chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On April 2, 2022, she was complaining about a sore throat that Saturday night. The next day on Sunday she had a fever and felt nauseated. She vomited 3 times. She also had a headache and a little bit of congestion. She kept complaining about a sore throat and headache on Monday and Tuesday. I took her to the doctor on April 5th and she was diagnosed with strep throat. The doctor didn't do the strep test swab. He just diagnosed her because of the symptoms she had. She was prescribed Amoxicillin 400mg/5mL Suspension 100mL. She drunk 10mL for 7 days. I never took her to a follow up appointment because they never gave her one as the hospital asked for so I ended up changing doctors. She went back to school on the following Thursday and Friday. She sounds like she has a little bit of allergies still, but she is doing much better after taking the Amoxicillin.
Chronic graft versus host disease; This is a literature report, Program ID: ().  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allogeneic haematopoietic stem cell transplantation (HSCT)" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: CHRONIC GRAFT VERSUS HOST DISEASE (medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200611693 Same reporter/product/event, different patient
Temperature was 101.9 then at 6AM it was 102; Muscle aches; She was hurting everywhere/ Body aches; She feels drained; She had a cough, she has a cough normally any way because she smokes but this was worse than normal.; felt like the flu; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-year-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Lot number: EW0171), via an unspecified route of administration, in Arm Left on 24Apr2021 at 11:00 (age at the vaccination 59-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine includes first dose of COVID vaccine (COMIRNATY, solution for injection, Lot number: ER8737) as DOSE 1, SINGLE on 03Apr2021 for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient says she had on Saturday she got her second shot of the vaccine for COVID. Patient says before Saturday, on Thursday and Friday she had a cough, she has a cough normally any way because she smokes but this was worse than normal on an unspecified date in 2021. She got the second dose Saturday and then Saturday evening she felt drained on 24Apr2021 and Sunday morning at about 5AM she woke up, and she needs to preface this by saying her normal temperature is 96.7 which is a couple degrees lower than other people normal, so Sunday morning she woke up at 5AM and she was hurting everywhere on 25Apr2021 and felt like the flu on an unspecified date in 2021, Patient had muscle aches, every piece of her body hurt and her temperature was 101.9 then at 6AM it was 102 on 25Apr2021 and during the day she some Tylenol and some other things to lower her temperature and she took some Aleve for body aches. Patient temperature went down to 99.4 and now today it was 98.6 which is a normal temp for everyone but is not back down to her normal. She thinks what she would like to know is, is it possible that she could have gotten the virus before she took the second dose of the vaccine or are these just side effects to the second shot. The outcome of the events fever and muscle pain was recovering and unknown for other events.
CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. 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: Unk) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 13-MAY-2021, the subject experienced chills. On 13-MAY-2021, the subject experienced fever. On 13-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The outcome of the fever, chills and headache was not reported. This report was non-serious.
No adverse event; The vaccine was given after it was expired after the expiration date of 03/11/2023 came out the freezer; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was given after it was expired after the expiration date of 03/11/2023 came out the freezer) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023 at 1:30 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was given after it was expired after the expiration date of 03/11/2023 came out the freezer). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine was given after it was expired after the expiration date of 03/11/2023 came out the freezer) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The vaccine was given after it was expired after the expiration date of 03/11/2023 came out the freezer).    Concomitant medication was not reported.  The vaccine had remained frozen until removed on 3/15/23 at 08:30 and placed in the refrigerator. The vial had not been exposed to any temperature excursions. Two doses of the expired vaccine were administered 3/15/23 at 13:30.  The vaccine was given to two patients.  Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715908 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2023: Live follow-up added: expiration date added. On 16-Mar-2023: Live follow-up added: Narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715908:1st patient
2 weeks after getting the first dosage of the COVID vaccine, I started spotting (brown discharge) and started bleeding during sexual intercourse (this never happened to me before).  My periods became irregular (never had this problem before) and I had constant spotting . The Obgyn did ultrasounds and did a complete check up and couldn?t find anything abnormal. I?m now taking birth control to regulate this hormonal imbalance that I believed was caused by the vaccine.  My tubes were tied  and I don?t enjoy taking birth control pills , so I?m obviously not happy doing this. I?m hoping that the CDC can do further research on women and their cycles while getting vaccinated. Definitely not vaccinating my 3 daughters.
