chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; an improperly stored dose of VARIVAX was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender patient whose medical history, concurrent conditions, and previous adverse drug reaction/allergies were not provided.  On 01-AUG-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, used as directed to prevent varicella infection (lot number: W002596, with an expiration date: 24-JAN-2024, was verified to be a valid lot number; strength, dose, frequency, route of administration and anatomical injection site were not provided) (product storage error).  No additional adverse events (AE) were reported.
Swollen lymph node on the arm pit, size of a golf ball. Pain on palpation.
soreness on injection site; Rash (Injection Site); nodule on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness on injection site), VACCINATION SITE RASH (Rash (Injection Site)) and VACCINATION SITE NODULE (nodule on injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for an unknown indication.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness on injection site), VACCINATION SITE RASH (Rash (Injection Site)) and VACCINATION SITE NODULE (nodule on injection site). At the time of the report, VACCINATION SITE PAIN (soreness on injection site), VACCINATION SITE RASH (Rash (Injection Site)) and VACCINATION SITE NODULE (nodule on injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
stuttering; dizziness; joint pain; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPHEMIA (stuttering), DIZZINESS (dizziness), ARTHRALGIA (joint pain) and PYREXIA (fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced DYSPHEMIA (stuttering), DIZZINESS (dizziness), ARTHRALGIA (joint pain) and PYREXIA (fever). At the time of the report, DYSPHEMIA (stuttering), DIZZINESS (dizziness), ARTHRALGIA (joint pain) and PYREXIA (fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Moderna 1dose and 2nd dose previously and on 27dec2021 he received the booster shot. The patient had some side effects now that include stuttering, joint pain, dizziness, fever. The patient did not have the lot number of the vaccine. He had not contacted his doctor. No concomitant medications were reported. No treatment details were reported.
approx 24hr p/vax pt devel gen body aches/pain;3OCT had t100.8 in AM;had chilling throughout that day which eventually went into sweating;condition improved 5OCT;had local rxn in arm of discomfort, redness & swelling;(no med tx necessary);
About 2 weeks after first vaccine symptoms of lung dysfunction and possible infection developed nightly fever; after 2nd vaccine high fever developed within hours, lethargy, body aches and headache.  All of these symptoms subsided by 5/13/2021and left joint pain and inflammation in it's wake.
1/10/22 pt presents to ED from a fall after being dizziness; mild displaced left greater trochanter; (pt recently hospitalized from 12/7/21 - 12/15/21 for SOB); pt has a cough; found to be positive for COVID; O2 supplementation; ABX; Vitamins C, D, and zinc; remdesivir and dexamethasone; pt's condition worsened and he passed away in the hospital
I get a lot of migraines and tension headaches. So, between 10/21/2022 and 10/26/2022, I experienced some headaches that I didn't think much of. However, on 10/26/2022, I woke up with a headache that felt different than my typical headaches and that continued through the day. I tried treating it with ADVIL and TYLENOL which usually takes care of my headaches, but it did not work. It felt more like muscle or nerve pain and as it progressed it felt more like nerve pain coming from my neck and up over my head. This continued on until 11/03/2022, when it began to feel like it was coming from the base of my skull, over the top of my head, and into my eye socket. That nerve pass was causing me an intense amount of pain. I've experienced shingles on my head before and it felt very similar to that pain. However, I don't have a rash. I spoke with my mother, who was previously in the health care field about the possibility of internal shingles. I ultimately ended up going to the doctor and explained all of my pain issues but did not mention my recent vaccine, nor did they ask. It wasn't until I spoke with a friend about my experience, that I made a connection to my vaccine. I then did a bit of research and found that shingles has been reported in others post vaccine. My doctor is not treating me for shingles. They did prescribe TYLENOL with codeine, prednisone, gabapentin, and a muscle relaxer. The only thing they would have done differently, had I come within the first seven days would have been to prescribe an antiviral as well. I did message my doctor about the connection I made between my vaccine and the possibility of shingles, just to inform them of my discovery of the possible connection. I am supposed to contact my doctor again if the pain has not gone away in a few days. The pain is subsiding.
Itching; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and SWELLING (Swelling) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PRURITUS (Itching) and SWELLING (Swelling). At the time of the report, PRURITUS (Itching) and SWELLING (Swelling) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information provided.
Pain at time of injection, rash on arm, swelling of arm causing whole arm to hurt including down to fingers, bruising, nausea, fever (100), joint aches.
Left deltoid; injection site red. Swelling, sore and warm to touch. No treatment.
she was in so much pain; Arm was sore, not the rest of her body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore, not the rest of her body) and PAIN (she was in so much pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore, not the rest of her body). On an unknown date, the patient experienced PAIN (she was in so much pain). On 05-Mar-2021, PAIN IN EXTREMITY (Arm was sore, not the rest of her body) had resolved. At the time of the report, PAIN (she was in so much pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-062625 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Aug-2021: Follow up received and it does not contain any new information.
