chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after administering the dose there were a few drops on the outside/ pharmacist thinks the drops were on the patient's skin, with no reported adverse event; Initial information was received on 08-Jun-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient on whom after administering the dose of typhoid vi polysaccharide vaccine [Typhim Vi] there were a few drops on the outside/ pharmacist thinks the drops were on the patient's skin, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a 0.5 ml, total dose of suspect typhoid vi polysaccharide vaccine (Solution for injection) (lot number, expiry date was unknown) strength: standard via unknown route in unknown administration site for TB skin test (Tuberculin test), on whom the after administering the dose there were a few drops on the outside/ pharmacist thinks the drops were on the patient's skin, with no reported adverse event (accidental exposure to product) (latency: same day). The information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
sore arm; tiredness; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (tiredness) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (tiredness) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), FATIGUE (tiredness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Left arm swelling redness. First noted on 08/06/2005 no fever.
"31 yr old female with c/o redness on arm for 4 days and getting worse. Second COVID vaccine last Monday. Denies fever. Denies being pregnant.No contact with confirmed COVID 19 cases. no itch. bodyaches, chills last Tuesday and resolved last Wednesday."
patient missed period and had irregular breakthrough bleeding.  Loss of voice next day.  Fatigue.  Dizziness for 3 days
Shingles about a month after second shot.  Lasted about 4-6 weeks.
lt thigh swelling devel 7APR98 evening;increased swelling from thigh to knee w/redness & warmth 8APR98 & 9APR98;
2 doses of Moderna Covid-19 vaccine (monovalent) administered BUD.; We also had a temperature excursion.; 2 doses of Moderna Covid-19 vaccine (monovalent) administered BUD.; We also had a temperature excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (2 doses of Moderna Covid-19 vaccine (monovalent) administered BUD.), POOR QUALITY PRODUCT ADMINISTERED (We also had a temperature excursion.), EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna Covid-19 vaccine (monovalent) administered BUD.), PRODUCT TEMPERATURE EXCURSION ISSUE (We also had a temperature excursion.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 doses of Moderna Covid-19 vaccine (monovalent) administered BUD.), POOR QUALITY PRODUCT ADMINISTERED (We also had a temperature excursion.), EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna Covid-19 vaccine (monovalent) administered BUD.), PRODUCT TEMPERATURE EXCURSION ISSUE (We also had a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (2 doses of Moderna Covid-19 vaccine (monovalent) administered BUD.), POOR QUALITY PRODUCT ADMINISTERED (We also had a temperature excursion.), EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna Covid-19 vaccine (monovalent) administered BUD.), PRODUCT TEMPERATURE EXCURSION ISSUE (We also had a temperature excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (2 doses of Moderna Covid-19 vaccine (monovalent) administered BUD.), POOR QUALITY PRODUCT ADMINISTERED (We also had a temperature excursion.), EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna Covid-19 vaccine (monovalent) administered BUD.) and PRODUCT TEMPERATURE EXCURSION ISSUE (We also had a temperature excursion.).    No relevant concomitant medications were reported. No treatment medication reported.
Had imms. 12/14 evening, 12/15 tmp to 103, seen 12/16 noon for (L) upper arm erythema/swelling, axillary nodes. DTAP upper, MMR lower upper arm, bone sites involved, none (R) arm.
Next morning experienced pain at injection site. In addition, body muscle and joint aches and pain. Headache.
nausea; dizziness / increased in severity Jun/23/2021; Pain at injection site; BODY ACHES; This case was reported by a consumer and described the occurrence of injection site pain in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st June 2021, the patient received the 1st dose of Shingrix. On 21st June 2021, 30 min after receiving Shingrix, the patient experienced injection site pain and general body pain. On 22nd June 2021, the patient experienced dizziness. On 23rd June 2021, the patient experienced nausea. On 23rd June 2021, the outcome of the general body pain was recovered/resolved. On an unknown date, the outcome of the injection site pain, dizziness and nausea were unknown.   It was unknown if the reporter considered the injection site pain, general body pain, dizziness and nausea to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's child. The patient received first dose of shingrix and experienced injection site pain after 30 mins. On the same day in the evening the patient experienced body aches which ended in the morning of 23nd June 2021. One day after receiving vaccination the patient had dizziness that started in the morning of and increased in severity on 23rd June 2021. Two days after receiving vaccination the patient had nausea started in the morning.
