chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information about patient 6 out of 10 patient.   This case was linked to US-MODERNATX, INC.-MOD-2023-731451 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731451:Master case
Develop sort of a rash all over his body; Body is break out all over; This is a spontaneous report from a contactable consumer (patient's wife). A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 17Jul2021 (Batch/Lot Number: EW0198) (at age 45-years-old) as dose 1, single for covid-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 27July2021, it's like 9-10 days after, patient developed sort of a rash all over his body. Reporter was calling to see if this could be associated with the vaccine because that never happened to him before and reporter was reading about the vaccine rash but don't know if it's applicable because it was like 9 or 10 days after the first shot. The patient was received Benadryl and a lot of cream because his body was break out all over. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Saturday 1/9/21:  Saturday around noon I started having nausea and internal heat through out my body, sleep interruption  and cold sweats during the night.  Sunday 1/10/21: the same as Saturday. Sunday  around noon I had internal heat through out my body, sleep interruption and cold sweats Monday 1/11/21 afternoon I developed a headache and pain in the left side of my neck around 5 pm I started dry heaving at work and on the drive home I started vomiting uncontrollably. The vomiting went on for quite some time after I got home, the vomit had a fowl taste and smell of sulfa. The Next morning Tuesday 1/12/21 : I still felt nauseous but no vomiting. I had fatigue, headache and lack of apatite, the same on Wednesday 1/13/21 and Thursday 1/14/21. Thursday 1/14/21 I have felt malaise and lack of energy still no appetite.
This was an erronous second bivalent booster given outside of guidelines. Patient had no reactions
Client received Tdap, MMR, and varicella vaccine on 5/21/18. Presented to clinic today, 5/24/18 with raised, red, warm to touch area approx 3 in in diameter. Painful to touch. No open areas drainage noted. Client was referred to PCP at clinic.
Tightness of chest, sore arm, hard to breath, tiredness, nausea
This case was reported by a consumer  interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were unknown.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingles vaccine.  The case was reported by the patient. The age at vaccination was not reported. The patient had chicken pox really bad as a child, so the patient was at risk. The patient just got 1st of 2 shingles vaccine. The injection really hurt and arm was very sore for a couple of days, well worth it if he/she could avoid the pain. The reporter said a good friend of his/her had shingles and was still fighting it several months later, the patient's friend was going through physically exhausted physically restless. No contact details were available.
Rash started on left side of stomach and I thought it was just an allergic reaction to body lotion or soap. I finally went to see a dermatologist in January when it got worse. The NP at Cancer Clinic prescribed Betamethasone ointment and it got better in 2 weeks. However, about a week after, the rash came back and had now spread all over my torso and chest and neck area. I went to see my primary care doc, who prescribed Prednisone 50mg x 5 days. After Prednisone, the rash got better, but a week later, it came back and this time, spread onto my scalp and spread to my groin and armpit area. I went to the ER and got another round of Prednisone and they gave me Benadryl, Pepcid AC, and a steroid pill in the ER. The rash has spread to my thighs, buttocks, back, and is basically all over my torso. It looks like hives combined with whiteheads and is super itchy. Yesterday, I went to urgent care and the doc prescribed Azithromycin and refilled Betamethadone ointment and gave my Hydroxyzine for the itch, since the itch keeps me up at night.
PT HAD HARD LUMP AT VACCINATION SITE THAT SHE NOTICED AFTER SHE WOKE UP THE MORNING FOLLOWING VACCINE ADMINISTRATION. SHE SAID IT WAS PAINFUL.
Papular rash in 3" area around each injection site, pt denies itching or pain. Mom reports "two bumps" night of vaccine then rash developed over weekend following vaccine.
This case was reported by a physician via sales rep and described the occurrence of strength loss of in a 79-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included blood pressure high and diabetes (controlled). In January 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced strength loss of (serious criteria hospitalization and disability) and acute pain (serious criteria hospitalization). The patient was treated with immunoglobulins nos (Intravenous Immunoglobulin). On an unknown date, the outcome of the strength loss of and acute pain were unknown. The reporter considered the strength loss of and acute pain to be related to SHINGRIX. Rerun: Additional details were provided as follows: The age at vaccination was not reported but it could be 78 or 79 years. The patient began to experience loss of strength in the legs and extreme pain.  Prior to this. Other than controlled diabetes and high blood pressure, the patient was in good health and completely self-sufficient. The patient was admitted to hospital from 20th March 2019 to 25th March 2019 and underwent numerous examinations. She also received intravenous Ig, but the treatment did not help. The patient was wheelchair bound and has begun to experience loss of strength in right arm as well. The reporting physician as well as neurology specialists believe this to be vaccine-related. The reporter wanted to follow up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 58 years, in left arm 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 included: "Hyperlipidaemia" (unspecified if ongoing), notes: Other medical history Hyperlipidemia. Concomitant medication(s) included: PRAVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Oct2022) Positive, notes: Positive antigen test 6 days post Paxlovid treatment; (unspecified date) Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received COVID-19 treatment with Paxlovid from 01Oct2022 to 05Oct2022. Patient received other medication in 2 weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Hives & h/a p/booster on 4MAR91; exposed to rabid cow on 27FEB91; Had warmth a few days later @ inject site; pass hx of DEV approx 15 yrs prior plus 1 booster 2 yrs later;
New onset of tinnitus; This case was reported by a consumer and described the occurrence of tinnitus in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID 19 VACCINE PFIZER for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and COVID 19 VACCINE PFIZER. On an unknown date, unknown after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was unknown.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were reported as follow: This case was reported by consumer. The age at vaccination was not reported. The patient experienced new onset of tinnitus after dose 1 of Shingrix and after dose 2 of Pfizer Covid-19 vaccine.  It was unknown if which product it was related to tinnitus.
