chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9-17-13 swollen left arm. Could not lay on my left side for 4 days. Still have a lump where shot was given. Shot was given on 9/12, on 9/13 had low grade fever and very tired. Have taken TYLENOL since 9/12. Red rash at site of shot. Flu and pneumonia shot give at same time in left arm.
Initial information regarding an unsolicited valid non-serious case received on 10-Oct-2018 from a nurse. This case is linked to cases 2018SA284725, 2018SA284730, 2018SA284726, 2018SA284727, 2018SA284723, 2018SA284722, 2018SA284728, 2018SA284732, 2018SA284733 and 2018SA284734. (Same reporter). This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number and expiry date not reported) via intramuscular route in the left deltoid on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. No information about any adverse event reported. 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. List of documents held by sender: none.
Got my shingles shot, still got shingles/Suspected vaccination failure; Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced 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 Shingles vaccine.     Additional Information: GSK receipt date: 11-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shingles shot and still got shingles. The reporter denied to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
10 minutes after vaccination patient started to have a pruritic rash on left upper arm. EMS on scene and took patient to Emergency Department for further evaluation. Patient left site 20 minutes after vaccination at this time erythema spread to upper chest and back. No medications given by staff or EMS prior to patient leaving facility.
A nurse reported that a 12 month old female received her 4th dose of Prevnar, as well as, MMRII, Comvax and Varivax on 11/22/00. The pt has a medical history of premature birth at 34 weeks gestation. On 4/22/01, at the age of 17 months, she was hospitalized for pneumococcal meningitis, serotype 19F. The pt recovered. The follow-up info received on 06/11/2001 indicated that the pt also received her first dose of MMR, her second dose of Comvax and her first dose of Varivax on 11/22/2000. She was hospitalized and blood cultures, chest x-ray and complete blood count were performed. The pt's blood cultures were positive for "Strep pneumoniae, serotype 19F" and her chest x-ray revealed a right lower lobe pneumonia. Her white blood cell count was 21.5 with lymphocytes at 25, monocytes at 14 and segmented neutrophils at 59. The pt was hospitalized for 2 days.
This spontaneous report was received from a consumer (who is a physician) refers to his 18 years old son with no pertinent medical history and no known drug reactions or allergies, who on 21-JUL-2012, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that on 25-JUL-2012, his son developed a fever (unspecified) and congestion, along with a runny nose. TYLENOL was given as a treatment for the experience. The consumer reported that today, on 26-JUL-2012, his son was still febrile and congested. At the time of the report the outcome of the patient was not recovered. The patient sought medical attention by consulting his father. The relatedness for patient developed fever, runny nose congestion was unknown for GARDASIL. Additional information has been requested.
gave just the adjuvant solution; gave just the adjuvant solution; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number FZ7Z4, expiry date 27th January 2023) for prophylaxis.   On 28th September 2021, the patient received Shingrix. On 28th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: Other health professional called and said they had given 2 appropriate doses of Shingrix to 2 patient out of the box of 10 and the 8 remaining doses they gave just the adjuvant solution so they do not remember which of the 10 patient got the full dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No reactions was reported for any patient (as reported). The reporter did not consent to follow-up. Sales representative stated that the health care professional declined follow up the case. This case was one of 9 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209483:same reporter US-GLAXOSMITHKLINE-US2021209482:same reporter US-GLAXOSMITHKLINE-US2021209478:same reporter US-GLAXOSMITHKLINE-US2021209470:same reporter US-GLAXOSMITHKLINE-US2021209468:same reporter US-GLAXOSMITHKLINE-US2021209467:same reporter US-GLAXOSMITHKLINE-US2021209463:same reporter US-GLAXOSMITHKLINE-US2021209462:Same reporter.
Diarrhea for 6 hours continuously and next day sporadic, headache with intense stabbing pain in base of skull, nausea, abdominal cramping for 6 hours, hot and cold feeling, and insomnia. Sleep and Tylenol
Approximately 2 weeks after receiving the Pfizer Covid 19 booster vaccination I began having persistent heart palpitations, I followed up with my Primary Care Physician, an EKG was done, reading showed NSR with PACs and PVCs. At that time blood work was  done (BMP and Thyroid Panel), results were normal. A follow up appointment with my Cardiologist's office showed a similar EKG reading. An Echo Cardiogram is scheduled for November 5th 2021.
