chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he was better; headache and dizziness; dizziness; chills; was in bed all day; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), BEDRIDDEN (was in bed all day), FEELING OF RELAXATION (he was better), HEADACHE (headache and dizziness) and DIZZINESS (dizziness) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Bone marrow disorder NOS. Concomitant products included OLANZAPINE for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced CHILLS (chills) and BEDRIDDEN (was in bed all day). On 09-Apr-2021, the patient experienced FEELING OF RELAXATION (he was better), HEADACHE (headache and dizziness) and DIZZINESS (dizziness). At the time of the report, CHILLS (chills), BEDRIDDEN (was in bed all day), FEELING OF RELAXATION (he was better), HEADACHE (headache and dizziness) and DIZZINESS (dizziness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for event include naproxen.
She had a sore arm a day or two after; She mentioned that it hurts every time she wakes up and gets out of bed.; terrific" joint pain on her shoulders and knees.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 01Nov2021 (Batch/Lot number: unknown) as dose 3 ( booster),single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 01), for Covid-19 immunization; Bnt162b2 (Dose 02), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She had a sore arm a day or two after"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "unknown", described as "terrific" joint pain on her shoulders and knees."; PAIN (non-serious), outcome "unknown", described as "She mentioned that it hurts every time she wakes up and gets out of bed.".  The lot number for bnt162b2 was not provided and will be requested during follow up.
In the  1-2 weeks after vaccination pt reports generalized weakness, polyuria, polydipsia, weight loss, vision changes. Presented to ED on 3/30/2021 and found to have DM2 with A1c of 12.4. Previously had well controlled DM2 on metformin 500mg. Most recent prior A1c was 7.0 on 11/12/2020
This child had a swollen, red molted area 1/2 around his left arm, warm, no streaks, resp and lungs Nml. Benadryl.
PAROTITIS SWELLING IN THE LEFT AURICULAR AREA APPROXIMATELY 5 WEEKS AFTER RECIEVING THE FLUMIST. SIBLING HAD SIMILAR EVENT IN 2008 AFTER RECIEVING 1ST FLUMIST
Had clots in his lungs / blood clots; Stroke; He received his first dose on 27Feb2021 and second dose on 26Apr2021; This is a spontaneous report from a contactable consumer(patient).  A 52-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Apr2021 at his 52-year-old (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. He previously received his first dose BNT162B2 for Covid-19 immunization on 27Feb2021 at his 52-year-old. The patient experienced stroke on 07May2021 with outcome of unknown , had clots in his lungs/blood clots on an unspecified date with outcome of unknown.  The clinical course was reported as follows: After her received his second dose of the Pfizer COVID-19 vaccine he ended up with a stroke. He had clots in his lungs and one broke off and gave him the stroke. He was just looking to see if there have any information about long term events occurring with blood clots, like is this a one time event or is there a potential for it to keep happening now that he had the vaccine in his system. He received his first dose on 27Feb2021 and second dose on 26Apr2021 and had stoke on 07May2021. He had a stroke after Pfizer shot, now coincidentally he had no other health issues. He did not know if it was related to vaccine COVID may not have been. He was healthy 52 year old male, no medicines no nothing headed with the stroke, they developed a blood clot in his lung ended up with the stroke.   Information about batch/ lot number has been requested.
RN removed vial of what was thought to be a new box of COVID bivalent vaccines, which was in fact COVID monovalent box in the "COVID Bivalent" bright yellow bin. COVID box was not labeled "Monovalent" as it has been in the past when received from pharmacy, which indicated to RN that it was the bivalent, as it was also placed in the bivalent bin. RN pulled up all 6 doses up, and put them in the appropriate area for MA distribution. All COVID doses were distributed to patients. RN was notified that the clinic needed more bivalent doses, and went to the fridge to grab a vial of COVID bivalent vaccine to pull for distribution. Once at her desk, RN noticed that the vial stated "COVID Vaccine", Not "COVID Bivalent". RN went back to verify that the box was also monovalent placed in the wrong bin. RN discussed with RN, RN that it might have been monovalent distributed, RN confirmed that the vial used this morning for vaccines was pulled from the monovalent box that was labeled without "monovalent" and put in the COVID Bivalent bin.  RN and RN went to nursing supervisor to report the incident. Supervisor was onsite who was the previous Nurse Supervisor. contacted IT in pharmacy to obtain a list of the patient's administered vaccines today. List retrieved. RN notified patients on 1/19 Per MD infectious disease head, 2 months until patients can receive bivalent dose.
