chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Nurse Practitioner (N.P.) concerning a female patient with a negative titer, who on unknown date was vaccinated with the first dose of VARIVAX (Merck) (lot#, dose and route not reported). It was reported that one week later following vaccination, the patient experienced deafness in her left ear and tinnitus in the right ear. The patient was not recovered from the events at the time of reporting. The patient sought unspecified attention (unknown location). Upon internal review, deafness was determined to be an other important medical event. Additional information has been requested.
I started seeing red blotches on my right arm and then it spread to both legs. I have eczema, so I thought that's what it was. I went to see my doctor, and she said it was a reaction to the vaccine. One of the nurses said the vaccine probably triggered my eczema and they have been seeing it a lot. She gave me a Vitamin D ointment and told me to use my eczema meds as well. It took a while to clear up, but it's better.
30APR sx started, wrist-aching, numb, knees, hands looked crippled, using Ecotrin since then, using mineral ice also, numb & tingling of hands has gone, MD called rt hand swollen;
Swelling of entire left arm with erythema warmth to mid forearm and back to scapula.
This is a spontaneous report from a contactable consumer (patient). A female patient, of unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, on Mar 14, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. She received the 1st dose on Mar 14, 2021. On Thursday, Mar 18, 2021, there was swelling and a weltering rash on the outside of her neck. She had an extreme sore throat on Mar 2021. She asked how she can treat these. She was still experiencing these side effects. The outcome of events: not recovered. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Refrigeration excursions identified/ Vaccines stored in the refrigerator underwent several temperature excursions; No adverse event; Vaccines have undergone several temperature excursions and may have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/ Vaccines stored in the refrigerator underwent several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Sep-2022 at 6:56 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 dosage form. On 24-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/ Vaccines stored in the refrigerator underwent several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/ Vaccines stored in the refrigerator underwent several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/ Vaccines stored in the refrigerator underwent several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient).    Concomitant medication information was not provided. The nurse reported about Moderna monovalent and bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022 that were administered to patients. The patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle. The patient received the fourth dose of Moderna COVID-19 bivalent vaccine on deltoid muscle and no adverse reactions were reported. No treatment information was provided.
Moderna COVID-19 Vaccine EUA: on clinic follow-up visit patient reports tongue and lip angioedema, nausea, and vomiting within five minutes of immunization. Patient did not seek treatment at vaccination site and went home. Symptoms persisted for one day and resolved without treatment.
Severe leg weakness; Went from walking with a cane without any assistance to walking with a walker to needing a wheelchair any time we leave the house within 4 weeks immediately following the 2nd dose; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 10Mar2021 13:00 as single dose for COVID-19 immunization. Medical history included breast cancer (Breast CA), diabetes, high cholesterol, hypertension (HTN), and known allergies to Sulfa, and Penicillin (PCN) from an unknown date and unknown if ongoing. The patient has no history of covid prior vaccination. Concomitant medications included rosuvastatin calcium (CRESTOR); fulvestrant (FASLODEX); palbociclib (IBRANCE); and metformin, all taken for an unspecified indication. The patient was also reported to be taking BP medication (unspecified) concomitantly. The patient previously took codeine and experienced allergies, and also previously received the first dose of BNT162B2 on 11Feb2021 01:00 PM on right arm, for COVID-19 immunisation. The patient experienced severe leg weakness on 12Mar2021. It was further described that went from walking with a cane without any assistance to walking with a walker to needing a wheelchair any time she leaves the house within 4 weeks immediately following the 2nd dose. As reported, it was a very fast decline. She has trouble ambulating by herself with the walker in the home and cannot be left alone at night. The events resulted in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 3 days, and disability or permanent damage. No treatment was received for the events. The patient was COVID tested post vaccination via nasal swab on 11Apr2021with negative results. The outcome of the event was not recovered.  Information on the batch/lot number has been requested.