Fever up to 102.4, headache, chills, fatigue, weakness, and muscle aches lasting 24 hours. Took ibuprofen to reduce fever.
Redness around injection site, two other red plaque near injection site (about 1 inch thick in diameter) appeared the following day. Reported no itching or shortness of breath, this occur on arm where PNEUMOVAX was given.
ADM: 11/29  Discharge: 12/1/07.  12/28/07 Reviewed hospital medical records which reveal patient experienced irritability, pale, limpness & cyanosis of lips & face on 11/29/07 followed by vomiting & sleepiness.  Admitted 11/30-12/1/2007.   Had 1 additional episode in hospital along w/low grade fever.  Neuro consult done.  Started on antiseizure med. FINAL DX: new onset seizures & fever, likely related to vaccine.
Severe pain in left arm (2 - weeks) nausea for two days and general aches & pains in body for two weeks. I was feeling great before the injection. (Horrible side effects).
Menstrual irregularities. Spotting  with heavier cycles. Spotting for weeks at a time.
Lichenoid Tissue Reaction (rash) covering every part of my body, lasting months. From the time it started, despite using prescribed topical steroids, it has not fully gone away. The rash first started in the armpits then erupted all over the body. I went to the dermatologist and also my PCP. I had a biopsy taken and the rash was attributed to an immune response to the (Pfizer) vaccine. Months later, the rash still appears sporadically on different parts of the body and chronically in the armpits, where it started. Antihistamines don't work effectively. I don't know how to get rid of this!
Nearly a week after injection, injection site is still visibly swollen, slightly warm to touch.  Blood clot passed vaginally (outside of normal menstruation schedule).
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 30-DEC-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M021731 with expiration date 29-OCT-2017 (dose and route of administration were not reported). The reason of the call was temperature alarm received via a Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 degrees Celsius for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
Neck stiffness, very bad headache, significant muscle aches, shaking, teeth chattering and clenching, fever.
I had pain in my lower left side. I thought it was a kidney infection. Lab tests indicated no kidney infection. Was sent for a CT Scan on 8/17, which found a large cyst on my left ovary. The OBGYN wanted an ultrasound, which was performed approximately 8/24. The ultrasound showed a septated ovarian cyst and fluid sacs in my uterus. She ordered a CA-125 blood test. The CA-125 blood test came back as 236 (normal is under 38). So, I was referred to a Gynecologist. I had my left ovary, both fallopian tubes, uterus and cervix removed. Tests came back and all was found to be benign.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUN-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N002336 with expiry date 19-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Adult dose inadvertently administered to a pediatric patient; Adult dose given to 13 years old; Extra Havrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 13-year-old female patient who received HAV (Havrix adult) (batch number 55M72, expiry date 13-DEC-2024) for prophylaxis.   Previously administered products included Hepatitis A (the schedule completed in November 2011).   On 18-APR-2023, the patient received Havrix adult. On 18-APR-2023, an unknown time after receiving Havrix adult, the patient experienced accidental overdose (Verbatim: Adult dose inadvertently administered to a pediatric patient), adult product administered to child (Verbatim: Adult dose given to 13 years old) and extra dose administered (Verbatim: Extra Havrix administered). The outcome of the accidental overdose, adult product administered to child and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 18-APR-2023 The nurse called to report an adult dose of Havrix was inadvertently administered to a pediatric patient. The reporter stated that an extra dose of Havrix was administered to a patient with an already complete schedule for Hepatitis A. The dose given was an adult dose reported. The patient completed the Hepatitis A schedule in November 2011, no specific vaccine reported. The reporter did not consent to follow-up. This case was identified as duplicate of US2023056791. Case US2023056791 was deleted and all the future correspondence will be added in the present case US2023056790 which stands as a case of record for this subject.
Moderate to severe localized pain in area of injection, bruising, swelling, redness. Inability to raise arm or use arm to lift normal household items (e.g., hairdryer).
This spontaneous report was received from a medical assistant concerning a 21 year old male patient with no pertinent medical history or drug/reaction allergies. The patient was vaccinated with lot # (H013831, expiration date 06-MAR-2015) dose 1, 0.5 ml GARDASIL (lot number H013831, expiration date not provided) on 07-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that on 08-JAN-2012, the patient developed lower lip swelling. No laboratory tests were performed. He was given unspecified antihistamines and on 08-JAN-2013, the swelling resolved. The relatedness for lower lip swelling was unknown for GARDASIL. Additional information has been requested.
