on this incident.
around 05/30/2021 started experiencing numbness and pain on left arm, along with chest pain. patient was hospitalized at local medical center for 1 week.
Pt received vacination around 5:30 pm on 10/09/08. At apporoximately 3am on 10/10/08 pt woke up and reported experiencing: "Really red eyes that were running and goopy; temperature of 102 F; muscle aches".  Pt reports that these symptoms resolved by the next morning and the only residual effect was slight headache.
Increasing dizziness; Vertigo symptoms; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Increasing dizziness) and VERTIGO (Vertigo symptoms) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 immunisation.     The patient's medical history was not reported.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Antidepressant therapy, TRAZODONE for Sleep problem, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DIZZINESS (Increasing dizziness) and VERTIGO (Vertigo symptoms). At the time of the report, DIZZINESS (Increasing dizziness) and VERTIGO (Vertigo symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not use any treatment medication. It was reported that the severity of events was 2/10 first and then at the time of report it was 5/10, gets better with the movement and had started to disrupt daily activities.
tingling sensation; numbness around the right foot going up to the half of my leg; cramping; headache; pain in her neck; muscle pain in her neck and shoulder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 15:45 (Lot number: EN6199) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 2003 (ongoing), notes: Verbatim: Asthma; "Allergies" (ongoing), notes: States they started a long time ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1 ,, Lot:EP6955 ,Right arm), administration date: 06Mar2021, for COVID-19 Immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 29Mar2021, outcome "recovering", described as "tingling sensation"; HYPOAESTHESIA (non-serious) with onset 29Mar2021, outcome "recovering", described as "numbness around the right foot going up to the half of my leg"; MUSCLE SPASMS (non-serious) with onset 29Mar2021, outcome "recovering", described as "cramping"; HEADACHE (non-serious) with onset 27Mar2021, outcome "recovering", described as "headache"; NECK PAIN (non-serious) with onset 27Mar2021, outcome "recovering", described as "pain in her neck"; MYALGIA (non-serious) with onset 27Mar2021, outcome "recovering", described as "muscle pain in her neck and shoulder".  Additional information: The patient stated " she had received the second dose of the Pfizer vaccine Saturday. She had a tingling sensation and numbness around the right foot going up to the half of her leg since yesterday afternoon." The patient wanted to know if these symptoms were reported with the vaccine. Informed the patient that these symptoms had not been reported with the vaccine. She should always talk with a vaccination provider, doctor, or other qualified health care professional about whether a specific treatment or medication was right for her and before starting a new treatment or activity. The patient was calling about the Pfizer, verified Pfizer Covid Vaccine. The patient stated she wanted to know, well she had her second vaccination this past Saturday 27Mar2021 and she felt fine but yesterday she was taking a shower and felt a lot of tingling, cramping and numbness in her foot and part of her leg, was that normal because of the vaccine, was it a side effect? Clarified it was her right foot and leg. The patient stated she also had a headache and pain in her neck that comes and goes. Stated it was like a muscle pain in her neck and shoulder. No treatment received. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) received 1st Dose of Pfizer Covid Vaccine.  No follow-up attempts are possible. No further information is expected.
Mom reported small lump at injection site left leg 13 days after immunizations given. No redness or pain at site.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm 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 was not reported. Concomitant medication(s) included: SYNTHROID, also reported as other medications/products within 2 weeks of starting COVID-19 treatment. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (2022) Positive, notes: I am now testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 07May2022 and stopped on 12May2022. Clinical course was reported as, patient started getting COVID symptoms a week after she finished Paxlovid on 19May2022 12:00 and she was now testing positive again. Patient not recovered from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Moderna Bivalent Vaccine administered expired on 5/27/23.  No signs or symptoms noted at time of administration.
Sore arm. Fever 99.9. Body aches. Dizziness. Nausea.
Had temperature to 102F that morning, family treated with Tylenol.  Had febrile seizure around 230 that was 1-2mins in length followed by drowsiness.  Temperature max was 104F.
The patient's arm was red. She complained of soreness, swelling, and fever at the injection site.