Around 30 minutes after vaccine, I started to feel dizzy and light headed  As the day went on, I started to get a headache and get very tired. Then around 5 I started to feel intense:  Headache Chills/cold Dizzy/light headed/almost fell over several times  Muscle weakness, could not carry anything or lift Muscles in face felt like they were melting down/stroke sensation Exhaustion Sore/achy everywhere  Tender left arm where shot was  Could not think/memory was gone/could not put together a sentence  Tightness chest/hard to breath   Could not keep eyes open  Had to lay down and sleep  with long pants long sweater, jacket and 3 blankets   I woke up the next morning and some of my symptoms were gone except I still felt tired and had some achy ness, pain and left arm hurt and had shooting pain in joints  Shooting severe pain in each joint, laster for 3 days, most severe in joints where I received vaccine but also in wrists, shoulder, elbows, hips, knees, ankles   At day 5 my left arm is still sore including muscles around injection site
Severe vestibular problems (lasted about 6 months) and required extensive therapy to fix it. Started as lightheadedness and severe fatigue for 3 months. The vertigo gradually got worse day by day. All symptoms began 11/18/21. I had to see an ENT and vestibular physical therapist. I had to get Video nystagmography for diagnosis as well.
Approximately 1 hour after receiving shot developed very painful stomach pains  and vomiting for several hours.  Woke up next morning feeling better until 1:00 pm when I spiked a fever, intense chills to the point I could not get warm, fatigue, headache.  Then came the debilitating muscle aches that felt like every muscle was going through a ?wood chipper?!  Symptoms lasted 2-3 days.
Neuropathy in feet started abruptly after 3 dose of vaccine. Asked if this could be vaccine related and physicians were unsure. This recent vaccine booster given and neuropathy symptoms started in my arms and hands bilaterally. Bee stings, lightning shock pains in my fingers.
Client received flu shot and developed hives to arm and left side of face. C/o itching hx of allergied (not eggs). RN adm. BENADRYL 50 mg IM (L) arm, Resolved in 15 min.
The physician reported that a patient received improperly stored vaccine.; No adverse event; This spontaneous report has been received from a physician referring to a patient of unknown age and gender. Patient's medical history, other concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not provided.  On 07-OCT-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, one dose, ((strength, dose, frequency, route of administration and site of vaccination were not provided; lot number W012163 had been verified to be a valid number; expiration date was reported and established as 12-APR-2024) for prophylaxis (improper storage of product in use). Administered dose of the vaccine experienced temperature excursion of 10.1 Fahrenheit (F) for 51 hours. There was no previous temperature excursion.  No additional adverse events were reported in the patient.
Client phoned to report symptoms of generalized inflammation, am stiffness in neck, shoulders,hips,and knees that began 10 days after receiving Tdap, and Twinrix(Hep A/B)on March 12,2008.Client states her primary care physician has referred her to a rheumatologist.
Fever, chills, headache, malaise, diarrhea onset within about 36 hours post vaccine. Lasted about 24 hours. Fatigue and limited stamina next 24 hours. One week to the day post vaccine, developed a raised, red, swollen and itchy patch in upper left arm at site of vaccine. The swelling lasted about 36 hours. Reduced with periodic massage.
Information has been received from a physician concerning a 15 year old female with no pertinent medical history and no known drug allergies who on 29-DEC-2009 and 17-FEB-2010 was vaccinated with a first and second (lot # 661953/1130X) doses of GARDASIL. There was no concomitant medication. On 17-FEB-2010 the patient experienced a headache that had lasted for five days. The physician reported that the patient did miss school for the headaches she was having, but the physician did not mention if the patient had recovered as of yet. The physician also reported that the patient was just prescribed YAZ (manufacturer unspecified) around the same time of getting GARDASIL but it was unknown of the patient started taking YAZ (manufacturer unspecified). The patient sought unspecified medical attention. No diagnostic laboratory tests were performed. Follow up information has been received from a healthcare professional concerning a 15 year old female student who on 17-FEB-2010, at 13:00, was vaccinated with a second (lot # 661953/1130X) dose of GARDASIL into right deltoid. The patient called on 22-FEB-2010 stated she experienced "non-stop" headache since she received injection. She missed school. The headache resolved on Saturday morning 20-FEB-2010. Follow up information has been received from a healthcare professional who reported that on 22-FEB-2010 (previously reported as 17-FEB-2010) the patient experienced headache lasting 2 days (previously reported as 4 days) and recovered. Additional information is not expected.
