chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe tinnitus in right ear.  Please note that I have had tinnitus in my right ear for over 18 years.  My tinnitus would vary in severity at times, some days worse than others, but a "bad" episode, if you will, would usually last a day or two, then go back to what I suppose I could describe as my "regular" severity.  Since approximately the day after my vaccine, my right ear tinnitus has been the worse in, well, about 18 years I think.  It has been constantly "severe" since about a day after the vaccine.
Pt is a 11 month old female who received vaccinations on 9/19/00. Child had severe GER and Laryngomalacia at that time and was on Zantac and Reglan. 4 weeks later, she developed spastic muscle movements. Reglan was decreased and she continued to have spasms and then was dx'd with infantile spasms. The 60 day follow-up states infantile spasm.
Shortness of breath Chest Heavy Lightheaded; Shortness of breath Chest Heavy Lightheaded; Shortness of breath Chest Heavy Lightheaded; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246, expiration date not reported), intramuscular on 14Jan2021 10:15 at single dose on the right arm for COVID-19 immunization. Medical history included chronic pain and known allergies to sulfa. The patient's concomitant medications were not reported. The patient experienced shortness of breath, chest heavy, lightheaded on 15Jan2021 at 10:00. The patient has not recovered from the events at the time of the report. The patient was not pregnant, has no prior COVID vaccination and was not tested for COVID post vaccination.
Bloody stool (diarrhea) began 1 day after receiving ROTATEQ vaccine.
Extra dose administered; received 3 doses of Menveo (1st - 23May2019, 2nd - 04Feb2020, 3rd - 28Jul2020).; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 7-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (1st dose received on 23rd May 2019). Concurrent medical conditions included sickle-cell anemia.   On 28th July 2020, the patient received the 3rd dose of Menveo. On 4th February 2020, the patient received the 2nd dose of Menveo. On 4th February 2020, not applicable after receiving Menveo and unknown after receiving Menveo, the patient experienced extra dose administered. On 28th July 2020, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 3 doses of Menveo, which led to extra dose administered. No symptoms reported. The health care professional did not provide the lot and expiry date for each dose. The consent to follow-up was granted. This case had been linked with US2021082161, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021082161:same reporter
Patient was given the Janssen Vaccine, and is only 16 years old. This vaccine has only been given Emergency Use Authorization for individuals 18yr and older.
Severe chills; Body aches; Hot flashes; Heightened senses; Headache; Soreness all over; Vomiting; Tingling legs and arms; Temperature hovered around 99.9; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GW0172) via an unspecified route of administration in the right arm on 21Apr2021 at 14:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included unspecified birth control for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 31Mar2021 at 14:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 02:30, the patient experienced severe chills, body aches, hot flashes, heightened senses, headache, soreness all over, vomiting, tingling legs and arms and temperature hovered around 99.9 (UNSPECIFIED UNITS), began 12 hrs after vaccine and lasted the whole day. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. On 22Apr2021, the patient underwent body temperature test and the result was 99.9 (Unspecified units). Therapeutic measures were taken as a result of severe chills, body aches, hot flashes, heightened senses, headache, soreness all over, vomiting, tingling legs and arms and temperature hovered around 99.9 and included the treatment with paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events severe chills, body aches, hot flashes, heightened senses, headache, soreness all over, vomiting, tingling legs and arms and temperature hovered around 99.9 were recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Pt. reports raccoon mask on face that was on fire, neck, shoulders, and bilat. arms to the elbows swollen, tender, painful. Severe headaches and vomiting.
I had a patient that was feeling a rush throughout her body right after receiving the vaccine and felt a little tired, I had the patient wait for 30 minutes and offered her water and asked if she needed to go to the hospital. Patient declined water and the need to go to the hospital and agreed to wait. I kept on checking on the patient until she felt better and made sure that she was ok before she left.
Chest congestion with slight wheezing beginning about three hours after injection and lasting for about 48 hours.
received Flublok Quadrivalent instead of Fluzone High Dose, no AE; Initial information was received on 05-Oct-2020 regarding an unsolicited valid non-serious case from consumer/non-healthcare professional.  This case involves a 66-year-old male patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (dose, lot number expiry date, route and site were unknown) for prophylactic vaccination on 11-Sep-2020 (wrong product administered).   Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  This was a case of actual medication error due to wrong vaccine administered (latency same day).  At the time of report, no adverse event was reported.  There will be no information available on the batch number for this case.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Present with weakness, confusion, dissorientation, sore area at upper arm. IV therapy CMP, CBC, CT scan head. Presents with weakness. Had pneumovax yesterday. This am is enable to help with assistant. Is emotional post HF of curt. Both legs sluggish and not moving well.  Chief complaint; severe weakness and pain in riht arm. This 79 yr old white male pt post stroke does normally stay at home with his wife and is able to ambulate with a walker by himself. He received Pneumovax vaccination in his right upper arm today and now has complaints of swelling and pain in his arm and severe weakness in his legs. His wife is concerned that he may have a stroke. He did seem guite confused and disoriented this morning upon awakening, although now a couple hours later he appears improved and he also exhibited profound weakness being unable to get himself up from the bed which he normally can do. He has no fever. no recent illness. No sore throat. He denies cough, nausea, vomiting, and denies chest pain. As per acknowledgement letter, Wyeth is the manufact. for vaccine #1 but the lot number is not available.
