chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; I get it all the time / had shingle shot and it hasn't helped 1 bit; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received the dose of Shingles vaccine and patient experienced shingles. The reporter stated he/she got it all the time and he/she have had shingles shot and it has not helped one bit. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Narrative: Patient received two doses of Moderna COVID 19 Vaccine in August 2021. The patient tested positive for COVID 19 on 16 Jan 2022. The patient presented to the ED with fever, weakness, and malaise. The patient was admitted on 16 Jan 2022 with COVID pneumonia and sepsis. The patient was treated with antibiotics and dexamethasone. The patient was discharged in stable condition on 3 Feb 2022.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 21-MAY-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Patient contacted the pharmacy on 6/23/19 to report she was still having muscle pain/limited mobility/limited range of motion.  She stated the shot hurt like a normal shot for "a few days" after the vaccination, but that the pain went away for a few weeks. She then said in mid-May, then pain came back after she was pulling weeds.  She said the pain is worse when she uses her arm and better with rest, OTC pain relievers, and hot pads.  She said the pain extends a little above and below where she got the shot, but is the worst at the site of injection which she estimates to be "about 3-4 inches below her shoulder."  She said there is no swelling or redness, but is concerned about lingering pain.  She was referred to her PCP which she said she has an upcoming appointment with on 6/27/2019.
COVID-19  02/16/2021  1 of 2  Spikevax-MOD 100mcg COVID-19  03/17/2021  2 of 2  Spikevax-MOD 100mc COVID-19  11/23/2021  3 of 2  Spikevax-MOD 50mcg RED    Symptomatic patient admitted with COVID to hospital 8/6/22
Four hours later immediate: back pain, malaise, arm sore. 24 hrs later: rash on face and neck, arm sore. Took ibuprophen and Tylenol.
Mother states that the child has rash of welts all over body. Started 22 hours after shots.
Sore Arm after first vaccine; Felt like a torn rotator cuff after first vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm after first vaccine) and MYALGIA (Felt like a torn rotator cuff after first vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm after first vaccine) and MYALGIA (Felt like a torn rotator cuff after first vaccine). On 24-Jan-2021, VACCINATION SITE PAIN (Sore Arm after first vaccine) and MYALGIA (Felt like a torn rotator cuff after first vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not provided. Patient stated to agent that  she had a Robust response to the first vaccine, when she got home her arm was very Sore, Felt like a torn rotator cuff and lasted for 3 days.   This case was linked to MOD-2021-278793 (Patient Link).
2 days of increasing weakness, exertional dyspnea and chest pressure.  He describes as pressure as a heaviness in the middle of his chest.
12-year-old patient incorrectly received pediatric Pfizer dose for dose 1 and dose 2.
pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR158011   Additional Information: GSK Receipt Date: 30-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received both shots. The patient was asking what to do to alleviate the pain. Additional Supportive Information: The follow up would not possible, as no contact, details were available. Note: It was not confirmed after which dose event occur so blank dose number kept.; Sender's Comments:  US-GSK-US2022AMR158011:Same reporter
Large muscle pain, all extremities and across shoulders   By 11/9/2010 started having wrist and elbow joint pain/stiffness.  Ibuprofen helps keep it tolerable.
patient experienced V tach and was shocked by ICD. Presented in Atrial flutter to ED and required emergent cardioversion
woke with red  spots on my  ankle,  elbows. knee and wrist.   I took Allergra 10mg The spots were Itchy
Case number PHEH2013US014891 is an initial spontaneous report received from a nurse on 02 Jul 2013. This report refers to a 12-years-old female patient. Her medical history and concomitant medications were not reported. It was reported that she was vaccinated only with the MenCYW-135 liquid component of MENVEO (batch number: X11064, expiry date: Dec 2013) on 20 Jun 2013 and did not receive MenA lyophilized conjugate. No adverse event was reported following the inadvertent administration.
Shivers, fever of 101 to 102 after Tylenol, headache, pain/soreness at injection site, redness and heat at injection site, tiredness, mild nausea.
This spontaneous report as received from a physician's assistant refers to a 6 months old patient. The patient was inadvertently vaccinated with a 0.5 ml dose of VAQTA (Lot # not reported) intramuscularly in the left thigh on 03-AUG-2012. No adverse effects were reported. Additional information is not expected.
