chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tightening occurred around my neck and chest area with tingling sensations in both legs from the knees down to the ankles right arm also tangled. This began happening on a daily basis sometimes tightening was more intense with less tingling in legs noted but more tightening around neck and chest. No pain associated with tightness.
2 hrs after injection , felt  a URGENT need for Bowel movement, while I was having this bowel movement, I had what I think was a severe  Panic attack, felt like I was going to die !!! lasted for 5 or 10 min. After which I felt fine , went to work ,after another 2 hrs I had the same episode ,at work. timing was about the same . went home . Had another aproximently  2 hrs from the last ,was  less severe . took a nap , BUT was unable to urinate for 6 hrs . Felt OK ,slepted fine. Felt OK the next couple of days Then had mild case of chills, then mild case of feeling poorly. Very slight fever.  AS of today I'm more tired then usual but not debilitating .
This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 47-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. On 13th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the physician for himself. The patient received 1st dose of SHINGRIX on right deltoid. The patient described experiencing a lot of pain during administration of the first dose of SHINGRIX. He said that it "felt like a stabbing with a knife". After the injection he experienced severe pain in his arm that lasted for two days. For the tolerability of 2nd dose of SHINGRIX, refer linked case US2018GSK160777 reported by the same reporter for himself. The patient had denied permission to contact their physician.
Initial unsolicited report received from a healthcare professional on 06-Apr-2015. A male patient (age not reported), whose medical history and concomitant medications were not provided, had received a dose of Tetanus Vaccine (dose details, batch number, expiry date, route and site of administration were not reported) and a dose of Smallpox Vaccine (dose details, batch number, expiry date, route and site of administration were not reported) on an unspecified date. On an unspecified date post vaccination, the patient experienced necrotizing skin reaction. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was reported as unknown. Upon medical review, the case was considered as serious due to important medical event: necrotizing skin reaction. Documents held by sender: none.
Lymphadenopathy/Enlarged Lymph node; This is a spontaneous report from a contactable physician. A 40-year-old male patient received bnt162b2 (BNT162B2 reported as Pfizer-Biontech Covid-19 Vaccine and also reported as Covid Vaccine; unknown lot number and expiration date), via an unspecified route of administration left deltoid (reported as once by injection on the left deltoid) on 18Dec2020 at a single dose for covid-19 vaccination. The patient has no medical history and concomitant medications.  The physician reported that he got the COVID Vaccine on 18Dec2020 and he got Lymphadenopathy as a possible side effect of the vaccine. It was recently (03Jan2021), he noticed an enlarged lymph node (Lymph node is on left supraclavicular, so above the clavicle on the left side). It could be unrelated, but he was told to call and report it. He would like to know were there patients in the clinical trial who got lymphadenopathy (which part of the body). He did not received treatment. He knows that lymphadenopathy was reported in the study. The reported considered the event as non-serious. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
the injection site is now magnetic.  This is limited to the site and nowhere else on the extremity
All of the following side effects occurred for 36 hours following my vaccination: Extreme fatigue; headache; fever; chills; night sweats; nausea; vomiting; dizziness; blurred vision; weakness; muscle aches throughout entire body; pain at injection site (only experience 24 hours after injection)
Likely nocturnal seizure. Woke up and noticed a bitten and bleeding lip and bitten tongue and some confusion and brain fog, and sore muscles.
About a half hour after receiving first dose (around 5:30??) my face, neck, chest & ears became flushed; it felt like a bad sunburn & felt a bit prickly. I applied a cold cloth to these areas in hopes it would calm down, but it didn?t help so around 6:15 pm I took 25 mg of Benadryl and at 6:30 I decided to go back to the place I received the injection to get checked out. The doctor confirmed the reaction & told me to take another Benadryl and continue taking as needed, and to watch for swelling of the throat. She also recommended taking Tylenol for any aches & pains that she guaranteed would come due to the response I had.  I was asked to stay a while for observation and then went home around 7:15pm.  Once home, around 8:00 pm I started aching so I took one extra strength Tylenol & went to bed. Around 2:30am this morning (4/7) I took another Benadryl because I?m still had an occasional prickly feeling.
Parent brought child in with dark red, very pronounced rash on all 4 extremities and both face cheeks. She said he had a fever from the 1st day but she did not record it-no obvious swelling at injection site. Mom said child still eats and drinks with no difficulty. I asked mom to bring child back in a day for another evaluation.
