chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gave the diluent for Shingrix rather than the mixed dose; Gave the diluent for Shingrix rather than the mixed dose; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows:  The age at vaccination was not reported. The reporter mentioned that, someone in his/her office gave the diluent for Shingrix rather than the mixed dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter mentioned that, the patient had to return to the office to get the full dose of Shingrix. No other information was reported.
We discovered that a patient received a vaccination that was not expired but was held at refrigeration temperature for 38  days.  Appropriate steps were taken to notify the state and are coordinating efforts to notify patients to repeat vaccination.
Pt recvd Hep B vax in 1983; & tested pos for HIV antibodies; No further details were provided;
about 5hr p/vax pt started crying, vomiting & running a fever;pt vomited 3-4times during the noc ran fever over 103.6 until 8JUL98 mid day pt fussy for 2 days;mom treated child w/APAP q every 4hr;
Large red  circle appeared on my left arm a week after the shot was given.  It is warm to the touch.  It is not painful.  At first it looked like a bullseye.  No other symptoms at this time.    When I received the injection, there was some pain to the touch, redness, and heat, but that subsided in a couple of days.
2 Generalized Tonic-Clonic seizures x 10-15 min. Eyes rolled up, bumped head 3 days prior. No fever. Had URI.
This spontaneous report was received from a healthcare worker refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot # K020216, expiry date 17-SEP-2016; lot # L016427, expiry date 13-APR-2017, (dose, frequency and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of five reports received from the same reporter. Additional information has been requested.
07FEB95 about 8AM pt exp t103 ax & lethargy; given 2 droppers fo APAP; 1PM mom noticed pt exp jerking of muscles & disorientation mom called EMS & pt taken to ER where evaluated by MD & fever was reduced; dx febrile sz;
Patient c/o fever (100max), nasal congestion, cough, headache, sore throat, malaise starting on 10/10/09. Seen in clinic on 10/12/09 for continued symptoms. Throat culture neg for strep. Supportive measures prescribed. On 10/14/09, pharyngitis and cough had improved but continued with malaise. Tmax 101 on 10/13/09.
Severe fatigue, aches, pain from vaccination site and fever. Noticed fatigue and aches 12Jun at 0500. Symptoms worsened as the day progressed. Took temperature when able (12Jun13 1700) and it was 103. Called vaccination hotline they recommended 800mg ibuprofen, fever and all symptoms decreased significantly.
Pt became nauseated, lightheaded, and dizzy about 3 minutes post vaccination (Janssen). Pt was laid down on the floor and feet propped up on chair. BP 112/74. Vomited x3. Symptoms began improving after vomiting. Repeat BP 116/80. Pt sat up and was observed for 15 minutes. Pt has history of similar reactions post blood draws.  Pt left after 15-minute observation period with symptoms resolved.
Muscle weakness in the hand and close to arm; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient had two doses of vaccine in January and February. The patient experienced muscle weakness in the hand and close to the arm after this almost 8 months, that's some collateral effect or not on an unspecified date in 2021. Outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient received Menveo instead of MMR; This case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a 49-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 1st December 2022, the patient received Menveo. On 1st December 2022, unknown after receiving Menveo, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date: 1-Dec-2022 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient was accidently administered a dose of Menveo instead of MMR (manufacturer unknown) at his local pharmacy, which led to wrong vaccine administered.
Patient states that about 5 minutes after vaccine they felt "pins and needles" sensation in their left arm and hand.  Covid vaccine was given in left deltoid.  Patient waited 30 minutes after vaccination with no new symptoms.  Patient denies the need for any further medical attention.  Patient left with a companion.
Approx 18 hours after injection significant redness, warmth, swelling and pain developed involving whole extensor surface of right upper arm around injection site
2 hrs p/immun pt started screaming cont 6 hrs mom called MD @ 8PM same day 8SPE92; no fever  or sore leg; pt got APAP every 4 hrs, started a/immun;
swelling in the armpit, tender to the touch in the armpit moving closer towards the chest area. Bruising under the armpit and unable to lift normal weights that I normally lift. Itching and redness to the shot area. Warm to the touch.
Fever, rash 1 week after vaccination rash resolved for 24-48 hours then came back as gives-like rash.
Arm underneath painful; Arm underneath swollen; Lymph nodes painful; Lymph nodes swollen; Left arm sore at injection site; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis. The patient was allergic to sulfa (sulfonamide) and all GERD medications (drug allergy). Concomitant medications included ondansetron (ZOFRAN), vitamin d nos (MANUFACTURER UNKNOWN) and multi vitamin (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication and unknown if ongoing. The patient previously took polysorbate 80 (MANUFACTURER UNKNOWN), sodium sulfate (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously took SIMPONI ARIA IV (intravenous) 50mg for psoriatic arthritis. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 16:00, the patient experienced left arm sore at injection site. On 04Apr2021 (24 hours later), the patient's arm underneath and lymph nodes were painful and swollen for 4 days. The events did not result in a visit to  doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of these events. The clinical outcome of the event left arm sore at injection site was resolved on an unspecified date in 2021 while that of the events arm underneath painful, arm underneath swollen, lymph nodes painful and lymph nodes swollen were resolved on an unspecified date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Fever 100F. Aching joints.  Headache. Sore throat. Earache   Chills. Itching at injection site
10 MINTUES AFTER THE SHOT PT FELT DIZZY. HE FELL OUT OF HIS CHAIR AND HIT HIS HEAD. WE CHECKE HIS BP  AND IT CAME HIGH 173/97 WITH LOW PULSE 54. PT DID NOT HAVE ANY OTHER SYMPTOMS. WE MONITORED HIM FOR OVER AN HOUR AND HIS BP AT HE END STILL STYED AT 174/110.  PT WAS ADVISED TO GO TO ER AND GET IT SCHKED OUR FOR CONCUSSION AS WELL.
