chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received the first dose of Shingrix on 2018 / have not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 74-years-old male patient who received Herpes zoster (Shingrix)(batch number 3PD3E, Expiry date 8th October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient received the first dose of Shingrix on 2018 and came back on the day of reporting to receive the second one.  Till the time of reporting, the patient did not receive 2nd dose, which led to in incomplete course of vaccination. This case has been linked with case US2020254931, reported by same reporter. The reporter consented to follow up.   Follow up information received from pharmacist on 23rd June 2021: On 23rd December 2020, the patient received 2nd dose of Shingrix (0.5 ml) intramuscularly, which led to lengthening of vaccination schedule. Te batch number and expiry date was updated. The VAERS details were updated.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020254931:same reporter
Got shot 10/23. Pt. reports chills and fever. By 3.5 hrs after, 7PM felt chills, "heat", and "on the verge of nausea". Fell asleep, woke up next day at 10AM with temp of 100.5 F, but felt "as though it was 105 F". It lasted until 1-2PM Saturday 10/24, so about 18 hours, then symptoms went away abruptly.
Narrative:  " Influenza Immunization: The patient declines to receive the recommended dose of seasonal influenza vaccine. Comment: reports a "reaction" when he gets one." 1/3/22 preventative medicine note
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated on pharmacy with PNEUMOVAX23 (lot # J007786, expiration date: 25-SEP-2014). Route of administration and dose were not reported. Concomitant medications were not reported. On 27-SEP-2013 the patient experienced serious swelling at the injection site and complained of pain. These injection site reactions were larger than the pharmacy has ever seen before. The patient sought for medical attention and treatment was given for the events (not specified). The outcome of the adverse events was reported as recovering. The relationship between PNEUMOVAX23 and the adverse events was not reported. The pharmacist stated there have been 5 or 7 patient who have received this Lot and have not reported any reactions. A lot check was requested by pharmacist. This case is linked to case 1310USA003793 and 1310USA002354 via same reporter link. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included surgery (had many surgeries in life and prior to getting SHINGRIX). Concomitant products included hydrocodone. In April 2018, the patient received SHINGRIX (intramuscular). On an unknown date, immediately after receiving SHINGRIX, the patient experienced pain in arm, throbbing pain, shoulder pain, muscle soreness and neck pain. On an unknown date, the outcome of the pain in arm, throbbing pain, shoulder pain, muscle soreness and neck pain were not recovered/not resolved. The reporter considered the pain in arm, throbbing pain, shoulder pain, muscle soreness and neck pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported to VAERS by the patient's pharmacist. The patient received SHINGRIX vaccine in the end of April 2018 in the left arm. The patient could not specify exactly when the events happened. However, soon after the SHINGRIX injection his whole arm where he received the injection was sore. The muscles of arms started getting sore. The patient started noticing that when he was sitting in a reclining chair and was resting his left arm on the arm chest, the pain from his arm was radiating up to his neck and shoulder. If the patient was in bed sleeping and he was side sleeping, it did not matter which side he slept on, he would get throbbing pain from bicep area of his left arm. The patient was on 3 pills of 5 mg hydrocodone a day. Even with that dose, he was still feeling the pain that he had as a result of getting the SHINGRIX. The patient had provided the contact details of his physician.
pain; injection site is painful, puffy & hot; Both my arms feel like they weigh a 1000 lbs; aching from my neck down to my navel with severe muscle aches; aching from my neck down to my navel with severe muscle aches; shortness of breath; nauseous; diarrhea; This is a spontaneous report from contactable consumer(Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in Arm Right on 26Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 05Mar2021, patient had first Pfizer shot. Patient's left arm hurt for 4 weeks, so patient got second shot in right arm on 26Mar2021.That day patient ended up in the ER in horrible pain. Patient was put in a sling and given pain meds. 22 days later patient was still in pain. Patient had injection site pain,  injection site was puffy & hot. Both arms felt like they weigh a 1000 lbs. Patient was aching from neck down to navel with severe muscle aches. Patient experienced shortness of breath when talk and patient was nauseous every time patient eat and had diarrhea since 2nd dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
listless, lethargic, anorexic w/weakness in legs 10-12 p/5 doses; bitten in 2 places on leg by rabid fox; mom & child recvd tx; on Augmentin for 7 days immed p/incident; condition resolved in 7-10 days w/no treatment; f/u 12NOV92 pt recove;
Newly diagnosed multiple sclerosis; This literature-non-study case was reported, (Newly diagnosed multiple sclerosis) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS (Newly diagnosed multiple sclerosis) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS (Newly diagnosed multiple sclerosis) outcome was unknown. Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MULTIPLE SCLEROSIS (Newly diagnosed multiple sclerosis) to be related.    Concomitant medication were not provided.  Reported Newly diagnosed Multiple sclerosis (MS) following recent exposure to mRNA COVID-19 vaccines. Latency from vaccination to initial presentation varied. Neurological manifestations and clinical course appeared to be typical for MS including response to high dose steroids in 4 cases and additional need for plasmapheresis in one case; Sender's Comments: This is a literature-non-study case concerning a 46-year-old female patient with no reported medical history, who experienced the serious unexpected event of newly diagnosed multiple sclerosis. The event occurred on the unknown day after the unknown dose of mRNA-1273 vaccine administration. The event was conservatively assessed as related with the product administration since the temporal association cannot be assessed at this time. The rechallenge was not applicable since the dose number was not disclosed.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.