This spontaneous report as received from a pharmacist via a company representative refers to an unspecified number of patients of unknown age. On an unknown date the unspecified number of patients were vaccinated with ZOSTAVAX (lot number, expiration date, dose, route and indication not reported). The pharmacist stated that "in general, we have seen swelling, redness, and a rash around the injection site after the administration of ZOSTAVAX in an unspecified number of patients." No patient specific information was reported. The outcome of the events was unknown. It was unspecified if the patient's had sought medical attention. Additional information has been requested.
An unknown knot occurred in my back. Not a cyst or hematoma. Dr did surgery today to remove it..stated it was some sort of inflammation.; An unknown knot occurred in my back. Not a cyst or hematoma. Dr did surgery today to remove it..stated it was some sort of inflammation.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 31Mar2021 09:00 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included Hypertrophic cardiomyopathy. Concomitant medication(s) included Metoprolol (METOPROLOL TARTRATE), Verapamil (VERAPAMIL), Atorvastatin (ATORVASTATIN). Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on 02Mar2021, administration site (arm right), lot number EN6202 for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced an unknown knot occurred in his back. Not a cyst or hematoma. Dr did surgery today to remove it stated it was some sort of inflammation. Sample sent to Pathology on 15Apr2021 01:00 with outcome of not recovered. The patient was hospitalized for the event for 1 day. Therapeutic measures were taken as a result of events includes attempted to drain in Er Then Neuro surgeon. The clinical outcome for events was not recovered.
No other adverse event occurred; First dose adminsitered intramuscularly on 10/15/2021. Second dose administered subcutaneously on 11/11/2021.; This spontaneous report as received from an other health professional refers to a patient of unknown age. The subject concurrent conditions, medical history, concomitant therapies were not reported.  On 15-OCT-2021, the patient was vaccinated with the first dose with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), intramuscular (IM), (Lot number: S036663, expiration number: 14-NOV-2021) for prophylaxis. (Experienced incorrect route of product administration). On 11-NOV-2021, the patient was vaccinated with the second dose with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), subcutaneously (SC), (Lot number: S036663, expiration number: 14-NOV-2021) for prophylaxis. It was reported that, no adverse event (AE) occurred. At the time of the report, the outcome of the event was not reported.  The causal relationship between the event and the suspect vaccine was not reported.
Shortness of breath/difficulty breathing; Rapid heart beat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Sep2021 17:15 (Lot number: FE3592) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DYSPNOEA (non-serious) with onset Sep2021, outcome "unknown", described as "Shortness of breath/difficulty breathing"; HEART RATE INCREASED (non-serious) with onset Sep2021, outcome "unknown", described as "Rapid heart beat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller states is it a common thing, her 15 year old daughter got her 1st dose on Monday and she is complaining of shortness of breath and now is complaining that it is difficult to breathe so she is not sure if it's a side effect from the vaccine. Caller is asking had anyone else experienced this. Caller states she looked up side effects and didn't see shortness of breath listed. Caller states she was having allergy like symptoms but the breathing is new. When queried caller states she does not need emergent care, she is eating right now and she is ok. Prescribing Healthcare Professional Info: Caller does not have information to provide, that even prior to Covid they did doctor on demand and don't have a specific provider. Caller states she got her 1st dose on 20Sep2021 and the shortness of breath started Tuesday in the afternoon. States she was sent home from school yesterday because she was having difficulty breathing in the mid afternoon. Caller states she thinks she is going through different periods of it, that she remembers when she, the caller, got Covid she had to do steam showers and she has been making her daughter do that and that helps, she can go a couple of hours and then go back and do it again. Caller states they were in the car and she started freaking out and she told her not to hyperventilate and create a serious issue for herself.  No follow-up attempts are possible. No further information is expected.
