chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Licensed Practical Nurse and Office Manager refers to a female patient of unknown age. The patient's medical history included had antibiotics therapy, prior to receiving ZOSTAVAX. On 11-APR-2013 the patient was vaccinated with ZOSTAVAX lot # J000447, in deltoid area (dose, route and expiration date were not reported). After vaccination, on an unknown date in 2013, the patient experienced reaction at the injection site (deltoid area), which was red, with swelling and heat. The outcome of events was reported as recovered/resolved. The relatedness between event and ZOSTAVAX was not reported. It is unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10May2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.
received their first doses of the Pfizer covid 19 vaccines on 29JUN2021. His parents were diagnosed with COVID 19 after wards.; received their first doses of the Pfizer covid 19 vaccines on 29JUN2021. His parents were diagnosed with COVID 19 after wards.; This is a spontaneous report from a contactable consumer or other non-Health Care Professional for a female patient (reporter's mother) and report from a Pfizer sponsored program . A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on 29Jun2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 29Jun2021, the patient received their first doses of the Pfizer COVID-19 vaccines. On an unknown date in 2021, his parents were diagnosed with COVID 19 after wards. The patient underwent lab tests and procedures which included sars-cov-2 test was diagnosed with covid-19 on 2021 diagnosed with COVID 19. The outcome of the event covid-19 was recovered on an unknown date in 2021, the other event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Two-three days post-vaccination, patient developed an itching rash on the neck, back and chest. This lasted for roughly a week. After two weeks, rash had cleared.
Had itching and tingling in left arm on 1/7/2021.  That evening noticed red, raised, warm area about the size of a baseball at sight of injection.  Treated with cortisone cream which seemed to improve somewhat.
Extreme headache, chills, fever & overall body aches less than 24 hrs after vaccine...Took ibuprofen, drank lots of water , slept a lot, symptoms were milder after 24 hrs-no chills, still mild headache & slight body aches, still taking ibuprofen & drinking plenty of fluids
I was four days into my normal cycle of menstruation by the time I got my first dose of the vaccine. Hours later I experienced heavy lower back pressure that I attributed to my period so did yoga and stretched for relief. In the following days, when I would be nearing the end of my period (and should have only light bleeding), I  have since continued to experience an extremely heavy flow with what feels like moderate menstrual cramping with no change in these side effects.
Hubby and I got a sore arm; Hubby and I got / some tiredness for a couple of day; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and tiredness. On an unknown date, the outcome of the pain in arm and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and tiredness to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient's partner. The age at vaccination was not reported. The patient received shingles vaccine and experienced sore arm and some tiredness for a couple of days. At the time of reporting, the patient was fine and it was a time for his second shot. The reporter stated that they do not want to get shingles. No other information was reported. This case is linked to case US2021AMR151464, reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151464:Same reporter
1035A c/o tingling and numbness in left arm in left arm after flu shot B/P 140/90 no discernible difference in temperature of extremities color of both arms normal. 11/2/10 1154AM states left arm "still having feeling of coldness but less so". 11/2/10 250p TC for follow up reports feeling of cold & tingling lasted about 2 hours but is gone, c/o arm soreness at site.
Every nerve on fire. All over body.  Lasted at extreme level for 24 hours and lingered for days.
Warm; Sore to touch; Redness developed around the injection site; Itchy; Dose 1 start date on 20210322 and dose 2 start date on 20210408; This is a spontaneous report from a non-contactable nurse. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0162) via an unspecified route of administration in the left arm on 08Apr2021 at 09:15 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and unknown if ongoing. The patient previously took azithromycin (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW8727) via an unspecified route of administration in the left arm on 22Mar2021 at 09:30 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. On 17Apr2021, the patient experienced redness which developed around the injection site, warm, itchy and sore to touch. The patient had received the second dose outside the range of 19-42 days after the first dose and hence there was a medication error (inappropriate scheduling of vaccine administered). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site redness, warm, itchy and pain were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Vaccine at 11:30 ret home, began to cry inconsolably at 4pm left thigh red, hot, swollen. Refused to feed. Tylenol given , ice applied. To office at 4:45 still crying inconsolably. Left thigh red, hot, swollen and painful 7cm x 7cm. Motrin 100mg given ice applied and leg elevaged. 6pm, physican exam neg except for pain at site DTaP injection. No further redness. Care at home-ice q 2hr 10 mins each time, elevate leg, Motrin. 06/06/02 8am child slept well leg looks fine.
