chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The following day after the 2nd vaccine, I felt a small itching on the left side of my neck/shoulder blade. I didn't scratch but I felt swelling.   After softly rubbing my neck, I felt a little bubble as if there was liquid in the bubble area.  I thought maybe it was a side effect so I waited  a full week.  Along with the itching & swelling, there was a small amount of tender pain.  The swelling still persists.  On the 10th day after the vaccination (March 15th), I saw my doctor.  He felt the same area  sensation of a bubble around my shoulder blade.  So far, there has been no treatment.
1/14/21: 7:30PM = arm pain & extreme fatigue (hit by truck) and went to bed 1/15/21 0300am = woke up with 10/10 left arm pain - crushing, dizzy, nauseous, continuous night sweats - went to stand slowly and almost fainted immediately. took ibuprofen 800mg and applied anicar cream to left arm when I could get up - helped pain 6/10. am - left nostril congested, headache. ibuprofen 800mg 1/17: sore throat 1/18: worse sore throat and drainage - like a sinus infections, fatigue, headache (ibuprofen 800mg) 1/19: same as on 1/18 and now coughing up thick clear sputum also. Got COVID tested today, nausea COVID neg. took Cepacol lozenger, drank tea w/honey, soup 1/20: weds - headache, nausea, sore throat/drainage - improving - ibuprofen 800mg 1/21: same as on 1/20 but significantly better 1/22 - minor sore throat, on/off headache 1/23 all better 1/25 - returned to work. was off from 1/15-1/24 due to my reaction and pending COVID test result im still fatigued and getting headaches on/off. My headache history was fixed until receiving the vaccine on 1/14.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Information regarding medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with their first dose of unspecified GARDASIL or GARDASIL 9; then, on an unknown date, reported as "6 months later" received their second dose, also reported as unspecified if was GARDASIL or GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported for any vaccine). No adverse effects reported. Concomitant therapies were not provided. Additional information has been requested.
Very sick with fever of 102F for several days.  Delirious for several days.  Low energy, difficulty concentrating, fuzzy vision for 4+ weeks.  Fairly severe pain in left arm radiating from injection site to shoulder and elbow.  After 3 weeks, following the advice of my doctor, I went to a clinic for arm pain.  My O2 was only 94 at that visit.  Doctor at clinic suggested waiting 2 more weeks to see if arm pain went away and energy came back.  After 5 weeks arm pain subsided and energy returned, but I now have what appear to be allergies to pollen and dust that I have never had before (sneezing, headache, post nasal drip, etc.)
Patient was given second COVID vaccine 7 days sooner than scheduled. Patient has currently experienced no adverse effects.
Reaction began <48 hrs from injection. Likely due to Dtap. Left upper thigh, swollen, red, indurated thigh involving anterior and interior portions of left upper and mid thigh. Width 8-8.5 inches wide; length 9 inches wide. 8.5" x 9".
shingles; back pain, he had to go to ER; Extreme stomach pain, had to go to ER; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2022, the patient received the 1st dose of Shingrix. On 7th December 2022, 7 days after receiving Shingrix, the patient experienced back pain and stomach pain. On 11th December 2022, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the back pain and stomach pain were unknown.   The reporter considered the shingles, back pain and stomach pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-DEC-2022 Reporter's comments : The patient had stated that, he got the first Shingrix dose in left arm.  He stated that, one week later on 07 December 2022, he had extreme stomach and back pain and had to go the Emergency room (ER). He stated that a cat scan was taken at the ER.  He had reported, after seeing his physician on 12 December 2022.  The patient had stated that, he has had shingles since 11 December 2022.  The patient had stated that, he had filled out a GSK online questionnaire saying that he got shingles from Shingrix.  He was unsure whether he had filled out a online safety AE report.  No further information was reported to the agent by the patient. The patient did not know the lot number or expiration date of the Shingrix that, he had received.  The reporter did not consent to follow-up. Additional supportive information: 11 days receiving Shingrix, the patient experienced shingles.
Patient felt dizzy withen 20 seconds of receiving vaccine. LOC for 15-20 seconds following vaccine injection.
Fever, chills, joints hurt, migraine.  Everything lasted all night (5 hoursish). I woke around 6am with still a really bad migrane that didn't go away until around 3pm.
Severe headache, severe body ache, nausea, restlessness yet sleepy, joint ache
The Pfizer COVID-19 Vaccine vials were reconstituted with 1.6mL vs. 1.8mL of normal saline. This resulted in the patient receiving 33mcg of active vaccine component in the 0.3mL dose instead of the labeled 30mcg. This has been disclosed to the patient. Patient reports feeling fine, no adverse side effects. Reporting through VAERS is required given the increase in dose administered.