Narrative:  Patient experienced body aches in which lasted the weekend, stating all joints hurt 10/10 and tender. Joints did not swell and was not red. Continues to  have left great toe pain. Denies SOB, wheezing, cough, tongue/face/lip swelling,  fever.
ITCHING ALL OVER BODY; RASH; SORE ARM; FAST HEART BEAT OF 140 BPM; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vicodin drug allergy, and sulfa drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on left deltoid on 23-MAR-2021 15:30 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced fast heart beat of 140 bpm. On 23-MAR-2021, the subject experienced rash. On 23-MAR-2021, the subject experienced sore arm. Laboratory data included: Heart rate (NR: not provided) 140 pm. On 23-MAR-2021 16:15, the subject experienced itching all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and had not recovered from itching all over body, rash, and fast heart beat of 140 bpm. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
This spontaneous report as received from a healthcare worker (also reported as medical assistant) refers to unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # K005958 and expiry date of 09-FEB-2017 or lot # L018499 and expiry date of 25-FEB-2017 (unknown route, strength and dose). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Headache c/o hypertension post vaccination - bp was 165/116 - history of HTN Narrative:
When I caught COVID-19 I had a sore throat, headache, runny nose, minor cough, a low grade fever of 100.2 degrees, and fatigue. I saw my doctor and I was prescribed PAXLOVID. I also took some DELSYM cough medicine.
Patient's mother called the day after vaccination, mentioned daughter (who received Janssen COVID-19 vaccine) reported severe back pain and stomach pain the morning after. Patient went to hospital,  got CT scan, no results found. Patient was given pain medications.
Soreness was the initial symptom after the flu vaccination.  After the pain did not subside I felt what seemed like a lump in my arm where I was vaccinated, it hurt to touch.  Soon after the pain was accompanied by loss of range of motion through today.   Due to the pandemic I have been taking ibuprofen and Tylenol daily and icing my shoulder and arm.  I can no loner lift my arm completely, change my cloths comfortably.  I am in constant pain.  I do not know if the flu shot was injected into my tendon or what caused this reaction.
Patient reported feeling anxious and warm after receiving the vaccine.  Her heart rate was 130 at the time.  Subsequent readings: BP 160/110 O2 Sat  95% HR 119  BP 196/120 O2 Sat 96% HR 125  Patient was transported to the hospital.
Possible late 2nd dose of Shingrix on an unknown date; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an date received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Possible late 2nd dose of Shingrix on an unknown date). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date:01-NOV-2023 The reporter reported that possible late 2nd dose of Shingrix. No other adverse event information made available. The vaccine administration facility was the same as primary reporter. Sales representative information emailed to safety team. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Low-grade fever/ (98.8); Body aches; Headache; Chills; Cold sweats; This spontaneous case was reported by an other health care professional and describes the occurrence of COLD SWEAT (Cold sweats), PYREXIA (Low-grade fever/ (98.8)), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Left arm) on 02-Nov-2021, Pfizer (Dose 2) and Pfizer (Dose 2). Past adverse reactions to the above products included Headache with Pfizer; Low grade fever with Pfizer; and No adverse reaction with Flu shot. Concurrent medical conditions included Anxiety and Acne. Concomitant products included SPIRONOLACTONE from 15-Oct-2020 to an unknown date for Acne, ESCITALOPRAM OXALATE (LEXAPRO) from 15-Oct-2020 to an unknown date for Anxiety, LEVONORGESTREL (MIRENA) from 23-Nov-2018 to an unknown date for an unknown indication.    On 20-Nov-2021 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. On 20-Nov-2021 at 5:00 PM, the patient experienced COLD SWEAT (Cold sweats), CHILLS (Chills) and HEADACHE (Headache). On 20-Nov-2021 at 7:00 PM, the patient experienced PYREXIA (Low-grade fever/ (98.8)) and MYALGIA (Body aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) from 20-Nov-2021 to 21-Nov-2021 for Adverse event, at an unspecified dose and frequency. On 21-Nov-2021 at 11:00 AM, COLD SWEAT (Cold sweats), PYREXIA (Low-grade fever/ (98.8)), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, Body temperature: 98.8 (High) Low grade fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PYREXIA (Low-grade fever/ (98.8)), MYALGIA (Body aches) and HEADACHE (Headache) to be probably related. No further causality assessments were provided for COLD SWEAT (Cold sweats) and CHILLS (Chills).    Reporter stated that her race was also   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Patient's demographics, Historical vaccines, Patient's medical history, Concomitant and Treatment medications, Vaccine start date, Time and Batch number, Reporter's causality were updated.