Information has been received from a physician via a company representative referring to a 13 year old female patient. Concurrent conditions and medical history of the patient were not reported. On 07-JUN-2016, the patient was vaccinated with her second dose of GARDASIL 9 intramuscularly (dose unspecified). The patient was fainted after vaccination in doctor's office. The outcome of the event was unknown. Additional information has been requested.
Soreness in arm; Shoulder looks inflamed; Excruciating pain in shoulder that goes down the arm when patient reaches with it, pain radiates from shoulder to underarm; progressive pain; Feels like something is tweaked; Shoulder looks red; Underarm pain; Pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm), SWELLING (Shoulder looks inflamed), PAIN (Excruciating pain in shoulder that goes down the arm when patient reaches with it, pain radiates from shoulder to underarm), CONDITION AGGRAVATED (progressive pain) and LIGAMENT SPRAIN (Feels like something is tweaked) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU. Concurrent medical conditions included Seasonal allergy.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm), SWELLING (Shoulder looks inflamed), PAIN (Excruciating pain in shoulder that goes down the arm when patient reaches with it, pain radiates from shoulder to underarm), CONDITION AGGRAVATED (progressive pain), LIGAMENT SPRAIN (Feels like something is tweaked), ERYTHEMA (Shoulder looks red), AXILLARY PAIN (Underarm pain) and ARTHRALGIA (Pain in shoulder). At the time of the report, PAIN IN EXTREMITY (Soreness in arm), SWELLING (Shoulder looks inflamed), PAIN (Excruciating pain in shoulder that goes down the arm when patient reaches with it, pain radiates from shoulder to underarm), CONDITION AGGRAVATED (progressive pain), LIGAMENT SPRAIN (Feels like something is tweaked), AXILLARY PAIN (Underarm pain) and ARTHRALGIA (Pain in shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown
23 hours after second vaccination I had fever, chills, and severe body aches.   All three went away within 15 hours.
Pt received first Pfizer COVID-19 vaccine on 5/7/2021. Pt started to experience severe chest pain and went to the ED on 5/9. PMH of CAD, with coronary stents in 2011. Pt admitted to the hospital.
Systemic: Flushed / Sweating-Mild, Additional Details: pt felt flused after 10 minutes. Refused benadryl due to previous reaction.  Took asa 81 mg and zyrtec 10 mg. Symptoms resolved.
pt recvd ax 22SEP94 & 23SEP94 pt presented in sick call w/either a fever &/or a local or systemic rxn;sxs resolved p/several days;
3 hours following receipt of Tdap and MENACTRA vaccines the patient developed a severe bifrontal headache and several episodes of vomiting. No prior history of migraine headaches. No fever. Improving several hours following above episode.
Patient reports possibly getting a PNEUMOVAX vaccine 8-12 years prior. 110 mm red, slightly raised reaction noted on inside right upper arm, not connected to injection site day after injection. Treated with ibuprofen with marked improvement.
pt recv vax 14FEB97 & on 24FEB97 pt devel 30-40 rash-like lesions;
Patient received Pfizer COVID vaccine on 12/18/20 and 1/6/21. On 10/13/21, patient was admitted to our facility for DKA and COVID-19 pneumonia. As of today (10/15/21), patient is still in HCF.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 13-APR-2009, the patient's healthcare provider at a clinic administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In August 2017, the patient was treated by her healthcare provider at the same clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Large Red Patch, swelling, heat, hard.  Grew to about 3 to 4 inches over 3 days.  No pain.  Disappeared after day 3.
Patient was given vaccine that was past its "use by" date of 8/16/22. patient did not report any adverse effects.
Four days after injection (July 18-21), flu-like symptoms: fatigue, muscle ache, headache, fever, chills, burning under skin. Lasted four days. Two weeks after injection (August 4-7), flu-like symptoms:  fatigue, muscle ache, headache, fever, chills, burning under skin. Lasted four days. Lasted four days so far.
Upper arm was red, swollen, itchy and painful after HD flu shot. Patient went to urgent care the day after receiving shot. Urgent care recommended BENADRYL and ice for treatment and possible allergic reaction. Patient recovered fully 3 days after vaccine administered.