This case was reported by a physician via call center representative and described the occurrence of arrhythmia in a 78-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included atrial fibrillation. On 19th July 2018, the patient received the 2nd dose of SHINGRIX. On 19th July 2018, several hours after receiving SHINGRIX, the patient experienced chills, fever and abdominal pain. On 20th July 2018, the patient experienced arrhythmia (serious criteria GSK medically significant), skin peeling and oxygen saturation decreased. On an unknown date, the outcome of the arrhythmia, chills, oxygen saturation decreased, fever and abdominal pain were recovered/resolved and the outcome of the skin peeling was not recovered/not resolved. It was unknown if the reporter considered the arrhythmia, chills, skin peeling, oxygen saturation decreased, fever and abdominal pain to be related to SHINGRIX. The reporting physician was the concerned patient. In the next morning after vaccination, the patient experienced skin peeling on hands and the patient's heart rate was 122 for almost a half of a day, along with decreased pulse oxygen at 88 to 90 percent. The reporter did not have the dose, route, lot number or expiry date of SHINGRIX dose given.
Patient did not have an adverse event. Patient was given vaccine in clinic at age 13 and vaccine has not been approved for any patient under age of 16.
pt recv vax 26JUL95 & 17JUN96 pt exp chickenpox w/approx 110 lesions p/exposure to chicken pox in school;
After vaccination of 05/01/2021, after I started to itch not too bad immediately, I was able to ignore it.  That same night I was scratching everywhere and everywhere I scratched I had rash bumps and hives that got worse and worse ended up spreading all over my body. I tried Benadryl and other allergy medicine's but it would not subside took Benadryl for a few weeks then went to provider, because I could no longer take the itching and I have marks all over my body I had hives spreading from my arm to my chest back butt legs head to toe even  in my hair
Three and a half weeks after my first vaccine (2 days before my second dose) I noticed the left side of my neck was stiff and hurt. The pain started the shoot out into the back of my skull; Three and a half weeks after my first vaccine (2 days before my second dose) I noticed the left side of my neck was stiff and hurt. The pain started the shoot out into the back of my skull; Three and a half weeks after my first vaccine (2 days before my second dose) I noticed the left side of my neck was stiff and hurt. The pain started the shoot out into the back of my skull; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Feb2021 21:15 (Lot number: EN6200) at the age of 31 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), PAIN (non-serious) all with onset 13Mar2021 07:00, outcome "recovered" and all described as "Three and a half weeks after my first vaccine (2 days before my second dose) I noticed the left side of my neck was stiff and hurt. The pain started the shoot out into the back of my skull". The event "three and a half weeks after my first vaccine (2 days before my second dose) i noticed the left side of my neck was stiff and hurt. the pain started the shoot out into the back of my skull", "three and a half weeks after my first vaccine (2 days before my second dose) i noticed the left side of my neck was stiff and hurt. the pain started the shoot out into the back of my skull" and "three and a half weeks after my first vaccine (2 days before my second dose) i noticed the left side of my neck was stiff and hurt. the pain started the shoot out into the back of my skull" was evaluated at the physician office visit. Therapeutic measures were taken as a result of neck pain, musculoskeletal stiffness, pain.  Additional information: The patient did not receive any other vaccines in four weeks of COVID-19 vaccine. The patient received Valtrex as treatment for the adverse events. The patient has not been diagnosed with COVID-19 prior to vaccination. The patient did not undergo COVID testing post vaccination.   No follow-up attempts are possible. No further information is expected.
Patient was here to get a Covid Booster (updated Bivalent) and a flu shot. Both shots were administered in the Left Deltoid.  Within minutes patient reported feeling nubness and swelling in her lips and some throat symptoms. Epinephrine 0.3mg was administered to treat possbile anaphylaxis. Patient stayed on site for observation additional 30 minutes. Symptoms were resolved when patient left the site.
Vaccination site warmth; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth ). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided. No relevant concomitant medications were reported. Patient's arm was hot, she applied something cold to it, then was fine.
The pt was seen on 10/17/00 with a mild URI. The pt was taken to the ER on 10/18/00 with a fever and febrile convulsions.
Received vaccine after temperature excursion; A Spontaneous report was received from a consumer, concerning a 58-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) after temperature excursion/product storage error.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event were not reported.  On 18 Mar 2021, prior to the onset of the events, the patient received planned doses of mRNA-1273 for prophylaxis of COVID-19 infection which underwent temperature excursion/ product storage error.  Laboratory details was not provided. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event received vaccine after temperature excursion was considered as resolved on 18 Mar 2021.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273, lot # unknown  with no associated AEs.
