chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Did not receive the full dose of the vaccine; The needle was not completely locked in; A spontaneous report  was received from a consumer concerning a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced did not receive the full dose of the vaccine and the needle was not completely locked in.   The patient's, medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patients received the first dose of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient did not receive full dose of vaccine and some came out from injection site. The needle was not completely locked in.   Action taken with the second dose of Moderna vaccine in response to the events for these 2 patients was not reported.  The outcome of the events, did not receive the full dose of the vaccine and the needle was not completely locked in, was resolved on an unknown date.; Reporter's Comments: This report refers to a case of Incorrect dose administered and needle issue for mRNA-1273, lot # unknown with no associated AEs.
Uncontrollable shivering Chills Body aches Mild fever(99.2F) Cough HEADACHE Fatigue Confusion Nausea Shivering and chills resolved within 7 hours All other AES ongoing at 5 days
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 23-MAR-2018, the patient was vaccinated with improperly stored PROQUAD (dosing details were not reported) (lot # N028444, expiry date: 09-APR-2019) for prophylaxis the vaccine was administered with properly stored sterile diluent (MERCK). The vaccine was stored at a temperature of  14 degree Celsius to -10 Celsius (-9.9 degree Celsius) for 17 hours and 11 minutes. No previous temperature excursions reported. No adverse effects reported. No product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA007217: US-009507513-1804USA007886.
No additional information provided; Nurse reporting a patient was administered VARIVAX after a temperature excursion.; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 11-JAN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number U019904, expiration date 24-JUN-2023 (route of administration not reported)  for prophylaxis (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion of 12.4 degrees Farhrenheit (°F) for 20 Minutes. Also, the vaccine had undergone a previous temperature excursion from 6°F to 14°F (11.6°F) for 25 Minutes.
Pt recvd 1 dose of Engerix-B & exp difficulty chewing, edema on the inside of mouth, & the outside of face looked edematous;
had a sore arm that last a day; .This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198) single dose, via an unspecified route of administration on 29Jan2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had a sore arm that last a day. The patient received the second dose on 19Feb2021. The outcome for the event was recovered.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a nurse practitioner refers to unspecified number of patients of unknown gender and age. Information regarding the patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with VARIVAX (lot # M003439, expiry date: 19-JAN-2018 and lot # M006729, expiry date: 18-FEB-2018). Nurse reported that the vaccine reached 29.92 F for 30.25 hours. A data logger was used and the vaccines were back in range. There were no prior excursions. No adverse effects were reported. Additional information has been requested.
Patient had immunization at 5:40pm  on left arm. Patient returned back at 6:40pm showing she had a bleeding (stopped at the time)and swelling at injection site. She complained that she did not have reaction on first dose. RPH cleaned up the blood on injection site and applied another bandage for for her, then informed the patient that she still can have reaction to second dose even she did not have reaction to first dose. Her swelling was localized at the injection site. She was advised to watch for any potential allergic reaction like rash, SOB or unusual swelling (anaphylaxis), call MD or 911 if severe allergic reaction occurred. Meanwhile she may use ice pack and ibuprofen to bring down the swelling.
Body aches , chills and low fever, the next day. Was somewhat better second. Today 3rd day think better, just arm still sore from injection.
Patient alerted pharmacist that he had a history of fainting after getting blood drawn. Patient explained that it's anxiety and combination of watching needle and blood. Pharmacist gave patient the shot without patient looking at the needle. Patient was seated and doing well for 5 minutes. Approximately 5 minutes after vaccination, he started to have loss of consciousness and had what looked like a seizure for about 15 seconds. Patient slowly recovered consciousness and was able to say his name and
This patient shot was given at 11:22 AM. The mother brought the patient to the office at 1:10 PM same day. The patient's left arm was swollen from the elbow to the shoulder, no tenderness, or warmth to the site, or redness.
Skin around injection site bright red and warm to the touch.  Onset within 2 hour of injection with peak of redness at 48 hr. At peak redness 8 cm.  Duration 4 days.  No Treatment.
COVID-19; COVID-19; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for 28 patients. This is one of 28 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced COVID-19 (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date. The reporter stated that 28 people from a certain place tested positive.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101237061 Same reporter/product/events, different patient
Patient had itching of the upper arm the night the shot was given.  A rash developed the next day, which grew in size over a week. September 19th-21st the rash was still present but stable. The patient reported mild to moderate itching. There were no bug bites present.  The rash was an erythematous macular rash, ovoid 8cm with mild warmth. The rash and itching occcured below the site of injections. The patient was instructed to use a cool compress if the rash was itchy and an antihistamine as needed.
Woke at 3 a.m. (approx. 12 hours post-injection) with flu-like symptoms: nausea, chills, body aches, headache. No fever (37.1 C). I had the flu vaccine in September, so this seems unlikely to be influenza. Awake until 6:30, back to sleep until 7. Took 600 mg Ibuprofen at approx. 8:30 a.m.
Client was administered half a dose (0.25 mL) for his 1st dose, instead of 0.5 mL. Client was notified, AP hotline was called to asked what  proper step to take next. EMR record was submitted complete. No further dose was given to client.  Client did not have any adverse reaction from the dose.