Constant tiredness for over a week. Lost consciousness in a parking lot and hit head. Bleeding around the brain causing confusion and loss of memory
Loss of memory; Loss of focus.; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Loss of memory) and DISTURBANCE IN ATTENTION (Loss of focus.) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.     On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AMNESIA (Loss of memory) and DISTURBANCE IN ATTENTION (Loss of focus.). At the time of the report, AMNESIA (Loss of memory) and DISTURBANCE IN ATTENTION (Loss of focus.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.    Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Non-Significant Follow up added- reporter mail id
Patient fainted immediately after vaccine at approximately 10:42 am. After 30 seconds patient regained consciousness. He did experience muscle contractions. After 20 minutes he was able to be released to his parents after drinking some juice
broke out in hives all over my back; have a painful knot in my left armpit that's swollen and hard for me to move my arm; have a painful knot in my left armpit that's swollen and hard for me to move my arm; have a painful knot in my left armpit that's swollen and hard for me to move my arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Aug2022 at 15:15 as dose 3 (booster), single (Lot number: FJ4991) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "IBS" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE; FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]; CELEBREX; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; VITAMIN D [VITAMIN D NOS]. Past drug history included: Amitriptyline, reaction(s): "known allergies: Amitriptyline". Vaccination history included: BNT162b2 (Prev dose product=COVID 19,, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Prev dose lot unknown=True,, Prev dose lot unknown reason=Obscured by other product labelling, Prev dose administration date=15Sep2021,, Prev dose dose number=2,, Prev dose vaccine location=Left arm,), administration date: 15Sep2021, when the patient was 33-year-old, for COVID-19 Immunization; BNT162b2 (prev dose product=COVID 19, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=EW0175,, prev dose lot unknown=False,, prev dose administration date=14Aug2021,, prev dose dose number=1,, prev dose vaccine location=Right arm), administration date: 14Aug2021, when the patient was 33-year-old, for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 03Aug2022, outcome "recovering", described as "broke out in hives all over my back"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) all with onset 03Aug2022, outcome "recovering" and all described as "have a painful knot in my left armpit that's swollen and hard for me to move my arm". Therapeutic measures were not taken as a result of urticaria, vaccination site pain, vaccination site swelling, vaccination site movement impairment.  Additional information: patient did not received other vaccine in four weeks. No treatment received for ae. Patient did not had covid prior vaccination and covid was not tested post vaccination patient has Known allergies with Amitriptyline Other medications in two weeks reported as Trazodone. Flexeril. Celebrex. Protonic. Vitamin D and Other medical history is reported as Osteoarthritis. Fibromyalgia. IBS.  No follow-up attempts are possible. No further information is expected.
4-13,14,15,16 :  Fever and sweats while sleeping.  Palpitations / rapid heart rate prior to sleep.  Upset stomach.
Information has been received from a physician concerning his 61 year old white daughter with no allergies and a history of breast cancer 4 years ago and Non-Hodgkin's lymphoma of the cervix 2 years ago who on approximately 12-JUN-2007 was vaccinated with a 0.65ml dose of Zostavax. Concomitant therapy included "ARAMIDEX". On approximately 16-JUN-2007, 4 days after vaccination the patient experienced vertigo with loss of balance and mild headache; no fever. The patient was seen by her physician who felt it was benign paroxysmal vertigo vs. post vaccination reaction. She was treated with an antihistamine. The patient's oncologist had approved her of receiving the vaccine. No diagnostic laboratory tests were undertaken. At the time of report the patient's symptoms were improving. A product quality complaint was not involved. Additional information has been received from the physician who stated that approximately 26-JUN-2007 the patient was vaccinated at her physician's office and on 05-JUL-2007 patient experienced vertigo and balance difficulty. The patient had breast cancer from 2003 to 2007 and Non-Hodgkin's lymphoma from 2005 to 2007. The patient's oncologist cleared her before receiving vaccine. The patient was seen in her physician's office and subsequently in ER for central nervous system symptoms; slight facial weakness and seizure like activity. A CT scan was done and a 2 cm mass was found in right frontal lobe. It was reported that the patient was recovering with treatment for possible recurrence of Non-Hodgkin's lymphoma. At the time of report, the patient had recovered. The patient's experience was considered to be disabling by the reporter. No further information is available.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (strength, dose and route unknown, lot # L032184, expiration date: 25-NOV-2016). No adverse effects were reported. Additional information has been requested.
Arm is swollen, red, itchy. Lymph nodes under arm are swollen. Symptoms did not show until a week after injection. Also mildly nauseous with headache.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031B21A) for COVID-19 vaccination.     Concomitant products included CLONIDINE, LOSARTAN, AMLODIPINE, INSULIN DETEMIR (LEVEMIR) and INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN 10R) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided
Values of the platelates were lower than normal; Values of the lymphocytes were lower than normal; This case was reported by a pharmacist via call center representative and described the occurrence of platelets decreased in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th November 2019, the patient received the 2nd dose of Shingrix. On 30th November 2019, 1 days after receiving Shingrix, the patient experienced platelets decreased and lymphocyte count decreased. On an unknown date, the outcome of the platelets decreased and lymphocyte count decreased were unknown.   It was unknown if the reporter considered the platelets decreased and lymphocyte count decreased to be related to Shingrix.  Additional details were provided as follows: The patient took the blood test and 2 days later got the result and noticed that the values of the platelets and lymphocytes were lower than normal. The reporter needed to know if the vaccine can cause that effect. The reporter did not consent to follow up.
