chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies with latex with prolonged exposure" (unspecified if ongoing), notes: such as wearing latex gloves daily. Concomitant medication(s) included: VITAMIN B COMPLEX; COLECALCIFEROL; CALCIUM SUPPLEMENT WITH VITAMIN D. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EN6208, administration time: 10:30 AM, administrator route: Intramuscular, vaccine location: Left arm), administration date: 15Mar2021, when the patient was 51 years old, for COVID-19 Immunisation, reaction(s): "Laryngeal spasm", "panicked", "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: The vaccine was administered in a school or student health clinic. The patient did not have COVID-19 prior to vaccination and was not tested post vaccination. The patient did not receive other vaccine in four weeks. At the time of the second vaccine, I took famotidine (PEPCID), without incidence other than a sore arm again.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
In late June I developed knee pain. I went to see the doctor on 8/8. Doctor prescribed CELEBREX.
This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 67-year-old female patient who received Herpes zoster (shingrix) (batch number 333TE, expiry date 15th April 2023) for prophylaxis. Previously administered products included shingrix with an associated reaction of injection site pain (received 1st dose on 14th September 2021 and patient's (injected) arm and shoulder were sore, refer case US2021AMR266339). On 27th December 2021, the patient received the 2nd dose of shingrix. In December 2021, less than a week after receiving shingrix, the patient experienced injection site induration, injection site redness, injection site rash, injection site warmth and injection site pain. Rechallenge with shingrix was positive. On an unknown date, the outcome of the injection site induration, injection site redness, injection site rash, injection site warmth and injection site pain were recovering/resolving. It was unknown if the reporter considered the injection site induration, injection site redness, injection site rash, injection site warmth and injection site pain to be related to shingrix. Additional details were provided as follows: The patient self-reported this case. The patient received shingrix on arm. The patient indicated that with her 2nd shingrix shot her (injected arm) was a lot more soar this time and she got a red and raised spot. The patient stated with 2nd shingrix shot, had hard, red, raised and warm area on her arm about 3 inches wide and was very sore and asked was this normal. The patient indicated that on the morning of reporting day, when she got up, she noticed that it seemed to be getting better. It was not as big and not as hard as it was. It was not fully resolved till the time of reporting. The patient consented to contact her physician.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR266339:same reporter.
Pt experienced swollen arm (entire bicep), rash & fever. Extreme headache not recovering by migraine meds, chills, & tremors.
I received the vaccine at 0900 on 1/7/21. At around 0300 on 1/8/21, I woke up in the night due to a loud ringing inside my right ear. It was loud enough to keep me awake and the ringing has not stopped, even up until this point. I can still hear out of the right ear, but I cannot hear over the ringing. High pitch noises I can hear amplified, while it is difficult to hear anything else. I can also feel the vibrations in my inner ear during those high noises. I did take 800mg of Ibuprofen before bed and I know that NSAIDS can be associated with Tinnitus but this seems very out of the ordinary for me with no medical history and remarkable health screen.
Urticaria, full body. 12 hrs after flu vax, no other new exposures to my knowledge. Never happened before. Still advocate of the flu shot as a medical professional (PA).
FEB 21 I NOTICED A RASH ON MY ARM. IT STAYED ABOUT A WEEK. MY ARM IS STILL SORE.
Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hypertension and Diabetes. Concomitant products included ATENOLOL for Blood pressure management, METFORMIN for Diabetes, OMEPRAZOLE for an unknown indication.   On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitants included  Blood thinner, cholesterol pill. No Treatment medication was reported.   This case was linked to MOD-2021-364075, MOD-2021-364085 (Patient Link).
CoughWheeze, no taste, no smell, runny nose Narrative: Per nursing report: "called to report symptoms of no taste, no smell, coughing, runny nose all since 7-27-21. States left work on 7-29-21 with symptoms mentioned and came back on Friday. Tested negative on Sunday. Has had first dose vaccine as of 7-21-21. Recommended get PCR test and call back with results. PCR was negative. Employee had latent symptoms on August 4th and August 5th and was not able to come to work"
Nine days after receiving the vaccine I developed rashes on my elbows, knees, and ankles and in my joints. Wrse though, was the inability to bend my fingers after they swelled up and had incredibly itchy welts all over. Benadryl did not help0, the itching, soreness, and inability to bend my fingers persisted for approximately 4 days. I had a headache that was severe as well. I made two trips to the emergency room and then followed up with my primary physician.
