chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to unknown number of nursing students. The patients were vaccinated with 3 dose of hepatitis B (manufacturer unspecified and RECOMBIVAX HB could not be ruled out (Lot number unspecified) (vaccination site unknown) on an unknown date and not seroconvert. The nursing students who had completed the 3 dose series and it had been less than 6 months since completion were given additional another 3 doses of hepatitis B vaccine (manufacturer unspecified) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. The outcome was unknown. The patient had sought unspecified medication attention. This is one of three reports from the same reporter. Additional information has been requested.
FROZEN VACCINE WAS THAWED AND GIVEN TO PATIENT; This spontaneous report received from a pharmacist concerned a 71 year old male. The patient's weight was not reported and height was 71 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, frequency one total, administered on 18-JUN-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced frozen vaccine was thawed and given to subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of frozen vaccine was thawed and given to patient was not reported. This report was serious (Other Medically Important Condition).
Shot given 10/16/02-on 10/18/02 pt returns to office with swollen arm L with moderate redness and tenderness over deltoid area of L arm (upper 2/3 of upper arm).
Redness and Itching on surface of upper left arm. It occurred 9 days after vaccination. It spread from the top of arm down 6 inches and 3 inches wide. It?s been 3 days and no real sign of improvement. No pain and not been to doctors.
I started getting a sore neck on 10/22/22, didn?t think anything of it. Then on Monday 10/24/22 I was eating breakfast and wasn?t able to move my lips as well. Then I couldn?t smile. I went to the ER at the Medical center. They diagnosed me with Bells Palsy.
2cm induration at injection site on right upper arm. Tx ice, Motrin, observe Prognosis expected healing. MD stated no pre existing reason to not vaccinate
Initial and follow-up information has been received from a physician for the Pregnancy Registry for Gardasil concerning a 16 year old female with no medical history or previous pregnancies who on 13-APR-2007 was vaccinated intramuscularly with a 0.5 mL dose of Gardasil (lot # 655165/0137U). Concomitant therapy included pre-natal vitamins. On 01-MAY-2007 a pregnancy test was performed because of amenorrhea and found to be positive with an HCG results of 29576. The estimated conception date was 7 weeks and the estimated delivery date was 22-DEC-2007 (LMP was not known). On 16-MAY-2007, an additional HCG test was performed with a result of 74136. The patient sought unspecified medical attention. In May 2007, the patient experienced a spontaneous abortion. It was noted that the patient was currently under a physician's care and that she was permitted to return to normal activities without limitations. At the time of this report, the outcome was unknown. No further information is available.
Onset of side effects approx. 10 hours after injection. Headache, Slight fever, Sweating, Tiredness. Took Tylenol for headache and fever. Tiredness persisted until the next evening ( 24 Hours).
Swollen red painful right thigh - BENADRYL. Heat or cold. TYLENOL or MOTRIN, did resolve, couple days.
pt recvd vax & devel soreness, swelling, redness, firmness LL after inject; LL was red & warmth;
Generalized pink papular rash with fever 100-101 present x 4 days, rash seems intermittent.
This spontaneous report as received from a registered nurse refers to a 6 month old patient. On 25-JUN-2013 and 27-AUG-2013 the patient was vaccinated with the first dose and the second dose of ROTATEQ, suspension 2, (lot#, expiration date and route unspecified). On 28-OCT-2013 the patient was vaccinated with improperly stored of ROTATEQ, suspension 2, (lot # J007283, expiration date 27-SEP-2014 and dose unspecified). No adverse event reported. This is one of several reports received from same source. Additional information is not expected.
History left thigh swelling, redness after vaccination, evaluated 2 days after vaccination given, improved, no erythema, 1cm by 1cm firmness.
Had a mild case of shingles a year and a half after her second shot / Diagnosed by her HCP/ Confirmed vaccination failure; Had a mild case of shingles a year and a half after her second shot / Diagnosed by her HCP; This case was reported by a consumer via call center representative and described the occurrence of confirmed vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2018, the patient received the 1st dose of Shingrix. In September 2018, the patient received the 2nd dose of Shingrix. In January 2020, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient stated that, she had a mild case of shingles a year and a half after her second shot.  The reporter did not have the specific dates. The patient had phoned to praise the company about not using aborted fetus cells for vaccinations and upcoming Covid Shot. This case was considered as confirmed vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation were known at the time of reporting. The reporter did not consent to follow up.
