chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, Myalgia, Arthralgia, Extreme fatigue; arm soreness; subjective fever; Narrative:
Patient stated that the second day after receiving the vaccination that he had soreness on the left side of his neck and redness and pain at the injection site. The redness was about 3-4 inches in diameter around the area of the vaccination. No bruising however. Pharmacist spoke with patient about taking TYLENOL to help with pain or to use ice or heat whichever felt better on the neck and injection site area.
Covid symptoms started on 04/14/2022 around noon; tested positive 04/16/22. I had stuffiness, drainage, allergy symptoms, and developed fever. I had a home test first and then a PCR at urgent care. As fever started, I had a sore throat, coughing, soreness and achiness everywhere and I felt like I was hit by a bus, and headache. Symptoms lasted for about a week, at least by that next Thursday, and they were pretty much gone. I did get the monoclonal antibodies treatment. I did have concentration issues for awhile that lasted about two months and I would forget things and lose my train of thought. It seems to have gone at this point.
Excessively high blood pressure for a little over two weeks.  Awakened in the night by pressure in the chest and rapid heart beat.  Doubled high blood pressure medicine.  Issue appeared to resolve mid-September.
Patient anxious, dizzy, and had syncopal episode while being guided onto the cot. No falls or injuries. Monitored for over 30 minutes. No transport.
shingles; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: non allergic asthma diagnosed in her 20s around age 25 or 26, Continuing : True. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation. Vaccination history included: BNT162b2 (Dose : 1, Date of Administration:21Jan2021, Lot number:EL8982), administration date: 21Jan2021, when the patient was 50-year-old, for COVID-19 Immunization; BNT162b2 (Dose : 2, Date of Administration:17Feb2021, Lot number:EN6198), administration date: 17Feb2021, when the patient was 50-year-old, for COVID-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset Oct2021, outcome "recovered" (Dec2021), described as "shingles". The event "shingles" required physician office visit. Therapeutic measures were taken as a result of herpes zoster.  Additional Information: Caller reports never having shingles before or the Shingrix vaccine. Treatment received for herpes zoster was Valtrex.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200584927 same reporter/drug/event, different patient
COUGH; CONGESTION; BODY ACHES; HAVE HAD TO MISS DAYS OF ACTIVITY; FEVER; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced cough, congestion, body aches, have had to miss days of activity, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, cough, congestion, body aches and have had to miss days of activity was not reported. This report was non-serious. This case, from the same reporter is linked to 20220102687 and 20220102250.
56 years old received Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 56-year-old patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st August 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 31st August 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. The action taken with Bexsero Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The medical assistant reported that a patient of age 56 years old received dose of Bexsero, which led to inappropriate age at vaccine administration. The reporter wanted to know if it was likely to happen any side effects. The reporter stated that, reported with the data obtained before the call disconnected. Tried to contact health care professional so as to finish collecting missing data but without success. The reporter did not consent to follow up.
A week following my second Moderna shot. I was dizzy, nauseous, and had some blurred vision. I was diagnosed with BPPV, a type of Vertigo. I did physical therapy to move the inner ear crystals back to where they belong. Prescribed AntiVert for dizziness and Nausea symptoms. More physical therapy to follow.
Patient reported a scratchy throat and difficulty breathing. Patient received Epinephrine 0.5mg IM. Symptoms subsided and she was discharged without any further incidents
a blood clot from the left groin to the foot.  desolved  using blood thinner process.  Still receiving treatment as of today.
Information has been received from a registered nurse concerning a 10-year-old female who on 05-FEB-1999 was vaccinated with a first subcutaneous dose in the left arm of varicella virus vaccine live (Oka/Merck) (Lot # 627337/1057H). On 27-NOV-2007, the patient developed a case of breakthrough, described as a rash located on her trunk, back, face, legs and head. The patient had a fever and lesions from 50 to 500 in number. The school nurse diagnosed it. Follow up information provided no additional information regarding current patient status. A product quality complaint was not reported. Follow up information from the registered nurse provided no additional information. This is one of several reports received from the same source. Additional information is not expected.
Vesiculopapular rashes noted 2 days after receiving vaccine here in the office. Rashes all over body including around lips with some crusting.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3302), in left arm, on 28Feb2021 as dose 2, single (Lot number: EN6205), in left arm and on 18Nov2021 as dose 3 (booster), single (Lot number: FH5030) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: other medical history: High blood pressure; "PCOS" (unspecified if ongoing), notes: other medical history: PCOS; "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs. Concomitant medication(s) included: NIFEDIPINE.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: It was reported that patient was taking other medications within 2 weeks of starting COVID-19 treatment.
