chrisvoncsefalvay/vaers-outcomes huggingface dataset:
aches and pains in her upper arms and upper legs; injection site pain in the left arm; headaches; fever; Nausea; Vomiting; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (aches and pains in her upper arms and upper legs), VACCINATION SITE PAIN (injection site pain in the left arm), HEADACHE (headaches), PYREXIA (fever) and NAUSEA (Nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (aches and pains in her upper arms and upper legs), VACCINATION SITE PAIN (injection site pain in the left arm), HEADACHE (headaches), PYREXIA (fever), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Vomiting, at an unspecified dose and frequency; PROMETHAZINE HYDROCHLORIDE (PHENERGAN [PROMETHAZINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (aches and pains in her upper arms and upper legs), VACCINATION SITE PAIN (injection site pain in the left arm), HEADACHE (headaches), PYREXIA (fever), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided
Information has been received from a female consumer via a vendor refers to a female patient of unknown age enrolled in a market research. Concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with GARDASIL (dose, route, lot# and expiration date were not reported). Concomitant drug was not reported. Within a few months on an unknown date, the patient began to have muscular problem and she was not able to be the athlete she once was. The causality and outcome of the event were unknown. Additional information is not expected as there was no consent for follow up.
patients received 1st dose Pfizer on the 09/25/2021 at a difference pharmacy.  Patient requested a J&J vaccine at 10/02/2021 and administered  at 4:30pm. Patient did not show us the previous vaccine card or let us know they received a Pfizer vaccine prior to visit. Patient was called right after discovery on 10/02 at 4:45pm and will inform them of any further information of the event.
Pfizer Bivalent vaccine was administered per patient request. Upon finding vaccination card, it states that patient has already received Pfizer Bivalent booster on 10/15/22 at store pharmacy. Patient states he did not received covid booster and only flu shot. However, daughter states that he did get covid booster at store pharmacy. Pt. observed for 15 minutes with no adverse reactions.
redness, pain,  and warmth to left arm with tmax of 102.7 on 5-15
Persistent pain in left deltoid following vaccine very limited range of movement with abduction, pain, burning, weakness, deltoid tightness that at times radiates in muscle to elbow. Symptoms remain from administration to date.
Symtoms occurred on day Day 5 after being immunized. The left arm at injection site presented reddness, swelling and itching. Patient self treatment was Tylenol Tablets and topical application of Cortisone cream.
CAN'T WORK ANYMORE; JOINTS GET LOCKED INCLUDING THE ANKLE, KNEE, ARM, 2 FINGERS, ELBOW, SHOULDER; CAN'T LIFT HER ARM ABOVE HER HEAD; ARM WAS VERY HEAVY; ARM WAS VERY PAINFUL; NO STRENGTH IN THE ARM ANYMORE; LEFT ENTIRE ARM GOT SWOLLEN; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 10-AUG-2021 for covid-19 prophylaxis. Age at time of vaccination 55 years old. No concomitant medications were reported. On NOV-2021, the patient experienced left entire arm got swollen, joints get locked including the ankle, knee, arm, 2 fingers, elbow, shoulder, can't lift her arm above her head, arm was very heavy, arm was very painful, and no strength in the arm anymore. On an unspecified date, the patient experienced can't work anymore. Laboratory data (dates unspecified) included: Diagnostic ultrasound not reported (helped with diagnosis) ; and X-ray Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left entire arm got swollen, can't lift her arm above her head, arm was very heavy, arm was very painful, no strength in the arm anymore, joints get locked including the ankle, knee, arm, 2 fingers, elbow, shoulder and can't work anymore was not reported. This report was non-serious. This case, from the same reporter is linked to 20220915954.
Information has been received from a physician concerning a 15 year old female who on 03-JUN-2008 was vaccinated with a first 0.5 ml dose of GARDASIL vaccine (yeast) (lot number 659180/1758U) (injection site and route not reported). On the same day of vaccination the patient became pale, weak and vomited when she went to her car from the office. She did not faint or become dizzy. The patient was seen in the office. Subsequently, the patient recovered from the events. Additional information has been requested.
