chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache, dizzy, happens with every vaccine for him, sweaty cool skin 98/60, 86,18, 96%
no additional AEs were reported; received both PROQUAD nad VARIVAX today/ due to a human error; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.  On 29-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot # T034614, expiration date was provided and also validated as 10-APR-2022, at the dose of 0.5 milliliter, once; and also with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml, once, lot # T022315, expiration date was reported and also validated as 30-JUN-2022 for prophylaxis (strength, route of administration and anatomical location were not provided for both).  The patient supposed to get only measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) but also received varicella virus vaccine live (oka/merck)(VARIVAX) due to a human error (accidental overdose). No additional adverse events (AEs) were reported (no adverse event).
Puffiness to face and eyes starting 8 hours after vaccine administration, continued into the next day. Benadryl given. Symptoms resolved.
COUGH; PERSISTENT RUNNY NOSE; CHILLS; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 46 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced nausea. On MAY-2021, the subject experienced fatigue. On 19-MAY-2021, the subject experienced cough. On 19-MAY-2021, the subject experienced persistent runny nose. The action taken with covid-19 vaccine  was not applicable. The outcome of the cough, chills, nausea, fatigue and persistent runny nose was not reported. This report was non-serious.
In the month following the vaccine,  I gained 30 lbs.   I'm still easily short of breath and fatigued, which has not improved,  and I've gained an additional 10 lbs in the 5 months since the initial rapid weight gain.
Missed the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
No additional adverse events reported.; the 3rd dose of RECOMBIVAX HB was administered to a patient less than 16 weeks from the first dose.; This spontaneous report was received from a nurse referring to a 3 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  On 08-DEC-2020, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (0.5 ml; strength, route, lot # and expiration date were unknown) for prophylaxis. On 07-JAN-2021, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (0.5 ml; strength, route, lot # and expiration date were unknown) for prophylaxis. On 26-MAR-2021, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (0.5 ml; strength, route, lot # and expiration date were unknown) for prophylaxis, which was administered to the patient less than 16 weeks from the first dose (inappropriate schedule of product administration). The reporter had very limited information, no other information known at reporting time. No additional adverse events reported.
headache; malaise; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): (Janssen).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown". Additional information: The patient was previously treated with 2 doses of Pfizer Covid-19 vaccine (tozinameran) (Dose Number in series 1) (form of admin, route of administration, dose, and batch number not reported) for prophylactic vaccination. On an unspecified date, the patient experienced headache, malaise and nausea (Dose Number in series 1). The patient was previously treated with Moderna COVID-19 vaccine (elasomeran) (Dose Number in series 2) (form of admin, route of admin, and batch number: unknown and expiry: unknown) dose was not reported for prophylactic vaccination. On an unspecified date, the patient experienced headache, malaise and nausea (Dose Number in series 2). The patient received additional company suspect vaccine covid-19 vaccine ad26.cov2.s (Dose Number in series 3) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination which was off label use as inappropriate schedule of vaccine administration (Dose Number in series 3). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced headache, malaise and nausea which was worsened (Dose Number in series 3). It was stated that, "Just had a JnJ as a 4th shot after Pfizer primary series and one Moderna third shot (full strength). Anecdotally, the side effects from the JnJ shot were worse than the first three. Headache, malaise and nausea as with the others, but far greater intensity. The outcome of the headache worsened, malaise worsened and nausea worsened, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.  Reporter Causality was provided as Possible. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The patient received a Shingrix vaccine on 8/19/2021. The patient came in today (9/2/21) complaining of limited range of motion and a tingling sensation radiating down the administration arm that started 3 days after the vaccine and has got progressively worse. The patient indicated that they had reached out to their provider and were awaiting a reply.
pt recv vax & devel an inj site rxn characterized by redness, pain, induration, warmth, & swelling the size of a softball or larger;
Itching at the injection site; Injection site swelling; The injection site had huge amount of redness; Injection site was hot/ the localized reaction warm to touch; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (The injection site had huge amount of redness), VACCINATION SITE WARMTH (Injection site was hot/ the localized reaction warm to touch) and VACCINATION SITE PRURITUS (Itching at the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 1. On 06-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (The injection site had huge amount of redness) and VACCINATION SITE WARMTH (Injection site was hot/ the localized reaction warm to touch). On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site). The patient was treated with LORATADINE for Itching, Swelling and Rash, at an unspecified dose and frequency and IBUPROFEN for Redness and Swelling, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (The injection site had huge amount of redness), VACCINATION SITE WARMTH (Injection site was hot/ the localized reaction warm to touch) and VACCINATION SITE PRURITUS (Itching at the injection site) 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 medication patient used ice packs as his arm was hot at injection site
Varicella vaccine given on 8/1/23 in left upper arm. Came in clinic today with suspected reaction to vaccine.  There was a 6cm erythema. There was induration, warmth and a vesicular area in the center of reaction noted.
