chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From initial information received on 24/Oct/2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 54-year-old female patient received a dose of TD ADS Adult, lot number U0826AA, expiration date 23/Sep/2004, administered in the right deltoid (route of administration not reported), on 21/Oct/2003. The following day, the patient developed jaw pain, achiness in arm and joints, and stiffness in the right deltoid where the vaccine was administered. The next day, the patient stayed home and took Motrin after which she felt better the following day.
Headache, Arthralgia, NauseaVomiting, fever, sleeplessness Narrative:   Other Relevant History:
Expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 20-year-old male patient who received HBV (Engerix B) (batch number 4F472, expiry date 6th November 2022) for prophylaxis.   On 4th December 2022, the patient received the 3rd dose of Engerix B. On 4th December 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's comment: The reporter stated that on 4th December 2022 a patient had been administered a dose of Engerix-B that had expired on 6th November 2022. Additional Supportive Information: The patient received expire dose of Engerix B which leads to expire vaccine used. The reporter gave consent to follow up.
covid arm; This spontaneous case was reported by a consumer and describes the occurrence of   in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Migraine. Concomitant products included SUMATRIPTAN (IMITREX [SUMATRIPTAN]) from an unknown date to 11-Mar-2021 for Migraine.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not reported.   This case was linked to MOD-2021-143721 (Patient Link).
Moments (~1 minute) after the vaccination, the patient described  his ears as filling with fluid and he became very dizzy. He and his mother went to the restroom where she helped him to the floor so he did not fall. He reports not remembering walking to the bathroom, and was woozy when I (the pharmacist) arrived to the restroom. His breathing was elevated, and he was pale in color. No emergency medication was administered . Paramedics arrived to check him out, and he left the store under his own power.   The vaccine-administering technician reported that he seemed very nervous to receive the vaccine today. When I was talking to him in the restroom he admitted that he has a history of anxiety/panic attacks when receiving vaccines in the past.
jittery and nervous unable to stop trembling, pounding in chest with extremely high heart rate 120 to 140.  Either extremely dry mouth or potentially some tongue swelling, stomach/ intestinal spasms/discomfort
pt recvd vax & exp small patch on chin which devel genl eruption that was itchy; also devel bluish patches in the skin; t102, seems to feel bad; taken to ER thought to be having an allergic type problem; rash improved by morning;
Arm pain with the previous 3 doses; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain with the previous 3 doses) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-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 PAIN IN EXTREMITY (Arm pain with the previous 3 doses). At the time of the report, PAIN IN EXTREMITY (Arm pain with the previous 3 doses) outcome was unknown.            No concomitant medications was reported. No treatment information was reported. It was reported that patient received 1st two doses were full dose.   This case was linked to MOD-2022-525546, MOD-2022-525609, MOD-2022-525616 (Patient Link).
Information has been received from a certified medical assistant (CMA) referring to an approximately 23 year old male patient. The information of concurrent conditions, medical history and concomitant medications was not provided. On 14-JUN-1993 and 29-SEP-1996, the patient was vaccinated with the first and the second doses of MMR II injection, 0.5 ml subcutaneously (therapy type: HSA, lot# and site unspecified), respectively. On an unknown date the patient failed to seroconvert to mumps. On 22-MAY-2015 the antibody titer test was drawn and result was the patient was non immune to mumps. The third dose of MMR II injection, 0.5 ml subcutaneously (therapy type: unknown, lot# and site unspecified) was administered on an unknown date in June 2015. The reporter questioned if they need to draw another titer after the third dose of MMR II was administered. No adverse effects were reported. At the time of the report, the patient still failed to seroconvert to mumps. Additional information is not expected as the reporter did not wish further contact.
woke up 9am next morning arm  was very sore to the touch but could move it and go about daily activities with minimal pain in movement. Redness the size of my palm around injection site. 24 hours after injection, multiple welts appeared approx. 3 finger lengths below injection site (no other welts or hives on my body just near injection site). Welts lasted another 24 hours and by Sunday evening had smoothed out and meshed together. Woke up Monday morning and site is a light pink and just sensitive to touch. Contacted my Dr. above information.
Headache; insomnia; This is a spontaneous report from a contactable Other HCP (patient). A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in right arm on 25Jan2021 at 05:00 PM as 2nd dose, single for COVID-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. Medical history and concomitant medication were not reported. Facility where the most recent COVID-19 vaccine administered was hospital. 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. On 26Jan2021 at 07:00 PM, patient experienced headache, insomnia. No treatment was received for the adverse events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.  Follow-up (15Apr2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
I?ve been having extreme hot flashes/sweats upon the slightest exertion ie; walk, after taking shower. I have to sit  for awhile until it subsides or in front of a fan.  I have been through menopause years ago so these are not from that. I have not sought a doctors advice as of now.  I am hoping this problem goes away.......