27JAN92 temp to 105 rx w/APAP beg w/during night x 4; 28JAN92 inc temp & legs hurt mom then took pt to hosp & pt given meds;
Fever of 100 for two days.  Cough, chest hurts, muscular aches.  Cough is still ongoing.
Patient got 1st dose in Shingrix series on 10/10/22.  On 11/15/22 patient came in and talked to me about the adverse reactions she had.  The next day the patient had a rash down her arm but also had stinging in her eyes.  She saw her eye doctor and they recommended to skip dose number two or to follow up with their primary care provider.  The PCP also said to bypass dose number two.  The patient came here and just wanted to let us know what had happened.
I had some Virgo that on November 27th.  It is ongoing.  I went to see a doctor about this.  I took a COVID-19 test, negative results.
large, reddened, itchy area, oval about 2 inches by 3 inches; large, reddened, itchy area; slight swollen on the left deltoid; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (large, reddened, itchy area, oval about 2 inches by 3 inches), VACCINATION SITE ERYTHEMA (large, reddened, itchy area) and VACCINATION SITE SWELLING (slight swollen on the left deltoid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (large, reddened, itchy area, oval about 2 inches by 3 inches), VACCINATION SITE ERYTHEMA (large, reddened, itchy area) and VACCINATION SITE SWELLING (slight swollen on the left deltoid). At the time of the report, VACCINATION SITE PRURITUS (large, reddened, itchy area, oval about 2 inches by 3 inches), VACCINATION SITE ERYTHEMA (large, reddened, itchy area) and VACCINATION SITE SWELLING (slight swollen on the left deltoid) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.; Sender'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.
Patient received vaccines MENACTRA and Men B. After receiving vaccines patient was alert and talking then stood up and fell onto floor face first. Fell onto right cheek, had a bruise forming. Patient went unconscious and starting having a seizure. Dr and RNs at bedside. Oxygen was placed on patient and he came back to full consciousness. Patient was alert and oriented at that time. EMS called. Vitals were done. Initially 74 HR, pulse ox 96 BP 160/80 on 6L. HR dropped to 52. After a few minutes BP went to 138/62, HR 56, Pulse ox 100. Patient complained of right shoulder soreness, back of his head hurting, nauseated. Patient sat up in the chair as he awaited for EMS. Glucose and IV started in room.
Rash around the injection site; Diluent only was given; inappropriate dose of vaccine administered; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number 3425X, expiry date 18th December 2021) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix and FLUAD. On 2nd October 2019, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In October 2019, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were reported as follows: A pharmacist reported that the diluent only was given for the Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Also Fluad HD was co-administered in the same site. The patient developed a rash around the injection site. The reporter consented to follow up.  This case has been linked with US2019180863, reported by same reporter. It was unknown if the reporter considered the injection site rash to be FLUAD HD.
Hand tremors in right hand beginning 6 hours post vaccine, beginning at 5:30 am the next morning (2/5/21) tremors began in left hand as well. Tremors are still happening as of now
This case was reported by a consumer (the subject) and described the occurrence of arm soreness at injection site in a 63-year-old female subject who was vaccinated with Influenza vaccine unspecified (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included depression, high blood pressure and high cholesterol. Concurrent medications included SYNTHROID, Blood pressure medication, Anti-cholesterol medication, Vitamins and Antidepressant (unspecified). On 5 November 2013 at 17:30 the subject received a dose of Influenza vaccine unspecified (unknown, left arm). On an unspecified date in 2013, within months of vaccination with Influenza vaccine unspecified, the subject experienced arm soreness at injection site. The subject reported she received the flu vaccine a few weeks ago; brand name and manufacturer were unknown. She reported she did not know when she first started experiencing arm soreness, but that the soreness is not going away. At the time of reporting the event was unresolved. Follow up was received from consumer on 19 December 2013. The consumer (subject) confirmed that she was vaccinated with FLULAVAL (GlaxoSmithKline); previously the subject did not know which manufacturer or brand name.
This is a spontaneous report from a contactable physician received via a sales representative. An approximately 19-year-old female patient received the second single dose of TRUMENBA on an unspecified date for immunisation. No other vaccinations were administered at that time.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced urticaria all over her body on an unspecified date after vaccination, with unknown outcome. The physician advised them to administer diphenhydramine (BENADRYL) for treatment. No follow-up attempts possible. No further information expected.
One hour after receiving vaccine patient felt sweaty, lightheaded & faint.  Did not pass out.
Interchange of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a male patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included HEPATITIS A VACCINE (VAQTA) for prophylaxis.   On an unknown date, the patient received Havrix at an unknown dose and the 1st dose of VAQTA. On an unknown date, unknown after receiving Havrix, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown  Additional details were received as follows: The age at vaccination was not applicable for this report.. The patient received a first dose of Vaqta (non GSK vaccine) about 6 months ago and wants to continue the series with Havrix, which led to interchange of vaccine products. The patient have not received till the time of reporting. The reporter consented to follow up. No lot number or expiration date of any vaccine .
less than half the dose was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (less than half the dose was administered) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced ACCIDENTAL UNDERDOSE (less than half the dose was administered). At the time of the report, ACCIDENTAL UNDERDOSE (less than half the dose was administered) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment medication was unknown.  This report refers to a case of accidental underdose for mRNA-1273 with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of accidental underdose for mRNA-1273 with no associated AEs.