Patient presented with raised rash, red itchy area on left arm midway down upper arm. Complained of dry sinuses as well and said his reaction was immediate.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not reported. On 30-AUG-2016, the patient was vaccinated with improperly stored PROQUAD, rHA, lot # M019232, expiry date 17-OCT-2017, 0.5 ml. Vaccine was exposed to a maximum of 9F and a minimum of 6.8F for a cumulative time frame out of recommended storage range for 23 hours. Data logger in use yes. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
This patient had received her 1st dose of Moderna, and this second dose, that I administered was Pfizer and not Moderna. Pt. was observed for 30 minutes. Pt. denied any signs or symptoms of allergic reaction. This RN did not observe her with shortness of breath, dizziness, or facial swelling/body rash.
No additional AE reported; Patient was administered expired VAQTA; This spontaneous report has been received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 03-MAY-2022, the patient was administered an expired hepatitis A vaccine, inactivated (VAQTA) as prophylaxis (lot number U004367, which was determined to be valid for syringe formulation, with an expiration date of 11-APR-2022) (dose, dose number, vaccination scheme, route and anatomical location of administration were not reported) (expired product administered). No additional adverse event was reported.
Information has been received from a physician through the pregnancy registry concerning a 20 year old female who on -18-JAN-2005 was vaccinated with a dose of Varivax (lot # 646665/0712N). Subsequently the patient has since tested positive for pregnancy, her LMP was 07-DEC-2004. No symptoms were noted. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information from the physician indicated that the patient was tested for varicella antibodies on 04-JAN-2005 before vaccination and the result was negative. It was reported that the patient did not experience varicella or herpes zoster symptoms post vaccination. On 20-JUN-2005 the patient gave birth to a male infant who was born 27 6/7 weeks from LMP was considered an other important medical event. Additional information has been requested.
Information has been received from a physician concerning a 10 year old female who in June 2001 was vaccinated with varicella vaccine. Subsequently, the pt developed greater than 100 lesions over the entire body. There was no further info about the pt provided. It was reported that the vaccinated pt was playing with her 3 year old niece, who was a normal "healthy" child at each others' homes and five days later the child developed 20-30 vesicular lesions through a possible secondary transmission. It was noted that to the physician's knowledge, there was not a current outbreak of varicella in the community. Additional info has been requested.
stiffness in hands; tightness in hands; toes curling under; headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness in hands), MUSCULOSKELETAL STIFFNESS (tightness in hands), FOOT DEFORMITY (toes curling under) and HEADACHE (headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness in hands), MUSCULOSKELETAL STIFFNESS (tightness in hands), FOOT DEFORMITY (toes curling under) and HEADACHE (headache). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness in hands), MUSCULOSKELETAL STIFFNESS (tightness in hands), FOOT DEFORMITY (toes curling under) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided    Reporter did not allow further contact
woke up and had chills and shaking  then a very bad headache until about 5am i got up and took some tylenol slept about an hour then got up and felt bad the rest of the day slept off and on all day
Resident received expired Moderna vaccine, expired on 10/13/2021. No ASE noted.
Red, swollen area left deltoid, 60cmx45cm for 2 days. Left arm pain.
Headache, Myalgia, Fever, fatigue, can't sleep Narrative:  Fever 101, myalgia, headache, fatigue, can't sleep.
Patient received 3rd Moderna vaccine dose and developed fevers within hours of the dose, the fevers continued for weeks. He was admitted to the hospital on 10/1/2021 "serum sickness" like symptoms and transaminitis
Pt reports swelling and pain in the (R) arm that radiates to her neck. Pt also states that the area is red.
pt recvd vax; redness, pain, swelling, itching at site & n p/ dose 2; pre tx w/ dph dose 3; no rxn;
being 33 weeks pregnant; Bells Palsy, gotten progressively worse; This prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 29-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th January 2023, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was 13th March 2023. The patient received Boostrix at week 33 of the pregnancy. On 23rd January 2023, 3 days after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the patient experienced vaccine exposure during pregnancy. The patient was treated with antibiotics nos (Antibiotics Therapy (Unknown)) and steroids nos (Steroids). On an unknown date, the outcome of the bell's palsy was not recovered/not resolved and the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was lost to follow up.   It was unknown if the reporter considered the bell's palsy to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-JAN-2023 Reporter's comment: The caller was the patient and had reported that she had received an Boostrix dose in the right arm. She had reported of experiencing Bells Palsy on 23 January 2023 and was diagnosed by Healthcare Professional (HCP). She had reported that, the HCP had prescribed antibiotics and steroids as treatment.  She had reported that, her condition had gotten progressively worse, since the onset.  She had reported being 33 weeks pregnant and the expected due date was 13 March 2023. The reporter did not consent to follow-up.
