chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches in large muscles.  From mid torso down through thighs.  Became overly sensitive and emotional due to the fatigue of the aches.  Started the evening of Friday, March 19th, peaking on Monday March 22 and began to subside.  By March 24, I began to feel more normal.  At the peak of the side effects I felt weak and shaky standing from seated position or vice versa.  Muscles felt weak like after a heavy workout or run. Felt no extra energy for anything.  Also noticed chills, especially in left hand after the vaccine was dispensed.
No adverse event/ 0 known adverse events; Indavertently administered improperly stored GARDASIL 9/ Vaccine temps went out of range. Vaccine given; This spontaneous report was received from a licensed practical nurse (LPN) regarding to a 12-year-old female patient. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions, and allergies were not provided.  On an unknown date, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, formulation, anatomical location, route of administration, lot number and expiration date were not reported) for prophylaxis. On 02-FEB-2022, the patient was vaccinated intramuscularly, in her left deltoid, with an improperly stored (product storage error) second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot number U007667 with an expiration date of 23-MAY-2023 (dose was not reported) for prophylaxis. There were no additional adverse event details. Administered dose of vaccine experienced the temperature excursion of 27.2 degrees Fahrenheit (F) and 49.8 F for 8 hours 30 minutes and 21 hours and 15 minutes respectively. There were no previous excursions reported. The improper storage was recorded by digital data logger.   This is one of nine reports received from the same reporter. ; Sender's Comments:  US-009507513-2202USA007814: US-009507513-2202USA007815: US-009507513-2202USA007816: US-009507513-2202USA007817: US-009507513-2202USA007818: US-009507513-2202USA007812: US-009507513-2202USA002574: US-009507513-2202USA007813:
Pallor, temperature 105.1. Father read our "after the shots" pamphlet and medical doctor told him what to look for. Saw face was pale took rectal temp and read 105. Gave Tylenol. Called about 2:50pm. Medical doctor told him to put in bath, review in 1/2 hour and call. Review temp was 99.8. Father insisted patient had been very pale and temp was 105, not 100.5.
This spontaneous report was received from a nurse and refers to a 4 month old patient of unknown gender. There was no information about pertinent medical history, drug reactions and allergies and concomitant medications provided. On 08-JUL-2015, the patient was vaccinated with the first dose of VARIVAX (lot#, expiration date, dose were not reported) and MMR II (lot#, expiration date, dose were not reported), both vaccines were given subcutaneously. No adverse effect was reported. Additional information has been requested.
Immediately after receiving the shot, I felt light headed and nauseous.  After a few minutes, I passed out and was told I had "seizer like symptoms for 30 seconds".  When I came to, I was overcome with sweat, started vomiting and was rushed to the emergency room.  After 4 hours at the ER and feeling very fatigues, I was released.
arm is going to be sore; This is a spontaneous report from a Pfizer-sponsored program 159558. A contactable consumer (patient) reported for self. Unspecified age and sex patient received second dose of bnt162b2 (Pfizer BioNTech COVID-19 vaccine, solution for injection, Batch/Lot number: EN0169, expiry date: unknown), dose 2 via an unspecified route of administration on 19Feb2021 as dose 2, single for covid-19 immunisation. Patient historical vaccine included patient received first dose of bnt162b2 (Pfizer BioNTech COVID-19 vaccine, solution for injection, Batch/Lot number: unknown, expiry date: unknown), dose 1 via an unspecified route of administration on 19Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date patient experienced arm was going to be sore and he would like to know if he can rub it with an alcohol. The outcome of the vent was unknown.  No follow-up attempts are possible. No further information is expected.
Immediately after receiving 2nd GARDASIL vaccine along with DTap vaccine, patient fainted. She was unconscious for 2-3 seconds. Awoke with shaking, examined by provider, lied down, legs elevated and drank some juice. Held in office for 20 minutes
DIARRHEA; NAUSEA; CHILLS; This spontaneous report received from a patient concerned a 57 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, intramuscular, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced diarrhea. On 06-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 06-APR-2021, and had not recovered from nausea, and diarrhea. This report was non-serious.