COVID positive; COVID positive; flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 26Sep2021 as dose 3 (booster), single (Lot number: FE2588) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 03May2022, outcome "not recovered", VACCINATION FAILURE (medically significant) with onset 03May2022, outcome "unknown" and all described as "COVID positive"; INFLUENZA LIKE ILLNESS (non-serious) with onset 03May2022, outcome "unknown", described as "flu like symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Positive; (10May2022) Negative; (14May2022) Positive. Therapeutic measures were taken as a result of covid-19.  Additional Information: Antiviral details: Product: COVID 19 Treatment (Paxlovid) on 03May2022 and stop date=08May2022. Indication is used for treatment of COVID-19. The patient had no Known allergies. The patient received other medication in 2 weeks Bystolic. Adverse event: The patient experienced COVID positive 03May with flu like symptoms. Started on Paxlovid same day. Good response. Completed course on 08May with strong metallic taste and diarrhea and mild muscle aches as side effects. Tested negative 10May. Again became symptomatic on 13May- marked Ronny nose, congestion, mild GI symptoms. tested positive on 14May. Adverse event start date is on 13May2022. If patient was not recovered. The patient did not receive treatment.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Vaccination failure and COVID-19  which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
"I ache all over. They said that anthrax vaccine can settle in your joints", 33 year old ADANG currently followed by HC for suspected post/small pox vaccine myopericarditis. During 6-12 week cardiac update in July, pt had new complaint of joint and muscle pain. In June, 2003, pt noted new onset pain in multiple joints and muscles. Joint pain began in bilateral knees and elbows and later affected ankles, shoulders, wrists, hips, neck and fingers. Describes joint pain as "aching". Myalgias experienced in lower back, calves and biceps. Describes pain "like muscles are tight after excerise". Rates intensity of pain as 5-7 on pain scale of 0-10. Pain is intermittent and migrates without specific pattern. Pain increases with weight bearing and upper extremity use; hand especially hurt after driving long distances. Gets some relief with 3-4 Tylenol and with Ben Gay rub. Denies redness or warmth at joints. Occasionally has mild edema of hands. Currently experiencing dull, generalized headaches approximately 1 x week. Date of onset of cardiac-related symptoms: 4/27/03. Developed substernal chest pain with mild shortness of breath that lasted approx. 1 hour before resolving spontaneously. The following morning, experienced recurrence of shortness of breath and chest pain that radiated to his jaw and down his left arm. Also, complained of left arm of numbness, generalized weakness, diaphoresis and dizziness when walking. His evaluation at that time showed diffuse ST elevations and positive troponins. Currently, pt reports no cardiac-related symptoms. During June and July, 2003, pt experienced some dyspnea on exertion and  decreased exercise tolerance. He participated in a cardiac rehab. program for 3 weeks with improvement of symptoms. Now, back to baseline. Pt may take Propanolol and Immitrex (no cardiac contraindication). Stop smoking!
This spontaneous report as received from a licensed practical nurse refers to the three patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD injection (lot # M021428 with expiry date on 19-OCT-2017, albumin status: recombinant human albumin (rHA); dose was not reported). No adverse effects were reported. Additional information has been requested.
7 days, post vax, the pt had a temperature of 105.4F (rectal) with listlessness and minimal other symptoms.
pt recvd vax; 23jan95 red papules, fever 102.6; throat cult = neg; 30jan95 rash much worse;
The patient received Menactra that was exposed to negative 51 Fahrenheit for about 14 hours with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via Global Medical Information (GMI) (Reference number- 00672249) and transmitted to Sanofi on 07-Jul-2021.  This case involves a 16 years old female patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], which was exposed to negative 51 F (Fahrenheit) for about 14 hours (Product storage error).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.5 ml second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6919AA, expiry date: 13-Apr-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to Product storage error temperature too low (latency: same day).  It was reported "The physician mentioned that the temperature excursion was discovered after 3 people had already received the Menactra and she called to confirm if revaccination was needed"  At time of reporting, no adverse event was reported.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. The classification as a medical error was 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 had contributed to or is to be held liable for the occurrence of this medication error.