20 YO FEMALE CONSCIOUS AND ALERT WITH A GCS OF 15 COMPLAINING OF HAVING ITCHING AND HIVES TO THE LEFT FOREARM. PT WAS JUST GIVEN HER COVID 19 SHOT. PT DENIED CHEST PAIN, N/V/D, SHORTNESS OF BREATH, BLURRED VISION, DIZZINESS. PT HAD A PATENT AIRWAY WITH EQUAL CHEST RISE AND FALL. PT HAD SOME HIVES TO THE LEFT FOREARM. PT HAD NO DIFFICULTY BREATHING OR RASH ANY WHERE ELSE. PT HAD NO OTHER DCAPBTLS, HEENT WAS UNREMARKABLE. PT VITALS WERE TAKEN AND RECORDED. PT WAS GIVEN 50 MG OF BENEDRYL PO BY EMT. PT WAS OFFERED TRANSPORT TO THE LOCAL HOSPITAL FOR FURTHER EVALUATION. PT REFUSED
DAY OF SHOT:  ARM STIFF AND PAINFUL.   Took ibuprofen and iced area.   Very painful.   ER VISIT THEY DID NOTHING.  **DAY AFTER SHOT:  LARGE PAINFUL DARK BRUISING UNDER ARMPITS DOWN RIGHT SIDE TO RIGHT UNDER BREAST. MISSED SEVERAL DAYS OF WORK DUE TO REACTIONS. DID NOT RETURN TO DOCTOR OR HOSPITAL OR REPORT REACTION TO PHARMACY WHERE SHOT WAS GIVEN.  INJECTION SITE NOT PAINFUL OR BRUISED BUT ARM WAS VERY STIFF AND SORE FOR DAYS. ** high fever and pain in arm which was a normal reaction.   Took ibuprofen and applied heat for pain..
1cm X 3cm raised, reddened welt, warm to touch, sensitive to touch (not painful, not itchy).
High Fever; Vomiting; I'm getting weak. I just don't eat or drink.; I'm getting weak. I just don't eat or drink.; I'm getting weak. I just don't eat or drink.; get tired; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that,  A patient of unspecified age and gender received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced Vomiting and high fever, getting weak, tired and patient couldn't eat or drink. His job was sending him notice and he was asking to get a paper to stay home because of his adverse events. The events assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
30 hours after immunization, my lower left leg began to hurt. Within four hours I could barely walk. There was no swelling or redness present. It was a muscle pain in my calf and behind my knee. I took Tylenol and went to bed. The following day the pain was less intense, and I wore a compressive knee brace. On the second morning the pain had subsided and I could walk with a limp. The following day, all symptoms had disappeared. I did not seek medical advice.
patient was accidentally inoculated with Fluzone High Dose; patient was accidentally inoculated with Fluzone High Dose;Initial information received on 12-Oct-2021 regarding an unsolicited valid non-serious case received from consumer/non-healthcare professional via call center via Medical Information (Reference number- 00810818).  This case involves a 13-month-old female patient who accidentally inoculated INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 07-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose (latency: same day).  It was reported "Is there any thing I should be concerned about? What should I monitor?"  At the time of reporting, no adverse event was reported.  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 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.  There will be no information available on the batch number for this case.
significant sore arm 48 hours body chills lasted 12 hours muscle pain lasted 48 hours  headache 24 hours sore throat- 3+ days (still experiencing) generalized malaise for 3+ days (still experiencing)
Patient presented to the emergency department on 10/26/2022 for evaluation of gradually worsening of weakness in both legs and back pain that started on 10/21/2022.   She started feeling this way after getting her Covid booster earlier that day.  She also received an influenza vaccine a few days AFTER symptoms started (influenza vaccine was administered on 10/24/2022).   A CT thoracic and lumbar spine with contrast showed no central canal stenosis.  Neurology was consulted. LP was done which revealed albumino-cytological dissociation. Given concern for post-vaccine mediated Guillain Barre Syndrome, patient was started on IVIG. Completed 5 days of IVIG with mild improvement. Transferred to acute inpatient rehab unit to continue rehabilitation.
Information has been received from a physician concerning a 72 year old female, with allergies to penicillin, sulfonamide, erythromycin ethylsuccinate, HYZAAR, with pulmonary hypertension, atrial fibrillation and cardiac failure congestive medical history, who was vaccinated with the first dose of ZOSTER (dose and injection site/route not reported) on 01-AUG-2008 AM. There was no concomitant medication. Subsequently the patient developed some respiratory pulmonary issues within a few days post vaccination. The patient also developed fever and body aches after 09:00 AM on 05-AUG-2008. The patient was given oral antibiotics and recovered. The patient sought medical attention in the office. No further information is available.
50-year-old patient received a pediatric dose of Engerix-B; 50-year-old patient received a pediatric dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 50-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Previously administered products included Engerix-B (1st dose received on 10th March 2023) and Engerix-B (2nd dose received on 14th April 2023).   On 22-SEP-2023, the patient received the 3rd dose of Engerix B pediatric. On 22-SEP-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: 50-year-old patient received a pediatric dose of Engerix-B). On an unknown date, the patient experienced adult use of a child product (Verbatim: 50-year-old patient received a pediatric dose of Engerix-B). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-NOV-2023 The nurse via call centre representative reported that a 50-year-old patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter did not consent to follow-up. .
Several hours after Pneumovax 23 injection my entire deltoid muscle was severely swollen. I had a rash that covered my upper arm. That night I had severe chills. The next day my arm was swollen from my shoulder all the way down to my elbow with redness that covered my entire upper arm and into my left axillary area. The chills continued through the second. I am an RN and my arm looked so bad I thought I had cellulitis that had developed in the arm. Third day after my arm is still swollen and red although not quite as bad. I did seek medical help at a walk in clinic because I thought it was cellulitis. I will never take this infection again.