Patient received J&J vaccine 5/11/2021. Per patient report, he spoke to healthcare provider about getting a "booster" of Pfizer. PCP advised that he do so.
swollen area on my axilla/swollen area the size of a fist; hard to do anything on that side/hard to lay on that side; at the injection site it was swollen/pretty good size; It is a hard lymph spot; it is very tender; injection site less and moved to the axilla; hard to do anything on that side/hard to lay on that side; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (swollen area on my axilla/swollen area the size of a fist), VACCINATION SITE DISCOMFORT (hard to do anything on that side/hard to lay on that side), VACCINATION SITE SWELLING (at the injection site it was swollen/pretty good size), LYMPH NODE PAIN (It is a hard lymph spot) and LYMPH NODE PAIN (it is very tender) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A, 010M20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN (STATIN [SIMVASTATIN]), ASPIRIN [ACETYLSALICYLIC ACID], LORAZEPAM, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and GLUCOSAMINE for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, 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 experienced VACCINATION SITE LYMPHADENOPATHY (swollen area on my axilla/swollen area the size of a fist), VACCINATION SITE DISCOMFORT (hard to do anything on that side/hard to lay on that side), VACCINATION SITE SWELLING (at the injection site it was swollen/pretty good size), LYMPH NODE PAIN (It is a hard lymph spot), LYMPH NODE PAIN (it is very tender), LYMPHADENITIS (injection site less and moved to the axilla) and VACCINATION SITE MOVEMENT IMPAIRMENT (hard to do anything on that side/hard to lay on that side). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 500 mg twice. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (swollen area on my axilla/swollen area the size of a fist), VACCINATION SITE DISCOMFORT (hard to do anything on that side/hard to lay on that side), VACCINATION SITE SWELLING (at the injection site it was swollen/pretty good size), LYMPH NODE PAIN (It is a hard lymph spot), LYMPH NODE PAIN (it is very tender), LYMPHADENITIS (injection site less and moved to the axilla) and VACCINATION SITE MOVEMENT IMPAIRMENT (hard to do anything on that side/hard to lay on that side) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-386114 (Patient Link).
Employee received Fluzone Quadrivalent flu vaccine on 09/24/2020 (2 weeks ago). She has been having pain and inflammation in her left upper arm since that time. She has pain with left arm internal and external rotation only. No pain with flexion, extension, abduction or adduction and no pain at rest. Her pain wakes her up at night when she rolls onto her left arm. Her pain is localized to anterior bicep region. She has full ROM of her left shoulder. She denies any numbness, tingling or radiating pain. She was started on a Medrol Dose pack and will follow-up at clinic in 1 week.
Bloody stool. head and body pain, weakness and fatigue.    Body pain cleared up by 11/24 but bloody stool remained. I went to a doctor who  said to monitor over the next couple days and if bloody stool continues to take a steroid that was prescribed.
When I went to sleep it was like a ton of bricks; Backache; My skin was sensitive; Arm hurting at the injection site; Headache; Elbows hurt; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (When I went to sleep it was like a ton of bricks), BACK PAIN (Backache), SENSITIVE SKIN (My skin was sensitive), VACCINATION SITE PAIN (Arm hurting at the injection site) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007821A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced INSOMNIA (When I went to sleep it was like a ton of bricks), BACK PAIN (Backache), SENSITIVE SKIN (My skin was sensitive), VACCINATION SITE PAIN (Arm hurting at the injection site), HEADACHE (Headache) and ARTHRALGIA (Elbows hurt). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Mar-2021, INSOMNIA (When I went to sleep it was like a ton of bricks), BACK PAIN (Backache) and HEADACHE (Headache) had resolved, ARTHRALGIA (Elbows hurt) outcome was unknown. At the time of the report, SENSITIVE SKIN (My skin was sensitive) and VACCINATION SITE PAIN (Arm hurting at the injection site) outcome was unknown.            Concomitant product use was not provided by the reporter.
High fever over103 for 12hrs.   Low grade fever still present. Covid arm. Rash , soreness, warmth at injection site.  This is a he second shot. No adverse reaction with first shot.
pt accidentally ingested DTP (amount unk); during the office visit pt (unattended) reached syringe & evidently pulled the plunger out; needle cap still intact approx 1 1/2 hrs later pt began vomiting; stopped w/in 24 hrs; pt recovered;
Information has been received from a licensed practical nurse concerning a 19 year old female patient with penicillin allergy who on 09-NOV-2010 was vaccinated with the first dose of GARDASIL without incident. At 09:00 on 01-MAR-2011 the patient received a dose of GARDASIL (Lot# 666597/0768Z, Expiration: 17-OCT-2011) (dose, strength and therapy route were unspecified). A lot check has been initiated. Concomitant therapy included SEASONIQUE and ZYRTEC. In January 2011, the patient experienced mononuceleosis. At 13:26 on 01-MAR-2011, the patient was involved in an automobile accident and suffered some bumps and bruises. The patient was not hospitalized. At the time of report, the patient was recovering. Therapy was not discontinued. There was no lab diagnostics. The patient sought medical attention. Bumps, bruises and automobile accident were considered to be life threatening by the reporter. Additional information has been requested.
