chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2013US02537 is an initial spontaneous report received from a nurse on 05 Dec 2013: This report refers to a patient of unknown age and gender. This patient was given only MenCYW liquid component of MENVEO (batch number: M12131) intramuscularly on an undetermined date. No adverse event was reported following this administration error.
A non-serious spontaneous report of inadvertent administration of expired product was received from a non-health professional concerning a 26-month-old female, subsequent to H1N1,  Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The product's labeled expiration date was 12-Feb-2010. The re-assigned expiration date was 15-Jan-2010 due to Field Correction Notice. The patient received the vaccine on 18-Jan-2010 for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Pt developed generalized itching and hives, onset approx. 2 hours post vaccine given. Seen next AM with hives, mild erythema multiforme. No PH allergies. Pt also on day 9 of amoxicillin at time of vaccine.
Patient noted bruising in her left arm at injection site and reddness and swelling in her lower left arm (about the size of an orange).  The red area is also warm.
Extreme heat, dizzy, impaired vision,  rapid heart beat,  nausea, weakness, headache
The reported states "Don't know", understands the infant was DOA at the hospital but was not verified. Autopsy also states pulmonary edema, lung congestion, kidney congestion, congestion of adrenals. Cause of death given as sudden infant death syndrome.
pentacel administered to patient instead of vaxelis with no reported adverse event; Initial information received on 01-Aug-2022 regarding an unsolicited valid non-serious case received from health professional. GMI number: 01215610  This case involves a patient of unknown demographics who was administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel] instead of VAXELIS with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect VAXELIS not produced by Sanofi Pasteur at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for immunization. On 01-Aug-2022, the patient was administered suspect Pentacel once instead of Vaxelis at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for immunization with no reported adverse event (wrong product administered, latency same day).  Action taken: Not applicable for both suspects.  At time of reporting, the outcome was Unknown for the 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 guidelines. 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.
Client c/o localize itching at the site immediately following vaccine administration.  Client seen by EMS.  No swelling or redness noted at site.  VS are as follows:  B/P 116/82, HR-71, O2-99,  During observation pt. voice decrease in sensation and was cleared to go by EMS.
approx 10min p/vax pt c/o itchy, swollen, watery eyes;inc edema noted on upper & lower lids;DPH given pt remained in hlth ctr approx 1hr for observation home eyelids remain edematous;
multiple pts with arm pain; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in an unspecified number of patients 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter had multiple patients with arm pain that lasted a couple weeks or more.
8/17/21. EE with symptoms of HA, sore throat, and stuffy nose.   Tested positive for Covid 19  on 8/17/21.  He's still symptomatic with a stuffy nose.  Remains isolated and will do antibody testing.
2nd shot warm arm; 2nd shot sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (2nd shot warm arm) and VACCINATION SITE PAIN (2nd shot sore arm) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (2nd shot warm arm) and VACCINATION SITE PAIN (2nd shot sore arm). At the time of the report, VACCINATION SITE WARMTH (2nd shot warm arm) and VACCINATION SITE PAIN (2nd shot sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported.
On 09/12/2001 mother contacted this RN  per telephone call to report the following: Approximately an hour or two after he received his immunizations on 09/11/2001, he developed dime size or smaller size hives on his back, chest, arms and a couple on his legs with no additional symptoms. His mother contacted an ER who advised the mother to give Benadryl. Mother gave Benadryl, 1 dose about 30 minutes after onset of hives, mother stating hives cleared about 45 minutes after first dose of Benadryl was given. His mother contacted the pt family doctor on 09/12/2001,informing Dr of the previously described information. Dr. advised mother to also notify the Health Department regarding the previously noted information.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 11-JAN-2008 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-JUL-2012 the patient was treated at a community hospital for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Cellulitis outcome determined at urgent care- redness swelling itchiness and warm to touch
Patient went into AFIB 2 hours after getting the Moderna booster. He was admitted to the hospital where cardioversion was performed and he was also given sotalol.
This spontaneous report as received from a physician refers to a 3 year old female patient. On 27-MAR-2013 the patient was vaccinated with the first dose of (merck) VARIVAX in the arm. Other suspect therapies included PREVNAR 13, administered in the same arm on the same date. No concomitant drugs were taken. On 27-MAR-2013, 5 to 10 min after onset of therapy the patient experienced 50 cent piece size hive between the 2 injection site. There was no itching or pain and it resolved within 5 hours. The outcome of 50 cent piece size hive between 2 injection sites was reported as recovered/resolved. Causality was not provided. Additional information has been requested.
having a bad taste in his mouth; terrible gastric reflux; heartburn; tired; sickly; This is a spontaneous report from a contactable consumer received via Medical Information Team.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient reported he felt tired and sickly. On 11Jan2021, he started having a bad taste in his mouth and terrible gastric reflux and heartburn. Medication did help the reflux, but "the bad taste was still in mouth". The patient outcome of " tired and sickly" was recovered on 11Jan2021, the outcome of gastric reflux and heartburn was recovering and the outcome of "the bad taste" was not recovered.  The information on the batch number has been requested.
