chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-JUL-2023, the patient received the 1st dose of Shingrix. On 25-JUL-2023, 6 hrs after receiving Shingrix, the patient experienced muscle soreness (Verbatim: muscle soreness). The outcome of the muscle soreness was unknown.   It was unknown if the reporter considered the muscle soreness to be related to Shingrix.     It was unknown if the company considered the muscle soreness to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JUL-2023 The reporter was patient. The patient called to asked for advice on how to handle her muscle soreness after administration of Shingrix vaccine. The reporter did not want to provide personal information, so all they were able to gather was her telephone and zip code. The reporter requested to consent the follow up.
some injection site pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "some injection site pain".   Additional information: Patient too experienced some injection site pain, but resolved after 2 to 3 days. Patient was wondering if you have seen prolonged pain in the clinical trials and if there was any advice with respect to the second dose (e.g., use the other arm).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient called to advise me that her arm has a swollen, reddened, hot knot on the right deltoid and that she has a swollen lymph node on R. side of her neck that is tender to touch and noticeable to co-workers due to swelling.
Information has been received from a physician concerning a female under 18 years old with no pertinent medical history who on 18-FEB-2009 was vaccinated with her first dose of GARDASIL (lot number, route and site not reported).  There was no concomitant medication.  On approximately 20-FEB-2009, 2-3 days after receiving vaccination the patient experienced syncope and went to the emergency room.  Electroencephalography (EEG) and neuro-consult were performed with no result reported.  The patient recovered from syncope after treating and was released from the emergency room on the same day.  Additional information has been requested.
Patient wife called me on 9/26/18 and reported that starting the day after the injection, Sunday morning, the patient experienced nausea and lethargy. He also had a all over body rash. She said he felt warm to touch but was not running a fever as the thermometer was reading 98.5 and 98.7. The wife said the patient was not experiencing itching or pain with the rash. I asked that she call the family doctor, and make him aware of the reaction to determine if there was anything the doctor wanted the patient to do to relieve some of the symptoms he was experiencing.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). A 38-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Helicobacter pylori" (unspecified if ongoing), notes: history of Helicobacter pylori treated with amoxicillin and pantoprazole three months ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: ACUTE HEPATIC FAILURE (medically significant), outcome "unknown", described as "acute liver failure"; MENTAL STATUS CHANGES (non-serious), outcome "unknown", described as "altered mental status"; YELLOW SKIN (non-serious), outcome "unknown", described as "yellowing of her skin"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "right upper quadrant pain"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; RASH PRURITIC (non-serious), outcome "unknown", described as "Pruritic rash"; VOMITING (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Biopsy liver: portal inflammation with interface activity; diffuse lobular inflammation; perivenulitis with abundant lymphocyte; plasma cells consistent with seronegative AIH, notes: drug induced AH; Blood test: 2.4, notes: showed international normalized ratio; 212 U/L, notes: alkaline phosphate; 3769, notes: ALT; 1572 U/L, notes: AST; 23.8 mg/dL, notes: total bilirubin; Hepatitis viral test: normal; chronic liver disease workup: normal; Physical examination: normal, notes: mentation, scleral icterus, jaundice, and a maculopapular rash; Scan: no intra-or extra-hepatic biliary duct dilation; Serology test: normal. Therapeutic measures were taken as a result of acute hepatic failure, mental status changes. Additional information: Several etiologies of drug-induced AIH are well-established, cases secondary to COVID-19 vaccination have been minimally reported. Common adverse events for COVID-19 vaccination have been noted such as fever, chills, fatigue, headache, and muscle pain. Several rare side effects have occurred including immune thrombocytopenia and one other suspected case Of Pfizer- BioNTech COVID-19 vaccination-induced AIH reported in the literature. In that case the patient developed symptoms within one week of the first dose. This case serves to report a potential association and not necessarily causation between the Pfizer BioNTech COVID 19 vaccination and AIH. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a physician via sales rep and described the occurrence of shortness of breath in a adolescent female patient who received BEXSERO. On 27th July 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 27th July 2016, several hours after receiving BEXSERO, the patient experienced shortness of breath (serious criteria hospitalization and other: serious as per reporter). On 28th July 2016, the outcome of the shortness of breath was recovered/resolved. The reporter considered the shortness of breath to be possibly related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The physician indicated that the patient received vaccination and a few hours later was admitted to hospital at night due to shortness of breath and trouble while breathing. On 28th July 2016, the patient was released from the hospital. It was unknown if the patient would receive the second vaccination in the series. The sales representative put in a request to the Medical Science Liaison (MSL), but he would advise her that this report had already been completed.