Information has been received from a physician concerning a female who was vaccinated with the second dose of GARDASIL (lot# 658558/1061U). Subsequently the patient experienced macular type rash on her chest and stomach. the physician reported that this "rash had appeared after receiving both first and second doses". The physician also reported that the rash was non-pruritic. Unknown medical attention was sought. The patient recovered on an unknown date. No product quality complaint was involved. Additional information was involved.
Information has been received from an office manager concerning a female who was vaccinated with a dose of PNEUMOVAX (lot # 655152/0889F).  Subsequently, the patient experienced pain at the injection site, swelling and her arm was hot to touch.  The patient sought unspecified medical attention.  The office staff is requesting a lot check.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the research center and was released.  This is one of two reports from the same source.  Additional information has been requested.
Fatigue, nausea, muscle pain in the arm where the injection was, and headache. I could not sleep.
DOUBLE DOSE RECIEVED; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 ml, administered on 22-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-MAR-2021, the subject experienced double dose received. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of double dose was not reported. This report was non-serious.
General Confusion; Aphasia; Difficulty Talking Coherently, difficult time remembering wife and son's names; Intermittent Sharp Headaches; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CONFUSIONAL STATE (General Confusion), APHASIA (Aphasia), INCOHERENT (Difficulty Talking Coherently, difficult time remembering wife and son's names) and HEADACHE (Intermittent Sharp Headaches) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Lumbar myelography (patient had a somewhat similar response several years ack to a lumbar myelogram. The fluid that is introduced called isovue which has iodine possibly aused the response.).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced CONFUSIONAL STATE (General Confusion), APHASIA (Aphasia), INCOHERENT (Difficulty Talking Coherently, difficult time remembering wife and son's names) and HEADACHE (Intermittent Sharp Headaches). On 31-Jan-2021, CONFUSIONAL STATE (General Confusion), APHASIA (Aphasia), INCOHERENT (Difficulty Talking Coherently, difficult time remembering wife and son's names) and HEADACHE (Intermittent Sharp Headaches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Computerised tomogram: (Inconclusive) Neither a CT Scan nor a MRI showed acute occurrence of bleed or blockage. On 30-Jan-2021, Magnetic resonance imaging: (Inconclusive) Neither a CT Scan nor a MRI showed acute occurrence of bleed or blockage.     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 relevant concomitant medications were reported.   No treatment information was provided.
Redness, hardness, swelling at injection site BENADRYL topical, BENADRYL by mouth symptoms started to occur approximately 24 hours after injection went to doctor 6 days after shot.
Received vaccine at a pharmacy. Fever, full body muscle aches, pain lasting 24 hours or more. Unable to do normal level of activity. Some relief with ibuprofen.
Janssen COVID-19 Vaccine EUA Side Effects I encountered are Including Low Fever, Body Aches, Tiredness, Headaches, One day After injection. Body Aches  and Headaches continued for 4 days after.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-JUL-2015, the patient was vaccinated with an improperly stored dose of M-M-R II lot # J005706, expiration date 15-AUG-2015 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 51 degrees Fahrenheit for 15 hours. There were no previous excursions reported. Data logger: unspecified. Lot number J005706 is an invalid lot number for M-M-R II. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact healthcare worker.
Pt. states that after receiving the 1st dose of Phizer 08/25/2021, started experiencing symptoms immediately of swelling throughout the right arm starting at the wrist moving up. Currently experiencing swelling along the whole right side of body. Physician recommendation of Auto-Immune Test done and follow-up with Results and check in.
Daptacel was mistakenly given to an 11 year-old child/ no AE; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an 11 years old patient (gender unknown) who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patients past medical history and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA).  On 11-Apr-2019, the patient received a fifth dose in series of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5206AA, expiry date 17-May-2018 via intramuscular route in the right deltoid.  It was an actual medication error due to inappropriate age at vaccine administration. It was reported that Daptacel was mistakenly given to an 11 year-old child.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender- none.
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT OF LEFT CALF, UNSPECIFIED VEIN
Ovarian pain that lasted for over a week. I did not believe there was any correlation until I received the second dose and began having ovarian pain to the point of not being able to stand up. It lasted several days. Both times it happened within a few hours over receiving the dose.
Received PROQUAD and KINRIX on 5/23/17 in (R) thigh. Now with 8 cm x 16 cm area with non pitting edema. 0.5 cm x 1 cm area of erythema lateral to that also without fluctuance or tenderness. No fever, chills, nausea or pain. Both reactions in (R) thigh. (+) redness and swelling.
loud high pitched ringing in both ears. Hearing not affected. treated with prednisone injections. did not change or inprove. Ringing has remained to date
3 pts exp non-specific itching @ areas other than inject site, w/in 48 hrs of receiving Engerix-B;
1 YOpatient was administered an adult dose; 1 YOpatient was administered an adult dose; This case was reported by a physician via call center representative and described the occurrence of accidental overdose in a 1-year-old female patient who received HAV (Havrix adult) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 27th October 2021, the patient received the 1st dose of Havrix adult. On 27th October 2021, unknown after receiving Havrix adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.  Additional details were provided as follows: Physician reported that a 1 year old patient was administered the first dose of an adult dose of the Havrix vaccine inadvertently, which led to accidental overdose and adult product administered. The reporter consented to follow up.
