chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Physician Assistant referring to a 1 year old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 04-APR-2018, the patient was inadvertently vaccinated with a dose of GARDASIL 9 0.5 ml, intramuscularly, for prophylaxis (strength, lot # and expiration date were not reported), instead of the intended ACTHIB for prophylaxis (strength, dose, route, lot # and expiration date were not reported). The Physician assistant reported that this was a product confusion because the Medical Assistant, who administered the GARDASIL 9, thought the letters "HPV" and "HIB" looked similar on both of the vials. The Physician Assistant reported that the ACTHIB was in a vial with a green cap and was an unknown strength and size. Additionally, the GARDASIL 9 was a 0.5 ml vial with a brown cap. It was unknown if the patient received the dose of ACTHIB. No adverse effects were reported and a Product Quality Complaint was filed. At the reporting time, the outcome of product quality issue was unknown and the causality assessment between product quality issue and GARDASIL 9 and ACTHIB was not provided.
This patient is one of a cluster of 2 patient's with the same reporter and same vaccine administered; however lot number was not reported. Initial report received from a patient on 19 October 2010. A 61-year-old female patient had received a dose of FLUZONE HIGH-DOSE (lot number not reported) at 9:30 am on 18 October 2010, and within 15-20 minutes later, she complained of a sore throat, SOB (shortness of breath) and coughing. The patient subsequently developed severe headache, dizziness, nausea, diarrhea, and complained of numbness and tingling in her hands and feet. It was also reported the patient had pain (not described) and that 90 minutes after vaccination the patient was sick. The patient has no known allergies and denied any pre-existing medical conditions or concurrent illnesses at the time of vaccination; however the patient was taking concomitant medications of PREMPRO and "MDV". She had not experienced any other adverse events with prior vaccinations in the past. The patient does receive the flu vaccine annually. At the time of this report, the patient was feeling better but still complained of a headache although not as severe. Documents held by sender: None. The reporter for this case is the same as for non-serious case 2010-06028.
I had a sore arm and was red and swollen. I went to the doctor and received a steroid injection and antibiotic injection.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On approximately 31-JAN-2016 reported as 8 months ago, the patient was vaccinated with the first dose of RECOMBIVAX HB and on 31-AUG-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not reported. No adverse effect was reported. Additional information has been requested.
Numbness in left-side of face 5 minutes after injection, lasted several days. 2-3 weeks after vaccine, tinnitus started in both ears. Tinnitus still continues.
2/6/2021 patient came to the pharmacy and reported that she developed a rash the second day after receiving the first dose of Moderna vaccine on 1/25/2021. She also experienced red and soreness on her arm, it went away on its own. On 2/4/2021, her rash came back and she took Benadryl. She noticed the deltoid muscle on her arm became harder to touch. Patient showed the pharmacist her arm and no rash was observed. Provided patient with Moderna EUA paper and advised patient to report to CDC if severe allergic reaction is observed. She can also call ModernaTX to report reactions. Patient will discuss with her physician before getting the 2nd dose.
Rash on back of neck, itchy hives on arms and legs. Started with a few small bumps on injection arm. BENADRYL offers minor relief.
I received my 5th dose of Pfizer Bivalent booster on 10/06/2022. On 12/10/2022 I experienced Cardiac arrest. I was hospitalized for 5 days. I went to the urgent care at 03:00 PM first because I was experiencing shortness of breath and fluid retention. By 08:00 I was admitted in the hospital. At the hospital they did several test. They prescribed me with furosemide, LIPITOR and baby aspirin. I got out of the hospital on 12/17/2022.
pt to ER, crying forcefully, had emesis x2, cheeks red rashy, also rt thigh red, warm, swollen, tender to touch;
The day after the immunization, the patient experienced itching and a rash developed around the site of injection. The rash has persisted from 10/26-10/31.
had the first dose in 2018; This case was reported by a pharmacist  and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up. This case was linked with case US2021227965, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021227965:same reporter
PT STATES THAT SHE IS HAVING SHOULDER PAIN. UNABLE TO LIFE ARM ABOVE SHOULDER LEVEL AFTER RECEIVING TWO VACCINATIONS. IT IS SLIGHTLY BRUISED AND PT COMPLAINS OF MUSCLE PAIN. VACCIANTION WAS GIVEN AND WITHIN 12-20 HRS EFFECTS WERE FELT AND PT CALLED PHARMACY
Seriousness criteria other medically significant (OMIC). Initial report received on Nov 3 2005 from a health care professional. A female geriatric patient had received an (route and site not reported) administration of Fluzone SV 2005-2006 usp, lot number and date of vaccination not reported. At an unspecified time later, the patient developed a whole body chicken pox like rash that was macular papular in appearance with some clear fluid filled vesicles. She was admitted to the hospital (date not reported) from an emergency care facility and was treated by an infectious disease physician. Biopsy of the vesicles were completed and the results were pending at the time of this report.