Diffuse erythematous, tender, swelling left deltoid area on site of DTaP shot a day after immunization.
eczema; Pruritic rash; Mild redness; Generalize rash, worsening rash; itching all over body; This case was reported by a lawyer and described the occurrence of eczema in a patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for product used for unknown indication.   On an unknown date, the patient received Shingrix (unknown). On an unknown date, an unknown time after receiving Shingrix, the patient experienced eczema and itchy rash. On an unknown date, the outcome of the eczema and itchy rash were unknown.   It was unknown if the reporter considered the eczema and itchy rash to be related to Shingrix.  The initial information was received on 10 December 2020 via medical record. (Case medically confirmed). On 18 September 2020 the patient received recombinant Zoster(Shingles) vaccine 0.5ml in right deltoid. As per report dated on 08 October 2020 The patient had itching all over the body, in the morning he had rashes was given prednisone. The patient rash was worsening to legs and arms causing him to became very itchy. As per emergency department note dated on 14 October 2020, 76 year old male with multiple medical problems presents with pruritic rash that was diffuse and mostly noted on the extensor surface of his body as well as the intercrural region of his groin. The patient has been doing with this on and off for several weeks now since getting immunization of shingles, Tetanus, pneumonia. The patient had some Eczematous rash on extensor surfaces of leg, arms and intercrural region of his groin with some lichenification. The patient had mild redness. The patient had generalized rash and pain.
This is a spontaneous report from a contactable physician, the patient. A forty-two-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 13:00 (at the age of 42-years-old) as a single dose. Medical history included uterine bleeding, Hodgkin's lymphoma x 3 status post autologous bone marrow transplant, anemia, gastric sleeve surgery, chronic rhinitis, high Thyroid Stimulating Hormone (TSH). The patient had no allergies to medications, food, or other products. Concomitant medications included levothyroxine sodium (SYNTHROID), norethendrone (MANUFACTURER UNKNOWN) and ferrous fumarate (MANUFACTURER UNKNOWN), all taken for unspecified indications from unknown dates.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, the patient had itchy rash on neck and skin peeling on face. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included self-treatment with steroid cream (fluocinonide). The clinical outcome of the events itchy rash on neck and skin peeling on face were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
I experienced clogged milk ducts 6 days after each dose of my Pfizer COVID19 vaccine. The symptoms appeared in the morning and lasted about 12 hours in the first instance, 4-6 hours in the second instance. The clog was in the left breast, same side as the injection. Symptoms were much more severe after the first vaccine, but responded to home care both times. I had never experienced a clogged duct before and haven't had once since. After the clogs resolved, I experienced milk blisters that lasted several days.
Labored breathing, confusion/brain fog, disorientation and loss of focus, fever, extreme body chills, cold sweats, generalized aches and pains, severe malaise. Was not able to drive anywhere to seek medical evaluation. Did not yet feel threatened enough to call for ambulance but was scared about the breathing and mentation changes.   The first dose of the Moderna lot 011D21A caused hematemesis which I self treated with omeprezole for  3 days.  The other symptoms from the first dose were all common side effects. The second dose was much more severe.
Patient has a history of chronic panic attack . Present with signs and symptoms of anxiety. Patient reports feeling lightheadedness and dizziness after vaccine. Vitals all in normal limits . After being asses patient reports feeling better. Patient walk out of facility back to prior function
This spontaneous report was received from a healthcare worker and refers to unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored M-M-R II (strength, dose, frequency and route were not reported) lot # L009214 with an expiry date of 17-MAR-2017. No concomitant medications were reported. Patients did not seek any medical attention. No adverse effects were reported. There was no product quality complaint. This is one of the several reports received from the same reporter. Additional information has been requested.