This is a spontaneous report from a contactable dentist calling on behalf of his mother. A 95-year-old female patient started to receive PREVNAR13 intramuscular on 18FEB2015 at 1DF, single and CORTISONE, via an injection in her hip from an unspecified date at unknown dose for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced she has been out of it, confused/seems very confused, lethargic and trouble walking on 19FEB2015. The patient underwent lab tests and procedures which included blood test: it was all fine on 17FEB2015. The action taken in response to the events for PREVNAR13 was not applicable and for cortisone acetate was unknown. The outcome of confused and lethargic was not recovered and trouble walking outcome of unknown. Follow-up (20FEB2015): New information received from the same contactable dentist includes: product data and reaction data.
Redness and inflammation at the site of injection that started 6 days after the vaccine administration. Patient was seen on day 10th after the vaccine administration  and cellulitis of the left shoulder was found on assessment. Patient has tried cold compresses at home with good results, however redness and inflammation has not resolved yet.
9 hours after the shot I got a fever , my body started shaking uncontrollably, my whole body hurt everywhere , I was nauseated and dizzy .
Fever, chills, body aches, very lethargic, vomiting, dizzy, headaches
Right after getting the vaccine I got a metallic taste in my mouth that wasn't there before, and it has lasted the las two hours (since I got the shot)
Information has been received via a company representative, from a nurse practitioner, concerning the adolescent daughter of a friend, who was vaccinated (date and dose not specified) with a dose of Gardasil. Following the vaccination, the adolescent experienced a headache which lasted about 2 hours. No further information is expected.
*  Sinus congestion within 24 hours *  Coughing w/  Phlegm * Shortness of breath.  Just walking across room caused heavy breathing.   Not normal for me * Very noisy breath when laying down.  In particular on left side * Headache from poor sleep/breathing * No fever * Lasted for 2-3 weeks. * After 2 1/2 week, Dr. prescribed Prednisone.  This cleared up the condition within 3 days
01/25/2022 : I started with having a fever, body aches and pains, pain in both of my lungs, severe shortness of breath, fatigue, exhaustion, muscle weakness, I spoke with my pulmonologist and was given an antibiotic and prednisone. On February 4th, we did a chest x-ray due to the symptoms that were still occurring. This showed mid-left lode pneumonia. I started to notice that when I took Ibuprofen eased the systems I was having. March 1st I did another chest x-ray that showed pneumonia mid-right lode. I still did not continue to get better. March 26th I called about pain in both lungs and the symptoms I was still having previously, I had another x-ray on March 26th that showed a third new pneumonia on the left lower lobe. Ibuprofen continues to give me ease of breathing, These symptoms have prolonged now for over 2.5 months. I am currently on broad spectrum antibiotics. I have a dry deep cough in addition to all the other symptoms. Lately I have also been having night sweats that has dissipated since. I was also told that there was irreversible scar damage on both lungs from the radiology report.
Reaction began 06/03/2003 after shot given 06/02/2003.  Dollar sized red area and leg swollen.  No fever.  Benadryl and Motrin given.  Warm/cold compresses.  Improved by afternoon and next day child has (down) pain.  Able to walk ok.
10 1/2 cm x 9 1/2 cm localized site reaction, erythema (blanches) warmth and mild induration; tender to touch
Nurse completed attestations with patient. Patient had not experienced any previous reactions to the Covid-19 nor any other vaccines. Nurse advised was administering the Moderna booster. At approximately 930am, the patient received the vaccine and the nurse completed the 15 minute observation period and noted  no adverse reaction in the portal.  The patient's sister (caregiver) was present during the vaccination and the observation. No adverse reaction was observed. At approximately 130pm four hours after the vaccine), the patient's sister (caregiver) reported to Agency that her sister was having trouble breathing and felt hot.  Agency advised calling 911 and/or speaking to the primary care physician. Caregiver advised their brother is a physician and they had contacted him. Caregiver advised the patient thought the room was just too hot and they declined to call 911.   At 630pm, the caregiver called Agency to advise the patient was feeling worse and they were calling 911.