Uncontrollable shivering, fever of 99.7, nauseated. Took luke warm shower and took 2x200mg ibuprofen. Reported this 2 hours after symptoms so not sure how long it will take to recover.
A patient who received Pentacel vaccine, was inadvertently administered a dose of IPOL as well, hence received 2 polio vaccine doses in the same day, no AE; Initial information received on 13-Aug-2020 regarding an unsolicited valid non-serious case from other health professional (clinical manager).  This case involves a 4-year-old female patient who was vaccinated with a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], was inadvertently administered a dose of IPV (VERO) [IPOL] as well, hence received 2 polio vaccine doses in the same day (extra dose administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient had received no other vaccines or concomitant medication.   On 13-Aug-2020, the patient received fifth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ329AAA and expiration date: 04-Apr-2021) via unknown route in unknown administration site and on also received a 0.5 ml dose of suspect IPV (VERO) (multi dose vial, lot P1F541M and expiration date:07-Dec-2020 ) via unknown route in unknown administration site as prophylactic vaccination.  It was an actual medication error due to extra dose administered (same day latency).   Reporter stated that the Pentacel was given, so that the patient received an extra Hib vaccine dose by getting the Pentacel.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Swelling in arm; Redness; Fever; Injection site is hurting really bad; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in arm), ERYTHEMA (Redness), PYREXIA (Fever) and VACCINATION SITE PAIN (Injection site is hurting really bad) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALPRAZOLAM (XANAX) and ENOXAPARIN SODIUM (CLEXANE) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection site is hurting really bad). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in arm), ERYTHEMA (Redness) and PYREXIA (Fever). At the time of the report, PERIPHERAL SWELLING (Swelling in arm), ERYTHEMA (Redness), PYREXIA (Fever) and VACCINATION SITE PAIN (Injection site is hurting really bad) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient post receiving their first dose of vaccine stated their left arm at injection site was hurting really bad.  On 20-Apr-2021, the patient reported that they experienced swelling in arm, redness and fever post receiving the first dose of vaccine.  Reportedly, the patient took the second dose on 04-Mar-2021. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up was received on 20-Apr-2021 and added additional events experienced after first dose. Updated the Action taken. Included second dose date in I-narrative supplement.
Patient called the vaccine clinic on January 19th to discuss his potential reaction to the vaccine. Patient stated he had a lazy eye and a face twitch after the 2nd Pfizer vaccination, which was later diagnosed as bell's palsy. He stated he was again having a lazy eye and face twitch that began about two days after receiving his booster dose of the covid vaccination. Patient stated one of his other family members had a similar reaction.
Nodule (round) lateral neck same side of vaccine. Didn't notice it before receiving the vaccine.
Patient reports redness and swelling around the injection site the size of an egg in terms of shape. She also reported red fingerlike projections that wrap partially around the arm.  Offered patient acetaminophen and patient declined. She would prefer to ice injection site. She is to follow up with provider if issue persists or worsens
Information has been received from a physician concerning a female patient who was vaccinated with the first dose of GARDASIL (lot number was not provided) within the last week (in October 2008).  The patient fainted in the waiting room of the physician's office after receiving her first dose of GARDASIL.  She was taken to the emergency room for x-rays of her neck, but results were not provided.  It was not known if she was admitted to the hospital.  The patient recovered on an unspecified date.  Additional information has been requested.
Night sweats with no fever. Started approximately 8 hours post shot. Has continued for 48 post vaccine.
Ran low grad fever, pain inj site and joints. Then the pain went to every organ. Saw the Rheumatologist and it was classified as Cytokins Storm.  Prescribed Prednisone.
Started with sore throat and mild cough. By 11:00 PM I had body aches and chills. I could not sleep at all due to chills and body aches. I then had a horrible headache and a fever of 100.4 at 4:00 AM. I still have a headache and body aches at 10:00 AM the next morning.
