chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a seven- months old patient who was vaccinated with only ACTHIB portion of PENTACEL (Single administration) (lot C5426AA for Dtap-IPV, expiry date: 04-Oct-2019, lot C5529AA (vial) lot C5529AA(carton)) (dose in series, route and site of administration was not reported) on 15-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included PREVNAR 13 for Immunisation; and ROTAVIRUS VACCINE for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique and product use issue since only the ACTHIB portion was administered but that was reconstituted with sterile water, did not receive all the components. It was not reported whether the patient experienced any adverse events. 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 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. Documents held by sender: none.
Covid symptoms started 01/02/2022 with sore throat, shortness of breath, cough, runny nose, and body aches. These symptoms are still ongoing. I tested positive for Covid on 01/04/2022.
The pt's developed cellulitis, swelling, redness and warmth to the left arm. The pt also had a fever of 101 for 24 hours. The right arm had redness, warmth at the injection site.
Pt recvd 3 dose of Engerix-B 10OCT90, 20NOV90 & 23APR91; 4JUN91 tested for Anti-HBS & found to be non-reactive; 11JUN91 recvd 4th dose; 5th Engerix-B dose given on 31JUL91; devel vertigo;
Developed chicken pox-like rash which lasted about 1 week, no fever noted and less than 50 pox noted.
Coughing began 1 week after 2nd VARIVAX administration. Coughing worse with swimming, temp 101-102, intercostal muscle retractions, pulse 150, resp 50. Seen at ER. See sheets. Dx bronchitis. Tx with oral steroids and ALBUTEROL nebulizer.
Rash on my body started to be observed about 28hrs post my 2nd dose of Pfizer COVID-19 vaccine. Rash first appeared in the neck area, then gradually migrated to face and lower back around 10pm. I woke up in the middle of the night feeling itchy in my legs and feet. Rashes on my body disappeared when I woke up today (02/05/2021), but my upper eye lids still felt itchy and swollen. Rashes on my upper eye lids faded in the afternoon on 02/05/2021.
Sick; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case is linked to case 2020SA291942 (same reporter)  This case involves a patient (unknown demographic) who was sick (illness), while patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) concomitant medication 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 were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (Unknown latency, non-serious event) after the administration of INFLUENZA VACCINE.  Only 20 percent chance it is the right shot for this flu.  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time or reporting, the event was recovered from sickness duration was 2 weeks.  There will be no information available on the lot number for this case.
This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 39-year-old female patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT .5 ml. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at the vaccination was not reported. The Clinic manager stated that the flu shot left her arm sore for one week. None of the immunizations led to hospitalization. This case has been linked to case US2017GSK183784 and US2017GSK183816, reported by same reporter for same event.
This spontaneous report was received from a registered nurse via company representative refers to a patient of unknown age. On an unknown date in OCT-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # J004387, expiry date 04-JAN-2015). On an unknown date in OCT-2013, the patient experienced swelling, pain and stiffness at the injection site after administration of PNEUMOVAX23. There was no treatment rendered for the events. There was no lab tests performed. The outcome of the reported events were unknown. The patients sought medical attention. This is one of the two reports received from the same reporter. Additional information has been requested.
Shortness of breath and Cough, Pain where the shot was given, Swelling and redness, Fever and headache, Nausea and diarrhea, stomach ache, Swelling of uper arm.