client stated feeling dizzy few seconds after injection and had vasovagal response and passed out for approx 3 seconds, v/s remained stable, client required no further treatment, observed for a total of 35 mins, client states feeling better after 5 mins.  left facility in stable condition, ambulating w/o assist, accompanied by mother ( who also received injection w/o incident)
52 yo with history squamous cell cancer in mouth, treated with surgery and radiation1/2021; got p fizer 3/30 & 4/27; by June/ July had jaw pain,  work up Revealed recurrence,  no with another big surgery with flap/trach
Information has been received from a medical assistant concerning a 23 year old female with no medical history, allergies or drug reactions who on 11-JAN-2007 was vaccinated with the first dose of GARDASIL vaccine (lot no. 658488/1264U) 0.5 ml, IM. Concomitant therapy included hormonal contraceptives (unspecified). On an unknown date,  the patient experienced nausea, vomiting and light headedness after getting the first dose of the vaccine.  Subsequently, the patient recovered from nausea, vomiting and light headiness. No laboratory test was performed. Additional information has been requested.
Sore left arm, tight neck left side of injection, slight headache. Eyes slightly achey.  Slightly tired.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 26-NOV-2014 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot# J010613, expiration date 11-JUN-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 48, 1 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Dm" (unspecified if ongoing), notes: Dm; "hyperlipidemia" (unspecified if ongoing), notes: hyperlipidemia; "depression" (unspecified if ongoing); "ptsd" (unspecified if ongoing), notes: ptsd. The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "Known allergies: Compazine", notes: Known allergies: Compazine; Wellbutrin, reaction(s): "Known allergies: wellbutrin", notes: Known allergies: wellbutrin; Ozempic, reaction(s): "Known allergies: ozempic", notes: Known allergies: ozempic. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". 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: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Patient received Moderna vaccine lot 042L20A at 1623 on 01/25/21.  Later that evening she felt off- partly because the air was off in the ER and she took her pulse ox and HR  and HR was 97 o2 was 91 reports no rash at that time.  Came home and took a cool shower and 25 mg of benadryl. Morning of 1/26 she noticed a fine rash on her left lower neck and upper chest.  She had Dr.  look at it when she got to ER to work- they thought it looked like heat rash (air was still out).  Her skin felt uncomfortable and rash worsened to where a co-worker noticed.  The NP checked her and it had spread to her abdomen and back - not legs.  It felt like fire and was painful, but did not itch.
Pt recvd vax & exp prenancy-like sx like enlargement & tenderness of the breasts, nausea & abdo cramping; pt then visited on OB who reported that pt was exp hepatitis-like sz & a urinary tract infect;
Fever, chills, body aches starting 8pm, somewhat better with ibuprofen. Fever broke around 5am and headaches started around 7am, with lingering lethargy.  Janssen COVID-19 Vaccine
Development of hives at about 35 to 36 hours. Hives on the trunk, arms, and extremities. No facial or head involvement.  Awoken from sleep with diffuse hives around 1:30 am on 1/9/21 after experiencing mild hives about 4 hours earlier. Took 37.5 of Benadryl, 1000 mg of Tylenol, 40 mg Pepcid, 20 mg of Zyrtec, and 40 mg of Prednisone.  Hives eased. Around 2:15 am.
he as diagnosed with covid on that day; he as diagnosed with covid on that day; cold; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient himself) of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: ER8727; Expiration date: unknown), intramuscular, administered in Arm Left on 06Apr2021 14:00 as 1ST DOSE, 0.3 ML SINGLE for COVID-19 immunization.  Medical history included diabetes mellitus from 1997 and ongoing, myocardial infarction from an unknown date and unknown if ongoing, heart attack from 1979 unknown if ongoing , issues associated with orange ongoing. The patient had not any other vaccine 4 weeks prior to COVID-19 vaccine and not had any adverse events. The patient had not Family Medical History Relevant to adverse events. The patient's concomitant medications were not reported.  The patient experienced as he was diagnosed with COVID on that day (COVID-19), drug ineffective and cold on 27Apr2021 with outcome of recovered.  On 06APR2021 he got his first dose. He said he was supposed to go back and get his second dose on 27Apr 2021 but he got a positive result of COVID. He stated that he went through 14 days of quarantine and Tuesday of this week was the 14th day. He stated that on 11MAY2021 that his quarantine was ended. Caller clarified that he tested positive for COVID on 27APR2021 and that he received the first vaccine on 06APR02. He states that he original second dose was scheduled for 27Apr2021 but he could not take it because he was diagnosed with COVID. He stated that he has not been doing anything because he has been under a 14 day quarantine. He states he has just been sitting there waiting. The patient underwent lab tests and procedures which included SARS-COV-2 test positive: positive on 27Apr2021.  No follow up attempt are needed: No further Information is expected.