3-4 days after shot, developed aching and pain inner aspect both upper arms and has never let up. She saw local Dr. on 12/23/02. He thought pain might be d/t Lipitor, which he had her d/c. This did not help. 4/2/03 T.C. from pt, some pain continued to present. She said she is aware of pain constantly but has learned to live with it. She takes Tylenol at hs about 1-2 x week. On Tues. Dec. 1/, 2002. I went to the health dept to receive a tetanus shot. In speaking with a registered nurse, I came to the conclusion that at my age (82 yrs), I would never have had the initial or a booster shot. Therefore, we started the first shot of the series. I did not experience any soreness in my left arm. By the time I had an appointment to see my family doctor on Mon 12/23/02 I was experiencing painful muscles in my upper arms, across my shoulders, and back of my thighs. I mentioned this to my doctor and he told me to stop taking my Lipitor since that is one of the side effects of it. I have seen no help from doing this. I have an appointment to see my doctor for a 1 mo. follow up session on Tues. 1/21/03 which is also the day I am to go back for my second tetanus when I left the health office. One was a list of for returning for future shots, one was for me to fill out and bring back when I returned to the health office, and a third one of info concerning tetanus shot reactions. Today 1/18/03 I read through the 3 sheets to see if I had everything ready for 1/21/03 and discovered info on the third sheet regarding reactions that might occur after receiving the tetanus shot the lady at the health office had said I might get a sore arm where the shot was given. It is difficult dressing, combing my hair, lifting my body from a sitting to a standing position, and putting on or taking off a coat.
Nothing happened after the vaccine. Two months, on Nov 26 I didn't feel good, I had the COVID-19 home test, and it was positive. I had cough, sore throat. I had other COVID-19 tests and all were positive. I went to urgent care and the doctor recommended the monoclonal antibodies infusion, I felt 100% better.
Next day lump and redness. By the next day whole upper arm (oval) red, hurts, warm to touch.
pt recvd vax 22SEP93 & 1OCT93 pt exp transient & migratory arthralgias; 8OCT93 exp excruciating rt hip pain & was unable to bear weight on hip; hospitalized & a synovitis of the rt hip was dx; lab test on 10OCT93 showed WBC 9.6 (w/band 16);
symptoms started within 3-5 hours and lasted about 30 hours -cold (only lasted about 10 hours) -mild fatigue -mild headache -moderate soreness at injection site (followed by mild soreness for another 48 hours) -mild nerve tingling along  trigeminal neuralgia locations: the left side from top of head, down the left side face/ear, down the left side of neck -mild nerve tingling in left arm
I developed respiratory symptoms within 48 hours (starting the evening of 10/18/2007)of receiving the vaccine.  I am now on my 5th day of "cold-like" viral symptoms; e.g. coughing spasms, malaise, nasal congestion, headache, and achy feeling.  I still have these symptoms presently.
Fever, Breathing spells, tylenol 4-6 Hrs to treat fever. Administered shots on Monday (3.6.23), dad noticed today (3/8/23) 10cm 5x5
Tremors/seizures/tonic clonic  - lasted for 5 months, seem to have stopped at the time of this reporting
Sudden fever up to 102.5 by 12:00pm, uncontrollable shivering, body aches, tachycardia.  Treatment:  Tylenol, fluids, overnight hospital stay.
Case number PHEH2016US028837, is an initial spontaneous report from a nurse received on 02 Nov 2016. This report refers to a 67 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619221) into left deltoid, at a dose of 0.5 ml, intramuscularly on 12 Sep 2016. It was reported that, the patient vaccinated with FLUVIRIN that had experienced several temperature excursions (-2.7 Celsius for 06 hours and 04 minutes -3.6 Celsius for 21 hours and 48 minutes -3.4 Celsius for 21 hours and 02 minutes -3.3 Celsius for 21 hours and 03 minutes -3.3 Celsius for 08 hours and 04 minutes 1.2 Celsius for 01 hour and 01 minute 1.7 Celsius for 01 hour and 05 minutes). It was reported that, the vaccine was not frozen. It was stated that, patient did not experienced any adverse drug reaction, patient had been notified and will be revaccinated, FLUVIRIN that experienced temperature excursions prior to administration. No adverse event was reported following this medication error. The case was assessed as non-serious by the nurse. No additional information was provided.