About 25 minutes after administration, patient started to complain of itching all over, with redness and hives on forehead. Diphenhydramine was administered. The patient was monitored in the clinic for 10 minutes. The patient went home with their guardian.
INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a consumer concerned a 13 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced inappropriate age at vaccine administration, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age at vaccine administration and off label use was not reported. This report was non-serious.
Redness, swelling, soreness of vaccine site at (L) posterior upper arm 3" above elbow. Site was red, swollen after vaccine (1 day after) and recovered around Wednesday 6/14/16.
swelling in both feet and leg pain muscle. Pain meds Muscle cramps. Pain meds ,muscle relaxers.
Initial report received on 07 December 2009 from a health care professional. A 2-month-old male patient had received a first intramuscular right thigh injection of ACTHIB (lot number UF727AA, Sanofi Pasteur SA lot number D0586-1), and a first intramuscular left thigh injection of DAPTACEL (lot number C3157AA) on 15 October 2009. Hours post-vaccination (on the same day) the patient's chest turned red and his legs from his knees to his feet turned red as well. The right leg was swollen, and the patient was "extremely" fussy and cried for hours. No fever was reported. The patient had no concurrent illnesses at time of vaccination, and had no pre-existing medical conditions. He had previously received the Hepatitis B series with no adverse events. At the time of this report, the patient had recovered; however the recovery date was not provided.
This case was reported by a nurse and described the occurrence of fever in a 2 month old infant who received diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined. Medical history included gastroesophageal reflux disease. Concurrently the patient had gastroenteritis. On 1/21/05, the patient received the first dose of Pediarix (lot AC21A007AA). Approximately 36 hours later, on 1/22/05, following the administration of Pediarix, the patient experienced a fever greater than 103 degrees F. The patient was seen at a physician's office. On 1/22/05, a complete blood count showed increased white blood cells. The patient was hospitalized. Urine and blood cultures were negative. The fever resolved on 1/23/05. As of 3/21/05, the outcome of the increased white blood cells was unknown. The reporting health professional considered the events to be life-threatening. The reporting health professional also considered the fever to possibly be related to vaccination with Pediarix.
Day 2 (Saturday) following vaccination I became short of breath with pain in my chest and back. Was seen 4 days after vaccination (Monday, November 8th) and after subsequent testing, discovered a Pulmonary Embolism. Monday, November 8th I went into a walk-in clinic. Testing was done to include Covid-19, influenza, as well as blood work to include troponin and metabolic panel, x-ray and EKG completed. Troponin was elevated and was advised to be admitted to local hospital for further testing. Following admittance to hospital, further bloodwork drawn as well as troponin testing, which leveled out. D-dimer and C-reactive protein came back elevated. Ultrasound testing was done on legs and a CTA chest scan. CT showed multiple clots in lungs. Was put on a heparin drip until release the following day. Am currently on xarelto to help break up clots.  No clotting issues prior, no travel, no surgery, no immobility, no birth control used and no smoking.
At 3:30am, woke up and felt a lot of pressure on head, banging noise on right ear and hissing on the left.   Sat up and threw up vile, had dry heaves--no food came up. Patient was shivering from waist up.   Experienced another episode with similar symptoms around 7am.   Emesis continued until 8pm next night. If had 4-5 sips of a drink dry heaves would start. Episodes were scary; patient wanted to call an ambulance but could not get out of bed.  Patient laid in bed all day long.  On 9/28 went to doctor to get a note, to take the day off.  Ate only easy foods and Pedialyte. Provider in agreement to continue with rest and replacing fluids.  On same day went to pharmacist to let them know what happened.  On Sunday, recovered completely and went to work.  With previous vaccinations patient has been sore on the 2nd day but nothing out of norm.
Two large red, hot, achy, itchy areas where on RT arm where varicella and Menveo were given. Instructed to use ice or warm compress, Motrin, and Benadryl for itching.