Chills; Dizziness; Soreness at injection site; Fatigue; Muscle aches; Headache; TMJ aching (joint pain); Mild back pain on injection side; This is a spontaneous report from a contactable Nurse (the patient).  A 28-year-old female patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3246, expiration date unknown) via an unspecified route of administration on 05Jan2021 at 08:45 (at the age of 28 years old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included COVID-19 on an unspecified date, allergy to Penicillin and seasonal allergy from unknown dates.The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. Prior to the vaccination, the patient was diagnosed with COVID-19 (date not specified) The patient's historical vaccines include the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EK5730, expiration date unknown) on 15Dec2020 at 3:00 PM (at the age of 28 years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient was tested for COVID-19 after the first vaccination in the form of a nasal swab test on 24Dec2020 which was negative. Concomitant medication included cetirizine hydrochloride (ZYRTEC), biotin (BIOTIN), bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reports having experienced a headache five (5) hours post the second vaccine, soreness at injection site, fatigue and muscle aches eight (8) hours post the second vaccine, chills and dizziness twelve (12) hours post the second vaccine, and TMJ aching and mild back pain on injection side twenty-four to forty-eight (24-48) hours post the second vaccine. Treatment was received for the events and included acetaminophen and ibuprofen.The clinical outcome of the events headache, vaccination site soreness, fatigue, muscle aches, chills, dizziness, joint aching and back pain was reported as recovered on an unspecified date in Jan2021.  It is unknown if the patient has been tested for COVID-19 since the second vaccination.
Shaky; Cold; Clammy; Sore neck muscles; Joint pain; Couldnt sleep; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 04Mar2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 12Mar2021 at 21:30, the patient experienced shaky, cold, clammy, sore neck muscles, joint pain and couldn't sleep and all lasted for about 5 hours. On 23Mar2021, the patient underwent COVID-19 test and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shaky, cold, clammy, sore neck muscles, joint pain and couldn't sleep was resolved on13Mar2021.   No follow-up attempts are possible. No further information is expected.
Don't have and didn't note the exact date the symptoms started.  Initially they were very mild, and I shrugged them off, but the intensity increased over a couple of week.  It would come and go.  Then came to stay.  Wife researched online, and I started taking Zinc, (I already took Magnesium to supplement ) cancer meds, deplete Magnesium (Abiraterone); The Tinnitus continued, somedays, less, somedays more.  Disovered hydrating more than normal helped.  The Tinnitus dropped in intensity toward the end of 6 months... And was almost gone, when it came time for my Booster shot. (listed above #3)  Within a day, the Tinnitus was back, in full force, and worse than last time.  I began taking supplements; but, was out of some, and so, tried what I had, to no effect (Magnesium, potassium, Hydration, Calcium and B vitamin complex).  (tinnitus began to wane; but not by more than 50%-60% off and on, I figured, give it time)  Then it came, and didn't leave.  Finally, I bought and added zinc after 2 months along with Hydration.  It dropped to managable levels.  I forgot to add the zinc into my daily medication for chronic issues and the tinnitus returned... I realized I had not been taking teh zinc and started again.  Hydration alone, once again, was not enough.  It is now at around anywhere from not noticible to about 20-25%, worse in the mornings, and sometimes returning by evening.   I try to take, occasionally, an extra Predinisne, since I also use them to reduce inflammation, it does seem to help, along with Hydration.  But, I do not want to increase levels of Prednisone on a consistent level, my normal does being 5mg/day and  an extra dose PRN occasionally as needed and monitored by my doctor.   I am back on the zinc, with continued Hydration... Since I have Apnea; I use an APAP, machine, and it is natural to wake up dried out.  Again, rehydrating alone is not enough to eliminate the tinnitus.  However, zine (I am trying once a day)  has brought it down to levels mentioned above.  I will try Zinc 2x a day to see if that helps like before.. at one time, it was barely noticable.
