chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient was supposed to get a ppd and he was given ipol intradermal/ No AE; Initial information received on 17-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who was supposed to get a TUBERCULIN TEST [TUBERCULIN PPD] and accidentally was given IPV (VERO) [IPOL] intradermal,  lot P1A24 expiry date 26-Apr-2020, 0.1 ml in the left arm for tuberculin test on 17-Feb-2020. (wrong product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant vaccinations included INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX).  This is a case of actual medication error due to wrong product administered.  At the time of this report, 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.
This report descibed redness and swelling at the injection site in a 5 year old male who received DTaP. Concomitant vaccine: intramuscular poliomyelitis virus vaccine. On 03/05/01, the vaccinee received his first left thigh dose of DTaP and a left thigh dose of IPV. "Within one day" post-vaccination, the vaccinee experienced localized redness and swelling. He had an 8 cm wheal/flare at the injection site. A doctor visit was required. The vaccinee was treated on 03/07/01 with cetirizine hydrochloride two teaspoons per day As of 03/08/01, the outcome of the event was unresolved.
heart palpitations; Shortness of breath; dizziness; light headed; Booster; This is a spontaneous report from a contactable other hcp.   A 72-years-old female patient received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION Batch/Lot Number: 30145BA), dose 3 via an unspecified route of administration, administered in Arm Right on 14Oct2021 13:30 as dose 3 (booster), single for covid-19 immunisation. Medical history included osteoarthritis, rubber sensitivity, Known allergies: Latex, food: Avocados. Patient previously took first and second dose of (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION), dose 1 and 2 via an unspecified route of administration, administered, single for covid-19 immunisation.  The patient had not received any other vaccine within 4 weeks, Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. It was reported that, The patient experienced booster on 14Oct2021 13:30 with outcome of unknown, Shortness of breath, heart palpitations, dizziness/light headed on with outcome of recovering.   Follow-Up (29Oct2021): Follow-up attempts are completed. No further information is expected.  Follow-up (09Nov2021): This is a follow up-spontaneous report from a contactable other HCP. This other HCP reported for the 72-year-old female patient in response to HCP letter [sent to other HCP] via follow-up letter which included  Follow-up attempts are possible. No further information is expected.
no additional AEs; PROQUAD given instead of MMR II on 2/22/2023 to 52 year old patient. Caller reports that this was supposed to be patient's 2nd dose of MMR II.; PROQUAD given instead of MMR II on 2/22/2023 to 52 year old patient.; This spontaneous report was received from registered nurse and refers to a 52-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with 1st dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (anatomical location, lot #, expiry date, and route of administration were not provided).  On 22-FEB-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliter/once, lot #W028567, expiration date: 06-MAR-2024, administered for prophylaxis (anatomical location, and route of administration were not provided) instead of 2nd dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) was given to 52-year-old patient (product administered to patient of inappropriate age).  There were no adverse events reported (no adverse event).
PMH: syncopal event w/ Covid 2nd Dose  Vaccinated: 10:33 Reaction: 10:38 Pt reported dizziness. Vitals: 90/53, 79, 20 Pt stable and released from the vaccination site
EXTREME SWELLING OF THE LYMPH NODES OF LEFT ARM AND FEVER REACHING 102. GREEN DISCHARGE FROM INNOCULATION SITE.
It worked for me every year and i got the flu; Initial information was received on 18-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case is linked to case 2020SA295897 and 2020SA297164..  This case involves a female patient (unknown demography) who got the flu (influenza), while she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza), unknown latency following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.  It was reported that the vaccine work for patient every year.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown.  There will be no information on the batch number for this case.
On 1/08/09 Pt. awoke with flu like symptoms, pain in arms and purpura-like rash on legs.  Received prescription for steroid pack (pt. could not be more specific) to be taken for 5 days.  Pt. felt better on 1/09/09 but on 1/10/10 had swelling of wrists and ankles.  Rash remained.  At some point (pt. could not be more specific) he received another prescription for 5 days of steroids.  At some point he saw his physician.  On 1/22/09 he had a blood test (pt. could not be specific as to the type of test) which he states was positive for rheumatoid arthritis.  He was referred to a rheumatologist.  He has not had this appointment as yet.  After seeing his doctor, pt. developed bronchitis and was prescribed a Z-Pack. He is recovering from this illness at present.  2/5/09 Received PCP medical records of 1/12/09. FINAL DX: Purpura Records reveal patient experienced pain in bilateral forearms, raised red itchy rash bilateral thighs, pain in legs & feet x 4 days.  Patient had contacted family member who is MD & was tx w/steroids & NSAIDS w/improvement.  but symptoms recurred when steroids complete accompanied w/swelling of wrists & ankles, bruising of wrists & persistent rash on both legs.  Exam revealed extensive non-blanching purple coalescent macules on legs & grey green bruising on volar aspects of wrists.  Tx w/continued steroids & labs were ordered.