This spontaneous report as received from a physician refers to several patients of unknown age. The patients were vaccinated with VARIVAX (Lot#, dose and route not reported) instead of ZOSTAVAX for shingles. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was not known if the patients sought for medical attention. Follow-up information has been received from a physician via a telephone memo on 10-AUG-2012 concerning that 12 patients were administered VARIVAX (Merck) instead of ZOSTAVAX. The physician did not want to provide any patient identifiers, but stated that the clinic was making follow-up calls at the time of reporting to 9 patients who would be vaccinated with ZOSTAVAX 2-3 weeks later. And this is one of the 9 patients. No further information is available. This is one of several reports received from the same source. Additional information is not expected.
Information has been received from a medical assistant referring to 2 or 3 patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored VAQTA (dose and route not reported; lot # K005323 and expiration date: 10-FEB-2017; data logger). There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Information has been received from a physician concerning a female who on 23-AUG-2007 was vaccinated with the first dose of Gardasil.  On approximately 23-AUG-20007 the patient experienced hives on her neck and face.  The patient sought medical attention from her physician.  Additional information has been requested.
I started having vaginal bleeding. It was light in quantity and brownish in color. I have never had vaginal bleeding with this pregnancy before. When I was out of town, I went to the nearest Medical Center on 11/5/2021. They hooked me up to a monitor to check the baby's heart rate. They checked my cervix. They did an ultrasound, but could not find anything, and they didn't find a cause as to why I am experiencing vaginal bleeding. They really weren't concerned because it was just light bleeding. Today, 11/9/2021, I went to see my PCP doctor at Wellness Center. They checked the baby's heartbeat. They checked my cervix also and didn't find anything concerning. I was told to go back to the ER if the vaginal bleeding had increased. I am still experiencing the light bleeding. This is my first time having a baby, and the baby's due date is February 8, 2022.
Sick; This case was reported by a other health professional via sales rep and described the occurrence of sickness in a adult patient who received Herpes zoster (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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received 1st dose of Shingrix and was sick. For tolerances of 2nd dose, refer case US2019GSK081721.
Dizziness, Headache, Myalgia, Arthralgia, Fever, CoughWheeze, NauseaVomiting, inj site pain/sore, chills, sore throat, swollen lymph nodes Narrative:  inj site pain/sore; body aches, fever, chills, headache, nausea, vomiting, dizziness, sore throat, swollen lymph nodes, headache
EXCRUCIATING PAIN THAT GRDUALLY RESOLVED IN 4 DAYS
Became sick after 3rd HPV GARDASIL vaccine was diagnosed with POTS. Waiting to see neurology has memory problems, muscle and nerve twitching and shocking headaches.
This spontaneous report as received from a physician refers to two unspecified female patients in their 50's. The patients' medical history included postherpetic neuralgia. On an unknown date the patients were vaccinated with ZOSTAVAX, vial, (lot #, expiration date, dose and route unspecified) for Shingles Vaccination. Concomitant medication included Unspecified Pain Medication. On an unknown date, within two weeks both patients stated that their postherpetic neuralgia had gone away. The pain had not come back as of reporting date. The patients had not sought medical attention. The event outcome was unknown. Additional information has been requested.
PATIENT ASKED TO GET THE SECOND DOSE OF MODERNA. TECH ENTERED AND ADMINISTERED  THE SHOT WITHOUT REALIZING IT WAS 15 DAYS EARLY UNTIL PATIENT GAVE HIS VACCINATION CARD. THE SYSTEM FAILED TO FLAG THAT IS WAS TOO EARLY. PATIENT RECEIVED THE FIRST DOSE ON 05/09/21