I found out I was pregnant in February 2022; Hydrops; I had togout of state to have the medically necessary termination procedure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26May2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 27 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Allergy: Morphine", notes: known llergies: Morphine. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 04May2021, when the patient was 27-year-old, for Covid-19 immunization. The following information was reported: OEDEMA (hospitalization, congenital anomaly, medically significant) with onset 01Feb2022, outcome "recovered with sequelae", described as "Hydrops"; MATERNAL EXPOSURE BEFORE PREGNANCY (hospitalization, congenital anomaly, medically significant) with onset 01Feb2022, outcome "recovered with sequelae", described as "I found out I was pregnant in February 2022"; ABORTION SPONTANEOUS (hospitalization, congenital anomaly, medically significant) with onset 01Feb2022, outcome "recovered with sequelae", described as "I had togout of state to have the medically necessary termination procedure". The patient was hospitalized for maternal exposure before pregnancy, oedema, abortion spontaneous (hospitalization duration: 1 day(s)). The events "i found out i was pregnant in february 2022", "hydrops" and "i had togout of state to have the medically necessary termination procedure" required physician office visit and emergency room visit. It was unknown if therapeutic measures were taken as a result of maternal exposure before pregnancy, oedema, abortion spontaneous.  Additional Information: Patient have given birth to two perfectly healthy girls in 2013 and in 2018 without any fertility issues. she found out she was pregnant in Feb2022. When she arrived to her first prenatal appointment in Mar2022 it was determined that she suffered from Hydrops which before was very uncommon but there have been several documented cases of this happening to women who were at fertility age and had received the covid vaccine prior to their pregnancy. After weeks of traveling all over the state seeing specialists, she was told that it was not a viable pregnancy and my unborn daughter was in heart failure and it was recommended to her that she terminate the pregnancy and that the specialist had seen a rise in miscarriages in patients who received a vaccine. she had to go out of state to have the medically necessary termination procedure that her insurance wouldn't cover and she strongly believe it was from the vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After each shot, I had a headache, flu like symptoms, chills, I was tired. No desire to eat. I was having urinary bladder bleeding and pain. Like a urine infection, however it was negative. Headaches. My entire spine was in pain. Achiness all over. Sinus respiratory issues. I contacted my doctor and he tried to give an antibiotic for what he thought was a urine infection. There was no urine infection, just an infection. Now I am seeing a urology, but we do not know what it is yet.
Patients parents admitted to falsifying  child's age for registration, after administration of dose. Patient was 11 years of age and not eligible for a booster dose under guidelines.
I wake with flu like symptoms. I had a sore throat, chills, fever, and headache that lasted for about a day and a half.  Two days later, I had burning in my mouth that went to my throat. I was diagnosed with oral thrush. It took about 3 weeks to go away.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Elongated raised area on left arm at injection site. MD observed at scheduled visit after injection. Occurred 3 days after injection
Flushing, tingling of extremities, increased heart rate. Initial BP 135/79 (pulse 125). F/u BP 138/83 (pulse 106), 98% O2 sat.
Around 4am on 3/25, I was dry heaving. This last about 3 days. I also had soreness around the injection area and a headache
Raised are of erythema, induration and pain at injection site (deltoid region bilaterally).
"pt recv vax 8AUG97 & 11AUG97 pt reported having flu like sx over the weekend;large amount of swelling @ site & redness, very hot & h/a & just feeling not well;"
Patient has always had frequent but very mild nosebleeds if it's too cold or if sinus is acting up.  This morning patient woke up with heavy posterior and  nasal nose bleeding.  He has tried sitting up straight, cold pack on the nose bridge, pressure and it still bleeds.  Since this heavy nose bleeding started after the 2nd Covid vaccine, we wonder if it is related.
He fainted fell out of chair was pale, lasted for maybe a minute. Woke up when on floor. We elevated legs put coat under his head. He kept saying "how did I end up on the floor". I got Dr. and he checked his breathing and heart asked how he felt.
Next day following vaccine - lymph nodes in neck above clavicle swollen and soft tissue swollen.  The area below the clavicle- chest wall above left breast was swollen and tender. This has lasted going on a week and is starting to dissipate, but still there.  Day after #2 vaccine I also had fever 100.5 for 12 hours, chills and headache.   Brain fog for 2-3 days post vaccine
second dose was received more than one year after; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 394kF, expiry date 23rd September 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 13th October 2021, the patient received the 2nd dose of Shingrix. On 13th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter stated that the second dose was received more than one year after the initial vaccination, which led to drug dose administration interval too long. The adverse event filed as inappropriate schedule of vaccine. The reporter consented to follow up.
