chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1APR92 seen by MD for rash on body, swollen lymph glands in neck 7APR92 pt reported joint pain, started in rt wrist, progressed to fingers, other wrist, knees; fingers on lt hand swollen, also lt ankle; MD advised anti-inflam 10APR92;
On 01/28/2001 the patient experienced a headache followed by eruptions of lesions, described by the nurse as approximately 40 vesicles on the child's arms, chest, back, face and scalp with some crusting. There was no treatment ordered. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 14-FEB-2017 at 11:04, the patient was vaccinated with improperly stored VARIVAX injection (lot # M018436) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000473: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453.
This spontaneous report as received from a pharmacist refers to a 63 year old female patient with stroke. On 03-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot# J000446; expiry date: 11-APR-2014), 0.65 ml, subcutaneous in the arm for prevention of shingles. Her relevant concomitant medications and relevant past drug history were unknown. Immediately after getting ZOSTAVAX on 03-MAY-2013, she experienced shooting pain all the way to the spine from her arm. Later that same day, she began experiencing swelling in her arm where she received the injection, upset stomach, increased heart rate, dizziness, right ear pain, and mild fever. Her temperature was around 100 degrees. As of 04-MAY-2013, it was unknown if she would received ZOSTAVAX again and the events continued. Additional information has been requested.
RED, HOT, SWOLLEN, AND TENDER INSERTION SITE. DIARRHEA AND VOMITING. OCCURRED 12 HOURS AFTER IMMUNIZATION. KEFLEX 750MG QID. IBUPROFEN. PHENERGAN QID PRN. IMMODIUM PRN. NO MILK PRODUCTS OR CAFFEINE FOR A COUPLE DAYS. ICE OK, ALT WITH HEAT.
Left arm became swollen and red after shot (PNEUMOVAX) over a few hours. Pt took ibuprofen for issue overnight. Between report at 9:30 1/17/18 and noon 1/17/18 - swelling down, no headache/pain just discomfort. Pt says no further intervention is needed after suggestions to seek further treatment.
Pt recvd 3 doses of Engerix-B, 3rd dose given 17SEP90 & it was determined that pt did not convert to a protective surface antibody level;
pain in his lower back; Pain radiates down legs; sounds like Sciatica; pain in hips; inflammation in his lower back and hips; This spontaneous case was reported by a pharmacist and describes the occurrence of BACK PAIN (pain in his lower back), PAIN IN EXTREMITY (Pain radiates down legs), SCIATICA (sounds like Sciatica), ARTHRALGIA (pain in hips) and INFLAMMATION (inflammation in his lower back and hips) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-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 experienced BACK PAIN (pain in his lower back), PAIN IN EXTREMITY (Pain radiates down legs), SCIATICA (sounds like Sciatica), ARTHRALGIA (pain in hips) and INFLAMMATION (inflammation in his lower back and hips). At the time of the report, BACK PAIN (pain in his lower back), PAIN IN EXTREMITY (Pain radiates down legs), SCIATICA (sounds like Sciatica), ARTHRALGIA (pain in hips) and INFLAMMATION (inflammation in his lower back and hips) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  The patient was prescribed with Steroid injections.
Patient reports experiencing accelartated speech and thinking 15-20" after receipt of vaccine lasting several hours. Hyperverbal behavior was noted by fellow staff.
She got her vaccine, her arm was sore.  Then about 3:00 PM she started feeling really nauseous, and then started throwing up.  Then after that she started getting stomach pains in the top of her stomach, really bad.  She had both of them going on, then her pain went into her back.  It just go so bad that she went to the hospital, and spent 6 days in the hospital, and was transferred to another HCF where she spent 6 days with diagnosis of acute pancreatitis.  She did have her gallbladder removed prior to this, (9/25/21) and could not figure out why she had it, she does not drink.  She had multiple tests performed at the hospital.  Once she was discharged she was OK, except that she still was having a lot of stomach issues, like when she eats she would go to the bathroom within an hour.  She went back to the doctor on 6/16/22 and they were going to schedule her an APT the next month, but the doctor said that she needed seen sooner and was seen on 6/16/22 to the specialist, and on 6/17/22 she had an ERCP, which revealed that her bile duct may have been damaged when she had the gallbladder removed, and it was closed off and rolled up into a ball.  She is now on medicine to digest all of her food.  She has another medication that she takes to keep her from using the bathroom fast.  She still has tenderness in her stomach and feels that she is not right.  She did not hear from the doctor who did the ERCP after her doctor contacted them for her to FU.    She had been feeling perfectly fine prior to the vaccine, and then within a couple of hours from the vaccine she was in the ER.
Patient noticed left arm redness and swelling about the size 2.5 inches x1.5 inches left arm-site of vaccination. Pt. states that it looks cellulitis.
This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 75-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6199), at the age of 75, on Mar 5, 2021, single dose, for COVID-19 immunisation. Medical history included arthritis (unspecified if ongoing); and hot flashes (unspecified if ongoing). No concomitant medications. The patient had diarrhea, onset Mar 6, 2021, with outcome of recovered (Mar 10, 2021). Additional information: Vaccine administered in the shoulder. No follow-up attempts possible. No further information expected.