Tired and headache first week. At one week Left arm had red rash, itchy and swollen for 3 days.
Started with back spasms on first day; subsided. Returned again the next day; subsided. On third day pain became unbearable, went to Hospital ER - they diagnosed kidney stone. Had various blood and urine tests. CT scan confirmed. Administered a lot of IV meds. Was admitted for observation. Stent was put in place and kidney infection discovered.   Sent home for 10 days to take antibiotics. On day 14 had urinalysis. On day 18 had stone surgically removed, stent replaced. On day 29 had stent removed.
Dead arm following day of injection, not occurred with primary series, unable to move upper arm in the 4 days following injection, no numbness or tingling down arm, sensitive to touch of upper arm, no rash or warmth or swelling, no bump at injection site, some limited movement in neck and soreness of L side of neck. Slight improvement since day initially following
Got shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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: HERPES ZOSTER (non-serious), outcome "unknown", described as "Got shingles". Additional information: The reporter stated "why are people having strokes after getting vaccine?. 5 months after vaccine I regret, I had stroke and my friend got shingles".  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Information has been received from a consumer concerning his daughter, a 9 year old female, who on 10-JUN-2009 was vaccinated with one dose of RECOMBIVAX HB.  There was no concomitant medication.  On 10-JUN-2009 the patient experienced fever of 100 degrees Fahrenheit and sore throat, however no injection site reaction.  The patient did not seek medical attention.  At the report time the patient had not recovered.  No further information is available.
pt recvd vax between AUG & SEP92 & exp arthralgia, paresthesia, numbness of fingers, shoulder & knee pain;
Soreness at injection site on 10/22/2021 Fatigue, headache, muscle aches, fever, soreness at injection site on 10/23/2021
A few days after receiving the vaccine she developed a rash on her back and abdomen. It has continued since then and at times is in the armpits or behind the knees. She was seen by a dermatologist who felt that it was triggered by the vaccine due to the immunotherapy she had received in 2019 causing her skin to react. He has since diagnosed it as chronic hives. She was on Prednisone for 3 weeks this month and did well but as soon as she finished it, the hives came back.
17 y/o given Moderna vaccine due to mom request.  Patient had no side effects. Second dose given on 10/11/21 as advised by PCP and ID MD2005.
Horrible headache for 6 days; Nausea; Chills; Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 03Aug2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any vaccination within four weeks prior to the vaccination. On 04Sep2021, the patient experienced horrible headache for 6 days, nausea, chills and sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events horrible headache was resolved on 10Sep2021 while nausea, chills and sore arm was resolved on an unknown date in Sep2021.  No follow-up attempts are possible. No further information is expected.
#1=week long severe headache, shingles, extreme pain in muscles, cramping feet, bones weakened, no energy #2=1st day paralyzed-could not move for about a half hour-ate through bones & extreme symptoms same as #1 (took months of rehab to eliminate pain) #3(booster) = extreme flu-like symptoms slept & did not eat for 21/2 days - still have unnamed sharp pains in muscles-cramping, etc. #1st shot - week long severe headaches (which I never get) - broke out in shingles for a month - extreme pain in muscles (sharp) & still throbbing - bones felt brittle, hard to walk - feet & hands other muscles sometimes cramped up - no energy #2 nd shot -  Same as above, except I did not break out in shingles again, though nerves kept flaring of as if I had it - Extreme problems with the shot causing sciattica, which I never have had before, took months of physical Therapy to straighten leg & muscles to keep from cramping & being in extreme pain - The morning after The shot, I was temporarily paralyzed - my heart beat has changed somewhat - I overall feel weaker Than before. Booster - Extreme flu-like symptoms & slept 21/2 days before I could wake up.  After effects- still very tired, feet & hands still cramp up all the time, still get pains in my muscles & my nerves still fire off like I have shingles  Note - There is a genetic defect in our family (SMDC?) That I am a carrier. None of my family seemed to have any side effects, but I am also The least affected by this gene defect and am the only one with (A-) blood-type.
lt upper thigh w/2x2 cm area; atrophy w/visible depression in area of DTP;
No adverse event; improper storage of product in use; This spontaneous report was received from a pharmacist referring to a 16-month-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      The varicella virus vaccine live (oka/merck)(VARIVAX) with lot number W025273, expiration date reported as 02-JUN-2023, but upon internal validation was confirmed as 10-AUG-2024  underwent a temperature excursion of 70 degrees Fahrenheit for 9 minutes on 02-MAR-2023, and on 09-JUN-2023, the patient was vaccinated with 0.5 milliliter (route of administration not reported) for prophylaxis (product storage error). No adverse event was reported.
The dose for the Moderna vaccine is .5 mL. The patient inadvertently received an extra 0.01 to 0.02 mL. The manufacturer instructed us to contact the patient to inform them that the increased dosage could potentially lead to side effects that could be local or systemic. No adverse events were reported by the patient.