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer.  A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm left on 08Apr2021 (Lot Number: EN6207) (at age of 51-year-old) as single dose for covid-19 immunisation.  The patient medical history included blood in his stool. Concomitant medications included mesalazine and tamsulosin, both taken for blood in stool. There was no additional vaccines administered on same date of the Pfizer Suspect. There was no other vaccine in four weeks.The patient was scheduled to get the second dose of the Pfizer Covid Vaccine on 29Apr2021. The patient want to reschedule because he took a Covid test and it came out positive. Event details: Last week ( also reported on 20Apr2021) he had a cold. His primary care doctor prescribed him medicine to take. He was still having headaches and coughing. He did not have a sore throat anymore.  He had a headache Tuesday (20Apr2021) and felt under the weather. He started to cough and had shivers. On Thursday (22Apr2021) he did a telephone meeting with his doctor and she prescribed him medication. He took it and he started to feel better. He still has headaches and coughing. After he took the medicine he started to feel better, and his symptoms weren't surfacing again. He still has some coughing, but he took Tylenol and felt okay. His cough wasn't too aggressive, it was just like a cold type of cough. It was not so severe. Last week (also reported on 20Apr2021) he came home having shivers and a fever. Now he didn't have a fever or shivers. He just has a headache and coughing, and it's not as severe. When she came home her mom said he had started to shiver. On Wednesday (21Apr2021)he started to take Coricidin cold and flu. He started taking those and started to feel a bit better. It reduced the fever and sore throat. They were symptoms of a cold. He took that as well as what the doctor prescribed, Azithromycin. The shivers went away with the cold and flu medicine and what the doctor prescribed. Most of his symptoms went away she believes Thursday or Friday (Apr2021). His fever went away on Wednesday (21Apr2021) when he took the cold and flu medicine and it reduced it. He didn't have a fever anymore. His temperature is always 97 or 98 when they take it. His sore throat started the same time as the fever on Tuesday (20Apr2021) to like Wednesday (21Apr2021). He started to gargle salt water and it went away. On Wednesday(21Apr2021) he took the cold and flu medicine and it helped make it go away. His symptoms started last Tuesday (20Apr2021) in the afternoon when he came home. The events did not result in emergency room visit. He had a new meeting with his primary doctor and told her how he was feeling. The outcome of events headache, cough was recovering, of shivers was resolved in Apr2021, of fever and Sore throat  was resolved on 21Apr2021, of the rest of events was unknown.
During injection of the vaccine liquid leaked from between the needle and the syringe. The patient did nto receive a full dose.
Arm immediately swelled and turned red, the Band Aid left an impression in her arm from the swelling, that was on Friday when she came to Employee Health on Monday the arm redness was about 4 inches wide darker red in color and still very warm with slight swelling. Because we concerned she may be developing cellulitis she was sent to the ER. They said it was allergic local reaction and that in time it should get better.
Twelve hours after first vaccine dose, experienced mild facial swelling, numbness. Resolved 6 hours later without intervention.
This spontaneous report as received from a consumer refers to her 79 years old sister. The patient was vaccinated with a dose of ZOSTAVAX (lot number, dose, route and indication not reported) on unspecified date in 2012. No other co-suspects were reported. No concomitant medications were reported. On 25-DEC-2012 the patient experienced eye pain and developed blisters around her eye and on her forehead. The patient sought unspecified medical attention and was given an unspecified treatment. The outcome of eye pain and blisters around her eye and on her forehead was reported as not recovered. The relatedness for eye pain and blisters around her eye on her forehead was not reported for ZOSTAVAX. Additional information is not expected.
Acute uticaria starting at injection site 10 days post vaccine, spreading all over  body within 2 hours of onset
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 05-Feb-2021 and Pneumonia.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had covid infusion shot on 5 Feb 2021.  No treatment medications were provided.
A patient was administered VARIVAX after a temperature excursion; This spontaneous report was received from a medical assitant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 01-JUN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number U029496, expiration date 21-SEP-2023 for prophylaxis (dose and route of administration not reported) (product storage error).      The vaccine underwent a temperature excursion of 8.3 degrees Farhrenheit for 15 minutes. No previous excursions were detected.
Right arm swollen and red, slightly warm/tender to touch. Went to Urgent Care, was told by PMD that probably local reaction to MCV4, and was told to take OTC BENADRYL by mouth and topically. Shots were given on 08/07/2018 and reaction occurred 08/09/2018. Went to urgent care this a.m. 08/10/2018. Phone call to pt./Mom to check on child, child eating and doing okay. No c/o nausea/vomiting or fever.
This case was reported by a consumer via call center representative and described the occurrence of shivers in a 74-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included peritoneal dialysis (at home daily), blood pressure high and type ii diabetes mellitus. On 25th June 2018, the patient received the 1st dose of SHINGRIX. On 25th June 2018, less than a day after receiving SHINGRIX the patient experienced shivers, erythema and pain. On 26th June 2018, the patient experienced pain ankle, leg pain, cough, sputum discolored, bronchitis and influenza-like symptoms. On an unknown date, the patient experienced balance difficulty. On an unknown date, the outcome of the shivers, erythema, pain ankle, pain and influenza-like symptoms were recovered/resolved and the outcome of the leg pain was unknown and the outcome of the balance difficulty, cough, sputum discolored and bronchitis were not recovered/not resolved. It was unknown if the reporter considered the shivers, erythema, pain ankle, leg pain, balance difficulty, cough, sputum discolored, bronchitis, pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller was friend of patient who received SHINGRIX on last Monday. The patient experienced soreness and redness at the sight that has resolved. The patient also experienced shivering that night and the next day after receiving SHINGRIX the patient  developed a bad cough with green sputum. 1 day after receiving SHINGRIX, the patient was seen by his physician and a chest xray ruled out pneumonia, he was diagnosed with Bronchitis and given Ceftaline antibiotic, but that was not helping the friend reports. At the time of reporting, the patient experienced terrible pain in his ankles, knees and legs that are like shooting pains that get worse with walking and she states it is affecting his balance when walking. The caller was friend of the patient. She was calling to provide doctor's information with permission to contact them.