post injection experienced tingling, burning pain over left clavicle and into L neck; post injection experienced tingling, burning pain over left clavicle and into L neck; post injection experienced tingling, burning pain over left clavicle and into L neck; nerve pain (hyperaesthesia, tingling, zinging); nerve pain (hyperaesthesia, tingling, zinging); nerve pain (hyperaesthesia, tingling, zinging); This is a spontaneous report from a contactable physician. An adult non-pregnant female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) intramuscularly on 22Dec2020 at 19:45 as a single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies and known allergies: sensitivity to toluene and strong fragrances, from unspecified dates and unspecified if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (reported as other medications in two weeks) included clarithromycin (CLARITIN) taken for an unspecified indication from an unspecified date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Dec2020 at 19:45 the patient experienced "post injection experienced tingling, burning pain over left clavicle and into L neck" and "nerve pain (hyperaesthesia, tingling, zinging)". The clinical course was reported as follows: "Injection was painless, starting 5-10 minutes post injection the patient experienced tingling, burning pain over left clavicle and into L (left) neck. No associated rash, redness, color or temperature change. No swallowing or breathing difficulty. Nerve pain (hyperaesthesia, tingling, zinging) persisted 3 weeks later at lower intensity over medial clavicle and supraclavicular fossa aggravated by clothing, Valsalva, certain L arm movements." The adverse events resulted in a doctor or healthcare professional office/clinic visit. Treatment was given in response to the events and included gabapentin. The clinical outcomes of the events "post injection experienced tingling, burning pain over left clavicle and into L neck" and "nerve pain (hyperaesthesia, tingling, zinging)" were recovered/resolved with sequel (with lasting effects). It was also reported that the patient was tested for COVID-19 post vaccination on 04Jan2021, with a nasal swab, which was negative.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Pt felt dizzy, was pale and felt faint. Immunization was given at 15:25 with no treatment needed.
Approximately 10 minutes following vaccination I began having sharp chest pains in the center of my chest, accompanied by spells of dizziness, on and off. The dizziness subsided the following day on 1/4/22 although the chest pain has not.
This spontaneous report was received from a registered nurse and refers to multiple patients of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medication were not provided. On multiple unknown dates, the patients were vaccinated with improperly stored ROTATEQ, GARDASIL 9, PNEUMOVAX 23, M-M-R II and VAQTA (dose, route, lot numbers and expiration dates were not provided) for prophylaxis. No adverse effects were reported. The temperature for the vaccines stored was 32 degrees Fahrenheit to 35 degrees Fahrenheit with 143 hours and 27 minutes time frame. On the "28th" of an unspecified month and unspecified year, there was a previous temperature excursion (unknown temperature and time frame). The call was not because of a data logger. No further information was provided. Additional information has been requested.
I have been experiencing neck and back pain, I am currently in physical therapy and seeing an orthopedic surgeon. I also have been having chest pains that radiates to the left arm and causes muscle pains, runny nose, and coughing.
No additional AE; A HCP called and reported that a dose of VARIVAX was reconstituted with Sodium Chloride instead of the Merck supplied diluent and was administered to a patient.; This spontaneous report has been received from Other Health Professional, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported.    On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, for prophylaxis, (lot number: W025273, which was determined to be valid, expiration date reported and validated as 10-AUG-2024) (strength, dose, route of administration and anatomical location were not reported) in combination with Sodium chloride (strength, dose, route of administration, lot number and expiration date were unknown)(Product preparation error).  No additional adverse events were reported in the patient.  This case was determined to be non-valid due to the lack of patient's identifiers.  Follow up information has been received from the physician assistance on 21-APR-2023. This case was regarding a 24-years-old female patient.  On 18-MAR-2023, the patient was vaccinated by a trained health care profeccionalwith the reported dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, in the right deltoid (lot number: W025273, which was determined to be valid, expiration date on 10-AUG-2024) in combination with hepatitis b vaccine rhbsag (YEAST) (ENGERIX-B), in the left deltoid (lot number: NT9X3), both as prophylaxis (strengths, doses, schemes and routes of administration were not reported). It was previously reported, the administered varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with 0.9% sodium chloride instead of diluent. It was reported the patient was notified and there was no adverse event. On 21-APR-2023, the patient was administered an additional dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route of administration and indication, lot number and expiration date were not reported). The outcome of product preparation error was reported as recovered.
Information has been received from a registered nurse concerning a 15 year old patient who on 15-SEP-2010 was vaccinated intramuscularly into the left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 665902/1426Y, Exp Date 02-JUL-2011). The nurse reported that on approximately 17-SEP-2010, one day post-vaccination, the patient developed high fever of 102F and swelling of the left arm from shoulder to elbow. On 17-SEP-2010 the patient was seen at the doctor's office. At the time of the report, the outcome of the patient was not reported. The nurse reported an investigation of the specific lot. This is one of several reports from the same source. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information had been received from a registered nurse concerning a 15 year old female patient who on 15-SEP-2010 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 665902/1426Y, Exp Date 02-JUL-2011). On 16-SEP-2010, the patient experienced febrile, swollen, hard, red and warm. On an unspecified date, the patient recovered. No other information reported. Additional information not expected.