arm tenderness, swollen lymph nodes in arm that was injected. Narrative: N/A
Arm still sore, but that also happened after first shot; This is a spontaneous report from a contactable consumer (patient). An elderly non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration, administered in left arm on 31Jan2021 15:30 (Lot Number: EI9262) as dose 1, single for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included unspecified known allergies to Penicillin and Demerol. Concomitant medications included ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin B12 NOS, vitamin D NOS, vitamin E NOS, zinc (CENTRUM MULTIGUMMIES); calcium and Vitamin C [ascorbic acid] form unknown date and unknown if ongoing. No other vaccine administered in four weeks. On an unspecified date, the patient stated arm still sore, but that also happened after first shot. Patient had no COVID prior vaccination and not tested for COVID post vaccination. Outcome of the event was unknown at the time of reporting.   No follow up attempts are needed. No further information is expected.
BLOOD PLATELETS ENLARGED; INR DROPPED FROM 2.3 TO 1.6.; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included genetic blood clotting factor 5d.T he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included warfarin for genetic blood clotting factor 5d.  On an unspecified date, the subject experienced blood platelets enlarged, and inr dropped from 2.3 to 1.6. Laboratory data (dates unspecified) included: Blood test (NR: not provided) blood platelets are enlarge, and INR (NR: not provided) INR DROPPED FROM 2.3 TO 1.6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood platelets enlarged and inr dropped from 2.3 to 1.6. was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as Non serious.
Pain developed at the site of injection and continued for 7 months.  Arm was unable to be lifted above the shoulder, pain severe enough to interfere with sleep requiring sleeping in a recliner chair instead of the bed.  Could not do general exercises to maintain arm and shoulder strength.
Extreme headache, fatigue, tiredness, muscle pain for the past 14 days. Lack of energy to perform on a daily basis,  Taking Excedrin daily by pain comes back after 3 hours of taking it.
This spontaneous report as received from a registered pharmacist refers to a currently 60 years old female patient. On 27-SEP-2012, the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). The pharmacist reported that on an unknown date, "shortly thereafter vaccination", the patient broke out with itchy rash on her torso. The patient ignored the itchy rash as there were no other symptoms. The patient did not consult a physician for the itchy rash. The patient had her routine medical exam in February 2013. At this time her physician diagnosed her with a mild case of shingles and stated he did not think it was related to the vaccine. The outcome of mild case of shingles was unknown. Additional information has been requested.
I woke up with fever, fatigue, sore throat, chills, headaches,  body aches, and loss of appetite.  I could not get up and walk, I was too exhausted.  My symptoms continued to worsen and I pass out from shortness of breath and my daughter took me to the ER.   They took a chest x-ray, ran some tests, covid test, blood work and I was admitted to the hospital.  I stayed in the hospital for 4 days.  I was diagnosed with pneumonia and given IV antibiotics.   I was to follow up with PCP, pulmonologist, and given oral antibiotics for another 2 weeks.  I have not gotten the 2nd shot since I had such a severe reaction to the 1st dose.  It is now 6 months post vaccine,   I am still having symptoms that have not resolve.  I am constantly fatigue, no energy, and shortness of breath.  I have not recovered from the  adverse event from the vaccine.
15 days after vaccination on March 9, 2021  after I received my vaccine I had a massive stroke/CBA when I woke up couldn't type and followed by a complete collapse and paralysis of left side. I called 911 and went to the ER. I was then sent to the Hospital where the doctor cleared the clot placed stents in my Carotid artery. I went to  rehab March 16th where I was treated by the doctor.
