chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic reaction; voice gone; throat swelled; itchy forearm; tiny white little fluid pin head spots; face swelled; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (voice gone), PHARYNGEAL SWELLING (throat swelled), PRURITUS (itchy forearm), URTICARIA (tiny white little fluid pin head spots) and SWELLING FACE (face swelled) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced APHONIA (voice gone), PHARYNGEAL SWELLING (throat swelled), PRURITUS (itchy forearm), URTICARIA (tiny white little fluid pin head spots), SWELLING FACE (face swelled) and NAUSEA (nauseous). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction). At the time of the report, APHONIA (voice gone), PHARYNGEAL SWELLING (throat swelled), PRURITUS (itchy forearm), URTICARIA (tiny white little fluid pin head spots), SWELLING FACE (face swelled) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient said she is prone to allergies and has tons of allergies from last 40yrs.She was treated with Prednisone 40mg for 5 days.
6/14/21 7:00 pm- Received vaccine 6/14/21 7:15 pm - Felt itchy spot on left thigh (thought it was a mosquito bite) 6/15/21 - Itchy spot on left thigh bigger, but skin not showing any sign of "bite" 6/15/21 - Present (8/5/21) - Itchy spot size increased in size from below left knee, up to left hip.  Left Thigh: numbness, tingling, burning muscle pain, painful tendons, skin feels severely sunburned, phantom "bugs crawling under skin",  severe pain wakes me up at night.
Initial information received on 31-May-2018 regarding an unsolicited valid non-serious case received from Pfizer PCS under other manufacturer reference number- 2018197329 on 31-May-2018 and transmitted to Sanofi. This case involves an unknown age patient who experienced allergy to tetanus vaccine, while he/she received vaccine Tetanus Toxoid. 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 Tetanus Toxoid produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. The patient developed a non-serious allergy to tetanus vaccine (allergy to vaccine) following the administration of Tetanus Toxoid. Final diagnosis was allergy to tetanus vaccine. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergy to tetanus vaccine.
after vax pt complained not being able to move her rt arm without pain, & arm, eyes & whole body felt like its burning up. knot at the inject site. tylenol given, did not help
Pt. was given high-dose flu-shot at approximately 3:15 PM 9/11/17. Pt. returned to pharmacy at approximately 3:30 PM complaining of bilateral tightness of jaw area radiating from tooth area. Described as feeling like pulling a muscle. No difficulty breathing, minor trouble swallowing and belching observed. Pt. was given 50 mg BENADRYL orally and observed. Pt. was observed by pharmacist until he stated he was feeling better. Customer was accompanied by wife who was instructed to notify EMS if symptoms return.
Unsure of onset of symptoms. States "sometime last week"; c/o aching, calves hurting, headache, and nausea.  Referred to PMD.
pt recvd vax & mom states @ 330PM 4AUG93 pt had t102 then 1AM 5AUG93 had t104.1 p/cooling down w/wet rags; no sz; pt t102.1 @ 7; taken to hosp had diarrhea;
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative through social media  concerned a 40 year old patient of unspecified, sex, race and ethnicity. 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, and batch number were not reported and expiry date: Unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The company was unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On an unspecified date, It was reported that "It had nothing to do with how much you care about others, you were aware that the vaccinated could still spread Covid and still contract it. Reporter also stated that patient got pretty sick with Covid and was in the ICU (Intensive Care Unit) right now on a ventilator. Patient was fully vaccinated (coded to suspected clinical vaccination failure, and suspected covid-19 infection)". The patient was hospitalized on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Life threatening and Hospitalization Caused / Prolonged). This report was associated with a product quality complaint 90000205504. This case, from the same reporter was linked to 20211212673 (multiple patient).; Sender's Comments: V0: 20211212261- covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20211212261- covid-19 vaccine ad26.cov2.s-suspected covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This case was reported by a consumer via call center representative and described the occurrence of rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash, runny nose, feeling unwell, mass and skin warm. On an unknown date, the outcome of the rash, runny nose, feeling unwell, mass and skin warm were unknown. The reporter considered the rash, runny nose, feeling unwell and mass to be related to SHINGRIX. It was unknown if the reporter considered the skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The events were told to this reporter by a pharmacist. The pharmacist told this reporter that several patients experienced a softball size rash that was warm to touch but not itchy with a lump underneath that lasted 2 weeks or so. Some patient's also experienced a running nose and just felt crummy. The reporter repeated the information that was provided by her pharmacist to her. She would not give her pharmacist name but said she would tell her to call GSK to report the events the pharmacist had observed.