Within 5 minutes of the shot, my skin began to itch all over (legs stomach, arms, neck) and my tongue went numb.  I have had this reaction before with exposure to wet polyurethane.  The doctor looked at my leg to see if if there was a rash (there was not) and she gave me a bendryl.  The symptoms subsided.  I stayed at the clinic for a total of 2 hours.  Later that evening, the itching came back so I gave myself one benedryl and the itching subsided.  The following morning the itching was gone and my tongue felt better.
Allergic type reaction- Itching of body, throat soreness with trouble swallowing and hoarse voice. Treated on scene with IM EpiPen , PO Benadryl , and EMS gave IV solumedrol . Given iv Pepcid  at the ED.
9 pm: both left and right palms on pad below thumbs started to itch and hands and fingers looked blotchy red. Itch subsided with in one hour. 11:30 pm: Woke up from sleep because I experienced uncontrollable shivering and was cold. Added a blanket to my bed. Fell back to sleep. 2:30 pm: Woke and knew I had a strong fever but did not have a thermometer to take temperature. Got up to take some Tylenol but had to ask my daughter for assistance because I became very dizzy and immediately went back to bed. I started sweating a lot and felt nauseous. I swallowed two extra strength Tylenol caplets with a large glass of water and fell back asleep. 7:00 am: I woke up and had no fever. The fever never returned but I felt a bit light-headed in the morning and tired all day; took a few naps. By evening I felt more like myself. Gradually gained my usual strength by the end of Monday. On Thursday morning  09/06/2018, I  felt 2-3 times for like 10 minutes each time as if I was fighting some of the ill-feeling symptoms (but it could have been the extremely hot weather we had where we were too, so I kept hydrating. I felt much better by noon).
This spontaneous report was received from an other health professional refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of PEDVAXHIB with lot number L014429 and expiry date- 15-MAR-2018 (dosing regimens unknown). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The reporter considered events to be not related to PEDVAXHIB. Additional information has been requested.
Information has been received from a female nurse concerning herself who "recently" in approximately May 2009, was vaccinated with a dose of PNEUMOVAX (Lot # not reported) intramuscularly. "Recently" in approximately May 2009 after getting the vaccine she had cellulitis at the injection site. At the time on the report on 05-MAY-2009 the patient recovered from cellulitis. Follow-up information was received which reported that the 30 year old medical assistant with no pertinent medical history and no known allergies/drug reactions who on 30-APR-2009, was vaccinated with the first dose of PNEUMOVAX (Lot # 662599/1076X) intramuscularly into her right arm at 14:00 hours. It was reported that on 30-APR-2009 at 16:00, the medical assistant's arm began to be heavy and she was unable to raise it. On 01-MAY-2009, she had fever of 103 degrees and she began to have red marks going down the arm. On 03-MAY-2009 the medical assistant recovered. There was no illness at the time of vaccination and there were no relevant diagnostic/laboratory tests performed. The patient did not seek medical attention. No further information is available.
Rapid increase in heart rate 3 minute after injection (from 77 to 134)- lasting approximately 5-8 min. Elevated heart rate (20 beats above normal on average) for the day following while resting, rapid increase in heart rate with mild activity.
Metallic taste; low body temperature 97.1; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 08Mar2021, outcome "not recovered", described as "Metallic taste"; BODY TEMPERATURE DECREASED (non-serious) with onset 08Mar2021, outcome "not recovered", described as "low body temperature 97.1"; FATIGUE (non-serious) with onset 08Mar2021, outcome "not recovered", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysgeusia, body temperature decreased, fatigue. Additional information: Prior to the 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 receive any other vaccines within four weeks prior to the COVID vaccine. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient states: "I am experiencing strong headaches, fever, hot ear with redness, constant flashes of light and unbalance."
As soon as injection was given, pt had flushing and respiratory distress. Albuterol per neb. 0.083% and epinephrine .20 given.
Patient received her second dose of Twinrix on 9/25/08 at 1300.  At 1430 client stated that she began to have rash on forehead, cheeks, and both arms.  Itching was noted, and eyes and nose watering and also itching.  Around 1900 client stated that throat felt scratchy also, but rash had not increased, not raised just red and blotchy.  Client did not do treat the rash or call M.D.  Client stated she went to bed arount 0130 and the rash had faded to whiteness and itching stopped.  At 0930, 9/26/08 client relayed that rash gone and no other signs of problems was she aware of.  Client stated that she is sensitive to alot of synthetic products, and foods, and had taken the Herb 5HTP after receiving the injection. Client stated she had taken this before but it had been awhile and that she has had rashes from other herb supplements.
drug ineffective; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "drug ineffective"; COVID-19 (medically significant), outcome "unknown", described as "covid".  Clinical information: The patient reaching out to you to get help with eliquis 5 mg patient insurance would not pay for it but patient need the medicine and patient did take their shot but patient still got the covid , patient was suffering with blood clots in lungs and need the eliquis medicine to help so patient asked how to receive a discount or free samples of this medicine, patient would leave there name and phone number they look forward to hearing from phone number .  The lot number for bnt162b2 was not provided and will be requested during follow up.