Nausea/Vomiting and fever/chills and redness on the left arm 15cmx15cm.
This case was reported by a other health professional via sales rep and described the occurrence of adverse reaction in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. GlaxoSmithKline representative was notified that a patient experienced a reaction after receiving the SHINGRIX vaccine. No additional details were available.
weakness; Sore arm; tiredness; vaccine from expired vial has been administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine from expired vial has been administered), ASTHENIA (weakness), PAIN IN EXTREMITY (Sore arm) and FATIGUE (tiredness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    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 EXPIRED PRODUCT ADMINISTERED (vaccine from expired vial has been administered). On an unknown date, the patient experienced ASTHENIA (weakness), PAIN IN EXTREMITY (Sore arm) and FATIGUE (tiredness). On 20-May-2021, EXPIRED PRODUCT ADMINISTERED (vaccine from expired vial has been administered) had resolved. At the time of the report, ASTHENIA (weakness), PAIN IN EXTREMITY (Sore arm) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.     This case was linked to US-MODERNATX, INC.-MOD-2021-155542, US-MODERNATX, INC.-MOD-2021-155523 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Patient demographics (gender and ethnicity) and additional events Sore arm, tiredness, weakness were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-155542: US-MODERNATX, INC.-MOD-2021-155523:
Angioedema; treated with and EpiPen, famotidine, and diphenhydramine; swelling and tingling are reducing
Redness and swelling to right thigh, where Hepatitis b was given right thigh nontender and mildly indurated. Pt came in for TB reading and mom pointed out swollen right thigh. Reported to doctor and prescribed Benadryl and APAP Also, advised to apply cool compresses to shot site.
8SEP93 7 days p/vax t102; broke out in fine rash on head & trunk on 15SEP93; seen by MD;
Information has been received from a licensed practical nurse regarding her 16 year old daughter who, on an unspecified date, was vaccinated with her first dose of GARDASIL. Subsequently, "within a couple weeks", the patient developed plantar's warts on her foot. The patient had the wart treated and it resided. On an unspecified date, the patient was vaccinated with her second dose of GARDASIL. Subsequently, the patient developed plantar's warts again on the same foot. The patient had the wart treated again, and again it resided. On an unspecified date, the patient was vaccinated with her third dose of GARDASIL. The patient did not developed plantar's wart or have any other symptoms after receiving her third dose of GARDASIL. The reported stated that the patient received all three doses of GARDASIL according to the dosing schedule. As of the date of this report, the plantar's wart have not returned and the patient is "doing fine now". Additional information has been requested.
Initial report received from a consumer on 28 Oct 2010: This patient was vaccinated intramuscularly with only the MenCYW-135 component of MENVEO (batch numbers unknown) without the lyophilized Men A conjugate compound. On an unspecified date, the patient received full dose of MENVEO. No adverse events reported following this administration.
About 30-45 minutes after vaccines were administered, parent reports son started vomiting, headache, nausea, and shortness of breath. These symptoms lasted for approximately 2 hours per parent.
pain everywhere; sweaty; feels hot even when the thermometer says that his temperature is normal; shortness of breath; feels like close to get sick; itchy eyes; irritated eyes; watery eyes; headache that is like "not coming on a full blast"; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced everything and then he started describing that he have pain everywhere, he was all sweaty and feels hot even when the thermometer says that the temperature was normal, he had shortness of breath, feels like close to get sick, he had itchy, irritated and watery eyes and was dealing with a headache that is like not coming on a full blast. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Presented w/ SOB, weakness, fever, body ache, cough, fatigue. Tested by PCP, Covid+. Tx for Covid pneumonia w/ IV steroids, Vit C, Zinc. male who was admitted for persistent Covid pneumonia symptoms with respiratory insufficiency and borderline low oxygen levels down to 89% room air.  Patient had been on outpatient antibiotics steroids as an outpatient.  Patient had CT a with no pulmonary embolism but with persistent pneumonia.  Patient was started on IV steroids along with vitamins C and zinc and supportive care and did have some clinical treatment and decrease inflammatory numbers overnight.  Patient remained afebrile but desat to 89% with ambulation with symptoms of sob.  Pt would be setup for home 02 and finish off po meds.
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Nausea, stomach pain, facial itching, lips itchy, sweating, weak feeling, throat swelling. Started approximately 1 hour after injection. Took 2 BENADRYL between 1 and 2 pm and used albuterol inhaler. Saw doctor at 4:30 pm - symptoms greatly improved.
Experienced coughing and vomiting during post vaccination observation period. Slightly elevated BP and pulse oximetry 90% on room air. Transported to ED, at triage stated feeling better, no further nausea or vomiting. Pt left ED before receiving an care. Telephone call to home, wife reported pt feeling fine, no issues.
fatigue; chills; loss of appetite; This is a spontaneous report from a non-contactable consumer. A female patient of unspecified age received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 27Mar2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On unknown date in Mar2021, the patient experienced fatigue, chills, loss of appetite. Treatment received for the adverse events was reported as unknown. The clinical outcome of the events of fatigue, chills and loss of appetite was unknown.   No follow-up attempts are possible. Information about lot/ batch number cannot be obtained.