This 4-year-old male received 4 doses of Haemophilus b conjugate vax. Subsequent to the 4th vax on 04/23/1993, the pt developed Haemophilus influenzae type b meningitis as evidenced by the CSF culture. Upon internal review, the pt's experience was considered "an other medical event." This was reported as a case of vax failure. The pt's outcome status was "yes. No further information is available.
Rash over entire body, Itchy, Headache, Nausea, tired, weak.
Dizziness within minutes of shot; burning sensation as injection site; Exhaustion lasting all day long, extremely foggy brain, blood circulation is poor; feet get red while sitting, hands getting red and prickly feeling.  Zingers to the stomach, only on the first day.  Zingers to the upper left chest area on 5-24-2021.  My joints have been sore since day of injection.
Pregnant patient received the 1st Moderna covid-19 vaccination; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st Moderna covid-19 vaccination) in a 35-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 039A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (complication of shoulder dystocia upon delivery and live, full-term birth.) and Pregnancy. Concurrent medical conditions included Drug allergy (Sulfa), Rash lupus-like (Lupus- NOS) since 01-Feb-2020, Drug allergy (Ceclor), Drug allergy (Bactrim) and Drug allergy (cephalosporins - rash). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and ASPIRIN [ACETYLSALICYLIC ACID] for Pregnancy, HYDROXYCHLOROQUINE for Rash lupus-like, VITAMIN D NOS for Vitamin D deficiency.   On 12-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 21-Nov-2020 and the estimated date of delivery was 24-Aug-2021. On 12-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st Moderna covid-19 vaccination). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy.  On 12-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st Moderna covid-19 vaccination) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Ultrasound foetal: normal (normal) 12 week US. On 03-Mar-2021, Ultrasound foetal: normal (normal) 20 Week Ultrasound.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The date of positive pregnancy test was 24-Dec-2020. The patient has an established prenatal care. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received contains non-significant information.
This spontaneous report as received from a 69 years old female consumer as part of a marketing research program. The patient's medical history included with chronic obstructive pulmonary disease (COPD) and interstitial cystitis. The patient's concurrent conditions included with history of bronchitis. On an unknown date of October 2014 the patient was vaccinated with PNEUMOVAX 23 dose 1, intramuscular (dosage, frequency, lot# not reported). No concomitant medications reported. The patient reported severe case of bronchitis verging on pneumonia several months after pneumo vaccine. She is unsure the (illegible) vaccine she received. She thought it was related to a strain of pneumococcal potentially post return from another country. At the time of the report the dose was already taken. On 15-JAN-2015, the event bronchitis and pneumonia were recovered with sequelae. The reporter considered bronchitis and pneumonia to be not related to PNEUMOVAX 23. Additional information has been requested.
The next day following the vaccination I experienced mild chest tightness and discomfort including shortness of breath on exertion such as walking.  The symptoms resolved in the evening and came back stronger the next day (day 2nd post-vaccine), same but stronger intermittent dull chest pain and "poking" pains around the heart area and between the shoulder blades. The shortness of breath and weakness, lack energy on exertion. All symptoms are still present on Monday (11/29/2021), a week post-vaccination.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6203), in left arm, on 23Mar2021 as dose 2, single (Lot number: ER8730), in left arm, on 07Oct2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 18Apr2022 at 16:30 as dose 4 (booster), single (Lot number: FJ6369) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; PRILOSEC [OMEPRAZOLE MAGNESIUM]. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were not taken as a result of vaccination failure, covid-19. Patient had no known allergies. Patient did not receive any treatment. The vaccine dates on the review screen are all one day earlier than entered on the data entry screen.
Pt. was vaccinated with Dtap on 11-10-14. 3 days after vaccination developed face swelling, lips and tongue - problem resolved.
On 6/2/09 / 6 days post vaccine noticed warm to touch /redness / swelling / itchy at around injection site on left arm.
3 min after second dose was given, Pt. became very dizzy, BP taken 78/40 HR 86 Pulse ox 100, Gave water and juice, BP after 5 min 80/40 HR 92 pulse ox 100, Pt. still feeling dizzy, legs elevated,  called first responds, Pt. taken to ER in wheelchair.