Swollen, hard, and warm left arm.  Treated with Tylenol and hot packs.
Poor sleep; swelling at injection site; light fever; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 11:15 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: POOR QUALITY SLEEP (non-serious) with onset 27Sep2023 at 23:00, outcome "recovering", described as "Poor sleep"; HEADACHE (non-serious) with onset 27Sep2023 at 23:00, outcome "recovering"; PYREXIA (non-serious) with onset 27Sep2023 at 23:00, outcome "recovering", described as "light fever"; VACCINATION SITE SWELLING (non-serious) with onset 27Sep2023 at 23:00, outcome "recovering", described as "swelling at injection site". Therapeutic measures were not taken as a result of poor quality sleep, vaccination site swelling, pyrexia, headache.  Additional information: Patient does not get covid prior vaccination. Patent not tested positive for COVID post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Discharge provider MD   Primary care physican DO Admission date 5/31/2023 Discharge date Jun 2, 2023   Discharge diagnosis 1. Sepsis due to covid 19, sepsis resolved 2. Acute hypoxic respiratory failure, resolved  3. Hypokalemia, resolved 4. Hypomagnesemia, resolved  5. Persistent atrial fibrillation 6. S/P TAVR 7. Fabry disease 8. COPD 9. ILD 10. Obesity 11. Type 2 diabetes with diabetic neuropathy  12. Dysphagia, unspecified  13. Essential hypertension     Hospital Course He was admitted with sepsis due to covid 19 with tachycardia, fever, hypoxia, lactic acidosis. He was initially requiring 2L oxygen by nasal canula. He had hypokalemia and hypomagnesemia that resolved after being replaced. He was given IV fluids and his lactic acidosis resolved. His covid infection was treated with Decadron and remdesivir. No antibiotics were given because there was no bacterial infection identified in additional to his viral infection. The following morning, he was weaned off oxygen supplementation and was saturating normally on room air. He was seen by physical therapy and occupational therapy who recommended home health care at discharge however, he declined this. The remainder of his chronic medical conditions were stable. He was prescribed 3 additional days of decadron to complete a total of 5 days. Remdesivir was stopped.    Patient was discharged home in stable condition
Narrative: COVID infection following COVID vaccine series 04/23, Pfizer, dose #1 (NON-FACILITY) local county DOH 05/09, Pfizer, dose #2 (NON-FACILITY) local county DOH 12/27 COVID swab, result: detected 12/27 pt cc: cough myalgias, rhinorrhea, sore throat exposure: wife
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received SHINGRIX. Concomitant products included Alendronate and amlodipine. On 18th March 2018 11:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th March 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced injection site erythema, injection site nodule and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site nodule were recovering/resolving and the outcome of the injection site pain and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site erythema, injection site nodule and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient did not know the lot number or expiration date. At 11:30, the patient received SHINGRIX on right arm. The patient felt that the vaccine was administered too low on her arm in the biceps, which led to vaccine administered at inappropriate site. On an unknown date, a nodule occurred at injection site and the patient experienced redness about the size of a fifty cent piece and the site was also painful to touch. It grew for several days but was not almost resolved.
First Vaccine given on 12/31/2021. Local Pharmacy. Pfizer. Lot: FH8030. Intramuscular. Left Deltoid.