Pt arrived at 15 months on 8/9/11 and showed me a spot on Rt outer leg that appeared to be fat necrosis from a previous vaccine first noticed by mom after 12 month visit. Hep A was given at that point at that visit on 5/9/11. No treatment - will monitor.
No adverse event; HCP called MNSC to inquire about MMR II dosing schedules and provided the following AE.  HCP states that a 19-year-old female patient with no MMR II immunity, received two doses of MMR II "approximately two and a half weeks apart". HCP states the dat; HCP called agency to inquire about MMR II dosing schedules and provided the following AE.  HCP states that a 19-year-old female patient with no MMR II immunity, received two doses of MMR II "approximately two and a half weeks apart". HCP states the dat; This spontaneous report was received from a certified medical assistant, and refers to a 19-year-old female patient. No information was reported concerning the patient's medical history, concurrent conditions or concomitant medications.   On 13-JUN-2022, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot number T031436, expiration date on 15-SEP-2022, as prophylaxis. Approximately two and a half weeks later, the patient received another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot number U022175 with expiration date on 17-JUL-2023).   No adverse events were reported.
This spontaneous report as received from a nurse refers to a 11 month old (also reported as "five days before 12 months") patient of unknown gender. No information on patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 28-JUN-2001, five days before 12 months of age, the patient was vaccinated with the first dose of VARIVAX, lot number reported as 0231L, valid for number 638492/0231L, expiration date: 14-AUG-2002. Next, on 07-APR-2008, the patient was vaccinated with the second dose of VARIVAX, lot number reported as 1848U, valid for number 660037/1848U, expiration date: 15-NOV-2009, both vaccination administered subcutaneously (doses not reported). No adverse effects were reported. Additional information has been requested.
Information has been received from a physician concerning a 2 month old patient who was vaccinated PO with the first dose of ROTATEQ. Concomitant vaccination administered within the same visit included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. Subsequently the patient experienced diarrhea and was hospitalized for two days (specifics unknown). It was noted that the "event resolved on its own and the patient was fine." There was no product quality complaint. Additional information has been requested.
Patient is a 72 y.o. male with a history of CKD3, panhypopituitarism, C-Diff (10/2022) who presented to Hospital 3/19/2023 with c/o weakness and confusion. (+)COVID test 3/18/23  Na 132, creatinine 1.63, WBC 13, hemoglobin 12.1 chest x-ray with prominence of interstitial markings, unremarkable CT brain without contrast. He was treated with Paxlovid and remained stable on RA. He was discharged home 3/23/23 in stable condition.   1. Acute Metabolic Encephalopathy: 2/2 COVID-19 infection, AKI, hyponatremia. CT-Head 3/19/23: chronic microvascular ischemia. Improved with supportive care. 2. COVID-19 Infection: no PNA seen on CXR. Partially Vaccinated (Moderna x3, last 2021) symptom onset 3/17/23, (+)test 3/18/23. Continued 5 days of Paxlovid on 3/23/23.   3. AKI on CKD3: Baseline Cr 1.4, Cr 1.7 on admit, improved to 1.3 by 3/20/23 with holding home ARB. ARB resumed 3/21/23 and creat stable 3/23/23. 4. HTN: Held home ARB for relative hypotension and AKI. Restarted 3/21/23.Ongoing OP monioring. 5. Panhypopituitarism: Continued home Synthroid, initially on Stress-dose steroids, resumed home hydrocortisone 10mg / 5mg / 5mg on 3/22/23 6. Type 2 diabetes: Last A1c 7.3% (2/2023). SSI while inpatient. Resumed home meds on discharge. 7. Acute Hypovolemic Hyponatremia: Baseline Na 135, Na 132 on admit, due to diarrhea.  8. Hyperlipidemia: Continued  fenofibrate, held lipitor while on Paxlovid, can resume 3/24/23. 9. Chronic Iron Deficiency Anemia: Baseline Hgb 12-13, Hgb 11.3 on admit. Iron studies 3/20/23 Iron 16, Ferritin 58, Iron Sat 5%. 2 doses of IV Iron followed by PO Iron
Presents for fatigue and cough x1wk, gradually worsened. Admitted for COVID. Tx: IV hydration, symptomatic tx. DC to home.
my smell and taste are still off, smells and tastes bad; my smell and taste are still off, smells and tastes bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), in 2020 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single; Manufacturer Unknown), for Covid-19 immunization. The following information was reported: DYSGEUSIA (non-serious), PAROSMIA (non-serious), outcome "not recovered" and all described as "my smell and taste are still off, smells and tastes bad". Additional information: The patient got the 2nd dose vaccine 3 years ago and patient's smell and taste were still off, smells and tastes bad.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.