Approximately 3 hours after the dose: feverish, headache. Continued overnight to massive migraine, fever, nausea (dry heaves), joint pain in right hand and extending under armpit near right breast, shivers and then sweats, extreme lethargy but restlessness when trying to sleep. (Similar adverse effects after the first dose in December 2019.)  23 hours after the vaccine: Some nausea, migraine remains.
Developed a rash; Swelling of left arm around the vaccine injection site; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 05Apr2021 at 09:45 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 16Apr2021 at 22:00, 11 days after the vaccination, the patient developed a rash on COVID vaccine arm and swelling of left arm around the vaccine injection site. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine (BENADRYL PLUS) oral and local steroid (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events developed rash and swelling of left arm around the vaccine injection site were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
in 24 Hours I had swollen lymph node under arm left arm where vaccine was received.  That subsided after 2 weeks.  One week Later I started to and continue to have rashes and pimples  on my arm and legs  after a number of days they open at the top and scab over looking line burn marks and spread out as wide as 1/2 inch to 1 inch surface, depending on how big the pimple was.  They are itchy and painful at times.
Starting on Wednesday morning, couldn't hear in left ear and over the day both ears starting to lose hearing. Thursday both ears felt like they were clogged and continued to get worse and felt pain and have a fever up until today. Patient also experienced ringing in the ear and discomfort. Pt would not use phone. Also experience dizziness. Patient was seen at urgent care on 7/7/21 and was diagnosed as a double ear infection and was prescribed cefdinir.
itchy red rash, emerged 8 days later on forearms, face, neck. Was not traceable to contact dermatitis or other known exposures, allergens, or illness. Well tolerated, did not miss work. Oral Benadryl 25-50 mg and topical anti-itch cream (camphor-based, not antihistamine) resolved symptoms enough to not affect much of daily life. No additional allergy symptoms. Duration around 3 days.
Mild left facial swelling noted morning after vaccine. Onset 630am (received vaccine 11am yesterday).
Fever - hot to the touch. 100 after TYLENOL. Cried 4 hrs straight. No treatment  x TYLENOL.
On 17 Dec 02 pt was seen by Dr. for c/o bilateral rash at injection area x 2 days. As per MD, pt was in no apparent distress and no fever. Noted red papular rash on bilateral thighs (more on the R thigh), red papule with pustule x 1 on LUE. No rash elsewhere. Instructed pt to return to clinic if rash progresses. No meds.
Developed hives (urticaria) in underarms, waist and legs. Prescribed MEDROL DOSEPAK 4 mg and ZYRTEC.
Information has been received from a physician's office concerning a 6 year old female with no known allergies or past medical history who on 15-JUN-2001 was vaccinated SC in the right arm with a dose of Varivax (lot# 636368/1341K). Concomitant vaccination included a dose of MMR (lot #638359/0163L) SC in the left arm. There was no illness at the time of vaccination. On 12-JUL-2006 the patient developed 10-15 scattered vesicular lesions all over. The patient was treated with diphenhydramine hydrochloride (Benadryl). Subsequently, the patient recovered. Additional information is not expected.
Received H1N1 FLUMIST MED500805P. Approx 1 HR later c/o H/A. Teacher noted student was "zoning in and out" during class. Student passed out, weakness, c/o diff breathing, EMS called, transported to ER per ambulance. Weak, shaky, pale. EMT reports PAC's and PVC's noted on rhthym strip. Student at that time was feeling better. Disch from ER 7:00 PM.