17 years old/less than 18 y/o got the 1st dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old/less than 18 y/o got the 1st dose of vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old/less than 18 y/o got the 1st dose of vaccine). On 10-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old/less than 18 y/o got the 1st dose of vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
arm soreness; running fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) and PYREXIA (running fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and PYREXIA (running fever). In 2021, PAIN IN EXTREMITY (arm soreness) had resolved. At the time of the report, PYREXIA (running fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported. No treatment medications were provided.
devel hives on abd less than 24hr p/vax;has taken DPH;
Quadracel was mixed with the Pentacel powder which is the Hib component with no reported adverse event; Initial information received on 03-Aug-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves an unknown age and unknown gender patient who was administered with diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] which was mixed with the diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] powder which is the hib component 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 was administered with diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] (formulation, strength, dose, batch number and expiry date not reported) which was mixed with the diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] powder (strength, dose, batch number and expiry date not reported) which is the hib component with no reported adverse event (product preparation error).  It was reported, she states that it is not that they were given together but that the Quadracel was mixed with the Pentacel powder which is the Hib component. She states that it is not a problem because they are both a liquid DTaP-IPV and the "same thing just packaged differently". She states that she is calling to make doubly sure it was reported correctly because she was concerned because it said an "extra dose because it wasn't, it was just given a little differently".  Action taken was not applicable.  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 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.
Patient describes severe left shoulder pain with in minutes of receiving 2010 influenza vaccine. Patient reports treating pain at home with warm compresses and ice off/on without improvement. Pain has persisted for 2 weeks. Health Dept referred to PCP for follow-up and evaluation.
This spontaneous report as received from a healthcare worker refers to a 11 year old patient. On 01-MAY-2014 the patient was vaccinated with a dose if ZOSTAVAX (lot#, dose and route unspecified) instead of VARIVAX. No adverse effect reported. Additional information has been requested.
Fever, slight chills, red skin 5-6 inches in diameter, 2" below vaccination site of RD (Pneumovax).
painful inject @ time, burned cont to hurt; rt arm immobilized, chills or hot, h/a, aching all over, 11NOV rt arm began to swell, red lines around upper arm w/center area of reddened, induration; widened to 2" band around upper arm (hot); ;
This spontaneous report was received from a Nurse refers to a 10 year old patient. On 21-APR-2014, the patient was vaccinated with VARIVAX (0.5 ml once) subcutaneous in left deltoid region. Other suspect therapies included DTAP (manufacturer unknown) (dose and frequency were not reported) and meningococcal vaccine (unspecified) (manufacturer unknown)  (vaccinated in the left deltoid) (dose and frequency were not reported). On 21-APR-2014 (also reported as within 24 hours of receiving VARIVAX (Merck)) the patient experienced high fevers, headaches, injection site swelling and just lying around and sleeping. The patient sought medical attention and was seen by primary care physician and directed to apply tea bags and ice to area and take BENADRYL. The outcome of the events was not reported as recovering. The reporter did not provide the causality between the event an the suspect drug. This case is linked to the case 1404USA014484 and 1404USA014726 (same reporter link). Additional information has been requested.
Patient's parent made an appointment online for booster shot for patient. It was missed at screening by pharmacist that the patient is 14 years old. In the vaccine room, I assumed it was already screened by the pharmacist and I administered the vaccine. I contacted the clinic to let him know the situation. I contacted the patient's pediatrician to inform them and also informed the patient's parents. The only adverse effects likely to happen is muscle soreness and the common side effects reported from the vaccine (chills, fever, fatigue, etc). facility will take care of any medical bills if there is any.
Diaphoretic, syncope for approximately 2 minutes, panic attack, rapid breathing. Transported to nearest  ER by EMS.
One half of a two-part vaccine was given to the child. No adverse reaction was noted as far as this nurse knows. Depart of Health was contacted immediately after this was discovered during a routine clinic audit and gave guidance to re vaccinate the child. Attempted to contact the child's parent twice and got no answer. Voicemails were left.
Pt stated severe body aches to where he could hardly get out of bed, nausea, vomiting, headache and chills.  Pt stated he never went to the doctors and has been off work but is feeling recovered and about to return to work.
This spontaneous report as received from a medical assistant (also reported as Licensed Practical Nurse) refers to an unknown number of patients' of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these patients' were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M006708, expiry date 02-JUN-2018) (strength, dosing details, anatomical location were unknown). No adverse effects were reported in any patient. The vaccine was exposed to the temperature of -0.1 degree Celsius for 1 hour 9 minutes; 1.5 degree Celsius for 23 minutes; 1.5 degree Celsius for 25 minutes; 1.7 degree Celsius for 21 minutes; 0.7 degree Celsius for 50 minutes; and -0.3 degree Celsius for 1 hour 25 minutes. No product quality complaint was involved. This is one of 3 reports received from the same reporter source. Additional information is not expected as the reporter did not wish to be contacted.