Serious pain in muscles and, particularly joints. Treated with Celebrex, aspirin, ibuprofen. At this time (03/02/2014) pain has subsided but still present.
pt recv vax & devel chest tightness & SOB that evening that persisted; returned to clinic 2 days later for eva; had bronchospasm; peak flow 200; treated w/Albuterol nebulizers & pred; sx resolved in 2 days
First dose: felt achy; First dose: little bit of chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 48 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: asthma; "covid-19", start date: Mar2020 (unspecified if ongoing); "Pneumonia" (unspecified if ongoing). Concomitant medication(s) included: INHALERIN. The following information was reported: PAIN (non-serious), outcome "unknown", described as "First dose: felt achy"; CHILLS (non-serious), outcome "unknown", described as "First dose: little bit of chills".  Additional information: The caller reports her son received both of his Covid 19 vaccines and he was sick with both doses. The second dose was really bad for him. She does not know if her son filed a safety report. The caller reports her son had the Covid 19 virus in Mar2020 before masks were mandatory and he was one of the first groups who contracted the Covid 19 virus before anyone knew anything about the virus. He works and he traveled. He contracted the Covid 19 virus there along with two coworkers. She reports her son is a Covid 19 "long hauler". She clarified that after he had the Covid 19 virus he's had continual relapses and problems after having the virus. He decided to get the Covid 19 vaccine because he had read that people who are Covid 19 "long haulers" are having success in eliminating their long term Covid 19 virus symptoms. She reports that her son was fine the day he received the Covid 19 vaccine. She reports he was excited to have received the vaccine. Her son's first Covid 19 vaccine she reports was mild. Her son felt achy and had a little bit of chills. She does not know the dates her son received his Covid 19 vaccines, or the NDC/Lot/Expiry for either dose. She reports he was not hospitalized when he had the Covid 19 virus. Her son was advised to stay out of the emergency room. She reports her son hasn't been for a thorough check up at the doctor's office at that time in Mar2020, her son did do video doctor's appointments and he was prescribed an antibiotic for pneumonia. When probing adverse events for other vaccinations, she reports he works and travels extensively and probably was getting all kinds of vaccines for his traveling. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not experience any adverse events prior to vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received her 2nd dose  Covid vaccine and approx one hour after the dose had slight throat edema and redness of her throat and chest. No lips/airway involvment. She had premedicated with zyrtec per her MD and received 25 mg PO Benadryl at 1500 in the tent. Her home epipens are at her side as well as her inhaler. Started to cough and have some throat itchiness approx 30 mins later. Escorted to ED.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 01-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 120 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
After cessation of flu like symptoms from vaccine (roughly 48 hours after vaccination), unilateral ulcerations of the genitalia (largest being roughly 2cm in diameter) that involved sloughing of grayish yellow exudate, like that of a lipschutz ulcer, began to form. This was accompanied by extreme pain upon urination. Topical corbetasol ointment was applied to the area 5 days after ulceration first started. This seemed to be successful in speeding up healing. The appearance of slight scarring has begun to form 12 days after signs first appeared.
DELTOID BECAME SWOLLEN WITHIN HOURS OF SHOT; SWELLING SUBSIDED IN APPROX. 24HOURS, BUT LEFT A FAINT (ITCHY) RASH AROUND THE INJECTION SITE. AFTER ANOTHER 24HOURS, SAME RASH SPREAD TO FACE. (CONTAINED TO LEFT CHEEK, SAME SIDE AS SHOT). ALL OF RASH SEEMED TO FADE AFTER ABOUT 48HOURS FROM ONSET.
Patient was admitted for a descending colon perforation and contiguous large abscess. Patient underwent drainage and improved and was eventually discharged
Patient developed redness and irritation at site of MMR injection. Patient was scratching at site of injection which then became superficially infected. Treated for impetigo on 7/21/14.
Puffy and itchy eyes about 15 min post injection - no temp - Epinephrine 0.1 ml given, BENADRYL Rx given 1 tsp q 8 hr PRN.