This spontaneous report was received from a nurse referring to a physician, a male patient of unknown age. The physician's medical history, concurrent conditions or concomitant medications were not reported. In December 2016, reported as within the last week, while 3 babies (2 age 4 months and one aged 2 months with not specified genders) were vaccinated with a dose of ROTATEQ (orally, Lot # M022373, expiration date: 20-FEB-2018; dose not reported) for prophylaxis; and after they experienced an adverse event (projectile vomiting), the reporter filed a product quality complaint  because the ROTATEQ in all three cases seemed more viscous. To be sure that the ROTATEQ was not a bad batch, the physician put a few drops of the ROTATEQ on his fingers and then tasted the vaccine occupational exposure to product). He reported that this vaccine was fine and he did not experience an adverse effect. This is one of the 4 cases reported by the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA010135: US-009507513-1612USA010136: US-00950713-1612USA010099:
Patient must be in a wheelchair and was driven here by her daughter. I came the patient's vehicle to give 2 vaccinations (Prevnar 20 and Fluad 65+). Patient received both vaccinations in right arm on passenger side of vehicle. After a few seconds, the patient stated she didn't feel well and began to have trouble breathing. Also stated she had chest pain. Daughter called 911 while I monitored the patient. We had EpiPen on standby while waiting for emergency services. Emergency services arrived and the patient was taken to the hospital for further treatment.
60 day old past 25 2/7 week infant became lethargic, apneic, and needed to be placed on oxygen approximately 6 hours after Pediarix imnunization injected into thigh. Infant had a septic work up of blood and urine (unable to collect CSF), which were negative. Pediarix was lot # AC21B149AA by Glaxo Smith Kline. 10/31/08-records received-9/18/08-respiratory distress syndrome increased spells and desaturations. Low lung volumes with focal airspace disease.
p/vax pt devel swelling in one arm & foot;the next day pt devel swelling in the other foot & soreness in shoulder blades & genital area;the swelling had not resolved;
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received HAV (Havrix 720) (batch number LY35X, expiry date 16th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd February 2023, the patient received Havrix 720 and Havrix Pre-Filled Syringe Device. On 23rd February 2023, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-Feb-2023 The licensed practical nurse called to inquire for any information available. The licensed practical nurse reported that they inadvertently administered an expired Havrix pediatric dose to a patient today on the day of reporting.  The healthcare professionals confirmed expired dose was administered in their facility.  The reporter consented to follow up. Additional supportive information: The licensed practical nurse inadvertently administered patient an expired dose of Havrix 720, which led to expired vaccine used.
Large  2 inch long by 1.5 inch wide by 1/16 inch tall welt. Red boundary with white/yellow interior. All noticed today 7/20, 8 days after first shot. No treatment yet. No outcome.  (Important) was prescribed methylprednisolone on 7/01/20, did not starter taking steroid till 7/19/20. Got shot at same pharmacist that prescribe the steroid.
1 day p/shot pt woke crying-unable to move lt arm, h/a, pain in joints & bones, dizziness, temp 101.1, trouble breathing, walking & vomited;
Overdose/ adolescent patient was inadvertently administered an 1 mL Adult Havrix dose instead of the 0.5 mL dose; Overdose/ adolescent patient was inadvertently administered an 1 mL Adult Havrix dose instead of the 0.5 mL dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 12-year-old female patient who received HAV (Havrix adult) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   On 11-JUL-2023, the patient received Havrix adult (left deltoid) 1 ml. On 11-JUL-2023, an unknown time after receiving Havrix adult, the patient experienced accidental overdose (Verbatim: Overdose/ adolescent patient was inadvertently administered an 1 mL Adult Havrix dose instead of the 0.5 mL dose) and inappropriate age at vaccine administration (Verbatim: Overdose/ adolescent patient was inadvertently administered an 1 mL Adult Havrix dose instead of the 0.5 mL dose). The outcome of the accidental overdose and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-JUL-2023 The reporter was a medical assistant. The reporter wanted to know if they would still require a second vaccine and how to proceed with series. The reporter further asked if any reaction from getting the higher dose and what to look for. The reporter did not consent to follow-up. The reporter reported that an adolescent patient was inadvertently administered an 1 ml adult Havrix dose instead of the 0.5 mL dose, which led to accidental overdose and inappropriate age at vaccine administration.
Dizziness, chest pain, headaches, nause, stomach pain, hot and cold, burning sensation in the legs, blurred vision. These symptoms have been going on for 5 days.
Ongoing- Fatigue, Chills, Itchiness all over upper body, pain at injection site, chest pressure, shortness of breath, lowered SpO2 (89-92%) and heartrate (down to mid 50's from baseline mid 70's) and blood pressure (down to 110/60 from baseline 125/75), headache after verbal conversations
felt dizzy after getting both covid-19 and hpv vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 9-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; hpv vaccine (HPV VACCINE), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "felt dizzy after getting both covid-19 and hpv vaccine".  Additional Information: The patient had a COVID-19 vaccine and HPV vaccine co-administered on same day and felt dizzy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.