I'm not doing too well; can't drive; This is a spontaneous report from a Pfizer sponsored program, Pfizer Patient Assistance and Savings Program. A contactable 52-year old male consumer (patient) reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) on an unspecified date via unspecified route as a single dose for COVID-19 immunization and pregabalin (LYRICA) from an unspecified date, route, dose, frequency, and indication unspecified. Medical history and concomitant medications were not reported. The patient reported that he just had the COVID shot and can't drive (unspecified date). He was not doing too well from the second vaccine. The action taken in response to the events for pregabalin was unknown. The clinical outcome of the events can't drive and not doing too well was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with an improperly stored doses of ROTATEQ (lot number, strength, dose and route were not reported). No adverse effects was reported. The outcome of the patients event was not reported. Additional information has been requested.
Expired Hvrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 71-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 8th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     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: 10-FEB-2023 Reporter's Comments: The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.  Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
not had another period/ No period; prospect of early menopause as her periods are very regular; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8736; Expiry Date: unknown) via an unspecified route of administration in Right arm on 25Jun2021 in the afternoon (at the age of 40-year-old) as dose 2, single for COVID- 19 Immunisation. Medical history included ongoing sleep. Family History were none. Concomitant medication included cyclobenzaprine for sleep, norethisterone (DEBLITANE, lot number: 20076009; expiration date: Oct2022 and discard by date: 12Aug2022) for birth control. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8736, Expiry Date: unknown) via an unspecified route of administration in Right arm on 4Jun2021 16:00 (at the age of 40-year-old) as dose 1, single for COVID- 19 Immunisation. It was stated that after getting the first dose of the vaccine, she had a very strange light period; it never became a real period, just spotting the whole time instead of no period. Patient did not take any other vaccine within 4 weeks Prior to COVID19 vaccination. The patient was received second dose of Pfizer vaccine on 25Jun2021 in the afternoon. She has not had another period/ No period at all in Jul2021; Aug2021; Sep2021. The patient was not visited to Emergency Room or Physician Office. The patient had a telehealth appointment with her PCP a couple of weeks ago in 2021, her doctor and the specialist were very concerned about the prospect of early menopause as her periods are very regular; they want to do a FSH test. She has not had any tests or treatment yet. Outcome of the event amenorrhea was not recovered and other event was unknown.
pt recvd vax & had fever; 11x11cm swelling & redness of arm;
Moderate pain, swelling, redness, swelling, itching at injection site 8 days after receiving shot
On 9/2/20, 1 week after receiving his immunizations, patient developed a vesicle at the site of immunization on his right thigh and over the next 24 hours developed several more vesicles adjacent to the immunization site.  On 9/3/20,   He also developed fever to 102.8 on 9/3/20.  His fever was 101 at home on 9/4/20.   Patient seen in the office on 9/4/2020 and vesicles had "dried up."
This spontaneous report was received from a nurse practitioner, and refers to an unspecified numbers of patient of unknown age and gender. Medical history and concurrent conditions were not reported. On unknown dates, the unspecified number of patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # J013394; expiration date on 25-AUG-2016, and K021444; expiration date on 17-SEP-2016 (strength, dose, anatomical location and route of administration were not provided). There was not concomitant medication reported. No adverse effects were reported. There was not a product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Fever, Pain in Left Arm which was pink color. No treatment other than cold compress and one Advil. Condition subsided on 12/7/2015, but began again on 12/9/2016.  Patient was seen by a doctor on 12/10/2015 who prescribed Keflex and condition improved.