Chronic intractable headaches requiring hospitalization. Intermittent vision disturbance, increased chronic pain. Vertigo
Patient was hospitalized due to breakthrough COVID infection. Patient received J&J vaccine on 05/14/2021. Patient was hospitalized from 12/29/21 - 01/01/22. Below is copied from discharge summary:   Hospital Course:   Patient is a 79 y.o. male with a history of CKD, Hypertension, hyperlipidemia, insulin-dependent diabetes mellitus, coronary artery disease status post CABG, and CVA with residual left-sided weakness presented to the emergency department for altered mental status x1 day prior to admission.   Acute Metabolic Encephalopathy  Resolve Likely 2/2 COVID-19  Ammonia level WNL   Diabetic foot ulcers, right foot Chronic XR neg for osteomyelitis   Blood cultures NGTD Podiatry consulted, no intervention need will follow as OP   COVID-19 viremia  Not  requiring oxygen  COVID-19 order set initiated  Supportive care    AKI on CKD  Resolve Cr at baseline Renally dose medications  Avoid nephrotoxic agents    CHF HFpEF 60%, TTE 8/22/21  No acute decompensation Continue statin and carvedilol    IDDM with hyperglycemia Resume OP tx   Coronary artery disease  CVA with residual left-sided weakness  Continue Plavix   BPH  Continue Flomax   Gastroesophageal reflux disease  Continue Protonix    Patient is discharged in stable condition with stable vital signs. All questions rearding hospital course and plan of care after discharge have been answered to satisfaction. Prescriptions for medications needed to be taken after discharge have been given to patient. Patient has been instructed to follow up with PCP, MD within the next 7 days after discharge. Patient verbalizes understanding all given instructions and has no further doubts regarding discharge.
Pt recvd vax 25FEB92 & on 25FEB92 reported discomfort/topical redness & swelling on 29FEB92 cc swollen glands, nausea & feverishness;
Woke with chills & goosebumps, then woke an hour later drenched in sweat. Alternated between chills & sweating for remainder of sleep. Woke in the morning & bones, joints & muscles throughout body feel achey. Headache & low grade fever.
Hives. I woke up with them the morning after the shot Wednesday and they lasted until Sunday, 4 days. I took BENADRYL on Wednesday morning hives were located on torso, chest arms, legs, neck, and face.
Patient felt dizzy and sweaty after the vaccine. He said he was also feeling a burning sensation in his stomach. He said he was hearing me as if I was very far away.  I offered him the bottle of water and I asked him to take it and wait another 15 minutes. He stayed and 15 minute later he was feeling fine. He said his symptoms were gone by the time he decided to leave (35 minutes after the vaccine was administered).
DVT's in right calf; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, in left arm on 16Mar2021 02:00 (at 57-years age) as single dose for covid-19 immunisation. Medical history included ongoing high blood pressure diagnosed in 2002 and it is under control with medications, ongoing diabetes diagnosed in 2000, neuropathy, allergies. The patient previously took first dose of BNT162B2 for Covid-19 immunization as Covid-19 vaccine first dose. Concomitant medications included metformin taken for diabetes mellitus from 2010 and ongoing at 1000 mg, twice a day; hydroxyzine (HYDROXYZINE) taken for allergies and ongoing at 25 mg, once a day; omeprazole (OMEPRAZOLE) taken for high blood pressure and ongoing at 40 mg, once a day; losartan (LOSARTAN) taken for hypertension and ongoing at 100 mg, once a day; carvedilol (CARVEDILOL) taken for high blood pressure and ongoing at 6.25 mg, twice a day; gabapentin (GABAPENTIN) taken for neuropathy and ongoing at 800 mg, twice a day; trazodone (TRAZODONE) taken for sleep and ongoing at 100 mg, once a day; simvastatin (SIMVASTATIN) at 20 mg, once a day taken for blood cholesterol and ongoing; insulin detemir (LEVEMIR) taken for diabetes mellitus and ongoing at 30 uL, once a day. Patient hopes he was not going to die. States on Saturday 3Apr2021 he went to the ER because he had DVT's in his right calf and they gave him the pneumonia vaccine there and he was under the influence because he was on pain medications. Patient received the pneumonia vaccine on Sunday 04Apr2021. NDC, lot number, or expiry date unknown. Caller states he got the second dose of the Pfizer vaccine today 6Apr2021. patient hopes he was not going to die because he took the two vaccines so close to each other. Patient has had DVT's since 2014 but flared up this Saturday 03Apr2021. States it was under control and it is recovering slowly, blood is flowing, INR is flowing, and it is therapeutic. they gave him a heparin drip to dissolve it in the ER. Patient was admitted to hospital at 12 midnight on 04Apr2021 and got out on 05Apr2021. The outcome of the event was resolving.  Information on the lot/batch number has been requested.