Itching to vaccination site, extending to left lower arm at 12:08, Benadryl PO 25mg  administered 12:10 by nurse practitioner.  Symptoms resolved at 12:15, patient discharged to home.
Was admitted to hospital in December for another episode of afib with rvr after having 9 months of normal sinus rhythm.  Had TEE with cardioversion.  Now I am on elliquis 5 mg bid and cardizem 120 mg daily. Have an appointment with an electrophysiology to see about additional medications or ablation
no additional AE reported; received the vaccine from expired lot; This spontaneous report was received from an other healthcare professional (HCP) and refers to a patient of an unspecified age or gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided.  On 14-JUN-2021, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA, 0.5 ml, lot # R031629, expiration date was reported and also validated as 01-NOV-2020 (strength, route of administration and anatomical location were not provided) for prophylaxis (expired vaccine used). It was stated, that two patients came together to receive the vaccine and both received the same expired lot (split case regarding the other patient). No additional adverse event (AE) reported (no adverse event).  This is one of the two linked reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004193:
felt nauseated; Headache; chills; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (felt nauseated), HEADACHE (Headache) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19.     No medical History was provided by reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced NAUSEA (felt nauseated), HEADACHE (Headache) and CHILLS (chills). At the time of the report, NAUSEA (felt nauseated), HEADACHE (Headache) and CHILLS (chills) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
I woke up at 4:00am with severe vertigo with fainting. Every time I would try to sit up I would faint. Ambulance called, ER visit. Brain fog, memory loss, using wrong words. Was sent for PT and slowly that helped. Couldn?t walk by myself for 14 days. It?s been 10 months and I still have dizziness  every day, I use the wrong words and thoughts disappear mid sentence.  I was a healthy, active adult  prior to this vaccine.
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS, ASTHENIA, DYSPNOEA, INFLUENZA LIKE ILLNESS and PYREXIA in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 1039F21A, 030M20A, and 029120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced PYREXIA, CHILLS, and NAUSEA. On an unknown date, the patient experienced ILLNESS, ASTHENIA, DYSPNOEA, and INFLUENZA LIKE ILLNESS. At the time of the report, ILLNESS, ASTHENIA, DYSPNOEA, INFLUENZA LIKE ILLNESS, PYREXIA, CHILLS, and NAUSEA outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 08-Nov-2021, Body temperature 101 (High).         Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  Reporter stated With the booster however, she ran around like crazy yesterday after getting the vaccine, when she came home, she was fine, she went to bed but at 12:30 she woke up, and had fever (temperature at 101), chills, and nausea. She hardly ever got sick. Today she was still nauseated but she had been able to eat chicken noodle soup. When she worked from the couch to the kitchen, she was really weak. She felt like she felt when she had the flu few years ago. She felt so weak, and she was usually high energy, she went to the gym yesterday, but this took the wind out of her last night.  -This case concerns a 71-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious events of Illness, Asthenia, Influenza like illness, and Dyspnea, and the expected non-serious events of Pyrexia, Chills, and Nausea. The events occurred on the day after the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the earlier doses was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-381260 (Patient Link).
no fever;pt devel chickenpox 8 to 12 lesions;duration 6-7 days;
injection site warm /palm size warm; redness at injection site; rash at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site warmth, injection site erythema and injection site rash. On an unknown date, the outcome of the injection site warmth, injection site erythema and injection site rash were unknown.   It was unknown if the reporter considered the injection site warmth, injection site erythema and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The health care professional stated that the patient experienced injection site reactions of a palm size warm, red rash.  The health care professional had no further details at the time of report. The health care professional declined to provide patient and vaccine information. The reporter did not consent to follow-up. The case has been linked with the case US2019GSK083545 and US2019079164 reported by same reporter.
The patient stated that she initially had slight pain at the injection site with no further problems.  The injection site pain had subsided but returned a few days later.  She indicated that the muscle pain has become increasingly more painful and now has problems with fatigue.  She stated that she did not have any swelling, rash or noticeable increase in temperature at the injection site.  She stated that she may want to seek medical attention.
After 1st dose, had Injection site/arm sorenesss, slight headache and fatigue for one day afterwards. Tylenol relieved headache. Arm soreness lasted 2-3 days but was mild.   After 2nd dose, had Severe chills, body aches, fever (did not take temp as I didn?t have a thermometer but body felt very hot) starting approx 9 hours afterwards.  Had to alternate acetaminophen and ibuprofen every 3-4hours to keep symptoms at bay. Symptoms lasted a total of about 36 hours then just felt tired for about 5 days after injection.