This spontaneous report was received from a registered nurse regarding an approximately 55 year old male patient. The concurrent conditions included an unspecified neoplasm, allergy to cat dander and allergy to dust. Information on the medical history of the patient was not reported. On 23-SEP-2015 the patient was vaccinated with PNEUMOVAX 23, (lot expiry date, dose #, anatomical location were not specified) intramuscularly. Other suspect therapies included ZOSTAVAX lot # L035285, expiry date- 15-DEC-2016, (dose # and anatomical location were not specified) subcutaneously. Concomitant therapies included amlodipine, lorazepam, triamcinolone acetonide, clobetasol propionate, calcipotriene, mometasone furoate (oral), VIAGRA, Lisinopril (manufacturer unknown), LEVITRA, PRAVACHOL, fluticasone propionate, ADVAIR, FLONASE, albuterol, CLARITIN, PROVENTIL, vitamin E and ascorbic acid. On 02-OCT-2015, the patient was vaccinated with ZOSTAVAX subcutaneously after being administered a dose of PNEUMOVAX 23. Approximately in the year 2015 (an unspecified amount of time after receiving ZOSTAVAX), the potent experienced guttate psoriasis and began visiting a dermatologist for his condition since an unknown date in December 2015 and treatment of phototherapy was given for the adverse event. Reporting nurse stated that the patient's brother, who was a dentist, felt that the patient ha developed shingles from ZOSTAVAX and that this was the cause of the guttate psoriasis. The patient had sought medical attention by visiting the physician. There were no lab diagnostics performed. There was no intervention to prevent serious criteria. Outcome of guttate psoriasis was reported as not recovered/not resolved at the time of reporting. There was no Product Quality Complaint (PQC) filed. Reporting nurse did not provide the causal relationship of the event guttate psoriasis with PNEUMOVAX 23 and ZOSTAVAX. Additional information has been requested.
Slight migraine headache, slight nausea, slight soreness on upper arm at injection site. Ibuprofen Lasted 2 days
Information has been received from a 60 year old female consumer with a history of an arm operation and severe vomiting caused by AUGMENTIN who on 12-JUN-2007 was vaccinated with a single dose of Zostavax. Concomitant therapy included BENICAR, NORVASC and ACTONEL. "Two days later" on 14-JUN-2007 the arm in which she was vaccinated "blew up like a balloon" and turned red-pink "the color of a raspberry". Within one week the arm returned to normal. Approximately 1 1/2 weeks later the patient developed five small crusty blisters on the back of her left thigh. There was no pain in the leg from these blisters and they subsequently went away. After this, the patient developed pain in the left thigh. Gradually, the pain progressively became worse. She had difficulty walking and had to limp on her left leg. The pain continued to progress "to the worst pain she has ever experienced." She was diagnosed with shingles. She was initially prescribed ZOVIRAX and subsequently she also took LYRICA and TRILEPTAL. As a result of taking these medicines, she experienced diminished memory. At the time of the report she continued to have pain, but it was not as severe as before. No further information was provided. There was no product quality complaint involved. Additional information ahs been requested.
Patients mom states 12 hours after vaccination dev: fever, chills, stiff neck. Symptoms got progressively worse throughout the day. on the evening of 4/8/21 patients mom describes patient talking "out of her head", fever, chills, leg pain, "bad" headache. On 4/9/21 patient woke up around 5:30 AM, sister helped to bathroom. reported leg pain, neck pain, headache. Laid back down. Sister found patient unresponsive around 9:00 AM. Sister performed CPR. Pronounced dead at patient's home by EMS.
really bad itchy; hurt inside; like a bump; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (really bad itchy), INJECTION SITE PAIN (hurt inside) and INJECTION SITE SWELLING (like a bump) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DEXLANSOPRAZOLE (DEXILANT SOLUTAB) and ROPINIROLE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE PRURITUS (really bad itchy), INJECTION SITE PAIN (hurt inside) and INJECTION SITE SWELLING (like a bump). At the time of the report, INJECTION SITE PRURITUS (really bad itchy), INJECTION SITE PAIN (hurt inside) and INJECTION SITE SWELLING (like a bump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Benadryl for Itching
I HAD THE 2ND MODERNA VACCINE ON 2-5-21. AT THIS TIME I WAS 6WK PREGNANT, MY ESTIMATED DUE DATE IS 9-28-21, AND I HAVE HAD ONE PREVIOUS UNEVENTFUL PREGNANCY. ON 2-8-21 I FELT A CRAMPING SENSATION IN MY LEFT CALF, WHICH INTENSIFIED THROUGH THE DAY. I WENT TO THE URGENT CARE, WHO SENT ME TO VASCULAR TO HAVE A DUPLEX ON MY LEG, WHICH WAS NEGATIVE. THROUGH THE WEEK THE CRAMPING INTENSIFIED EVEN MORE, AND MY LEG BECAME PAINFUL AND SWOLLEN TO THE POINT WHERE I COULD NEARLY WALK. I RETURNED TO VASCULAR, WHO DID ANOTHER SCAN ON MY LEG WHICH SHOWED NOT ONE, BUT 2 SEPARATE DVT'S.  I AM NOW ON LOVENOX TWICE DAILY THROUGH 6 WEEKS POST PARTUM.