Client presented to the clinic for his first dose of the Pfizer pediatric COVID-19 vaccine (Lot FK5618, received to the LD at 1621). Shortly after vaccination, the client c/o feeling dizzy. There was no diaphoresis, pallor, or LOC noted. No changes to breathing, SOB, or respiratory distress were noted. He remained sitting in his chair with appropriate balance and posture. The client was provided juice and drank it without difficulty. He chose a sticker and began to play with it, although his manner was listless and he responded to questions slowly and with a very quiet voice. At first, the client declined to lay down, but eventually he walked over to the cot without difficulty and needing no assistance. Once he laid down, he reported that he felt ?better?, but his demeanor continued to be listless. He denied changes in vision or hearing and reported no concerns with other body systems when prompted to assess and report. The client?s mother was in attendance. Education on vasovagal responses, what to watch for, and when to seek medical care was provided. The client?s mother verbalized understanding.  After a period of rest, the client sat up on the cot at 1634 and drank water. He reported that he felt ?good? but also a little dizzy. He did report that the sensation of dizziness had improved when compared to how he felt shortly after his vaccination. When offered a choice between laying back down or continuing to sit, the client chose to remain sitting. No pallor or diaphoresis was noted. Mood and mentation appeared WNL and consistent with his baseline (per his mother). The client began playing with his sticker, displaying more energy than he had previously. At 1639 the client stood up at the edge of the cot. He reported that he felt ?normal? and proceeded to walk without difficulty or requiring assistance. As he passed by the box containing prizes for children, he stopped to choose a toy. He began vigorously playing with his toy, sitting with his family in observation. No further s/s hypotension were visualized and he appeared to be to baseline. He remained under observation and continued playing actively until 1653, at which point the client exited with his family in a private vehicle.
This spontaneous case, initially received from a physician on 17-Nov-2017, concerning a 60-year-old, adult, male patient. The patient's historical vaccine included flu vaccine (in the past with no issues as reported). The patient's current condition was diabetes. On 03-Oct-2017, the patient received FLUVIRIN (dose: 0.5ml, route of administration: intramuscular, batch number: 1720701, expiry date: 30-Apr-2018). On 17-Oct-2017, 15 days after administration of FLUVIRIN, the patient experienced dysphagia, cough, and severe muscle weakness in legs (could not get up out of chair) and edema about 2 weeks after receiving FLUVIRIN. Barium swallow showed esophageal dysmotility, chest x-ray showed lower lobe interstitial lung disease, CPK (creatine phosphokinase) elevated, ANA (antinuclear antibody panel) negative, RA (rheumatoid factors) highly positive. The patient received LEVAQUIN and omeprazole. Then he received Prednisone taper (as reported) which had shown dramatic improvement. At the time of this report, the events were resolving. The reporter assessed the case as non-serious. Follow-up received on 12-Jan-2018: Non-significant follow-up received with no additional information. The reporter confirmed the batch number and expiry date. Narrative was amended accordingly.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (strength, dose and route were not reported) (lot # N023828 and expiration date: 25-JUN-2020) for prophylaxis (product storage error). The vaccine was stored in below 32 degrees Fahrenheit (F) / 0 degree Celsius (C) (-0.3 C) for 64 hours. The digital data logger was not involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1806USA012211: US-009507513-1806USA012213: US-009507513-1806USA011719.
This is a spontaneous report from a contactable pharmacist. A 7-year-old male patient of an unspecified ethnicity received a single dose of TRUMENBA, via an unspecified route of administration on 21Apr2016. Medical history and concomitant medications were not reported. The patient experienced fever and nausea on an unspecified date after receiving the vaccination and he was still having the same. Fever and nausea are controlled with the medication taken as a treatment: TYLENOL 15 mg per kilo and ZOFRAN 4 mg as needed. The final outcome of the events was reported as unknown. The pharmacist mentioned that she did not believe that nausea and fever were because of TRUMENBA, but it happened right after the vaccine was given to the patient, so she was calling to get more information whether it was happened actually with the vaccine.
L sided facial numbness, persisted 3-4h after dose #1, then 30 days after dose #2
Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: "electrical pulses across his arm"
Within about 1/2 hr, I had mild breathing trouble, metallic taste and itchy tongue and throat.  About 24 hours later I (May 12) had a rash covering my chest and stomach with more itchy throat/ tongue  (I would say moderate).  I went to urgent care and was given a steroid shot and prescription. I continued to have a rash and breathing has gotten worse.  I returned to urgent care today (May 15),  I was given a breathing treatment and prescribed an inhaler as well as another steroid shot.   I am still having symptoms, both rash and labored breathing.
Patient called pharmacy explaining she developed 104 degree fever 3 days after given flu shot & diagnosed w/mono 2 weeks after given flu shot.