PATIENT CAME IN TO GET SECOND SHINGLES VACCINE, VACCINE WAS GIVEN. UPON ENTERING VACCINE IN REGISTRY IT WAS DISCOVERED PATIENT HAD ALREADY RECEIVED 2 DOSES.
Sore arm; A spontaneous report was received from a consumer, concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine and experienced PAIN IN EXTREMITY/sore arm  The patient's medical history and concomitant product use was not provided by the reporter.  On an unspecified date, prior to the onset of event, the patient received first dose of mRNA-1273 (lot number unknown) intramuscularly for COVID-19 infection prophylaxis.  On an unspecified date, after the first dose of vaccine, the patient experienced a sore arm. No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event was considered to be unknown at the time of this report.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient reported feeling hot in her face and upper body, having a rash or hives, and flushing. Patient denied shortness of breath or swelling. Patient went home and took a BENADRYL, then came back to the pharmacy to report what had happened. Patient's symptoms had started to subside, but patient was instructed to take a second BENADRYL and stay in our waiting room to be monitored. Patient's primary care was called. Her blood pressure was 138/85 and her temperature was 98.1 F. Patient was sent home after 30 minutes had passed with a thermometer and instructions to call her PCP if she has a fever, and to call 911 if she feels shortness of breath or swelling in her mouth/face/throat.
INJECTION SITE LUMP VERY SORE; INJECTION SITE LUMP (HARD LUMP ABOUT THE SIZE OF A QUARTER); INJECTION SITE HARD; SWOLLEN VEINS (BLUE JAGGED LINE EXTENDING FROM THE INJECTION SITE ACROSS HER CHEST TO THE OTHER ARM, LOCATED ON HER FRONT, BELOW THE COLLARBONE ON THE LEFT SIDE); INJECTION SITE WARM TO TOUCH/WARM AT BUMP; FEELS LIKE THERE SOMETHING UNDER HER SKIN THAT SHE RUBBING; MILD HEADACHE (DESCRIBED IT AT THE FRONT OF HER FOREHEAD, AND DESCRIBES FEELING A BIT WARM); INJECTION SITE SWOLLEN; INJECTION SITE RED; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 190 pounds, and height was 66 inches. The patient's past medical history included: tore her other arm, and concurrent conditions included: thin skin, non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no known allergies. The patient have no history of drug abuse or illicit drug usage. The patient had no medical history. The patient past drug history included vitamins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816207, expiry: UNKNOWN) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced injection site lump (hard lump about the size of a quarter). On SEP-2021, the patient experienced injection site hard. On SEP-2021, the patient experienced swollen veins (blue jagged line extending from the injection site across her chest to the other arm, located on her front, below the collarbone on the left side). On SEP-2021, the patient experienced injection site warm to touch/warm at bump. On SEP-2021, the patient experienced feels like there something under her skin that she rubbing. On SEP-2021, the patient experienced mild headache (described it at the front of her forehead, and describes feeling a bit warm). On SEP-2021, the patient experienced injection site swollen. On SEP-2021, the patient experienced injection site red. Treatment medications included: paracetamol, and trolamine salicylate. On 14-SEP-2021, the patient experienced injection site lump very sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site lump very sore, mild headache (described it at the front of her forehead, and describes feeling a bit warm), swollen veins (blue jagged line extending from the injection site across her chest to the other arm, located on her front, below the collarbone on the left side), and injection site lump (hard lump about the size of a quarter), and the outcome of injection site swollen, injection site red, injection site warm to touch/warm at bump, feels like there something under her skin that she rubbing and injection site hard was not reported. This report was non-serious. This case, from the same reporter is linked to 20210925766.
This spontaneous report has been received from a registered nurse referring to a 4 year old male patient who was with no pertinent medical history or drug reactions/allergies. On 09-AUG-2012 the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (injection, dose and route not reported, lot# G016512, expired date 23-NOV-2013). On 29-JUL-2015 the patient was vaccinated with the second dose of (Oka/Merck) VARIVAX (injection, dose and route not reported, Lot L005298, Expiration date unspecified). There was no concomitant medication. The patient presented to office on 13-DEC-2015 (reported as 5 days ago), with lesions that appeared to be chickenpox. There was no treatment. The outcome of the patient was reported as not recovered/not resolved. Causality was not reported. This is one of the two reports from the same reporter. Additional information has been requested.