Injection site reaction (painful arm, red circle around site, large knot at injection site circle for 48 to 72 hrs.); couldn't roll over onto my arm.  Sharp stabbing pain in my right knee cap (arthritic knee). Painful joints throughout my body; even ankles.  Felt extremely tired for about 4 days.
G3 P1 mother, estimated gestational age of baby = 4 weeks. On day 4 post-vaccine (1/11/21) started with heavy bleeding and labs confirmed miscarriage.
On July 11th I felt a sharp pain at injection site off and on every day for the next 3 weeks. Starting July 25th my right shoulder aches and is sore around injection site and my arm feels slightly weaker.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 08-DEC-2015 the patient was vaccinated with dose of improperly stored (Oka/Merck) VARIVAX (lot # K006135 with expiration date: 29-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature excursion of 71 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. Additional information has been requested.
Patient admitted with covid-19 symptoms.  According to records, patient only received one dose of Moderna vaccine in March.  If patient received second dose it was not documented with the immunization registry. Patient ultimately had to be intubated during stay.  Patient was successfully extubated and discharged home from the hospital after a stint in inpatient rehab.
Patient presented to ED with complaint of left arm pain starting today (2 days post-vaccine). Axillary pain, lymph node palpable. Dx axillary lymphadenopathy. Patient received ketorolac 30mg IM x1 and discharged home from ED.
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE; COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and FLUOCINONIDE for an unknown indication. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 12-Dec-2020 and the estimated date of delivery was 18-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy. At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report was received from a medical assistant referring to 6 unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. From 03-SEP-2017 (also reported as "starting on or after 03-SEP-2017"), the patients were vaccinated with improperly stored doses of VARIVAX lot # M047662 with expiration date 02-DEC-2018, for prophylaxis (dose and route of administration were not reported). Concomitant therapies included STERILE DILUENT. No adverse effect was reported. It was stated that the temperature was between 15 and 46 Fahrenheit degrees with a time frame of 2 hours and 50 minutes. The call was made because a data logger. No previous temperature excursion was reported.
Pt complaints of chest tightness, difficulty breathing, and cough. No edema, patient was recommended to ER and went under their own power. Given Benadryl 50mg PO
GGT is off the charts,GGT is 460; triglycerides was also high, about 150; L-LDL was also a little high; This spontaneous case was reported by a consumer and describes the occurrence of GAMMA-GLUTAMYLTRANSFERASE INCREASED (GGT is off the charts,GGT is 460), BLOOD TRIGLYCERIDES INCREASED (triglycerides was also high, about 150) and LOW DENSITY LIPOPROTEIN INCREASED (L-LDL was also a little high) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAMMA-GLUTAMYLTRANSFERASE INCREASED (GGT is off the charts,GGT is 460), BLOOD TRIGLYCERIDES INCREASED (triglycerides was also high, about 150) and LOW DENSITY LIPOPROTEIN INCREASED (L-LDL was also a little high). At the time of the report, GAMMA-GLUTAMYLTRANSFERASE INCREASED (GGT is off the charts,GGT is 460), BLOOD TRIGLYCERIDES INCREASED (triglycerides was also high, about 150) and LOW DENSITY LIPOPROTEIN INCREASED (L-LDL was also a little high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood triglycerides: about 150 (High) about 150 (unspecified units). On an unknown date, Gamma-glutamyltransferase: 460 (High) 460 (unspecified units). On an unknown date, Low density lipoprotein: little high (High) little high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.