Patient was sitting in observation, post injection. Patient states that she got dizzy and fainted. Nursing staff saw the patient fall over and hit her head on the wall as she was falling to the floor. Patient was turned on her back and assessment was started. Patient was hooked up to a 12 lead EKG, vitals were obtained BP was low at 91/58 and pulse was 51, R:22 and 02:98%. Patients head was assessed for any trauma and none was noted, patient did report that she bit her tongue and a small laceration was noted on the tip. 911 was called and patient was transported via EMS.
patient received expired dose of YF-VAX, no AE; Initial information received on 28-Sep-2021 regarding an unsolicited valid non-serious case from another health professional via Medical Information (Reference number- 00789201).  This case involves patient (unknown demographics) who was vaccinated with the expired dose of suspect YELLOW FEVER VACCINE - US [YF-VAX], (expired product administered).  The patient's medical history, past medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect YELLOW FEVER VACCINE - US (vaccine lot number UJ372AA and expiry date: 22-Jul-2022, diluent lot number: U6427AA and expiry date: 20-Sep-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported "Caller reports that YF-VAX was received a few months ago and the actual product had a good expiration date but the diluent was short-dated and it expires Sep2021; caller requests replacement for diluent. Caller disconnected while on hold. caller further clarified that she spoke with Pasteur Customer Service and they sent a replacement diluent but she was sent sterile water. How purchased: Vaccine Shoppe, Number of units affected- 5 vaccines, Is dose not used or not available not used- not used, Whether product is available for return- diluent available for return o If the customer says no then advise them that if this happens again to retain the product for return to better assist in the investigation. If the customer states picture are available, ask to send us the picture. No broken vials or syringes with needles can be returned. Information to be gathered on the type of needle that was used by the end-user (e.g. gauge size)".  At time of reporting, no adverse event was reported.   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 the 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.
Sinus tachycardic with rate in 130s, dizziness, hypertension 138/92. Symptoms began 20 minutes following vaccination and resolved after 30 minutes.
Her neck has bothered her and is got Inflamed after getting the dose and also her auto immune information got worse.; Her neck has bothered her and is got Inflamed after getting the dose and also her auto immune information got worse.; Her neck has bothered her and is got Inflamed after getting the dose and also her auto immune information got worse.; pain; This is a spontaneous report from a contactable consumer (patient).  A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 02Aug2021 (at the age of 76-years-old) at dose 1, single in the right arm for COVID-19 immunisation. Medical history included thyroid disorder. Concomitant medication included steroids for thyroid disorder, and aniprazol. On an unspecified date in 2021, after the patient got the first dose of Pfizer COVID-19 vaccine, the patient stated that her neck bothered her and got inflamed. Also, her auto immune information got worse. The patient had pain. The patient did not receive the second dose due to this. Due to the events, the patient was treated with two injections in her neck and spine. The patient was waiting to get an abrasion in her neck on 04Oct2021, because of the pain (started on an unspecified date on 2021). The patient's inflammation increased a lot after the vaccination. Outcome of the events was not recovered.
Information has been received from a nurse concerning a 15 year old female who on 16-MAY-2007 was vaccinated with a first dose of Gardasil (lot 657622/0388U). On 16-MAY-2007, the patient was concomitantly vaccinated with hepatitis A vaccine (inactive) (manufacturer unknown). The nurse reported that the patient stated that she received a second dose of Gardasil, but the nurse noted that there was no documentation that the patient received a second dose of Gardasil. On 23-AUG-2007 the patient experienced fatigue, altered mental status and weakness. On 25-AUG-2007, the patient was brought to the emergency room. The patient was hospitalized (details and length of hospitalization not provided). The patient was visited by her physician on 25-AUG-2007, 26-AUG-2007, and 28-AUG-2007. At the time of this report, the outcome was unknown. Additional information has been requested.
Extra dose of KINRIX and PROQUAD given erroneously. No AE reported by patient.
Patient stated she had extreme itching on her hands (palms) and her legs, that started shortly after receiving vaccine. She also stated she got a mild case of shingles as well. Took and antihistamine to help with the itching.