Developed a cough; Terrible headache; fever of 100F; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Developed a cough), HEADACHE (Terrible headache) and PYREXIA (fever of 100F) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CARBAMAZEPINE (TEGRETOL), FENOFIBRATE, FUROSEMIDE, POTASSIUM CHLORIDE (LASIX + K), LISINOPRIL DIHYDRATE (PRINIVIL) and AMLODIPINE BESILATE (NORVASC) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (Terrible headache) and PYREXIA (fever of 100F). On an unknown date, the patient experienced COUGH (Developed a cough). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN ASPIRIN FREE) at an unspecified dose and frequency. At the time of the report, COUGH (Developed a cough), HEADACHE (Terrible headache) and PYREXIA (fever of 100F) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a 26 year old female patient with heart condition and allergic to an unspecified medication who on 28-JUL-2010 was vaccinated with a first dose of GARDASIL (Lot# unknown). Concomitant therapy included lithium and SEASONIQUE. The patient reported that she had the first dose of GARDASIL and on 10-AUG-2010, she had severe hair loss (patchy baldness all over her head). She additionally mentioned that she experienced a loss of around 60% of her hair and had bald spots on the sides and top of her head. She mentioned she was due for her second dose of GARDASIL today on 13-SEP-2010 but she did not take it because she was afraid that she was going to lose more hair. The consumer mentioned she got medical attention and saw a different doctor at every visit. The patient stated that her hair was beginning to grow back in the spots where it was lost. There were no laboratory test or diagnostic studies performed. The patient sought medical attention by a doctor visit (also reported as no). Additional information has been requested.
RASH ON LEFT ARM, FEVER, CHILLS, BODY ACHES, NAUSEA, DIFFICULTY BREATHING, PAIN IN CHEST WHEN BREATHING
On the day of the injection, I had pain in the arm to touch, mild redness and swelling which went away after a few days. On day 7 post injection, I noticed redness, swelling, increased warmth and mild itching at the injection site again.
Headache, fatigue, tingling on left side of face and lip, runny eye on left side.  Developed into 3 large cold sores on left upper lip.
pt recv vax in 1994 or early 1995;In MAY or JUN95 pt devel polyarthritis nodosa which was dx in SEP or OCT95 by a muscle biopsy;pt also exhibited fevers & weight loss;
breakthrough case of varicella (>100 pox) 2yr 5months p/vax;
i had regular symptoms the day of and after my vaccine. Headaches, body ache, tired, sore arm, slight difficulty breathing, and slightly faster heart rate. Those didn't really concern me since i took it as the vaccine is working like it?s supposed to. but starting yesterday when i woke up until this moment i?ve had a really weird pinching feeling by my heart and the side of my rib cage on the left side of my chest. that?s the only thing scaring me now since my other side effects have already gone away.
Fever; Rash; Numbness; Tingling; Nerve pain; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), dose 2 via an unspecified route of administration on 13May2021 (at the age of 21-years-old) (Lot Number: EW0170) as 2nd dose, single dose for covid-19 immunization.  Medical history included asthma. Concomitant medication included salbutamol (ALBUTEROL) taken for asthma. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number: ER8735) on 21Apr2021 for COVID-19 immunization. On 13May2021, the patient experienced rash, fever, nerve pain, numbness, and tingling. No treatment was received for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Pt had a vasovagal reaction to his first dose of Pfizer covid vaccination. I had administered the dose and patient was waiting in the waiting area. I checked in on him a few minutes later and he stated he was sweating and "just didn't feel too good". He also stated he was having blurred/"seeing spots" vision. I had my tech come with me. I had the patient elevate his legs on another chair, applied a cold pack to his forehead and advised him to close his eyes. The patient's brother went to get his mom at this time. When his mom arrived patient started to feel better, I continued to hold the icepack and asked him to tell me when he felt he no longer needed it. After a few minutes he no longer needed the cold back and was feeling better. I had my technician watch the patient for another 15 minutes and patient's family was advised to  help patient up and to walk with him to the car. I will be checking in on patient a little later today.
My Brother has been vomiting since 2/16/21 He is in Hospital since2/20/21 He is on IVs and antiemetic medicine but still vomiting
began experiencing chills, fatigue, swollen lymphnodes; began experiencing chills, fatigue, swollen lymphnodes; began experiencing chills, fatigue, swollen lymphnodes; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer reported that:   A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 17Jun2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 23Jun2021, the patient experienced chills, fatigue and swollen lymphnodes. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Inadvertent administration error. Tdap was administered instead of DTap. Contacted the manufacturer medical scientist who confirmed no immediate danger to the patient, verified administered Tdap is considered valid, verified subsequent vaccination in sequence should be DTap. Spoke to parent 3/15/23 to notify her; patient doing well. Spoke to parent 3/16/23, patient is doing well.
Information has been received from a pharmacist concerning a patient (age and sex not reported) who in the 1980's was vaccinated with Pneumovax 23. Sometime in the 1980's, the patient experienced an allergic reaction (details not provided) to Pneumovax 23. The outcome of the events was not reported. No further information is available.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 09Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Tree nuts" (unspecified if ongoing), notes: known allergies: Tree nuts; "Interchange of vaccine products" (unspecified if ongoing), notes: Dose 3: Pfizer / BioNTech/Dose 2: Moderna/Dose 1: Moderna. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Anti-viral details: product=COVID 19 Treatment, Treatment start date-02Jun2022, Treatment stop date-07Jun2022, Indication-Treatment of COVID-19. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Reported Event: Rebound Covid. Adverse events start date: 12Jun2022. If patient recovered was not recovered. If treatment ae was no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.