chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  COVID POSITIVE after COVID vaccine series completion on 03/04 COVID vaccine dose #1 03/25 COVID vaccine dose #2 04/02 Seen in ED due to "losing his voice x 2 days," dx: laryngitis, rx medrol taper 04/08 Walked in to primary care due to persistent laryngitis, non-productive cough, slight discomfort in chest w/ cough 04/16 Seen by PCP, 2 weeks of hoarseness 04/20 Seen by speech path, reports 3 weeks of raspy voice, increased coughing 04/22 Speech path conducted stroboscopic voice evaluation-found erythematous left vocal cord, right/irregular appearance of right vocal cord 04/30 Seen by ENT, found bilateral vocal cord lesions, COVID tested for pre-cop, COVID positive, reports sore throat (due to raspiness) 05/02 Pt reports continued sore throat, doesn't believe he has covid, as was out mowing grass and was fine
Starting itching on 4/6/21 and a red raised bump(rash) appeared on chest, stomach, back, legs, and neck and continued. No problems breathing.
Intussusception resolved with Barium Enema after special Enema on 11/1/09.  11/18 & 11/19/09:  ED record and vaccination records received for date of service 10/31/09. Dx:  Intussusception Assessment:  Presents with intussusception, admitted. 12/10/2009 ED record, Admission and consult notes for 10/31-11/1/2009,  patient with c/o's persistent vomiting x 2 days. Tx: IVF, NPO, barium enema + for intussusception
Violent chills (couldn't stop shaking); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic cough" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codein, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 3 , Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 19May2022, outcome "recovered", described as "Violent chills (couldn't stop shaking)". Therapeutic measures were not taken as a result of chills.  No follow-up attempts are possible. No further information is expected.
Narrative:  PT RECEIVED PFIZER COVID 19 VACCINE ON 1/15 AND  DEVELOPED RASH WITHIN A WEEK. PER PHARMD PROGRESS NOTE  ON 1/28/21, "Overall, reports doing ok. Main complaint is a new rash that has  developed on both legs. Estimates that the overall size covers about a hands-width  on both sides. Describes tiny, "match-head size" red spots. Denies pain or itching.  Estimates that is started 5 days ago. Denies unusual bruising or bleeding. Please  note, given the timing on the development of his derm issues, beginning shortly  after his first covid vaccine, I entered a VAERS report. Granuloma annulare has been reported as a rare, but potential SE, occurring after vaccination. " 2ND  PFIZER COVID 19 GIVEN, ON 2/5/21. ON MARCH 3 1, DEMOTOLOGY  CLINIC COWLETED A BIOPSY ON RIGHT THIGH AND LEFT CHEEK  AND ON 4/13, PER DERMATOLOGY, "He was last seen in clinic on 3/31/21 at  which time a biopsy was performed consistent with GA". REPORTED SPREAD  OF RASH ALONG TORSO. BIOPSY ON CHEEK WAS CONSISTENT WITH  AK AND WAS HEALING WELL PER DERM. NO NEW BLEEDING,  NONHEALING OR TENDER LESIONS REPORTED. ON 4/22, PHARMD REPORTED PTS MAIN COMPLAINT WAS "Main conviaint remains his  ongoing rash, now characterized as disseminated granuloma annulare by derm  This is worse from his groin to knees, but also has areas on his back and abdomen.  He has been using the clobetasol, but hasn't noticed any benefit. He doesn't have  derm f/u until Aug. I instructed him to call for sooner flu in 2 weeks if no  improvement." PT WAS SEEN BY PHARMD, HYPOGLYCEMIA REPORTED  ON SEVERAL OCCASIONS HOWEVER LOOKS LIKE  HYPOGLYCEMIA/UNAWARENESS WAS AN ONGOING ISSUE FOR THIS PATIENT EVEN BEFORE VACCINE.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L037554, expiration date 25-DEC-2017, lot # L026602, expiration date 19-OCT-2017, lot # L024993, expiration date 17-OCT-2017, lot # M017983, expiration date 30-MAY-2018 (exact dose and route of administration were not reported). There was no adverse effect reported. These doses of GARDASIL 9 were exposed to 51 degrees Fahrenheit for 2 hours 30 minutes, 47.9 degrees Fahrenheit for 5 hours 20 minutes, 33 degrees Fahrenheit for 6 hours 50 minutes, and 47.6 degrees Fahrenheit for 20 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
About 10 seconds after receiving the Pfizer Covid vaccination, the patient passed out for about 10 seconds, then quickly came to.  She was dizzy and nauseous afterwards and vomited twice.  The patient was placed on the floor with feet elevated.  After about 5 minutes she was able to keep some water down and eat some crackers.  The patient was monitored for 30 minutes while her symptoms steadily improved.