This is a spontaneous report from a non-clinical study program, by a contactable consumer (the mother) who reported similar events for two patients (her two sons). This is the first of two reports. A 21-year-old male patient received TRUMENBA, Lot Number and Expiration Date: J28923 JUN2016 via an unspecified route of administration at 0.5 ml, single on 20JUN2015. The patient was not having any other medical conditions and as not taking any other  medications. On 21JUN2015, the patient experienced swelling and tenderness of lymph node under arm/tenderness at the injection site/glands at the injection site are swelling under the arms. Therapeutic measures taken as a result of the events included administration of ADVIL. The patient did not undergo any lab work. The outcome of the events was recovered. The patient's brother reported the same events after administration of the same vaccine (first dose). Follow-up (22JUN2015): New information from a non-clinical study program, by a contactable consumer (mother) includes: report type from spontaneous, patient's age, date of administration, details of the events, onset and outcome, treatment. Follow-up (16JUL2015) and 6JUL2015): New information from a non-clinical study program, by a contactable consumer (mother) includes: vaccine details, event onset and outcome.
I am completing this for my sister, who died today 5/5/22.  She told me that following the shot, she became very sick and was in bed in pain for 2 weeks. Before the shot, she was relatively healthy, working full time, was active in her community and garden.  Following the shot, over the next months, she told me she suffered from the following: High Blood Pressure, Worsening Eye Vision Health, Anxiety and Panic Attacks, Worsening Neuropathy. A Fall that broke her leg, necessitating a rod placed in her leg with surgery, Edema, Rash, Autoimmune Issue, Incontinence, Jaundice,and Kidney dysfunction,finally Liver Failure.
Client received influenza and hep A vaccine at 4:30 PM on 12-16-2014. Developed low grade fever through the night then good on 12/17/2014 but went to ER at midnight after having febrile seizure. Temp was 103 degrees in ER.
about 10 mins after patient recieved the Moderna vaccine she came in c/o numbness to lip area only and felt warm like mint.  Vitals obtained.  SPO2 100% on RA  BP138/82 P70 and regular.  Denies any difficulty breathing or shortness of breath.   Rapid response called and patient transfered to ER for observation
I had a sore throat, difficulty swallowing, and coughing. I tested positive for COVID-19 at home. My doctor prescribed me Z-PAK. I started feeling better after a couple days of taking it.
feels dizzy and woosey; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer, reporting for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine this morning, on an unspecified date in Jan2021, and felt dizzy and woosey - wondering if that was normal. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Multiple erythema papules on face, trunk and perineal area; erupted 11 days, post vax. Afebrile, no runny nose or cough.
PATIENT RECIVED VACCINE AND PASSED OUT WITHIN 5 MINUTES AND REGAINED CONSCIOUSNESS, EMTs responded and patient was released, patient's  alternative domestic number listed above
Pt reported that the day after injection he experienced increased fatigue, headache, nausea, and reported that his "arm felt like it was punched." Pt reported 3/6/2020 that he has continued to have headaches and fever with nausea. Pt is taking Tylenol OTC for pain and fever relief.
This spontaneous report as received from a physician via company representative refers to a 12 year old (reported as 12 or 13 year old) female patient. There were no pertinent medical history and allergies. In May (year not reported) the patient was vaccinated with GARDASIL dose 1. Patient received second dose of GARDASIL in July (year Unknown). No concomitant medication was reported. On an unknown date the patient experienced swelling of the lymph nodes underneath her collar bone on the left side of her body like the size of the piece of corn in May and July after receiving the first and second doses of GARDASIL. Treatment was not given. No lab diagnostics were performed. There was no intervention to prevent serious criteria. Product quality complaint was not involved. The outcome of swelling of the lymph nodes underneath her collar bone on the left side of her body was unknown. The causality of swelling of the lymph nodes underneath her collar bone on the left side of her body with GARDASIL was unknown. Additional information has been requested.
The patient had a very sore arm the day after the vaccine. Two days after the vaccine the arm went limp. She got weaker, feeling very hot all over body, pain all over body, dizziness, had trouble walking, had trouble driving. She was homebound for 2 weeks. She is going to biochemical therapy.
Covid like symptoms left me bedridden for 36 hours. Temp, Chills, headache, nauseous, aches.
Gradual increase in right hip joint pain after first dose,  intensified after second dose and continued to worsen over the next two months.  Treated with a daily tablet of OTC naproxen since June 1.  Hip pain is decreasing and continuing to decrease, but not yet to the point where the daily naproxen can be discontinued.
pt on immunosuppressive therapy for RA; presents to ED with respiratory failure; O2 supplementation; positive for COVID; transferred to ICU; given dexamethasone and ABX for bacterial pneumonia; DNR; O2 sats worsened; pt's condition declined and she passed away in the hospital
COVID arm symptoms except a spotted rash instead of a red circle. Slight tightness in the right arm around the elbow and near arm pit area. 2 days of soreness on forearm near veins.