VR developed throat tightness, numbness in arms and legs instantly after receiving the injection. She notes that she has a hx of significant anxiety and believes this is all due to anxiety. Vital signs were all within normal limits. Symptoms were improved after a short period of time and the VR refused EMS services. She elected to drive home.
irregular menstrual cycle/2 hours after injection started menstruating. This was 7 days earlier than my cycle should have started; lower back pain; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Lot number: EW0153) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 15Apr2021, outcome "unknown", described as "irregular menstrual cycle/2 hours after injection started menstruating. This was 7 days earlier than my cycle should have started"; BACK PAIN (non-serious) with onset 15Apr2021, outcome "unknown", described as "lower back pain"; HEADACHE (non-serious) with onset 15Apr2021, outcome "unknown", described as "headache".  Additional Information: Event Narrative: I received the Pfizer vaccine first dose 15Apr2021, and 2 hours after injection started menstruating. This was 7 day earlier than my cycle should have started and I have very regular, predictable cycle. I am not on any birth control or medication. The main side effect was lower back pain and headache.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101640778 Same patient, same product in different dose, partial same event
redness, warmlh and a knot at the injection site; redness, warmlh and a knot at the injection site; redness, warmlh and a knot at the injection site; This spontaneous report was received from a medical assistant referring to a 53 years old female patient. The patient was allergic to levofloxacin (LEVAQUIN). The patient had no concomitant medication or pertinent medical history.  On 16-MAY-2019, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dosage detail, strength, lot # and expiration date were not reported) subcutaneously for prophylaxis and no reaction was expired for the first vaccination. On 17-OCT-2019, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # was reported as R026583, expiration date was reported as 17-DEC-2020, dosage detail and strength were not reported) subcutaneously for prophylaxis. On 18-OCT-2019 (reported as within 24 hours of the second vaccination), the patient experienced injection site reactions, had redness, warmth and a knot at the injection site. On 12-NOV-2019, the patient sought medical attention. There was no treatment or laboratory tests were performed for the events. It was reported that the therapy was continued. The outcome of the events was reported as not recovered. Causality assessment was not provided.  Lot number R026583 is not valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
Left arm became sore and swollen that evening with an area of redness about 3 inches in diameter. Red spots appeared on abdomen two days alter. Spots gone by 10/10/07.
Patient states that on 04/30/2021, she received her second Moderna covid-19 vaccine dose. Her first Moderna dose was completed on 04/01/2021. Patient states that 4 hours after the second dose, her left arm (site of injection) felt like "she got punched in the arm." She reports the soreness of the left arm has improved, but she states that the soreness is still present. Patient shares that the soreness is more like a burning sensation that comes and goes with and without movement. Use of Acetaminophen with mild relief.
Trigeminal neuralgia was triggered; some TN pain; Trigeminal neuralgia was triggered; face numbness on the left side (TN side) for 6 days; brain fog; nausea; This is a spontaneous report received from COVAES. A contactable consumer (patient) reported a non-pregnant 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: not reported and Expiration date: not reported) via an unspecified route of administration, administered on the left arm on 16Apr2021 at 16:45 (at the age of 44 years old) as dose 1, single for COVID-19 immunization. Patient's medical history included trigeminal neuralgia (TN) (left side of brain), unruptured brain aneurysm (right side of brain), anemia, and asthma. The patient was reported to have allergies to penicillin, contrast dye, latex, paprika, white wine, and vodka. Concomitant medications included carbamazepine, montelukast sodium (SINGULAR), fluticasone propionate (FLOVENT), fluticasone propionate (FLONASE) and GNC Vit (as reported). The patient previously took erythromycin for an unspecified indication and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since vaccination. On 17Apr2021, the patient stated that her TN was triggered and experienced face numbness on the left side (TN side) for 6 days, brain fog, some TN pain, and nausea. The patient did not receive treatment for the reported events. The events resulted to a visit to the doctor's office. The events were assessed as non-serious, did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient recovered from face numbness on the left side (TN side) was on 23Apr2021 while the outcome of the other