Per patient report: dizziness, left arm weakness, headache, body aches, fatigue, chills, sweating.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 1:35 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 1:25 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  It was reported that the storage condition of vaccines at the time of the excursion as frozen. Excursion duration was 1 month. On 19-Nov-2021, the vial moved from super cold freezer to the refrigerator. 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. None of the vials were punctured and no previous temperature excursions No treatment medication information was given.   This case was linked to MOD-2021-402935 (Patient Link).
patient developed bruising to the right deltoid initially after having COVID injection on 3/5/2021. she subsequently had the second injection on 4/1/2021 to the right deltoid. Now has indentation to the said area and appears to have muscle atrophy to the area.
Monday night Feb 6, 17 my neck started hurting. Tues morning I could not move my head. Tues night I put ABSORBINE JR. on neck, Wed still in pain could not move neck. That night used heating pad. Thurs called doctor. Fri saw Dr. put me on methocarbamol 500 mg 2 times daily. Pain improved but not totally.
Inappropriate dosing Schedule/took 2nd dose too late; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 19th July 2018, received first dose).   On 02-MAY-2023, the patient received the 2nd dose of Shingrix. On 02-MAY-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate dosing Schedule/took 2nd dose too late). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2023 The reporter was a patient. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.  The reporter did not consent to follow up.
pt seen in MD office for a well visit 8SEP97 pt recv vax same day;pt died 11SEP97 found w/cardiopulmonary arrest @ 1PM while sleeping;
Morning after injection, woke up with overall joint /muscle aches, not feeling well. Six hours later, woke up in the night feeling very dizzy, felt like "water was swishing in my head", head pressure, headache, and loss of balance when upright to walk. Symptoms became worse over the next 6 days. Tried  taking Dramamine with not much relief. Contacted MD x2 during that week who just encouraged hydration.  Contact Dept of Health on day 7,suggesting to complete this form. Was seen by Medical MD on day 8 to document symptoms, attributing to effects caused by receiving 2nd covid vaccine dose. Day 9, full symptoms returned. Day 10, only  symptom was headache.
Psoriasis showing up on both legs/arms and patch on the stomach; Eczema; This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (Psoriasis showing up on both legs/arms and patch on the stomach) and ECZEMA (Eczema) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 01-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In November 2021, the patient experienced ECZEMA (Eczema). In May 2022, the patient experienced PSORIASIS (Psoriasis showing up on both legs/arms and patch on the stomach). At the time of the report, PSORIASIS (Psoriasis showing up on both legs/arms and patch on the stomach) had not resolved and ECZEMA (Eczema) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, Biopsy: psoriasis showing up on both legs, arms and patch Psoriasis showing up on both legs, arms and patch on stomach.         No concomitant medications were reported. As per HUMIRA, psoriasis causality was per reporter as probable, action taken was unknown and de challenge not applicable and for Eczema Causality as per reporter was not provided, action taken with drug unknown and de challenge was not applicable. No treatment medications were reported.
This case was reported by a consumer via out of hour services and described the occurrence of numbness of extremities in a female patient who received Influenza vaccine. On 11th October 2017, the patient received Influenza vaccine. In October 2017, less than a week after receiving Influenza vaccine, the patient experienced numbness of extremities, tingling, weakness and loss of sensation. On an unknown date, the outcome of the numbness of extremities, tingling, weakness and loss of sensation were unknown. It was unknown if the reporter considered the numbness of extremities, tingling, weakness and loss of sensation to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. On Wednesday, the patient had received the flu shot. The patient had numbness and tingling down to my fingertips and some weakness. On Saturday, the day of reporting, she still had some loss of sensation down to fingertips. The patient hoped the next few days the events would continue to improve. On 16th October 2017, the patient was contacted to clarify her mailing address.
approx. 2hrs post dose mild HA  then nausea HA the worst one I've ever had Tylenol didn't help at all Muscle and bone pain(HA and muscle bone pain started within 8hrs post dose 14 hrs post dose nausea set in followed by 3 episodes of vomiting. then elevated temp of 101 with chills  this all lasted until 5AM Saturday 07132019 at this point I feel weak very glad HA has subsided and I actually feel hungry with no bone or muscle pain.
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 at 15:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing); "If covid prior vaccination Yes" (unspecified if ongoing), notes: If covid prior vaccination Yes. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Dec2022 at 05:15, outcome "recovering", described as "Sore arm". Therapeutic measures were taken as a result of pain in extremity.  Additional Information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. The patient did not receive any medications within two weeks of vaccination. The events did not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
01/08/2023 I had a cough, runny nose, oxygen saturation and temperature.  After testing positive for Covid-19I was prescribed  Molnupirizir. Symptoms are ongoing tested negative on 01/26/2022.
Itchiness to left arm and back as well as under right arm, no hives or stridor noted by medical staff PT was Also evaluated by  doctor.  PT stated no trouble breathing. PT remained for 15 extra minutes to be monitored further.
Pt rec'd 2nd dose of vax 30JUL89 & developed morning stiffness in the lt shoulder in which vaccination occurred; Also experienced severe motion pain upon abduction & rotation; Pt rec'd 1st dose of vax w/out adverse effect;