Pt c/o flu shot hurting when received. Was bruised and painful for apprx one week. Pt c/o area where shot was given still painful with certain shoulder movements.
had chills after shot and all night, very very tired, but not sleepy, couldnt sleep, next morning felt terrible throughout day felt dizzy, chills, upset stomach, headache, shot arm hurt to move and felt very heavy. very .very very tired again. couldnt sleep, restless again., not very hungry.  third day still some symptoms especially very tired, but not sleepy. next day just still very tired
Patient called the pharmacy today, September 8, 2019 indicating that she has beed having severe arm and shoulder pain since yesterday at the site were she got a flu shot and pneumonia sho,  2 weeks ago. She indicates that at the time of the vaccines she had no pain, no inflamation, no redness, no fever or any other side effect. It was not until yesterday that her arm started to hurt. I asked if she had injured her arm in any way, but she denies any injury. She indicates she took ibuprophen and applied ice packs but it has not really helped. Recomeneded she see her primary care physician tommorrow for further evaluation.
This spontaneous report was received from a Licensed Practical Nurse on 13-DEC-2016, concerning a 7 years old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 08-APR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD for prophylaxis (lot number: L050907) (dose number, frequency, route of administration and anatomical location were not reported). No adverse event was reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA013756: US-009507513-1610USA013820: US-009507513-1610USA013819: US-009507513-1610USA010040: US-009507513-1612USA008581: US-009507513-1612USA008583: US-009507513-1612USA008584: US-009507513-1612USA008585: US-009507513-1610USA013756.
6:02 PM- 1st dose of Moderna administered on RA, Lot # 029A21A   6:12 PM- pt. Complained of throat closing and hoarseness in voice. Dr.  by chair side monitoring patient   6:14 PM- EPI pen 0.3mg administered on right thigh by Dr. . Called 911 VS 147/97, 121, 96%   6:16 PM- Benadryl 50mg administered IM by licensed nurse VS 146/91, 119, 96%   6:21 PM- Pt c/o chest pain   6:23 PM- VS 128/85, 122, 96% Pt continues to complain of chest pain  Fire arrives and takes over.   Report given to  to , paramedic
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Tachycardia-Mild, Systemic: Unable to Sleep-Medium, Systemic: Weakness-Medium
Patient with history of type 2 diabetes. She was brought to the ED by EMS on 8/30/23 with a few days of sore throat, dry cough, body aches, fatigue, and weakness. In the ED, a COVID-19 test was done which resulted positive. Due to the degree of her weakness, the patient was admitted 8/30/23 - 8/31/23 for observation. Of note, the patient has received the primary COVID vaccine series and three boosters.
Approximately 18 hours post injection, severe headache detected upon awakening. Sharp pain across top of head.  650mg Tylenol, no improvement. 22 hours post injection, 400mg Ibuprofen, no improvement. Continued to rotate Tylenol & Ibuprofen every 4 hours, although did not generally improve the headache. 24 hours post injection, moderate to severe (fluctuating) exhaustion began. 24 hours post injection, low grade fever (99.6 - 100.8 F) & chills. Increased fluid consumption. Complete loss of appetite. 48 hours post injection, extreme dizziness, extreme nausea, loss of consciousness (fainting). Intake fluids. 60 hours post injection, improvement felt in headache & exhaustion. 72 hours post injection, symptoms 95% resolved.
04/28/2021: Patient transferred from Hospital with shortness of breath, COVID-19 Positive 4/30-5/16: Patient condition deteriorated. Had repeated episodes of hypoxemia and hypotension - was intubated on mechanical ventilation, eventually switched to pressure control inspiratory pressure, extubated, had to be reintubated. Developed A-fib, leukocytosis worsened, Xray showed tension pneumothorax on right side - chest tube placed. 5/17: Family counseled - patient placed on comfort care, remained on ventilator. Time of Death: 05/17/2021, 16:00 Causes of Death: Bilateral Pulmonary infiltrate, Acute hypoxic type 1 respiratory failure, ARDS, Right Pneumothorax, Acute COVID-19 viral pneumonitis with probable bacterial superinfection, Atrial fibrillation with rapid ventricular response, Septic Shock, Bleeding rom lung/ETT -  resolved, Possible Mucor in mouth, Candida tracheobronchitis, Previous history of prostate cancer status post radiation, dyslipidemia, hypertension present at admission.