Unknown.  Decedent died several days after receiving COVID-19 vaccine (unknown manufacturer).
neck pain; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 68-year-old female patient who received SHINGRIX (batch number D294J, expiry date 22nd March 2021) for prophylaxis. On 3rd October 2018, the patient received the 1st dose of SHINGRIX .5 ml. In October 2018, 14 hrs after receiving SHINGRIX, the patient experienced neck pain. On an unknown date, the outcome of the neck pain was recovering/resolving. It was unknown if the reporter considered the neck pain to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX at around 1:00 PM in the afternoon. On 4th October 2018 at 3:00 AM, the patient woke up with neck pain. The patient made an appointment with her physician about for the neck pain. It was little bit better, but not recovered. Still the patient could not turn her head to the back without pain.
This case was reported by a physician and described the occurrence of possible overdose in an adult subject of unspecified gender who was vaccinated with TWINRIX (GlaxoSmithKline). The medical Doctor's office requested TWINRIX dose 2 and TWINRIX Accelerated dose 2. Follow up information received on 17th October 2014: The patient details were updated.
1st dose 02Mar2023, 2nd dose 05Apr2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 34EC5, expiry date 02-JUL-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 05-APR-2023, the patient received the 2nd dose of Shingrix. On 05-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 1st dose 02Mar2023, 2nd dose 05Apr2023). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 13-Apr-203 The reporter gave permission for follow-up. An immunocompetent patient received second dose of Shingrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Information has been received from a medical assistant concerning a 24 year old female who on 30-JAN-2008 was vaccinated via intramuscular route with the first dose GARDASIL, 0.5ml/once. Concomitant therapy included YAZ. The reporter stated that on 09-MAY-2008 the patient developed injection site pain after receiving a second dose of GARDASIL (Lot # 660389/1968U). The medical assistant stated that the patient called the office and complained of soreness and pain at the injection site but said there was no lump or swelling. The reporter said that the patient did not have any reactions when she received her first dose of GARDASIL. No further information was available. Additional information has been requested.
ARM SWELLED, PATIENT FELT ILL - MILD FEVER, ACHY.
I noticed a small knot and redness around the site on the 2nd day. On the 3rd day I didn't notice the knot so I did not visibly look for the redness until the 27th. The redness is approximately 4 inches in diameter. There's no pain associated with this.
I received my second booster on 3/10/22 (4th dose). On 3/24/22 I went to the ER due to severe chest pain. Unfortunately, at that time they could not figure out in the ER what was wrong so I was sent home.  On 3/30/22 I went back into the ER for severe chest pain, shortness of breath, light headedness and fluid retention. I was admitted to the local Hospital when they eventually diagnosed me with Myopericarditis. I was discharged 9 days later on 4/8/22. I was treated with 2 weeks of 800 mg of ibuprofen 3x a day and Colchicine 0.6mg 2x a day. I ended up have severe side effects from the colchicine and ended up back in the hospital for 5 days. Now I am taking 0.3mg of Colchicine 2x a day.  I have been out of work for almost 2 months due to this diagnosis and I am still suffering from chest pain.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:12 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:12 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 47.99 for dose administered on 03-Apr-2021.  No concomitant medications were reported. Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Early morning 8/28 awoke with general illness (body aches, chills, fever, nausea, dizziness, severe headache/sinus pain). Fever spiked to 103.1F around 3AM. Scheduled appointment at local urgent care as soon as available. Acetaminophen helped to briefly lower fever. Severe symptoms and fever lasted about 3 days. Appetite/stomach still not back to normal levels as of 8/13. Have random bouts of severe nausea, stomach cramps, abdominal and back pain, and dizziness. Considering returning to PCP to check appendix (pain has become increasingly localized to lower right quadrant)
Right sided low back into hip area with unilateral dermatome appearance of erythematous and groups of vesicles. Probable Shingles: suspect secondary to varicella vaccine two weeks ago. Patient to cancel appointment for second varicella vaccine. Encouraged patient to keep lesions covered. Will treat with VALTREX 1 g PO TID times seven days. Advised 2 to 3 L of hydration daily.
Onset after receiving the day after the first booster. 2 vaccinations were both Moderna. 1st injection 1/11/21 and second 2/10/21.  Lot 011L20A, second lot 030M20A. Onset of numbness in left lower leg and frozen ankles to point of pain with walking. eventually numbness in the left check, now involving right cheek.  Initially thought to be neuropathy secondary to DM.  DM controlled with in 6 months of the First vaccination.  Was diagnosed with Gout and briefly treated with alopurinol and colchicine.