About 40 mins post vaccine the left side of my body went numb,. My face felt like it was drooping, my left eye wasn't blinking appropriately. I called the pharmacist, and my immunologist who both told me to go to the ER. Which I did. They ran lots of CT scans and determined that the vaccine threw me into an acute lupus flare.
ERYTHEMATOUS MACULAR RASH STARTED ON FACE THEN PROGRESSED TO TRUNK AND EXTREMITIES. NON PRURITIC OR TENDER RASH. PT AFEBRILE, EYES CLEAR, PERSISTENT RUNNY NOSE (FROM PRIOR TO VACCINE)
About 30 minutes or so after receiving the flu shot I started feeling like my heart was racing and lightheaded.  I felt like there was a brick on chest. I was also really weak.  I got home around 3 and immediately layed down.  When I woke up my throat felt like it was swelling.  My heart was still racing and I was uncomfortabley jittery.  I took both my blood pressure and pulse, which were both elevated.  I got scared and called my husbands' parents (my father in law is a nurse).  I took 2 Benadryl and some Nasacort.  My husbands parents then came over to deliver an Epipen and watch out for me.  As the Benadryl started to work my blood pressure and pulse went down.  My throat still felt consticted but it wasn't getting worse.  When I woke up the next morning my throat didn't feel as constricted but was real sore.  Felt jittery till about 1:00PM that afternoon.
Severe headache, dizziness, fever, severe body aches, myalgia, elevated heart rate, palpitations, chills, carpet burn feeling to left chest
No ADR Patient had no history of COVID-19 vaccination and inadvertently received the Pfizer bivalent vaccine which is not indicated for a primary series dose
his 2 adolescent daughters became ill with covid-like sxs/reported same illness days there after; This is a spontaneous report from a contactable other hcp. A adult male (age appx 40-year-old) patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 intramuscular on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. Medical history included moderately obese/apparent high BMI from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Not known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 via intramuscular route on an unspecified date for covid-19 immunisation. Consumer stated his 2 adolescent daughters became ill with covid-like SXS, patient reported same illness days thereafter, since recovered. Unknown sequalae. Appeared healthy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received treatment. The outcome of the events was recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report was received from a physician via company representative and refers to a 21 month old male patient. The patient had no pertinent medical history and drug reactions or allergies. Information regarding concomitant medication was unknown. On an unspecified date, the patient was vaccinated with VARIVAX (dose, route, anatomical location and lot# unknown) for disease prevention, which was reconstituted with sterile diluent (dose and lot# unknown). On 17-MAY-2017, the patient experienced rash and presented at physician office. On the same day, the patient began taking ZOVIRAX for treatment of the rash. Approximately on 19-MAY-2017 reported as two days after physician visit, the patient presented at physician office again with baby vesicles that were generalized on patient's skin. On 22-MAY-2017, the patient again presented at physician office "covered in a rash". On an unknown date in 2017, baby vesicles started to crust a few days later and patient recovered from "rash and baby vesicles" with no complications. Causality assessment was not provided by the reporter. There was no Product Quality Complaint (PQC) involved. The physician also reported that the patient's sibling, developed chickenpox "fourteen days after rash and baby vesicles" on patient recovered. The patient's sibling was 6 months old when chickenpox developed and sibling had never received VARIVAX. The patient's sibling began taking ZOVIRAX on an unspecified date, and chickenpox resolved without any issues. No further information provided.
My menstrual cycle is now all messed up. It came 2 weeks early last month. Now 1 week early this month.
Patient tested positive for COVID-19; Lack of efficacy; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Patient tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014c21a and 022c21A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy (allergy to Bee pollen) and Drug allergy (allergy to Flonase).   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, the patient experienced COVID-19 (Patient tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, COVID-19 (Patient tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. No treatment information was provided.  The patient had not received any other vaccines within 1 month prior to receiving Moderna COVID-19 vaccine.  Company comment: This is a spontaneous case concerning a 20-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19 and unexpected non-serious event of lack of efficacy. The patient received 2 primary doses of mRNA-1273 vaccine with appropriate dosage interval of 27 days. The events occurred approximately 217 days after the second dose of mRNA-1273 vaccine administration with positive SARS-CoV-2 test result. No other information surrounding the events was reported. The outcome of the events was reported as unknown. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-527285 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 20-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19 and unexpected non-serious event of lack of efficacy. The patient received 2 primary doses of mRNA-1273 vaccine with appropriate dosage interval of 27 days. The events occurred approximately 217 days after the second dose of mRNA-1273 vaccine administration with positive SARS-CoV-2 test result. No other information surrounding the events was reported. The outcome of the events was reported as unknown. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Seizure of appx 2 minutes. Went to ER where she had blood culture, blood tests, spinal tap, cath urine. All negative.