SICK TO STOMACH; STOMACH ACHE; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (SICK TO STOMACH), ABDOMINAL PAIN UPPER (STOMACH ACHE), HEADACHE (Headache) and NAUSEA (Nausea) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In 2021, the patient experienced ABDOMINAL DISCOMFORT (SICK TO STOMACH), ABDOMINAL PAIN UPPER (STOMACH ACHE), HEADACHE (Headache) and NAUSEA (Nausea). In 2021, ABDOMINAL PAIN UPPER (STOMACH ACHE), HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (SICK TO STOMACH) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  The reporters causality for the events of SICK TO STOMACH was not provided. The reporters causality for the events of HEADACHE and STOMACH ACHE with HUMIRA(ADALIMUMAB) was no reasonable possibility.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I had an allergic reaction of unknown origin. I have no reason to believe it was related to the covid vaccination. I had hives and swelling on my hands. It required antihistamines and steroids to control the reaction. I still have a small amount of redness in my hands, but it is mostly cleared up as of today.
Pt called health dept c/o redness and soreness at injection site of pneumonia vaccine. Reports red and sore 10/28/03 but increased soreness reported on 10/29/03. Advised pt to contact PCP if symptoms worsened.
serious reaction/ worse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (serious reaction/ worse reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (serious reaction/ worse reaction). At the time of the report, VACCINATION SITE REACTION (serious reaction/ worse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Severe nerve pain; This case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was unknown.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient asked was it common to have severe nerve pain following a shingles vaccine. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Local reaction: red, swollen, hard to touch. Went to Dr. Dx with early cellulitis - put on antibiotics 8/19/09.
Started to feel dizzy, sick to stomach 2100 on 2/9/21. 2200 felt flush, checked temp. 99.4. Took 2 Tylenol 500mg. Went to be. Woke up about 1 am drenched in sweat  hallucinating, seeing black shadows, red hands. Still dizzy and off balance. Went back to bed. Woke up this am 0800, no temp. feeling fine.
February 28, 2023, I had chills, high fever, temperature 103.4, my throat swelled up. It was very painful. On the right of the back of my throat it had white bumps. I took a COVID-19 home test and it was positive. I did another self-test on March 1, 2023, result was positive. I called my doctor that I had tested positive, and the doctor prescribed PAXLOVID. I took it for 5 days. On March 3, 2023 a dispatch health came to my house for my husband, and I was checked for strep throat, and it was negative. I was also given a COVID-19 test and it was positive. The throat issue continued for 3 weeks I had aches and pain and fatigue I had an unbelievable amount of mucous coming from my nose and mouth and constantly going down my throat. Worse than any sinus infection I have had in my life. I had a slight cough; it was mostly from the mucous than having the respiratory symptom. The throat was really weird it totally closed up and was super swollen on the inside, and it was super bright red. My right side of my throat it looked like a growth. It was a lot worse than having sore throat and strep throat in my lifetime. It took a month for the swelling of my throat to go down. I took a home test on the morning of the 9th of March, and it was negative. On March 10, at night, I started having a fever again of 101. I started to have a low-grade fever for a couple of days, and I was not feeling well. On the 11th of March, I took another COVID-19 test and the result was positive again. The doctor prescribed LAGEVRIO. I was told I had a rebound from the PAXLOVID. It took me 10 days after taking the LAGEVRIO to feel better. I did not have fever and the throat was getting better. I stopped short of 1 day from the LAGEVRIO because I had an allergic reaction. I got rash on March 19, on my legs. March 19, 2023, I took another COVID-19 home test and I tested negative. I have recovered but I have fatigue and I do not have that much stamina. But I also lost my husband on March 27, 2023.