Has not received 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided   Reporter did not allow further contact
1218 Complaint of feeling lightheaded. States she had a similar reaction to first vaccine. BP 99/58, R 15, O2 98%, P 93. 1230 BP 102/70, R 16, O2 98%, P 96. Patient states she feels slightly better but still a bit lightheaded. Declined offer for EMS. Alert and oriented x 4. Slow and steady ambulation. Denies any other symptoms.
Pt vaccinated to Engerix B suffered a miscarriage on 22FEB90 when 6 weeks pregnant. No hospitallization required. Reporting physician does not know if the event is related to the admin of the vax.
and burning sensation; Rash all over body; scars; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 28-year-old female patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose 1, single (Lot number: EW0161) at the age of 28 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (ongoing), notes: Epilepsy; "Brain Surgery" (unspecified if ongoing); "Tumor in Stomach" (unspecified if ongoing). Concomitant medication(s) included: VIMPAT taken for epilepsy, start date: 2011 (ongoing); ZONISAMIDE taken for epilepsy, start date: 2011 (ongoing). The following information was reported: RASH (non-serious) with onset 21Apr2021, outcome "recovered", described as "Rash all over body"; BURNING SENSATION (non-serious) with onset 21Apr2021, outcome "recovered", described as "and burning sensation"; SCAR (non-serious) with onset 2021, outcome "unknown", described as "scars". The events "and burning sensation", "rash all over body" and "scars" required emergency room visit. Therapeutic measures were taken as a result of burning sensation, rash, scar. Additional information: The patient got a rash all over her body and a burning sensation and was rushed to the hospital (ER). After 1-2 weeks, it resolved, but she has scars. She did not receive a secondary dose. It was reported that patient was treated and released in the ER. She stated, she saw 3 doctors there and they told her to use cream to put over it.
I developed sores on my scalp that were not necessarily itchy, but they were crusted, and they hurt. The sores seem to be chronic. After about 2 weeks I did see the dermatologist and he diagnosed me with Seborrheic Dermatitis. He advised I should alternate T-gel shampoo with Selsun Blue shampoo. He also prescribed Clobetasol. The Seborrheic Dermatitis never really went way, but after my booster it flared up again. I also have a patch of alopecia that I'm being seen for now.
Lump in my neck, near my collarbone, on the side where the vaccine was administered. Visible and painful to the touch.
SHORT-DATE PRODUCT (LOT FL2757, EXP 9/30/22) ADMINISTERED TO PATIENT ON 10/1/22
Due to a defect in the syringe, the needle retracted and vaccine leaked out as the vaccinator pushed on the plunger and only a partial dose, equal to or less than half of the dose, was given to the patient. Per guidelines, an immediate full dose was given to the patient afterwards. The patient was observed after for 15 minutes with no adverse reactions.
pt recv vax;awoke w/ pain in neck,tightness & discomfort in neck;diff breathing w/ pressure over sternum; painful, diff swallowing; dyspepsia & more belching than usual; was not able to eat or drink very much 10jul94;md prescribed maalox;
Breast-feeding; Arm is Sore; A spontaneous report was received from a consumer concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine and developed a sore arm and breastfeeding.  The patient's medical history included pregnancy (date of LMP: 12 Jun 2020, live full-term birth. delivery type: vaginal) and alcohol use 1-2 per week. Products known to have been used by the patient, within two weeks prior to the event, included Wellbutrin 150 (unit unknown) daily via oral route, multivitamin daily and fish oil daily.   On 30 Dec 2020, prior to the onset of events, the patient's received their first of two planned doses of mRNA-1273 (Batch number: 027-K20A, Expiry date: 22 Jun 2021) intramuscularly in the right deltoid for prophylaxis of Covid-19 infection.  On an unknown date, the patient reported sore arm and breastfeeding. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, sore arm and breastfeeding, was considered unknown.; Reporter's Comments: This is a case of product exposure during breastfeeding with expected event of vaccination site pain. Patient will continue to be contacted for further monitoring of AEs.
The night I got the booste,r Thursday, I developed achiness all over, pain in injection site arm, next day, Friday, had fever of 99.7 all day, achiness, headache. Saturday I had a bad headache, Saturday night I developed pain in my left armpit. Sunday morning 11:30 am my armpit is still sore and injection site us still sore especially to the touch. I didn't experience these symptoms with my first two doses. Just some tenderness at injection site. The Booster has been much different.