chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bronchial congestion, wheezing, coughing ... hard to breathe.  Initally went to clinic on Aug 6 where I received a COVID 19 test and prescription for Albuterol.  After several weeks with no appreciable improvement, saw my PCP.  He diagnosed the condition as bronchitis (viral) and prescribed an 8-day course of prednisone which I started on Sep 2.  Condition appears to be improving.  I have had this sort of bronchitis in years past significantly prior to the COVID pandemic.
Rash on sides and back of neck with itching.   Treatment prescribed topical steroid cream for 2 wk application, and an anti itch tablet to take as needed for itching.  Today 5/5/2021
tested positive; tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "adrenal hyperplasia" (unspecified if ongoing); "Known allergy:Fish" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Past drug history included: Paxlovid, start date: 15Apr2022, for Covid 19 infection, reaction(s): "nausea", notes: on 15Apr for moderate symptoms with Covid 19 infection.; Paxlovid, start date: 15Apr2022, for Covid 19 infection, reaction(s): "vertigo", notes: on 15Apr for moderate symptoms with Covid 19 infection. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, manufacturer unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive, notes: On 26Apr I became symptomatic again and tested positive.  Clinical Course: The patient was prescribed Paxlovid on 15Apr for moderate symptoms with Covid 19 infection. Patient stopped taking the medication after 2 full and one-half days of the 5-day regimen. It was stopped due to nausea and vertigo and a significant decrease in Covid symptoms. On 26Apr the patient became symptomatic again and tested positive. The symptoms are stronger than previous ones and 2 rapid test results within seconds revealed very dark test line before control line. The patient wanted to know that is there any info regarding taking a new full 5 day regimen after a partial dose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PATIENT FAINTED FOLLOWING TDAP INJECTION. APPROXIMATELY 5-10 MINUTES AFTER VACCINE ADMINISTERED, PATIENT TOLD HIS MOTHER HE WAS FEELING "LIGHTHEADED".  CHILD BECAME UNRESPONSIVE WHICH LASTED MOMENTARILY. NURSE ASSISTED CHILD TO LAYING POSITION. PULSE AND RESPIRATIONS CONTINUED. CHILD OPENED HIS EYES AND WAS ABLE TO SPEAK. BLOOD PRESSURE 102/64  WHILE LYING DOWN. PATIENT STATED HE WAS ABLE TO SIT UP AND THAT HE FELT BETTER. GAVE THE CHILD SOME WATER AND ALLOWED HIM TO SIT IN CLINIC ROOM. BLOOD PRESSURE WAS RE-CHECKED PRIOR TO THE CHILD GOING TO THE LOBBY WAS 110/68. DENIED ANY LIGHTHEADEDNESS OR NAUSEA. CHILD ABLE TO WALK TO LOBBY. INSTRUCTED MOTHER TO REMAIN IN LOBBY WITH CHILD 20 MINUTES.
Night of vaccination (1/26): muscle aches and headache, severe left arm pain at injection site 2:30 am (Wednesday 1/27) - woke from severe muscle aches especially in joints, injection site pain had spread to include underarm (armpit) of left arm with radiating/nerve like pain going down left side of body/ribcage to hip.  No fever.  Took Excedrin migraine and ibuprofen (no tylenol alone on hand). Suddenly had hot followed by cold flash and severe nausea. Then neurological panic attack (i have had this ONCE before approx. 10 years ago during a severe Migraine that was treated at ER). The anxiety attack did not affect breathing, but instead nausea and all over flashes of heat followed by BOTH arms from elbow to pinky and ring finger (ONLY) going numb. Called my primary care office and spoke to on call dr. While on phone with Dr. numbness and nausea resolved - less than 10 mins total. Agreed that was anxiety attack and all symptoms were within expected for vaccination. Returned to be to try and sleep.  Wednesday - 8 am to 10pm - severe body aches, slight elevated temp. 99.8, headache, and around 5pm started experiencing vertigo. Took maximum daily ibuprofen for body aches  and had some relief. No work or any productive activities were able to be completed.   Thursday (1/28): woke up less fatigued and less body aches. significant vertigo is still present. Headache is still present. No fever. Left arm pit still sore - no swollen lymph nodes that I can feel.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year 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: The case was reported by patient's wife. The age at vaccination was not reported. The patient experienced SHINGRIX on right arm. The patient experienced pain in right arm after receiving SHINGRIX. For tolerance of 2nd dose of SHINGRIX refer case US2019GSK055859.