Case number PHEH2014US000823 an initial spontaneous report received from a pharmacist on 07 JAN 2014 with the follow-up received on 26 JAN 2014. This report refers to a 08 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml of FLUCELVAX 2013/2014 (batch number: 004011A) intramuscularly on 07 JAN 2014 at 19:15. No adverse event was reported following this medication error.  Follow-up received from a pharmacist on 26 JAN 2014: Dosage and time of vaccination was updated.   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 26 JAN 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "adult product administered to child".
Initial information received on 13-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 years old male patient who experienced redness, swelling and increased skin temperature at site of injection/ nurse states almost looks like cellulitis, while he received vaccine QUADRACEL. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious patient experienced redness, swelling and increased skin temperature at site of injection/ nurse states almost looks like cellulitis but not quite that severe (vaccination site cellulitis) and (vaccination site inflammation) with unknown latency following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. Lab data was not provided. Final diagnosis was redness, swelling and increased skin temperature at site of injection/ nurse states almost looks like cellulitis. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown. List of documents held by sender- none.
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Additional Details: patient stated she had "covid arm" following her bivalent booster dose.  she did not need any medical intervention and did not see her doctor.  she treated with topical hydrocortisone cream only.
50 year old vaccinated female was admitted for multifocal pneumonia. She had tested (+) for Covid-19 on 2/14 but tested (-) on admission here. She was treated with antibiotics and steroids. D dimer was elevated but CT chest and BLE venous US (-) for thrombus. She is discharged home today in stable condition on oral medications.
presents with abdominal pain, vomiting, dizziness. Reports vomiting for 2 days. Felt some dizziness on her way to work in the uber today. Reports epigastric pain, constant, burning, non-radiating.
Myalgia right arm red, warm, raised area. Itchy with moderate firmness Narrative: Vaccine on 12/23/2020, Right arm warm, red area 3 inches in diameter, Itchy, moderate firmness (less firm than a few days ago). Sore, has psoriasis on elbow, has not missed work. Temp 97.2
RT ARM SUB CUT REACTION TO VARICELLA- REDNESS AND WARM TO THE TOUCH, PT HAS BEEN SCRATCHING HIS ARM- ARM MEASURES 12CM X 12CM- PT WAS TREATED WITH COOL COMPRESSES AND ADVISED TO TAKE BENADRYL BY NP
In March 9th I have developed bad itchy rash all over my neck, back, and arms. I have taken Claritin and cortisone to help with the side effect. On the 10th I have developed rash on my feet and stomach.
Horrible chills and spasms, violent shaking, high fevers, night sweats, low grad fevers 101.4 with Thera Flu tea. Lastly cold soars in mouth, red patches and very painful knot in left arm. A big red one on injection site, 4 small
Administering other patients for last 2 weeks that were in syringes for over 6 hours; Administering other patients for last 2 weeks that were in syringes for over 6 hours; A spontaneous report  was received from a Healthcare Professional concerning 30 unknown patients, who received Moderna's COVID-19 vaccine (mRNA-1273) from the extra unused doses in syringe which was brought back to pharmacy (PT: Product storage error)  and being used for administering to patients  for last 2 weeks that were in syringes for over 6 hours.(PT- Product Administration Errors)  The patient's medical history, was not  provided by the reporter. No Concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) for prophylaxis of COVID-19 infection.   On an unknown date, Health Care Professional (HCP) reported that, extra unused doses in syringe were brought back to pharmacy and being used for administering other patients for last 2 weeks that were in syringes for over 6 hours. HCP stated that it was first dose for all patients. She was one of the recipients of dose of vaccine from that syringe.  . Treatment for the event not reported.   Action taken with mRNA-1273 in response to the events Product storage error and Product administration error  was not reported.   The outcome of the event is resolved on an unknown date.; Reporter's Comments: This report refers to a case of Product storage error and Product administration error  for mRNA-1273, lot # 041L20.  with no associated AEs.