About 5 hours after shot started to feel tired and chilled.  Fever of 100-101 with chills until about midnight.  Fever continued on and off for about 36 hours after shot.  Second day only had fever with muscle soreness/aches and feeling tired, no chills on second day.  Fever broke around midnight the day after the shot.
After receiving vaccine, patient became dizzy, nauseas, and diaphoretic. Pt laid down for a little while and was given PO fluids. Pt felt better in a short time later and then went home
Patient received 1st vaccine on 11/13/21 at 4:45pm. After 5 minutes of patient receiving vaccine, patient has lost consciousness while waiting 15 minutes in the hall. Patient's family stated he had said he was feeling nauseas and wanted to throw up. After minutes of the conversation, the patient lost consciousness for about a minute. In the event, the family panicked and the Rph at the time heard the altercation from the pharmacy. The Rph at the time ran to see the patient immediately. After about a minute of the patient being unconscious, he regained consciousness. After the Rph reviewed patient's blood pressure and asked questions to the patient, the Rph found it adequate to call 911 for a more thorough evaluation of the patient. After EMT came to check on the patient, patient was deemed ok, but did not want to go to the hospital. After EMT had left, Rph asked the patient to stay for another 10 minutes as a precaution. After 40 minutes had passed in total,  patient was ok and Rph gave the ok to go home. Patient had left with his family.
Patient returned two days post PNEUMOVAX and flu shot to seek advice for redness and swelling of arm. From upper arm to lower arm, it was inflamed and warm to the touch. I advised him to take BENADRYL, ice it and see a physcian. He did and received cephalexin.
Lymph node swelling on collar bone area; Excessive belching without other potential trigger; This is a spontaneous report from a contactable pharmacist.  A 35-year-old female pharmacist reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN5318), intramuscular into the left arm on 02Feb2021 at 04:30 PM at single dose for COVID-19 immunization. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. Concomitanr drugs were unknown.  The patient experienced excessive belching without other potential trigger days 1 and 2 after vaccination and lymph node swelling on collar bone area 3 days after vaccination.  No treatment was received. the outcome of the events was unknown.
Janan received PPV23 on 10-03-2007.  She experienced achiness and headache on 10-4-07 for which she took Tylenol. 10-05-07 she presented in the office with c/o fever (100.6), headache, body aches, and swelling, redness, and pain at the injection site.  Ibuprofen 600mg and Benadryl were ordered.  10-9-07 she presented in the office with an increase in symptoms of the left upper arm.  She has an approx area of 7cm x 12cm around the injection site, which is erythematous and indurated.  There is an approx. 1cm area of bruising at the injection site.  Distal to the injection site is an approx 2cm area of coalesced small yellowish-pink vesicles.  There is no discharge at the site. Her arm is tender, but improving.  A Medrol dose pack was prescribed today.
soreness around the injection site; tiredness; aching in body; redness around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox and shingles.   On 11th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site pain, tiredness, pain and injection site erythema. On an unknown date, the outcome of the injection site pain, tiredness, pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain, tiredness, pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in the left arm intramuscularly. The patient reported after receiving the first dose of Shingrix had redness around the injection site, soreness around the injection site, tiredness, and aching in body and these all resolved within 24 hours.  The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020178047:same reporter
This spontaneous report was received from a registered nurse concerning an unspecified patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, lot number M036059 and expiration date 03-JUN-2019 (strength, dose and route of administration were not reported) for prophylaxis. The temperature excursion with GARDASIL 9 was 30 minutes between 9 to 25 Celsius degrees. No previous temperature excursion was performed and the temperature excursions were detected by a data logger. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of three cases from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA009373: US-009507513-1703USA009374: US-009507513-1703USA009372:
Later in evening, experienced headache, dizziness, temp 100 degrees F. Next day 2/24/10 - fever of 102 degrees F. . Varicella site red and swollen. Fatigue - slept 20 hrs. Malaise and stomach cramps. Fever resolved on 2/26/10.
MEDICATION ERROR:  PATIENT GIVEN AN UNDILLUTED DOSE OF PEDATRIC PFIZER..
Pt was seen for well child visit on 02/19/2002 and was given MMR #2, IPV#4, and DTaP #5. On 02/21/2002, pt developed significant area of erythema 10cm x 14cm on right thigh (at the site of injection) She also developed mild maculo paular eruption on upper left thigh.