STARTED GETTING ITCHY.  BY PM HAD HIVES ALL OVER BODY. STARTED TAKING BENADRYL.  SAW URGENT CARE ON 11/04/2010.  TO CONTINUE TO TAKE BENADRYL.  RASH BETTER BUT CONTINUES TO TAKE BENADRYL 3 TIMES A DAY.
arm hurt; fever; lots of chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), PYREXIA (fever) and CHILLS (lots of chills) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypertension and Cholesterol. Concomitant products included ATORVASTATIN (LIPTOR [ATORVASTATIN]) for Cholesterol, VITAMIN D NOS and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt), PYREXIA (fever) and CHILLS (lots of chills). At the time of the report, PAIN IN EXTREMITY (arm hurt), PYREXIA (fever) and CHILLS (lots of chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include medications for diabetes, for high blood pressure No treatment information was provided.
3" red area of swelling, tenderness pain on lt deltoid; fever x 2 days started on 20OCT92;
Patient DID NOT receive a Moderna COVID vaccine on 11/02/2021 as listed in data. The vaccine was entered into the computer system incorrectly by a source outside the System. Spoke with patient directly and reviewed his COVID vaccinations with him. Patient had his COVID card listing all COVID vaccines. Patient reports receiving 5 COVID vaccines in total. Patient's COVID vaccination record is as follows:                  1st dose=02/24/2021 Moderna monovalent 0.5mL Lot#001A21A, received                  2nd dose=03/25/2021 Moderna monovalent 0.5mL Lot#047A21A, received                  3rd dose=10/25/2021 Moderna monovalent 0.25mL Lot#026D21A, received at pharmacy                 4th dose=05/07/2022 Moderna monovalent 0.25mL Lot#004M21A, received at pharmacy                 5th dose=10/01/2022 Moderna bivalent 0.25mL Lot#057F22A, received at pharmacy.
No additional adverse event; Expired product administered; This spontaneous report was received from a nurse concerning a 27 years old patient. No information about the current condition, medical history or concomitant therapy was reported.   On 07-JUL-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1581027, expiration date: 03-JUN-2021 (also reported as 30-JUN-2021); at the dose of 0.5 milliliter) as prophylaxis (expired product administered).  No temperature excursion was reported. No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.devicelotnumber: 1581027; expirationdate: 03-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Patient states that 2 days after vaccination, she experienced severe muscle and joint pain to the extent that she was unable to function or do her rehab therapy that she is doing post knee replacement.  She also experienced marked redness on the injected arm, on the forearm area.
Right arm and shoulder sore, red, swollen and hot to the touch- 2 days after receiving the H1N1 vaccine.
Elevated temp (as high as 104.3), headache, vomiting, irritable 40 hours.
I felt very sick right away. I slept most of the day for a couple of days. I was very tired, exhausted and could not complete tasks. I had the worst suicidal thoughts ever experienced (I am diagnosed with complex PTSD). I disassociated on-and-off for a week or more. Trauma somatic responses in my left arm.
Given 3 Doses of Heplisav-B; Initial Report Received on 21-OCT-2022, 27-Oct-2022, 03-Nov-2022  This is a spontaneous report, received from a pharmacist regarding a 39-year-old female patient who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported.  Concomitant medications were not reported.  On an unknown date, dose 3 of HEPLISAV B (Lot #938233, expiration date 11-Mar-2023, NDC # unknown), route not specified, was administered in the left deltoid for hepatitis B immunization.   No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
I had a fever the night of the shots.  I was extremely achy and sore.  My arm was very sore for 4 days.  I could not touch or sleep on my right arm for 4 days.  The day after the shots I was very weak and nausious.