Pt experienced achiness on date of shot. Today elbow is red (~10 inches in length from top of arm to elbow), swollen and hot/warm to touch. Pt has been taking Motrin since Monday. This is pt's 5th vaccination.
PERIPHERAL NEUROPATHY 2/17/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
I just had symptom of flu, little ''type thing''; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "I just had symptom of flu, little ''type thing''". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter seriousness for I just had symptom of flu, little type thing: Unspecified.LOT#: Consumer stated, "I can give you the slash numbers whatever they are I dont know what that is 2/7X267LTW4S-CMQ." Expiry Date of COVID-19 Vaccine: Unknown.Consumer stated, "Yes correct my first and second I didnt have a problem, yeah I just had symptom of flu little type thing (further not clarified hence captured as per verbatim) and that is nothing but I never had this ever in my life." Consumer stated, "Yes, On Friday 24Sep I received my third my Pfizer booster which is third shot and after I got home three hours later my fingers, my thumb started to jerk and involuntary movements and its been that way for a week and I just wondered if this an adverse reactions of Pfizer and how long will it last.Other Products: No.Patient History: No.Investigation Assessment: Yes.Investigation: Consumer stated, "Any blood work:Yes. Yes I had a blood test yesterday. I guess they are checking electrolytes and my magnesium (further not clarified) was okay. So I am waiting to get some more results but that is just for the finger, for the finger you know because looking for electrolytes because my thumb is jerking after the 3 hours after the shot."Consumer was unwilling to complete the report. Further probing could not be done. Hence, limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3rd dose - last prior dose was 4/4/21.  Signifigant armpit lymph node swelling in left arm pit. Vaccine was given in the left arm . Shooting Pain up to a number 7 on 11/13/21.  Took IBU whuch helped.  Sore today with some shooting pain .  Pain level was up to a 5 in the am.  Still significantly swollen.   Contacting Dr tomorrow.
Information has been received from a nurse concerning a 25 year old female who on 16-APR-2008 was vaccinated in the left arm with a dose of GARDASIL (uncertain if it was the first dose). Concomitant therapy included YAZ for birth control. On 18-APR-2008 the patient experienced persistent pain in the left arm that prevented the arm from being raised. There was no swelling and no induration. The patient still had the arm pain as of 06-JUN-2008 when the patient was seen in the office. The patient was told to use ice therapy, but the ice was reported to make the pain worse. The patient had been placed on DIFLUCAN and VOLTAREN. On an unknown date, x-ray and unspecified lab tests were performed and no result was provided. The patient's persistent pain in the left arm was considered to be disabling. Additional information has been requested.
Fever 103.8; decreased appetite x 10 days; rash on trunk that spread to face and hands over 2 week period; strong personality changes- woke up mad every morning, inconsolable, appeared to be in pain, stopped speaking (only has a few words to begin with but definitely stopped communicating). Still, as of 8/21/18 (today) his personality is off- he's just not himself. The rash is almost completely gone; no fevers; appetite is back; still irritable which is not his normal personality.
pt recvd vax & exp swelling of the upper arm to back p/the 2nd dose;
No adverse event occurred. After administering the  first dose Moderna vaccine to the patient, we started to process the paperwork.  After an insurance rejection *MANUFACTURER DIFFERENT THAN INITIAL DOSE* I logged into the  database and discovered that the patient lied about his immunization history. He received Moderna on 12/27/2020 and 01/24/2021 at a medical center. He received J&J on 05/22/2021 and he received a dose of Pfizer on 06/28/2021.   I contacted the Pharmacy where he got his Pfizer, and informed them of his history.  I proceeded to call the patient to discuss his disregard for CDC protocols.  The was was shocked that I had discovered his previous immunizations.  I confirmed with him that he received all those doses on the specified dates.  I then informed him that he was operating outside CDC immunization guidelines and that I recommended he stop his shenanigans and we would not be administering an additional Moderna dose. The patient refused to state his motives for seeking so many vaccine doses.