Headache, Fever, NauseaVomiting, arm pain, chills, body aches (unspecified), fatigue Narrative:
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported). Concomitant therapies included sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursions of: -14 to -10 degrees Celsius for 3 hours and 45 minutes; -9 to 8 degrees Celsius for 3 hours and 30 minutes. There were no previous excursions reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001241: US-009507513-1706USA001242: US-009507513-1706USA001243: US-009507513-1706USA001244: US-009507513-1706USA001245: US-009507513-1706USA001246: US-009507513-1706USA001247: US-009507513-1706USA001248: US-009507513-1706USA001249: US-009507513-1706USA001250: US-009507513-1706USA001251: US-009507513-1706USA001252: US-009507513-1706USA001253: US-009507513-1706USA001254: US-009507513-1706USA001255: US-009507513-1706USA001256: US-009507513-1706USA001257: US-009507513-1706USA001258: US-009507513-1706USA001259: US-009507513-1706USA001260: US-009507513-1706USA001261: US-009507513-1706USA001262: US-009507513-1706USA001263: US-009507513-1706USA001264: US-009507513-1706USA001265: US-009507513-1706USA001266: US-009507513-1706USA001267: US-009507513-1706USA001268: US-009507513-1706USA001269: US-009507513-1706USA001270: US-009507513-1706USA001271: US-009507513-1706USA001272: US-009507513-1706USA001273: US-009507513-1706USA001274: US-009507513-1706USA001275: US-009507513-1706USA001276: US-009507513-1706USA001277: US-009507513-1706USA001278: US-009507513-1706USA001234: US-009507513-1706USA001235: US-009507513-1706USA001236: US-009507513-1706USA001237: US-009507513-1706USA001238: US-009507513-1706USA001239: US-009507513-1706USA001240:
Patient received the vaccine on 01/27/2021.  10 days later, she developed swelling, redness, hardened area with wormth at injection site.  Measurements are 12 cm in length and 9.5cm in width.  Per Dr. it looks like cellulitis.  He prescribed Bactrim.  Patient is scheduled for her second injection on 02/17/2021.
Patient had 3 inch diameter area around injection site; hard and warm to touch. Instructed to take Tylenol/Motrin and apply warm moist compress. Painless.
Information has been received from a physician concerning a 27 year old female, with no medical history and no allergies, who, as a child, was vaccinated with a first and second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live.  There was no concomitant medication.  It was reported that a titer on 10-AUG-2005 was negative for measles.  No adverse symptoms were noted.  It was reported that the patient has no recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
Headache, Myalgia, Arthralgia, inj site pain day1-2; joint pain, headache, body ache days 1-3 Narrative:
Information has been received from a physician concerning a 12 year old female who in May 2007, was vaccinated with the first dose of GARDASIL, in August of 2007 was vaccinated with the second dose of GARDASIL and in December of 2007 received the third dose of GARDASIL. The lot numbers were not known. On 22-JAN-2008, the patient experienced black out episodes 1&1/2 months after administration of her third dose of GARDASIL. The patient has been examined by a neurologist who diagnosed her with orthostatic hypotension. She has not had seizures or any episodes of syncope. She experienced visual disturbances but remains conscious at the time of reporting, the event persisted. The physician did not have any additional information because she is not her patient. Additional information has been requested.
Pt's mom reported redness at the site of injection. Pharmacist looked at the injection site and mild redness around the injection site was observed.
Pt developed red, itchy rash that started on chest and spread under arm on to beck. Pt was afebrile and says he is feeling fine.
Very high fever; skin clammy, hot and red; shot was hard in center didn't end for 24 hrs.
Information has been received from a physician concerning a female who was vaccinated with her second dose of Gardasil.  Subsequently, the patient called the physician to report that she experienced fever and rash on the arm (both considered non-serious by the physician).  Additional information has been requested.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (005570). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history included interstitial cystitis (unspecified if ongoing). The patient's concomitant medications not reported. The patient experienced unexpected therapeutic response, and improved pre-existing condition, with outcome of unknown. The patient stated, "I have interstitial cystitis. Since my vaccine, I haven't had any pain or flare-ups." Additional information: The patient just wanted to report a positive effect of the Pfizer COVID-19 vaccine they received. The patient also knew a few other patients that expressed this happening to them as well/also expressed this happening to them in an open forum. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
I tested positive on 7/21. Developed runny nose, sore throat, slight caught and extreme fatigue. I reached out to my doctor on 7/21 and started PAXLOVID that day. I got better within 5 days. I tested negative on 7/29. I started feeling badly again on 7/30. I tested on positive on 7/31.