This spontaneous report was received from a medical assistant referring to a multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. It was reported that since 16-MAR-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M032650, expiration date on 31-MAR-2019 (strength, dose number, route and anatomical location was not provided) for prophylaxis. The doses of GARDASIL 9 were in temperature of 48 °F (Fahrenheit ) degree for 52 hours. There was a previous temperature excursion as: 32°F (Fahrenheit ) for 15.5 hours. No adverse effect was reported and digital data logger was involved. This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA001059: US-009507513-1704USA001060: US-009507513-1704USA001058:
Tingling in her hands and feet; Skin is extremely sensitive to any type of clothing-sensory issue; Persistently asleep, takes naps ever day; Reaction was extremely painful initially; Extreme fatigue; chills; A spontaneous report was received from a consumer, concerning a female patient of age 37, who received Moderna's COVID-19 vaccine and experienced chills, paresthesia/tingling in her hands and feet, skin is extremely sensitive to any type of clothing/hyperesthesia, extreme fatigue, persistently asleep and  pain in the injection site.   The patient's medical history included Hashimoto's. Products known to have been used by the patient included progesterone, testosterone, liothyronine, and levothyroxine.   On 06 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number 012L20A) via unknown route for COVID-19 infection prophylaxis. On 05 Feb 2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On 05 Feb 2021, after second dose of vaccine, the patient experienced chills, paresthesia/tingling in her hands and feet, skin is extremely sensitive to any type of clothing/hyperesthesia, extreme fatigue, persistently asleep and pain in the injection site. Treatment medication with Tylenol, Ibuprofen, fexofenadine hydrochloride and cetirizine was reported.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the events was considered to be unknown at the time of this report.; Reporter'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.
Throat swelling, extreme throat pain, throat redness for 4 days and still happening with all the above symptoms. All started within 30 minutes of injection. .
Vaccine administration error related to temperature excursion from recommended storage temperature, not known to this writer to be associated with an adverse event. The local clinic has relayed to this writer that prior to the vaccine's thawing and administration to the vaccine recipient, the administered vaccine was stored in frozen temperatures for longer than recommended by the manufacturer. (This VAERS writer assigned to form completion was not the administrator of this vaccine).
by the end of the day after getting the vaccines, felt soreness to arm; soreness continued into the next day but by the end of the day, noticed redness, warmth, and swelling  along with increasing pain
Case number PHEH2013US018368, is an initial spontaneous report received from a pharmacist on 27 AUG 2013 and a follow up report from the pharmacist received on 08 OCT 2013. This report refers to a 23 years old female patient. She received only Men CYW-135 liquid component of MENVEO (batch number: X12097), intramuscularly without being reconstituted with Men A lyophilized conjugate component on 11 AUG 2013. On 28 AUG 2013, the patient returned to the clinic to receive new MENVEO. No adverse event reported following this administration error. Follow up report from the pharmacist received on 08 OCT 2013. The patient's present condition was updated.
Vasovagal syncope with nausea and vomiting.  Resolved with time. Parents present and took daughter home once stable and feeling fine.
Indurated, erythematous area (possibly small hemorrhage) 1.5 cm in diameter noted on L thigh approx. 3 1/2 hours after DTaP administration.
pain during injection and told pharmacist. Left arm pain began late that evening/early next morning. felt like tetanus shot. Pain progressed over the next 2 weeks with progressive limited range on motion, weakness and inabilityraise arm or lift away from body. Went to Urgent Care, received steroid dosepak, went back again a couple week later, got xray and MRI which revealed moderate fluid in bursa and small supra/infraspinatus tears. UC sent to to ortho dr and then diagnosed with SIRVA. Was put on steroid dosepak again with physical therapy. Still with pain and extremely limited range of motion with pain extending down the whole arm and into the scapula and neck now.
Flu shot received 11/17/09. Rash on trunk developed 11/19/09. Sought med advice 11/23/09. Steroid dose pack Rx.
I woke up with a coughing fit and I tested negative for COVID-19. I also had a sore throat, congestion, and diarrhea. I called my doctor, and he told me to go to the urgent care. When I was saw by the doctor, he thought I was having a heart attack. He did an EKG, and it was clear. He did not test me for COVID-19 or anything else and he sent me home. I tested positive for COVID-19 on 12/08/2022. My doctor prescribed me PAXLOVID. My throat is still a little scratchy and I have a little cough.
Mild fever, severe pain at site of vaccine injection Also bruising on forearm area same arm as vaccine injection
Early Booster dose Vaccination; Shot #1 was given 03/08, Shot #2 was given 04/05, Shot #3 was given 08/22 and booster dose was given 12/07. Per patient she feels fine, no adverse effects or side effects from vaccine.
Patient has had persistent shoulder pain at the location of shot and has had generalized pain since the date of the shot.
p/vax pt found in crib almost dead, barely breathing in hosp 2 days later had 6 sz;was on phenobarb x 6wk;had encephalitis, sz;
Acute onset of severe weakness and lethargy lasting about 24 hours. Gradual onset of completely altered bowel function since the vaccine.  for 76 years my bm's had been firm to hard with the rare exception of travelers diarrhea.  Since Covid vaccine, i have never had a bm as in the previous 76 years and am constantly worried about soiling myself.
Significant nose bleed multiple times; stopped after 10 min the first time and ~5 min following days with tissue