This case was reported by a pharmacist and described the occurrence of an injection site reaction in an adult pt who received hep B vaccine recombinant (Engerix B). The pharmacist reported several pt's experienced an injection site reaction following administration of Engerix B, however, pt identifiers were not provided. On an unspecified date, the pt received the first dose of hep B vaccine (Recombivax HB). On an unspecified date in 2004, the pt received the second dose in the hep B immunization series with Engerix B. The reporter stated that the Engerix B for this second dose came from either of two lots (ENG5563A4 or ENG5563B4). At an unspecified time following the administration of Engerix B, on an unspecified date in 2004, the pt experienced an injection site reaction characterized by stinging and burning. The outcome of the events is unk.
This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (It is still red), PALPITATIONS (Heart palpitations, (described as a heartbeat little bit faster)/I could hear it pumping), ORAL HERPES (2 humongous cold sores), VACCINATION SITE WARMTH (On the injection site, it was heated and hot) and MENOPAUSAL DISORDER (Worse one was this shot reactivated my menopause) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B81A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced HOT FLUSH (Had hot flashes from April 2021 to Nov 2021, It was terrible). On an unknown date, the patient experienced ERYTHEMA (It is still red), PALPITATIONS (Heart palpitations, (described as a heartbeat little bit faster)/I could hear it pumping), ORAL HERPES (2 humongous cold sores), VACCINATION SITE WARMTH (On the injection site, it was heated and hot), MENOPAUSAL DISORDER (Worse one was this shot reactivated my menopause), SCAR (One left a scar, they were the size of a nickel), HEADACHE (Low/dim headache for 2-3 weeks), LYMPHADENOPATHY (Really swollen lymph node under the center of my it was really swollen) and VACCINATION SITE ERYTHEMA (Injection site, it was red). In November 2021, HOT FLUSH (Had hot flashes from April 2021 to Nov 2021, It was terrible) had resolved. At the time of the report, ERYTHEMA (It is still red) had not resolved, PALPITATIONS (Heart palpitations, (described as a heartbeat little bit faster)/I could hear it pumping), ORAL HERPES (2 humongous cold sores), VACCINATION SITE WARMTH (On the injection site, it was heated and hot), MENOPAUSAL DISORDER (Worse one was this shot reactivated my menopause), SCAR (One left a scar, they were the size of a nickel), LYMPHADENOPATHY (Really swollen lymph node under the center of my it was really swollen) and VACCINATION SITE ERYTHEMA (Injection site, it was red) outcome was unknown and HEADACHE (Low/dim headache for 2-3 weeks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were reported.  Patient have no history of heart issues.
Ringing in the ears; had low grade tinnitus for about ten years/ became more prominent and is still present now; Pfizer booster; Pfizer booster; Pfizer booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 17:00 (Lot number: FL3197) at the age of 40 years as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "low vitamin D" (unspecified if ongoing); "low range B12" (unspecified if ongoing); "low grade tinnitus" (unspecified if ongoing), notes: Verbatim: had low grade tinnitus for about ten years/ became more prominent and is still present now. Concomitant medication(s) included: ATIVAN; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]. Vaccination history included: J&j (prev dose product: COVID 19, prev dose brand: J&J, prev dose brand unknown: False, prev dose lot number: 1805029, prev dose lot unknown: False, prev dose administration date: 15Mar2021, prev dose administration time: 01:00PM , prev dose dose number: 1, prev dose vaccine location: Right arm), administration date: 15Mar2021, when the patient was 40 years old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), IMMUNISATION (non-serious) all with onset 21Dec2021 17:00, outcome "unknown" and all described as "Pfizer booster"; TINNITUS (non-serious) with onset 24Dec2021 19:00, outcome "not recovered", described as "Ringing in the ears"; TINNITUS (non-serious) with onset 24Dec2021 19:00, outcome "not recovered", described as "had low grade tinnitus for about ten years/ became more prominent and is still present now". Therapeutic measures were not taken as a result of tinnitus, tinnitus.  Additional information: Patient had not received any other vaccine in four weeks. Patient was not tested positive before covid vaccination and not tested positive post vaccination. Patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
On 10/23/2022 the day after the vaccine I had fatigue, headache, but I did not think anything of it. It was just normal side effects from the vaccine. But then in the afternoon I started having chest pain. I went to the emergency room. They did a chest scan, blood work to check if I was not having any cardiac event or a blood clot. Then I was sent home to follow up with my primary care doctor and another cardiology team. I am still having the chest pain. It feels more like an inconvenience, not like I feel like I'm dying.
This case meets criteria for vaccine breakthrough review. SxS include weakness, intermittent fevers, decreased PO intake, myalgias, chest pain, chills, cough, N/V, SOB.
Breakthrough case admission after 3 vaccines Moderna 3/17/21 Lot# 002B21A;  Moderna 4/13/21 Lot# 025B21A;  Moderna 1/26/22 Lot# 013H21B