This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient of unknown gender. On 16-OCT-2013 at 09:30 the patient was administered with a MMR II (lot number H018184, expiry date 05-OCT-2014) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade. The patient experienced no adverse event. On the following date the MMR II was exposed approximately for 9.5 hours at temperature of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17:14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13:25 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13:56 to 16:08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7 degrees centigrade, on 18-OCT-2013 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
Patient with previous hx of seizure disorder started convulsing within 10 minutes of vaccination, fell to the ground and convulsed for approximately 7 minutes. Convulsions reduced significantly and patient was coherent without post-ictal state. EMS was called and she was taken to nearby hospital for further evaluation. Patient had reportedly taken ativan and depakote this morning prior to arrival.
BP:128/76 HR:80 02:98 headache and jittery. strong pulse, alert, does not like crowds and the vaccine.  EMS REFUSAL
Constipation - Information has been received from a consumer concerning her 2 year old daughter with multiple food allergies who on 23 Apr 2000 was vaccinated with varicella virus vaccine live.  The following day, the patient's mother indicated that her daughter was on a strict rotation diet.  So she always knew what her daughter eats and she not eat anything different.  but the day after vaccination, she was constipated.  Additional information has been requested.
Chest tightness half hour after shot , throat tightness and difficulty swallowing two hours , after shot itching in mouth and throat two hours after shot , I took some Ativan and lay down was ready to go to the ER win the symptoms started to get better
This spontaneous report as received from a medical assistant (M.A) refers to a male patient of unknown age. Concomitant medication, pertinent medical history, drug reactions and allergies were not reported. On 03-OCT-2014, the patient was vaccinated with PNEUMOVAX 23 0.5ml, intramuscular, lot # K007773 expiry date 01-MAY-2015, (dose was not reported), that had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Injection site still sore 1 month after 2nd shot. Rash still present around injection site. Numbness from left forearm to hand gradually increased over days & weeks & is now completely numb & patient struggles to use hand & grip/pick up things. Hasn't seen MD yet since he's concerned about cost. Said this never happened before.
No Adverse reaction. It was noted when patient arrived for his 2nd dose that he was under 18. 2nd dose was NOT given.
Patient received the pediatric Pfizer shot and after administration, he said his legs were wobbly.  We told him to have a seat and observed him and he was able to walk after being seated for over 20 minutes. His mother said he was doing better, and they left the store. I called to see how he was today 12/8/21 and his mother said his upper thighs felt tight and "heavy."   She told me she notified his doctor .
This spontaneous report as received from a Licensed Practical Nurse refers to patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (dose, frequency and route not reported). The Lot number ZOSTAVAX was reported as L03218, expiry 30-APR-2016 and L012478, 10-JUL-2016. No adverse event was reported at the time of this report. This case is one of the several reports from the same reporter. Additional information has been requested.
STARTED FEELING COLD/CHILLS AROUND 24 HOURS AFTER INJECTION.  INCREASINGLY FATIGUED THROUGHOUT THE DAY AND NIGHT.  WENT TO BED AROUND 2 PM AND SLEPT INTERMITTENTLY WITH CHILLS THROUGHOUT THE NIGHT.  TEMPERATURE OF 99.9 AROUND 8 PM.   WOKE UP AROUND 6 AM THE FOLLOWING DAY (SUNDAY) FEELING SOMEWHAT BETTER.  NOT SO COLD BUT STILL VERY FATIGUED.  FELT INCREASINGLY BETTER DURING THE DAY.   ALL SYMPTOMS GONE BY THE TIME I WOKE UP ON MONDAY
No adverse symptoms reported; the patient was vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.      On 24-OCT-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S002738, expiration date 28-JAN-2021, dosage detail, strength and route were not provided) for prophylaxis. Administered doses of vaccine experienced temperature excursion of 6 degrees Fahrenheit (F) to 14 F (-14 degrees Celsius to -10 degrees Celsius) for 10 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse symptoms were reported.
Patient received DtaP instead of TdaP, no additional vaccine will need to be given per CDC
Pfizer Covid Vaccine given in left deltoid IM. Starting at 9pm on 10/2/21 (the day of vaccination) patient experienced arm redness, swelling, and hot to touch at injection site. On 10/13/21 patient came into pharmacy to show arm to pharmacist. Injection site still looks dry and discolored. Patient is concerned about possible scarring.