was sick; Initial information was received on 15-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient).  This case involves a patient (unknown demography) who was sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) 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 at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) non-serious (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported as was forced for 25 years at work and became sick every year. Patient did not take any vaccine for 4 years and had no sickness.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
experienced CORONA VIRUS; experienced CORONA VIRUS; This is a solicited report from a non-Pfizer-sponsored program received from a non-contactable consumer (patient) based on information received by Pfizer from Abbvie (manufacturer control number: 21K-163-3828742-00).  A 64-year-old male patient received the first dose (dose 1) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 08Mar2021 (Batch/Lot number was not reported) (at the age of 63-year-old) as single dose for COVID-19 immunization; adalimumab (HUMIRA), via subcutaneous from an unspecified date to an unspecified date, at daily, Citrate free for Moderate to severe rheumatoid arthritis. The patient medical history was not reported. The patient concomitant medications were not reported. On 20Mar2021, the patient experienced Corona virus. COVID-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 08Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. The action taken in response to the event for adalimumab was unknown. The outcome of the event was unknown.  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (20Apr2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, there is a reasonable possibility that events were related to suspect drug. The case will be reassessed if additional information becomes available.
patient has had severe shortness of breath since receiving the vaccine; This is a spontaneous report from a contactable physician. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via intramuscular route of administration in the left arm on 16Mar2021 at 12:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Mar2021 at 16:00, the patient had severe shortness of breath since receiving the vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as the result of event. On an unknown date, the patient underwent o2 sat and the result was normal. On an unknown date, the patient underwent CXR, CT scan, echocardiogram and the result were unspecified for all. On 24Mar2021, the patient underwent nasal swab (COVID-19 test) and the result was negative. The clinical outcome of the event patient had severe shortness of breath since receiving the vaccine was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
vaccine thawed inappropriately/ vial was shaken; He actually got full dose instead of a booster dose on 22Oct2021; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vaccine thawed inappropriately/ vial was shaken) and ACCIDENTAL OVERDOSE (He actually got full dose instead of a booster dose on 22Oct2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vaccine thawed inappropriately/ vial was shaken) and ACCIDENTAL OVERDOSE (He actually got full dose instead of a booster dose on 22Oct2021). On 22-Oct-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vaccine thawed inappropriately/ vial was shaken) and ACCIDENTAL OVERDOSE (He actually got full dose instead of a booster dose on 22Oct2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2021, SARS-CoV-2 antibody test: 10.22 (High) it shows that he is positive for antibodies..         Concomitant medications were not provided. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Significant Follow-up - Reporter updating for antibody test results. And that he received full dose instead of booster dose.
Patient felt lightheaded, Sat down to wait after vaccination in pharmacy. Patient went stiff, head fell back, hands and feet jerking.  I ran over to her and tried to get her to wake up.  She opened her eyes and was able to talk.  She was very groggy and was clammy to the touch.  We called 911 and paramedics came.  They took her to the ER to get checked out.
Diarrhea;  loose and watery stool 3 to 4 times daily for one week, with cramping
Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On multiple unspecified dates, the multiple unspecified patients were respectively vaccinated with improperly stored GARDASIL 9) lot # L024993, expiration date 17-OCT-2017), dose and route unspecified for prophylaxis. The vaccines were stored at 11.6 degree centigrade for 1 hour and 50 minutes. Data logger was involved in the case. There was previous temperature excursion at 9.3 degree centigrade for 50 minutes. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008047.
I'm feeling tingling in my arms and legs regularly.  Sometimes there is a sharper feeling like a bug bite.   It basically feels like bugs crawling on my skin every few minutes or sometimes like a flea bite, but there are no bugs and no bites.
AE: Syncope Tx: no medication given, monitored symptoms and checked vitals. Juice and water resolved the symptoms Outcome: Patient was discharged to POV/Home.
experience felt like the flu; Slight headache; low grade fever; chills; She reports a fever of 101°F; feeling achy all over; This is a spontaneous report from a contactable consumer or other non-Hcp. A 80-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation; Solution for injection, Lot Number: EL9263 Expiry date: Unknown) via an unspecified route of administration, administered in Deltoid Left on 25Jan2021 at 13:15 as dose 1, single for COVID-19 immunisation. The patient medical history included bronchitis from an unknown date and unknown if ongoing She reported a long time ago, she would get Bronchitis, but not for a long time now. The patient's concomitant medications were not reported. On 16Feb2021 at 00:15 the patient experienced a fever of 101°f, feeling achy all over, chills, on 18Feb2021 patient experienced low grade fever, experience felt like the flu, slight headache, The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 16Feb2021, body temperature was 99 Fahrenheit on 18Feb2021. The outcome of events pain, influenza like illness and chills was unknown, outcome of pyrexia was not recovered.  Patient's Medical History (including any illness at time of vaccination) Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: None. She reported a long time ago she would get Bronchitis, but not for a long time now.  No follow-up attempts are possible. No further information is expected.