Blood in stool 3 days after vaccine. No intusscuption. Was told it was dairy allergy but it isn't
CAN'T RAISE ARM; FELT LIKE LIFTED SOMETHING HEAVY; ARM ACHING; PAIN BETWEEN ELBOW AND SHOULDER, FOUR INCH BELOW WHERE SHOT GIVEN; COULDN'T SLEEP LAST NIGHT; This spontaneous report received from a patient concerned a female of unspecified age. 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced couldn't sleep last night. On APR-2021, the subject experienced arm aching. On APR-2021, the subject experienced pain between elbow and shoulder, four inch below where shot given. On 26-APR-2021, the subject experienced can't raise arm. On 26-APR-2021, the subject experienced felt like lifted something heavy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from can't raise arm, and felt like lifted something heavy on 26-APR-2021, had not recovered from arm aching, and the outcome of pain between elbow and shoulder, four inch below where shot given and couldn't sleep last night was not reported. This report was non-serious.
GARDASIL administered 8/18/10. On 8/19/10, developed diffuse red, raised bumps on injection arm. Itchy, about the size of mosquito bites.
03/18 felt like I had been hit by a truck. Symptoms included cough, congestion, headache, sore throat, and fatigue. I have several illnesses and PCP instructed me to follow the plans we already had.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 17-MAR-2014, the patient was vaccinated with GARDASIL (lot # J010668, expiration date 29-APR-2016) 0.5 ml, intramuscular. Dose underwent temperature excursion and was exposed to 60F for 24 hours (supported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
On the day following my Covid Booster shot I awoke to a significant loss of balance and occasional vertigo that was diagnosed as Benign Paraoxymal Positional Vertigo. There vertigo episodes were treated and cured using the Modified Eply Maneuver. Loss of balance has persisted over the past 6 months. Recently referred to Vestibular therapy and balance exercises have helped some.   I also had several months of higher resting heart rate, the same as I reported after my first two Covid shots
numbness and tingling in the fingertips; swelling in the lymph nodes on the whole left side and under the armpit; numbness and tingling in the fingertips; swelling in the lymph nodes on the whole left side and under the armpit where she got the vaccine; This is a spontaneous report from a contactable Pharmacist. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 25Jun2021 for COVID-19 immunization. On 16Jul2021, the patient experienced numbness and tingling in the fingertips, swelling in the lymph nodes on the whole left side and under the armpit. Reporter stated they have a patient who received the second dose of the Pfizer Covid-19 vaccine on 16Jul2021, 3 days ago and experienced swelling in the lymph nodes on the whole left side and under the armpit where she got the vaccine and has had numbness and tingling in the fingertips. They did noticed this in the paperwork they hand out, the information sheet that this has been reported with the swelling of the lymph nodes at the injection site as a reaction. Wondering what the next step is or if they should refer her to the physician or is there a waiting period for resolving. Was calling to see what the recommendations are from Pfizer. This was her second dose. She had the first dose on 25Jun and had no issues. Outcome of the events was unknown.  Information about the Lot/batch number has been requested.  Follow-up (PRD/SRD 03Aug2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Additional Details: While sitting on the chair, patient fainted and started to have seizure for 1-2 second then recovered completely by himself. Called 911 but patient did not want to have any medical attention. After that, patient sit for more than 30 minutes before going home.
DOSE IN THE SYRINGE RAN DOWN THE PATIENTS ARE WHEN THE NEEDLE CAME OFF OF THE PREASSEMBLED SYRINGE, LEAVING THE NEEDLE IN THE PATIENT'S ARM.  NO HARM TO PATIENT OTHER THAN IT IS UNKNOWN IF SHE RECEIVED A PARTIAL DOSE OR NONE OF HER 2ND COVID VACCINATION.