pt recv vax; exp an allergic-type rxn,including nodule formation & erythema;allergist believed rxn possibly an allergy to thimerosal or aluminum;
PATIENT PRESENTED TO PHARMACY WITH A SORE SWOLLEN ARM THE DAY AFTER VACCINE WAS ADMINISTERED. ARM APPEARED TO BE IRRITATED IN INNER ARM AREA. PATIENT STATED THAT ARM WAS SORE AND REDNESS STARTED THE EVENING AFTER GETTING VACCINE. IT GOT SLIGHTLY BETTER WITH TYLENOL AND ICING
she broke out into live chicken pox; the injection site began to lump up and swell; the injection site began to lump up and swell; she was administered the shot in the left side of her stomach and not the upper backside of her arm; This spontaneous report was received from a consumer referring to herself, a 21 year old female patient. Information regarding her pertinent medical history, concomitant medications, and drug reactions or allergies was not provided.  On 18-JAN-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 1 injection, received the shot in the left side of her stomach and not the upper backside of her arm (product administered at inappropriate site), lot # R009409 with expiration date 29-MAR-2020, as part of an immunization update, as she was applying for an internship and was required to receive the vaccine.  On 25-JAN-2019, reported as exactly one week after receiving the shot, the injection site began to lump up and swell (injection site mass and injection site swelling), and she broke out into live chickenpox (varicella). She sought for medical attention and her primary doctor misdiagnosed her symptoms for eczema, and prescribed triamcinolone acetonide ointment, which helped her improve the itching. At the reporting time, the patient stated that she had not yet recovered from the adverse experience and that she still had bumps on her skin from the chickenpox outbreak.  The causality assessment between the events and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided by the reporter.
Sore shoulder where vaccine was given. Moved down arm all the way to elbow within 3 days with redness and swelling along the way. Fever, as much as 102 degrees.
Diagnosed with urticarial vasculitis on 06/09/2021 after biopsy of skin lesions
Joint pain, muscle aches, fever, nausea/vomiting, abdominal pain, severe headache, rapid heart rate, perfuse sweating, facial swelling
no additional AE reported; Office manager who is also a registered nurse reporting a patient was administered a dose of GARDASIL 9 after the labeled expiration date. Caller stated the GARDASIL 9 expired on 11-SEP-2022, but was administered on 5-OCT-2022. Caller confirmed the v; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, previous drug allergies or reactions, and concomitant therapies were not reported.  On 05-OCT-2022, the patient was vaccinated with a expired vaccine of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, lot number 687291, expiration date reported and internally validated as 11-SEP-2022, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). It was reported that there was not any temperature excursion and no additional adverse events.
No adverse event. Second shot was administered on 7/28/21, which is beyond 6 week window from first shot (4/30/21). Patient was informed of limited efficacy information beyond 6 week window and patient, with doctor's approval, decided to proceed with getting it. No issues with administration.
Stomach pain; Cramp; Indigestion; Flatulence; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), MUSCLE SPASMS (Cramp), DYSPEPSIA (Indigestion) and FLATULENCE (Flatulence) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), MUSCLE SPASMS (Cramp), DYSPEPSIA (Indigestion) and FLATULENCE (Flatulence). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) had resolved and MUSCLE SPASMS (Cramp), DYSPEPSIA (Indigestion) and FLATULENCE (Flatulence) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The pharmacist reported that the patient received a dose of ZOSTAVAX (lot# and expiry date unknown), 0.65 ml, once, subcutaneously along with an influenza virus vaccine (manufacturer unknown) (lot # unknown) on the same unspecified day "about a month ago" (approximately in January 2014). The pharmacist reported that the patient developed a "rash" at the injection site on unspecified date in 2014. The patient contact her (unspecified) physician who stated the rash was shingles and prescribed unspecified antiviral medication for the patient. Action taken was not applicable. At the time of reporting, the outcome of event was unknown. Additional information has been requested.
Student Administrator accidently administered PROQUAD dose intramuscularly instead of subcutaneously. Dose was readministered subcutaneously.
PT developed a fever of 101.5, which was followed by diarrhea that lasted for two days.  He also demonstrated irritability and abdominal discomfort.  As of 9/29/11 pt's mother developed a headache, which was followed by vomiting.  Symptoms indicate that pt shed live virus and infected mother.
Rash started on 4/9/2021 to hives to right breast, right upper arm, right and left flank, left buttock
Fever to 104 degrees 24 hr after injection with fatigue lasting 48 hrs.
Patient had chills, body aches, and diarrhea for the first 48 hours after receiving SHINGRIX. Those symptoms resolved. Patient has a sharp pain that still persists almost 2 weeks later in her bicep (SHINGRIX was administered in the deltoid). Patient went to see the chiropractor with no improvement in symptoms. She plans to see the reflexologist in the near future.