Lt upper arm w/ redness,induration, & pain 8cm x 8cm.
Allergic reaction at the injection site.  Rash, itching, red, irritated skin warmer to the touch on and around injection site.
Confirmed breakthrough case   COVID-19 (Pfizer) 1  01/15/2021  Pfizer EL3249   COVID-19 (Pfizer) 2  02/08/2021  Pfizer EM9810   COVID-19 (Pfizer) 3  09/28/2021  Pfizer EW0150
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history or concomitant mediations were not reported. On unknown dates, unspecified patients were vaccinated with improperly stored (Merck) VARIVAX lot # L002870 expiry date 27-JAN-2017, lot# L006386 expiry date 25-FEB-2017, lot# L013827 expiry date 21-APR-2017, lot# L012036 expiry date 07-APR-2017 (dose and route of administration unspecified). No adverse effects were reported. Additional information has been requested.
Headache, Nausea and Vomiting starting approx. 12 hours after injection given, along with low grade fever and very sore arm. Shooting pain with injection down entire length of arm. Arm warm to touch, minimal swelling noted per mother.
are was more tender than first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (are was more tender than first shot) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer since 2018.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (are was more tender than first shot). At the time of the report, VACCINATION SITE PAIN (are was more tender than first shot) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-074929 (Patient Link).
Received an expired dose of Menactra with no reported adverse event; Initial information received on 05-Jan-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of unknown demographics who received an expired dose of menactra with no reported adverse event, after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 05-Jan-2022, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site as immunization.  On 05-JAN-2022, the patient received an expired dose of menactra (expired product administered) (latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. No adverse event was reported.  Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Received an expired dose of Menactra with no reported adverse event).  At time of reporting, the outcome was Unknown for the event received an expired dose of menactra with no reported adverse event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Diarrhea; vaccine has a laxative in it; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and REACTION TO EXCIPIENT (vaccine has a laxative in it) in a  patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and REACTION TO EXCIPIENT (vaccine has a laxative in it). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company Comment: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
I had classic COVID-19 symptoms. I was extremely congested with a runny nose, coughing constantly. I had extreme fatigue with muscle and joint aches. I had chills and a low grade fever. I did not have any issues with my oxygen level. I had been in an airport with unmasked people. I started feeling not well on Monday and I contacted my physician and I was given monoclonal antibodies. By the time I had the infusion I was feeling better due to treating with bed rest, Tylenol and fluid. I am still currently very tired and fatigued but I am otherwise fine.
Information has been received from an immunization coordinator concerning a 24 year old female patient.  "Sometime last week" the patient was vaccinated with her first dose of GARDASIL 0.5 ml (lot number and site not reported).  Subsequently the patient experienced shortness of breath and dizziness.  Blood pressure was performed with no result reported.  The patient also was checked her lungs, but no result was reported.  "Soon after reaction" the patient recovered from shortness of breath and dizziness.  No further information is available.
Patient presented day after vaccine with swelling and redness below the injection site. Patient also stated that it felt feverish to the touch. Patient presented to the pharmacy and was advised to seek medical attention.
Tues Aug 19th pm took bandaids off and it was red, hard and swollen with hard knot of varicella injection site (L) ant. upper arm. Has gotten more red and swollen to present.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 12-APR-2016 the patient inadvertently received a dose of PROQUAD (dose, route, lot# and expiration date not reported) (Unapproved dose administered). Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
pt recv vax SEP95 & 15FEB96 pt was tested & had not seroconverted;No further details were provided;
Patient was 17 at time of administration.  The state has recommended that persons receiving vaccine outside approved EUA age range should have a VAERS filled out for those patients.
Parents report that after child given FLUARIX I.M. 9/8/14 had 1 night severe wheezing that night. No previous h/o wheeze.