Off label use; Booster, dose 4; Blood in stool; Nausea; Diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4097881.  A 41 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 4 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis, uveitis, psoriasis, colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID 19 Vaccine Trial. Vaccination history included: Bnt162b2 (First dose), administration date: 01Mar2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "Colitis ulcerative aggravated", "Blood in stool", "Flare ups increased to once a week", "Sickness", "Nauseous", "Diarrhea", "sore arm on covid vaccine shot", "Upset stomach", "Headache", "Fever", "Flair ups diarrhea"; Bnt162b2 (Second dose), administration date: 01Apr2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "nausea", "headache", "Diarrhea"; Bnt162b2 (Third dose), administration date: 01Dec2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "Blood in stool", "Diarrhea", "Nausea", "Headache". The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "Off label use"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster, dose 4"; HAEMATOCHEZIA (medically significant), outcome "not recovered", described as "Blood in stool"; NAUSEA (non-serious), outcome "recovered", described as "Nausea"; DIARRHOEA (non-serious), outcome "recovered", described as "Diarrhea". The action taken for adalimumab was dosage permanently withdrawn.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache; Fever; Exhaustion; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, fever and exhaustion. On an unknown date, the outcome of the headache, fever and exhaustion were unknown.   It was unknown if the reporter considered the headache, fever and exhaustion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The caller reported to mention one of her friends had Shingrix shot and experienced headache, fever and exhaustion. The reporter said she declined to provide any information at all related to the events. The reporter did not consent to follow up.
8/13/21 pt had a positive COVID test; 8/18/21 pt brought to ED via EMS with increasing SOB, positive for COVID, labored breathing; c/o pain in chest; given O2 supplementation; ABX and Decadron; COVID pneumonia; pt's condition worsened and she expired in the hospital
6 hrs p/vax pt twitching of arms; focal sz; having 10-12 focal seizures seen @ hosp;
High Fever, Swelling of Injection Sight Weakness, 3x6 Red Swollen Area around the Injection Sight and headaches.
hives (red rash over face, accompanied by small hives);breath sounds, inc lobes present/clear;denies any other sx;no tx order;duration @ 24hr;
1/2 HOUR RETURNING HOME FROM RX I OPENED APT DOOR AND WENT TO SINK AND THREW UP THREE (3) TIMES.  CALLED RX AND DESCRIBED VOMITING.  RX SAID IT IS ONLY A 1% REACTION TO THIS VACCINE.  EAT CRACKERS WITH 7-UP/GINGER ALE AND RELAX REST OF DAY.  R ARM IS HURTING AT INJECTION SITE WHICH IS USUAL SYMPTOM FOR ME FOR ALL VACCINES RECEIVED.  THIS IS 1ST TIME EVER VOMITING  FROM A VACCINE EVER.
Achiness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achiness) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Achiness) and HEADACHE (Headache). At the time of the report, MYALGIA (Achiness) and HEADACHE (Headache) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided. Patient wanted to find out if she can use Tylenol or Motrin for the achiness and headache.
This is follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a pharmacist concerning a 78 year old female with coronary artery disease, hyperlipidaemia, diabetes, and chronic urinary tract infections and a history of shingles who on 14-FEB-2007 at 13:20 PM was vaccinated IM in the left deltoid with a first dose of ZOSTAVAX (Merck). Concomitant therapy included flaxseed, glucosamine, omega-3 marine triglycerides, grape seeds, metformin, glyburide, LIPITOR, digoxin, DIOVAN, aspirin and MACRODANTIN. There was no illness at the time of vaccination. On 19-FEB-2007 or 20-FEB-2007 the patient developed pain along her trunk. There was no rash or lesion noted. There was no pain, rash or lesion at the injection site. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. Additional information has been received from a nurse practitioner who noted that the patient reported having developed shingles pain on the right side of her body the day following administration, 15-FEB-2007. She was given VICODIN for pain and had no relief. She took a homeopathic medication for shingles which relieved all pain in 10 days. The patient was considered recovered. The patient had no adverse events following prior vaccination. No further information is expected.
Case number PHEH2014US025138, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 39-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 27 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration (incorrect storage of drug).
9 days after shot, I got a swollen red rash at injection site has been swollen and red and itchy.  I believe this is COVID ARM.  Side effects immediately after shot include headache and body aches and chills.
Severe abdominal pain . Pepcid and gabapentin.  No positive effect.
Pt received imm inj per protocol, bandage was applied + clothing covered arm.  Pt was sitting on exam table and talking after injection.  Mother was in the room.  Pt touched left deltoid approx 1 1/2 minutes, nurse disposing sharps when pt fainted & fell striking nose.  Xray revealed nasal Fx, ENT consulted with splint.