Patient started to develop redness and swelling in left upper arm the evening of January 28 after receiving the vaccine that afternoon. The redness and swelling worsened on January 29. The redness, swelling and warmth is localized to the left humerus and elbow. No fever, trouble breathing, swelling elsewhere.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.  No treatment information was provided.
injection site pain; extreme tiredness; headache; chills; sweating; feeling unwell; dizziness; This is a spontaneous report from a contactable consumer. A 60-year-old male consumer (Patient himself) reported that he received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via unspecified route of administration in arm left on 28MAR2021 11:00 AM (at 60-years-old) as a single dose of administration. Patient medical history included high blood pressure, prostate cancer. No record of allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. On29Mar2021 3:00, patient experienced injection site pain, extreme tiredness, headache, chills alternating with profuse sweating, feeling unwell, dizziness. No therapeutic measures were taken for the event caused. Outcome of the events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Initial unsolicited report received from a consumer on 30 December 2015. This case involves a 64 years old female patient who was vaccinated with a dose of Flu shot (Batch number, dose, dose in series and site of administration were not reported) in the right arm in September 2015 and 0.5 ml injection of PREVNAR 13 (batch number: M16258, Expiry date: 30 Apr 2020; route and dose in series were not reported) in the left arm on 14 December 2015. The patient had asthma and respiratory problem (ongoing-diagnosed years ago), when she gets cold uses inhaler once a year and allergic to dust, mildew, ash and elm tree pollen. Concomitant medications included 10 mg/day of CRESTOR for cholesterol; half strength of Estratest from 15 years for hormone therapy; Singulair taking for about a year and Zyrtec for allergies, 15 mg Prevacid (once a day) for reflux, Vitamin C (2000mg once a day taking for years) for autoimmune and Multivitamin for years; Primrose oil and Biotin once a day for skin and hair from years; 500 mg two dose once a day of Vitamin D for bones and 1000 mg dose of Calcium plus D once a day for bones, 1500 mg dose of Fish oil with krill once a day for autoimmune and Glucosamine once a day for joints. In September 2015, few seconds (right after the injection) following the vaccination, the patient's arm was sore and could not lift her arm up for 24 hours. Laboratory data was reported as none. Corrective treatments were not reported. On an unknown date, after 24 hours the patient was recovered from the events. List of documents held by sender: none.
Arm remained sore and tender even though I did not baby it from day 2-day 6.  Some time on day 6, I noticed that the area around the injection site was still quite warm to the touch and had become itchy.  Yesterday, day 7 post vaccination, the itchiness intensified, and at times felt like it stung.  The area was rather warm to the touch.  This morning (1/19), I woke up with all of those symptoms but also an approximate 4"x4" raised, red hive surrounding the injection site.  The area below the skin feels firm and is still hot.  Not finding anything on the internet about this type of reaction.  Took 1 Benadryl to see if it helped (working so didn't want to take more).  Some minor relief for about 2-3 hours, but the symptoms are worsening now.
papular skin lesions about  noted on trunk, scalp and extremities. One big excoriated/ scabbed lesion noted on abdomen.
This case was reported by a nurse via sales rep and described the occurrence of local reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced local reaction. On an unknown date, the outcome of the local reaction was unknown. It was unknown if the reporter considered the local reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a significantly bad local reaction. For tolerance after 2nd dose of SHINGRIX, refer case US2018GSK202483. The reporter did not agree to be followed up.
Information was received from a nurse referring to an unknown number of unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were administered doses of improperly stored VARIVAX injection (lot# M049126, expiration date 15-DEC-2018) (Strength, dose, frequency, anatomical location and route were not reported) for prophylaxis. The concomitant therapy included sterile diluent which was used to reconstitute VARIVAX injection, was stored properly. The vaccines were exposed to 6 to 14 Fahrenheit degree (F) for 1.5 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects was reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA012152: US-009507513-1707USA012415: US-009507513-1707USA012416: US-009507513-1707USA012417: US-009507513-1707USA012419.