A 27 year old female experienced a severe headache, chills, sweating and gastrointestinal discomfort (nausea and vomiting) following the 2nd and 3rd doses of post-exposure RabAvert vaccination. Symptoms began on 9/4/01 and persisted for approx. 3 days.
Patient received in ER unresponsive, Fever 104, lumbar puncture revealed provisional dx. of meningitis/neisseria meningitidis.
Patient reports experiencing swelling of the left arm ( arm where the vaccine was given) from elbow down the following day after receiving the vaccine she also reports whole body hives starting 05/13/21. per pt took Tylenol but saw no relief
feeling unwell; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling unwell) in a 56-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling unwell). At the time of the report, MALAISE (feeling unwell) outcome was unknown. Not Provided          No concomitant medication was provided No treatment received by the patient   This case was linked to MOD-2021-330232 (Patient Link).
arm so sore; Running a fever; Headache; pressure behind eyes; very cold; A spontaneous report was received from a consumer concerning a 55-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, fever, headache, pressure behind the eyes and feeling cold.   The patient's medical history was not reported.  Concomitant medications included acetylsalicylic acid, vitamin D3, lisinopril, metoprolol, pravastatin, and an unspecified, over-the-counter heartburn medication.    On an unspecified date, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unknown date, the patient received Covid-19 vaccine and developed so sore arm, fever, headache, pressure behind the eyes, and feeling very cold. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown/ not reported.; Reporter's Comments: This report concerns a 55-year old female patient who experienced non-serious events of sore arm, fever, headache, pressure behind the eyes and feeling cold occurring within 2 days of her receiving the mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Little spaced; Dizzied; No energy; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Little spaced), DIZZINESS (Dizzied), ASTHENIA (No energy) and CHILLS (Chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced ASTHENIA (No energy) and CHILLS (Chills). On 09-Mar-2021, the patient experienced DIZZINESS (Dizzied). On 11-Mar-2021, the patient experienced FEELING ABNORMAL (Little spaced). At the time of the report, FEELING ABNORMAL (Little spaced), DIZZINESS (Dizzied), ASTHENIA (No energy) and CHILLS (Chills) outcome was unknown.            Patient took a pill for dizziness.
headache; nausea; chills/shivering; fever; sweating; body aches; unable to sleep due to body aches; pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 10Mar2021 13:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included kidney disease, recent surgery Jan2021 for brain aneurysm from Jan2021 (Other medical history), Penicillin (Known allergy: Penicillin) and COVID-19 (Covid prior vaccination). Concomitant medication included clopidogrel bisulfate (PLAVIX) and acetylsalicylic acid (ASPIRIN (E.C.) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. Patient did not test covid post vaccination. Patient experienced headache, nausea, chills/shivering, fever, sweating, body aches, unable to sleep due to body aches, pain at injection site on 11Mar2021 02:30 AM. Patient did not received treatment for the adverse events. The outcome of the events was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Started with headache, began shivering and put on multiple jackets. Had to go home and rest, woke up multiple times during the night.  Felt hot but didn't have a thermometer.  Took Advil and Tylenol.  Felt better today but returned to clinic and saw Nurse Practitioner.  Afebrile. Advised to rest, hydrate, use Advil if necessary.  Felt better today, 11/14.
Rash developing with 48 hours on left side of the neck, sore / scratchy throat,  arm soreness persisting.
Local reaction on site of injection. L thigh appears swollen, with a red blister like lesion. Redness around blister. Mother reports no pain, no fever, reaction appeared 1 wk post vaccine.
Patient admitted for nausea and vomiting as well as acute cystitis. Pt was treated with IVF, antiemetics, and antibiotics. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
Fever that lasted from Thursday 1/03 through early morning on Saturday 1/05. Extremely sore upper left arm that became red and hot to the touch. That pain travelled partially down the arm and also along the inner left side of the body (below armpit). Large red welt at site where shot was given--large and round like a baseball, hot and hard to the touch on Saturday...must have been worse on Friday but I was too sick to look at it--it never occurred to me that I could see it. Achy head, back aches, coughing, stiffness (stiff neck).
The day after (Thursday) I woke up and felt terrible. I had chills, sweats, nausea, no appetite, what I did eat I threw up. I had no energy. Friday I was so drained from not being able to keep anything down I had to be sent home from work. My brain wasn?t functioning because I was so nutrient deprived.    By Saturday night I was able to eat again and was feeling basically completely better.