events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe Pain; Headache; Fever; Chills; Blurred vision; Tingling in hands and feet; Shortness of breath; Fatigue; Sweating; Uncomfortable sleeping on left arm; Lack of appetite; Couldn't eat, couldn't drink; Couldn't eat, couldn't drink; Felt like there was inflammation in her stomach; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 39-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8435 and expiration date was not reported), via an unspecified route of administration in left arm on 28Apr2021 at 19:00 as a single dose for COVID-19 immunisation. Medical history included autoimmune disorder (reported as 2 years ago she had an ultrasound and was told she had a minor autoimmune). The concomitant medications included unspecified birth control pills and multivitamins. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8131), via an unspecified route of administration in right arm on 07Apr2021 as a single dose for COVID-19 immunisation and experience soreness at the injection site which lasted for about 2 days and she could not sleep on that side of her body. No additional vaccines administered on same date of the Pfizer vaccine. No prior vaccination (within 4 weeks). On 29Apr2021, the patient experienced severe pain, headache, fever, chills, blurred vision, tingling in hands and feet, shortness of breath, fatigue, sweating, uncomfortable sleeping on left arm, lack of appetite, couldn't eat, couldn't drink, felt like there was inflammation in her stomach. The consumer stated that "the symptoms started about 12 hours later of vaccination. She had severe pain, headache, fever, chills, blurred vision, tingling in her hands and feet, shortness of breath, lack of appetite, couldn't eat, couldn't drink, inflammation in her stomach, fatigue, and sweating. Stated most of the symptoms lasted about 5 hours. She did not go to the emergency room/ physician office; she had people around her keeping an eye on her. She took Naproxen, Ibuprofen, Aspirin, and Anti-histamines. She still had fatigue, feels uncomfortable sleeping on her left arm and sweating. The sweating was worse in the morning and kind of feels like when you have a flu or virus and wake up sweating." The patient underwent lab tests and procedures which included ultrasound: minor autoimmune on unspecified date (reported as 2 years ago). Therapeutic measures were taken as a result adverse events. Vaccination facility type: Warehouse event. The outcome of events fatigue, sweating and uncomfortable sleeping on left arm were not recovered whereas the outcome of all other events were recovered on 30Apr2021.  No follow-up attempts are needed. No further information is expected.
after his first shot he had a rash on his belly; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732, Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 03Apr2021 (at the age of 41 years old) between 12:00- 12:15 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. No vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. No Adverse events following prior vaccinations. No significant family medical history relevant to adverse event. No additional vaccines administered on same date of the Pfizer suspect. The patient experienced a rash on his belly after his first shot on 13Apr2021. Adverse event did not require a visit to Emergency Room/Physician Office. Patient went the following day. Therapeutic measure (patient used an Itch Cream) was taken as a result of the event. The outcome of the event was recovered on 21Apr2021.  No follow-up attempts are needed. No further information is expected.
Patient was to receive Hepatitis B booster instead was given HPV.  No adverse reaction noted.
received a dose of moderna after the BUD (beyond use date); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of Moderna after the BUD (beyond use date)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of moderna after the BUD (beyond use date)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose of moderna after the BUD (beyond use date)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.
One day after MENVEO vaccine, mother noticed, red, raised firm area at right deltoid. 2 days after area larger, still firm, hard, warm to touch, area 8 cm. Given Prednisolone 15mg/5ml. Take 10ml x2days.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL 9 (incorrect product storage) (lot # L038503, expiry date: 18-DEC-2017) (dosing regimen and frequency unknown) for prophylaxis. No concomitant medications were reported. No adverse effects were reported. The administered vaccine underwent a temperature excursion at 1.3 degrees (C) for a time frame of 12 minutes. Previous temperature excursions reported occurred on 06-JUL-2016 at a temperature of 2.2 C (low), 10.7 (high) for a time frame of 3 hours and 9 minutes and on 15-AUG-2016 at a temperature of 1.2 C for a time frame of 48 minutes. It was reported that the call was due to a data logger. No Product Quality Complaint (PQC) was involved. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative updated. Sender's Comments: MERCK 1611USA003118:Mfr number.