5x5cm indurated inflamed area on lt deltoid;pt recovered w/DPH
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 29-OCT-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 712 hours, with the recorded temperature of -1.66 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient says that she has had a sore shoulder for approximately 2 weeks so far since she received the vaccine. She says that she did not look while getting the vaccine, but that compared to other vaccines, it felt that it may have been given too high up. She said the pain has been constant (has not gone away and come back). The patient called 10/14/2018 and the pharmacist working at the time said she told her to take over-the-counter anti-inflammatory drugs and try to massage the area. Patient has not yet seen a doctor or other healthcare professional about this at the time of report.
Pt first known to have a fever 101 R @ MN & was given APAP; slept until 530AM 22OCT when dad heard pt kicking the bed & found pt seizing; t105.2 (R); pt had 2 more szs one in ambulance, one @ ER; hospitalized x 2 days; dc'd on Phenobarb;
sick; gonna die; Initial information regarding this unsolicited valid non-serious social media case reported by consumer (patient) and transmitted on 08-Dec-2020.  This case involves patient of unknown demographics who reported that he felt so sick (Illness) that he was gonna die (unevaluable event), while he/she received vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route on an unknown administration site.   On an unknown date, the patient who reported that he felt so sick (Illness) that he was gonna die (unevaluable event) after administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Within an hour I became very tired and had to sleep for hours. My arm turned red and developed hives and continued on my neck, chest, and other arm. It mostly did not go below my breast area . I went out 4 days later into the sun and developed sunburn with hives after 15 minutes. I had a base tan and was not expecting that.  A few days later I sunburned again and instead of just hives with the burn I also had burst little blood vessels under my skin. On day 3 I spiked a fever, had severe cramps for 2 days and then had diarrhea  for 2 days. My joints feel stiff and hurt. It's been 4 weeks and the hives are finally mostly gone but the stiffness/soreness are still here. The pharmacist would not give me the 2nd dose when I went today due to concerns and told me to report.
Diarrhea Fatigue for 24 hours post vaccination. Loose stools were for 3 days
10/15/09 Pt stated "4 hrs I got the flu shot I broke out in a rash on the L side of my body it then progressed to the rest of my body. I tried BENADRYL lotion but it didn't help my eyes got swollen and so did my face. I had to go to the ER in a.m."
100 degree fever. Very sore muscles. My lower back was so sore, I could not stand up straight for 3 days.
Complete loss of appetite. Body chills and aches. Headache and significant fever. Beginning six hours after shot administered and worsening over next six hours until I took 4 advils. Fever broken about 2 am.
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case is linked with 2018SA271076, 2018SA271075, 2018SA271077, 2018SA271072. This case involves an adult patient (age, gender not specified) who received the fluzone high-dose instead of the fluzone quadrivalent who are not 65 plus years of age, while he/she received vaccine FLUZONE HIGH DOSE and FLUZONE QUADRIVALENT. 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 INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE instead of QUADRIVALENT INFLUENZA VACCINE lot number not reported via unknown route. It was a case of actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and overdose. It was reported as 5 employees who received the fluzone high-dose instead of the fluzone quadrivalent who are not 65 plus years of age. The patient outcome is reported as Not Applicable for received the fluzone high-dose instead of the fluzone quadrivalent. 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 Directive 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.
Vaccination site indurated, erythematous 99.2 Temp. Body aches.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml injection, lot # L007495 with expiration date 24-JAN-2017 (route and dose were not reported). This specified lot number vaccine was exposed to temperature excursion. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) was 16, 31 and R, respectively. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
adult got a pediatric dose of the Moderna COVID-19 Vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (adult got a pediatric dose of the Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (adult got a pediatric dose of the Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (adult got a pediatric dose of the Moderna COVID-19 Vaccine) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (adult got a pediatric dose of the Moderna COVID-19 Vaccine).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to vaccine.  Reporter was enquiring if there were guidelines set in place if a patient received the wrong vaccine.  No treatment medication information was provided.   Reporter did not allow further contact
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was subcutaneously vaccinated with lot # (670385/0231AA), 0.65 ml ZOSTAVAX (expiration 16-MAY-2012) on 24- JUL-2012. No adverse effects reported. No treatment information was reported. It was unknown if the patient sought medical attention. Additional information has been requested.
7 days post injection developed injection site redness (delayed hypersensitivity/immune response). No redness for the first 7 days.