ED visit for hyperammonemia - treated and released. Hospital admission for Cirrhosis of liver with ascites, multifactorial cirrhosis type - procedure, Therapeutic Paracentesis and discharged. These visits were within 6 weeks of receiving the CVOID vaccine.
1. Immediately after vaccination, strong pain in entire affected arm, from injection site to fingers.  Pain in arm became severe 6 hours later.  Resolved shortly after taking 1 dose of ibuprofen. 2. Around 22 hours after vaccination, developed fatigue, intermittent low fever (99.1-99.7), and intermittent elevated heart rate (including one pulse reading of 120).  These symptoms, including elevated heart rate, persist 72 hours after vaccination.
Pt administered both VARIVAX and PROQUAD injections instead of VARIVAX and MMR injections.
right side of head sensitive to touch, sensitivity of scalp (right side of head), sensitivity above (right) ear, pins and needles feeling (right side of head); slight headache; This spontaneous case was reported by a consumer and describes the occurrence of SENSITISATION (right side of head sensitive to touch, sensitivity of scalp (right side of head), sensitivity above (right) ear, pins and needles feeling (right side of head)) and HEADACHE (slight headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced HEADACHE (slight headache). On 06-May-2021, the patient experienced SENSITISATION (right side of head sensitive to touch, sensitivity of scalp (right side of head), sensitivity above (right) ear, pins and needles feeling (right side of head)). On 06-May-2021, HEADACHE (slight headache) had resolved. At the time of the report, SENSITISATION (right side of head sensitive to touch, sensitivity of scalp (right side of head), sensitivity above (right) ear, pins and needles feeling (right side of head)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
little bit sore arm; little bit of the vision problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "little bit sore arm"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "little bit of the vision problem".  Additional Information: It was reported that all the Pfizer COVID Vaccines up until the patient had the third one. The patient had the usual, little bit sore arm and a little bit of that. Little bit of the vision problem with printing kind of small. It was kind of hard to read the card.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146030 Same patient/drug/ different dose/event;US-PFIZER INC-202300147023 Same patient/drug/ different dose/event;
2 month patient was given ProQuad instead of Prevnar; 2 month patient was given ProQuad instead of Prevnar. The wrong vaccine was ordered. The baby had received the wrong vaccine; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2402870-1. The original narrative from the sender is as follows:  2 month patient was given ProQuad instead of Prevnar. The wrong vaccine was ordered. On 8-03-2022 the physician called the mother of the patient and explained that the baby had received the wrong vaccine. Explained that side effects include fever, soreness at the injection site and rash.  Current illness included Congenital torticollis.  No known allergies.  The causal relationship between Vaxelis and the events, "2 month patient was given ProQuad instead of Prevnar" and "2 month patient was given ProQuad instead of Prevnar. The wrong vaccine was ordered. The baby had received the wrong vaccine" is not applicable due to the nature of the events.  No further information is expected.
Shingles - left side of face that caused a very bad ophthalmic infection. 4 weeks in I?m still recovering
This spontaneous report as received from a nurse refers to a 18 year old patient of an unknown gender. On 23-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
COVID arm or delayed cutaneous hypersensitivity. Redness, swelling, itchiness a week after first dose. A bit sore. I've taking Bandyl and iced the area and it seems to help
Chile, sweating  , body tremble and vomiting. Patient has to call EMS to emergency room. After discharged from ER, patient has nausea on the day 3 after vaccine, which last only one day.
Client received first COVID vaccine on 04-19-2021 at 10:00 or 11:00 am.  Adverse reaction slightly noticed later that day but more noticeable a day or two after vaccination.  This is a reaction noticed on chest of a red mark above left breast.  This went away but came back with a rash noticed over her body of arms, legs, back and chest.  This rash stings, is itchy and has a burning sensation.  The rash looks somewhat like hives, but has big red, patchy areas, and warm to touch.  Client has taken Benadryl and used Hydrocortisone cream with no improvement.  Client has an appointment to see medical provider today (04-27-21).
Information has been received from a nurse practitioner concerning a 15 year old female patient with a history of appendectomy conducted in December 2007 and a gall bladder removed in April 2008 who was vaccinated with the first dose of GARDASIL.  Four weeks later the patient experienced gastrointestinal and pelvic pain.  The patient was diagnosed as having high aluminum content and lost approximately 10 pounds.  At the time of this report, the patient recovered and was still undergoing nutrition therapy.  It is unknown if the patient sought medical attention.  Additional information has been requested.
Vaccine given 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Lot no. EW0171) on 05-Aug-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Following vaccinations, pt had syncopal episode approx. 5 sec. (?) diaphoresis, pallor placed supine extremities.