This is a spontaneous report from a contactable consumer. A male patient, of unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiry date: not reported), via unspecified route of administration, on Mar 10, 2021, single dose, for COVID-19 immunisation. Patient's medical history and concomitant medications not reported. The person is calling on behalf of her husband. Her husband is scheduled to get the second dose; however he had a fever and diarrhea on unspecified date in 2021. Reportedly, patient got the first dose of vaccine Mar 10, 2021. On Mar 28, 2021, patient was scheduled for the second shot. The reason reporter called was to schedule again. The outcome of the events: unknown. No follow-up attempts possible. Information about lot/batch cannot be obtained.
Soreness in left triceps. Some swelling. Body aches, feeling of impending cold in throat.  After 1 day: Itching in left calf After 2 days: Itching in left armpit.
Patient spouse reported that patient had muscle pain after vaccination that was not relieved after several days, and was made worse with any movement. Advised to have her contact PCP. She was sent from PCP to muscular specialist, which dx with nerve pain likely due to the flu vaccine administration.
I woke up with hives; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  On 16-MAR-2023, the patient received the 1st dose of Shingrix. On 20-MAR-2023, 4 days after receiving Shingrix, the patient experienced hives (Verbatim: I woke up with hives). The outcome of the hives was not recovered/not resolved.  It was unknown if the reporter considered the hives to be related to Shingrix.  It was unknown if the company considered the hives to be related to Shingrix.  Additional Information: GSK receipt date: 20-MAR-2023 The reporter was the patient and stated that, she had the shot and on the day of reporting, she woke up with hives. She had asked, if she needs to get the second shot. The patient asked what should she should do about hives as she was contiguous. No further details were provided. The patient had received the vaccine at a pharmacy but did not recalled the name of the pharmacy or contact information for the pharmacy. The reporter had denied consent to follow-up.
This case was reported by a nurse and described the occurrence of injection site swelling in a 5 year old female subject who was vaccinated with Infanrix for prophylaxis. On 8/11/05, the subject received the 5th dose of Infanrix in the left thigh (lot AC14B002AA). On 8/13/05, 2 days after vaccination with Infanrix, the subject experienced injection site swelling and injection site redness. The subject was treated with ibuprofen and warm compress. The events resolved on an unspecified date on or after 8/13/05 and on or before 8/15/05. The nurse considered the events to possibly be related to vaccination with Infanrix.
Rash - abd, face, back, itches started late after noon 11/17/11.
It was reported that a 57 year old female pt received a TD Adult vaccination on 01/26/2001 at 10am. Reportedly on 01/31/2001 in the morning the pt developed 2cm redness with .5 -1cm induration, no blisters on inner left forearm, itching and eye itching. Reportedly the pt recovered from this experience. From follow up # ! Correspondence received on 03 Apr 2001, no further information was provided. See reports U2001-00436, U2001-00438, U2001*00447 through U2001-00454 and U2001-00456 through U2001-00461, same reporter.
patient developed purpuric rash on the arm from the shoulder to just below the elbow that has persisted
January 28, 2021 Covid vaccine #1 February 25, 2021 Covid vaccine #2 8/2/2021- Patient Came into ED for back pain, came in with pain and said she had a fever 2 weeks ago of 103. Rule out ediology with Covid screen, high D-Dimer.  Covid positive and patient admitted.
Injection site reaction. Redness and pain around injection the injection site that appeared within 24 hours post vaccination. Continues now two days following vaccine
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's pertinent medical history was not reported. On 12-MAY-2014 the patient was vaccinated with ZOSTAVAX (subcutaneously). Other suspect therapies included acyclovir (manufacturer unknown). The patient was failed to discontinue her chronic acyclovir (manufacturer unknown) use before receiving the vaccine. The patient was still using acyclovir (manufacturer unkonwn) with no interruption in therapy. Thus, the pharmacist fears that a drug-vaccine interaction might occur. The patient experienced no known adverse effects. The patient present status was reported as other no known adverse effects. The outcome of failed to discontinue her chronic acyclovir (manufacturer unknown), drug-vaccine interaction might occur and no known adverse effects was unknown. The causality was not reported. Additional information has been requested.
3.6.2023 high heart rate. Ambulance to ER and one week hospitalization for AFib, etiology unknown.