Right arm was barely sore where injection administered; This is a spontaneous report from a contactable consumer (patient).  A 78-year-old male patient received first dose of BNT162B2 (Lot number: EL0142), via an unspecified route of administration on 11Jan2021 17:05 at single dose in the right arm for vaccination. Medical history included eye vitamin/To maintain good eye health, eye disorder, Heart supplement, heart disorder and he had his last annual physical with Pneumocystis pneumonia (PCP) in Oct2020. He had his flu shot in Sep2020. Concomitant medication included ramipril taken for probably at least 15 years, started in his 60s; atorvastatin taken for probably at least 15 years, started in his 60s. He believes this is the generic product for Pfizer Lipitor; acetylsalicylic acid (ASPIRIN CHILDREN) taken for probably at least 15 years, started in his 60s; ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS) (also reported as "Advanced Retinol Eye Study Disease") for eye vitamin/To maintain good eye health; bioflavonoids nos, lecithin, quercetin, ubidecarenone (CO-Q-10 PLUS) taken for probably at least 15 years, started in his 60s for Heart supplement; and unspecified multivitamin taken daily and probably taken all his life, all ongoing. This patient reported he was administered his first dose of Pfizer COVID-19 vaccine on 11Jan2021. There were no side effects; his right arm was barely sore where injection administered on 11Jan2021. Onset probably about 19:05-20:05 and he had recovered completely by the next morning when he woke. He had no discomfort during the night, no pain or throbbing, he felt very normal the next morning. He clarified that he has no medical conditions, no flu or illnesses of any other kind. He had his last annual physical with PCP in Oct2020; he has a twice yearly check-up with the Cardiologist that will be coming up soon. Stated that today is the 21st day and he is scheduled to get his second dose at 3:00pm. He asked how the incremental immunity builds up percentage wise after getting the first and second dose of Pfizer COVID-19 vaccine. He asked if there is any restriction or limitation on taking products like Tylenol, Advil or Aspirin before getting the Pfizer COVID-19 Vaccine; and if those products are ok to use to potentially treat side effects from the Pfizer COVID-19 Vaccine such as if patient has sore arm or something; and how soon after the second dose side effects can kick in-he believes the briefing documents he was given for the Pfizer COVID-19 Vaccine said 2-14 days. He asked this particularly because he has an hour drive home after this second dose and wanted to know what to anticipate before attempting to drive home. His wife thought someone told her not to take any Tylenol, Advil or Aspirin before getting the Pfizer COVID-19 Vaccine which they had not heard of elsewhere, and saw no mention of that in the briefing documents given for the Pfizer COVID-19 Vaccine. The with outcome of the event was recovered on 12Jan2021.
Patient received a pfizer monovalent covid-19 vaccine after 4/18/23, when the FDA deauthorized it. Provider will inform patient about the recommendation to receive the bivalent covid-19 vaccine after the minimum interval passes.
stomach pain which was worsened by eating; diarrhea; burps that taste like something; a minor feeling near where I got shot; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain which was worsened by eating), DIARRHOEA (diarrhea), VACCINATION SITE DISCOMFORT (a minor feeling near where I got shot) and DYSGEUSIA (burps that taste like something) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE DISCOMFORT (a minor feeling near where I got shot). On 12-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain which was worsened by eating), DIARRHOEA (diarrhea) and DYSGEUSIA (burps that taste like something). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) on 12-Jan-2021 for Adverse event, at an unspecified dose and frequency. On 11-Jan-2021, VACCINATION SITE DISCOMFORT (a minor feeling near where I got shot) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomach pain which was worsened by eating) and DIARRHOEA (diarrhea) had not resolved and DYSGEUSIA (burps that taste like something) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: No new information reported; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Received two doses of Tdap.  First dose 6/11/2009 and second dose today, 7/21/2009.  No adverse reactions at this time.
Dr treated pt for "shingles in her eyes". Shingles had almost cleared & pt received Flu shot & shingles exacerbated again. Dr told family he has 3 pts this has occurred with.
Patient experienced a vasovagal response post-vaccination (fainting).  She was lowered to the floor in time to prevent any damage to herself or others.  She did not experience any further reactions or need any further medical attention after the reaction.  EMS was called to the scene as a precaution, and also in response to her mother's fainting (who was not immunized - just in response to the patient's reaction).
erythema multiforme most promenent on lower extremities spreading to trunk;rx pediapred