Patient presented with cough, fever, and multiple falls. Patient ended up being COVID positive and fully vaccinated
Initial report was received from a health care professional on 30 May 2012. A female patient (age and date of birth not reported) had received an intramuscular injection of MENACTRA, sanofi pasteur Inc., lot number U3512AA (site not reported) and an injection of HAVRIX, GSK, lot number AHAVB18CA (route and site not reported) on 17 April 2012. Two hours post-vaccination the patient experienced acute urticaria and angioedema. The patient was treated with BENADRYL and taken to the emergency department (ED) by staff. The symptoms resolved. The dose of MENACTRA was also expired by four months. The patient had a history of asthma, allergic rhinitis and bipolar from fetal drug and alcohol exposure. The patient's outcome was recovered. Documents held by sender: None.
1351: Patient alerted RN staff that she was experiencing an itchy throat. No difficulty swallowing, no change in voice or mentation. Patient in no respiratory distress, no hives/rash/flushing noted. BP 154/86, HR 92, 99% O2  1355: 25mg Benadryl PO given.  1400: Patient states symptoms resolved, throat no longer itchy. Patient is in no acute distress. Patient to be observed by EMS for an additional 30 min. Patient discharged in good standing.  BP 147/92, HR 72, 100% O2
I been having issues with my stomach and in July in 2020 everything was clear and then I started having blood in my stool in  December of 2021 and the Dr, ordered me to go to the ED and they did a CT  of the abdomen and they stated there is a lot in there and think they it was ovarian and stated that it was bad. They did more testing and it is peritoneal cavity and I was diagnosed with stage 4 cancer of peritoneum in January 7, 2022.
received the first dose of Shingrix over a year ago and has not received a second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over a year ago).   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received the first dose of Shingrix over a year ago and has not received a second dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date 19 Sep 2023 The pharmacist reported a patient received the first dose of Shingrix over a year ago and had not received a second dose yet. HCP email was provided prior to abandoning if you want to follow up. Till the time of reporting patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.
Patient developed b/l tinnitus 2 weeks after receiving 2nd Pfizer vaccination. He denies prior h/o exposure to loud sounds. He did not have prior history of same/similar symptoms prior to onset.   Patient states he had tinnitus that started 2 weeks after receiving 2nd Pfizer Covid-19 vaccination on 4/22/2021; with first Pfizer vaccination of L arm, had  soreness at injection site and some swelling in lymph nodes two days later. (lasted for 48hrs, then self resolved). After second Covid-19 vaccination, had body aches on next day (lasted 48hrs, then self resolved); both doses were given in same Left arm. Ringing in ear R>L, persistence of this, not progressive or associated with other symptoms.
Patient reported paralysis of right arm for "2-3 days" after injection. She could not raise arm above breast height. Pain radiated up to neck and down to hips. No inflammation was reported. No treatment was given. Patient did not report to us until reaction was complete.
1 minute seizure with eyes deviated, left leg rhythmic movements. Seen at the ER. Normal head CT. No other fevers, seizures or other symptoms since event. Fever of 102.2 F noted prior to seizure.
acute autoimmune hemolytic anemia; patient had a history of PCR documented mild COVID in 4/2020
Soreness and swelling/fluid pocket  at injection site- significant discoloration/bruising followed on day 3, pain receding on day 5
a patient recieved an expired flublok quadrivalent vaccine, no AE; Initial information was received on 14-Sep-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case is linked to cases 2020SA252523 and 2020SA251862. (Same reporter)  This case involves a 42-year-old female patient who received an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided. The patient did not receive any concomitant vaccine.  On 12-Sep-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [prefilled syringe, lot number: unknown to reporter (UTR) as the expired vaccines were taken away before reporter could write down, expiry date 30-Jun-2020] via an intramuscular route at the left arm for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used. (latency: On the same day of vaccination)  At the time of report, 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 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.  There will be no information available on the batch number for this case.
Pain and swelling by vaccine site, swelling and pain in underarm.  Pain to the touch and when i move it. Body aches, stomachache, diarrhea and very tired.
rash large red spots on arms, legs, & face; MD states pt had an allergic rxn probably to vax;
This spontaneous report as received from a pharmacist refers to a 80 year old male patient. The patient's medical history included shingles 5 years ago. Patient's drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX. On unspecified date in February 2013, the patient got shingles again. On 20-FEB-2013, the patient received treatment and was given an unspecified oral antiviral and unspecified topical for itching and pain. On unknown date, the patient sought unspecified medical attention. The outcome of the patient got shingles was unknown. Additional information has been requested.