Developed irritability, sore throat, diarrhea 15 days after vaccination, few widely scattered varicella lesions on skin 2-3 days later.
Patient had a temperature of 101F with tenderness, swelling and redness at the vaccination site. Fever lasted two days. Redness and swelling lasted about one week.
This spontaneous report was received from a consumer refers to her 17 year old daughter. On 02-MAR-2009, the patient was vaccinated with the first dose of GARDASIL (lot#, expiry not reported) intramuscularly. The patient had not received any subsequent doses in the series. Since an unknown date, the patient experienced body aches, headaches, fast or irregular heartbeat, shortness of breath and stomachaches. The patient was experiencing bouts of these adverse reactions about 4-5 times each week. The patient had been seeing the certified nurse practitioner. The outcome of body aches, headaches, stomachaches, fast or irregular heartbeat and shortness of breath was reported as not recovered. Additionally, the reporter stated that she would be more than happy to talk with anyone at Merck to answer additional questions or provide further information about her daughter's unique adverse experiences. This is 1 of 3 reports received from the same reporter. Additional information has been requested.
received lot number involved in the Recall; received lot number involved in the Recall; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 31st December 2023) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pediatric office receptionist reported that between 18th July and 25th August 2021, the patient received recall Engerix-B lot, which led to recalled drug administered and drug dispensing error. The reporter consented to follow up. This case was 1 of 20 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021224975:Same reporter
1/31 - eve - itchy at site - hot to touch - raised area 2" x 3". 1/1/13 - remains itchy - very red, hot - no drng 3 welts have for med by 3 pm - increased headache nausea --> area has spread 6" long 4 1/2" wide. 1/2 - swelling around injection 2" round - remains very red, hot, itchy - no pain- area outside of circle - still increased warm 6" long 5" wide. 1/3/13 - same as 1/2 - increased itching - took BENADRYL last eve - no pain - area hot to touch - have been using mass & wm pks to area. 1/3 pain only if bumped or squeezed today. Still very itchy.
Person received the Pfizer vaccine as their COVID vaccine on  2/02/21.  They came in seeking their second dose at a Moderna clinic, 78 days after their first dose.  The medial provider onsite suggested they get the Moderna vaccine and complete the second dose of Moderna. They then received their first dose of Moderna on 4/21 and second dose on 5/19/21.
PT HAD TO GO TO THE ER WITH HIGH BP 226/101. PT WAS PLACED ON ADDITIONAL LISINOPRIL AND HYDROCHLOROTHIAZIDE. HIS BP PRIOR TO THIS DATE HAD BEEN STABLE. IT SPIKED ON THE 18TH AND EVEN AFTER THE ADDED MEDICATIONS HE REPORTS THAT IT IS STILL RUNNING HIGH BUT NOT AS HIGH AS WHEN HE WENT TO THE ER
Felt Dizzy faint nauseated wanted to vomit, pale, could not speak for approx 5 minutes felt
a few seconds p/recvd vax pt stopped screaming began to stare & was pale; This lasted less than 1 min;
Positive COVID +  5/2/2021  Admitted with extreme lethargy and syncopal episode, hypoglycemia, increased dyspnea with hypoxemia
While administering vaccine, the needle retracted before all of the immunization had been administered and the vaccine sprayed out onto the patients arm and back in the syringe. Unsure of how much of the vaccine was actually administered.
At approximately 9:30 pm, my bpm increased dramatically.  I normally have a 70 - 85 bpm and last my my heart rate ranged from 120 - 152 while lying in bed.  It still is above 100 today.
Soreness and reduced ROM of left arm around 8 PM on day of injection. Swelling and erythema of left arm from injection site to antecubital area on inner aspect of arm next morning.
I had muscle aches, sore throat, cough, fever and runny nose. I completed a COVID-19 home test and was positive on January 27, 2023. I contacted my provider and they prescribed PAXLOVID. My symptoms improved by that afternoon, but I had a rebound a few days later. I had vertigo and runnier nose as well exhaustion. I am still currently having symptoms. I'm just starting to feel better today. I have been taking TYLENOL and CLARITIN.
This spontaneous report as received from a nurse refers to an infant patient (age reported as 41 or 43 weeks) of unknown gender. On 12-SEP-2014, the patient, older than 32 weeks of age, was vaccinated with third dose of ROTATEQ 2ml, oral (lot number and expiration date were not provided). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
7/20/10 - arm red, sore, minimal swelling and low grade temp. 7/24/10 - woke up with swollen tongue, took BENADRYL - swelling decreased some. Decided to f/u with local urgent care - also c/o itching with hives in creases of body. Was administered steroid injection on 7/24/10 and 7/25/10. Also given 6-day steroid pack to take orally. Swelling begin to decrease. 8/10/11 - denies any symptoms.
Approximately 11 1/2 mm red, raised, hard, itchy, painful area. Instructed to ice & give antihistamine and TYLENOL/MOTRIN for pain and swelling.