This spontaneous report was received from a medical assistant, via company representative, concerning a female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient inadvertently received prematurely a third dose of with GARDASIL 9 for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported); the vaccine was administered with only a 3 week separation from the second dose. No adverse effects were reported.
SWOLLEN AND PAINFUL LEFT THUMB JOINT. PATIENT WENT TO DOCTOR & WAS DIAGNOSED WITH GOUT IN THAT JOINT.
Reddened area on (L) leg; warm to the touch; tightness of muscle.
Itchy bumps/lesions, no fever, papules covering entire body, headaches and rash x 3 days. Seen on 3/4/03 by MD.
One day after the flu vaccine given patient states she broke out with hives on her abdomen. Patient took BENADRYL and hives resolved.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Itching, hoarseness, headache, cold symptoms, fatigue - felt like I was going to faint after shot. Saw stars.
Full body aches,  101° Fever, severe headache by 2am 3/6/21; all symptoms continuing through the end of 3/7/21 Resolving by 3/8/21
Rc'd FLUMIST 12-12-13. Developed fever, cough severe dehydration, fatigue 12-18-13 required admission to ER for rehydration.
Day after vaccine patient kept complaining that arm was hurting and was crying, would not use arm to eat etc. I looked at arm around 3 pm and there was red splotchy raised rash from upper arm to about the elbow of arm and patient could not bend arm. I took photo and sent photo to patients pediatrician. She advised to give Benadryl and Neurontin over night. Rash has came down over night, and now is only in a small area right around injection sight, arm is still sore.
This spontaneous case, initially received from other health professional on 27-Sep-2018, concerns a female patient of an unspecified age. On 27-Sep-2018, the patient was administered FLUCELVAX QIVc instead of tuberculosis (TB) vaccine [dose: 0.1 ml, route of administration: intradermal, anatomical location: arm, batch number: 252226, expiry date: 31-May-2019] (explicitly coded as vaccine under dose, inappropriate route of vaccination and wrong vaccine administered). No adverse events report after administration of the vaccine. The reporter assessed this case as non-serious. Update received on 02-Nov-2018: Non-significant case correction (27-Sep-2018): The sentence in the narrative was changed from 'considering the event vaccine under dose as incidental nature and the events wrong vaccine administered and inappropriate route of vaccination as an accidental nature of the events' to 'considering the accidental nature of the events'. Follow-up received from the reporter on 03-Nov-2018: The reporter confirmed that the dose (0.1 ml) and route of administration (intradermal) of the vaccine. The anatomical location (arm) was added. No new information was available regarding the patient's age and adverse events. The narrative was amended accordingly.
Nausea, LOC, malaise,extreme pain inj. site. Unable to lift my L arm
Pt recvd 3 doses of Engerix-B; titer checked 6 months p/3rd dose; titer result was neg;
Information has been receivedd from a physician concerning a 17-year-old female who on 03-NOV-1998 was vaccinated with RECOMBIVAX. On 03-NOV-1998 the patient experienced flushing, burning and redenss on her face and chest which lasted approximately one hour and then resolved. Subsequently, the patient recovered from flushing and burning and redness. Additional information has been requested.
Pt developed red, hard area at site of injection. On 10/6/00 when pt reported it, it was 1-1 1/2" circular red, flat area. No pain or itching or hardness. Pt had reported it to MD on 10/4/00. On 10/9/00, the pt reported there was no redness or edema at site and feels fine.
Severe headache, chills and oscillating fever (100-101) for 24 hours
Chills, fever, upset stomach, loss of appetite, diarrhea, headache, "chest pressure"/shortness of breath, body felt heavy, extremely tired, big round red rash at injection site, lump at injection site treatment: BENADRYL, rest. Lasted 6 days.