care giver states pt cried all not 23APR97 & next morning was drowsy & could not hold heat up & seemed unable to move;taken to Er & was given DPh;
Information has been received from a health professional and the mother concerning her 1 year old daughter with no allergies or illness at the time of vaccination and no medical history who on 06/29/2001 was vaccinated with first dose of varicella vaccine SC, first dose of MMR vaccine SC, a fourth dose of Hib-TITER IM, and fourth dose of Prevnar IM. Subsequently, a couple of days later in July 2001, the mother reported that the child developed an outbreak of varicella. She had five to six lesions of varicella on her abdomen and face. On 07/16/2001, the physician's office was contacted by phone that the child had a few chicken pox like lesions on her trunk and arm. It was unknown if the child recovered. No further info is available.
For 5 weeks , have had frequent and long lasting numbness and tingling across my nose and cheeks, and sometimes around my left eye. and forehead. This sensation can last for hours.
Rash started morning of 4-17-19. All over body rash with red welts that come and go. Complains of very itchy scalp, trunk and extremities. Cheeks are flush and red. Denies shortness of breath and swelling of lips and face. Treated for urticaria. Given 10 mg/mL of DECADRON IM on left buttock in office and given a prescription for Hydroxyzine HCL syrup 10 mg/5mL orally, every 8 hours as needed for 7 days. Referral made to allergist for further investigation. Encouraged to go to the ER is she experienes shortness of breath or facial swelling.
chest pain, myocarditis treated with IVIG.  7/31/09 Hospital records received DOS 6/28/09 to 7/1/09. Assessment: Myocarditis. Patient presents with fever followed by sharp, nonradiating, substernal chest pain. Worse when lying down and improved with sitting up. Pain left elbow. Emesis. Headache frontal, bilateral pulsatile, with photophobia.  10/13/09 ICD-9 Codes Received: 422.90 Acute myocarditis unpsecified, 346.90 Migraine unspecified not noted as intractable.
HYPOXIA 2/19/2023 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE)
w/in 15 mins p/vax pt began convuls & vomiting x 45 mins; eyes rolled back; p/event slept & could not be aroused initially;
I had a fever, body aches, extreme, tiredness, sore throat, and a dry cough which is still going on. I went to a health center, and they tested me for COVID-19, and it was negative. They also tested me for the flu, and it was positive. I tested positive for COVID-19 the day at home. I still have cough and congestion.
Tingling in Hands and Feet Loss of core strength Clonus apparent during sustained muscle contractions Muscle twitching and shaking Lack of muscular strength
Physician reported that on an unspecified date after receiving the ROTATEQ the patient had a recent diarrheal illness/unspecified test was positive to Rotavirus; Patient is currently actively having bloody diarrhea; This spontaneous report has been received from a physician, via a company representative, concerning a 5-month-old infant (reported as 5 and a half months old) of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions or allergies were unknown to the reporter.  On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally for prophylaxis (reported as routine vaccination) (concentration, frequency of vaccination scheme, lot number, and expiry date were unknown to the reporter).  On an unknown date (reported as recent), after receiving the dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), the patient experienced diarrheal illness (rotavirus infection). On an unknown date, the patient had multiple tests that came back negative and an unknown test that tested positive for rotavirus.  On an unknown day in February 2020 (reported as currently), the patient was actively having bloody diarrhea (haematochezia).  The physician did not know if the patient had received any treatment for the reported events, or if medical attention was sought. However, the physician confirmed that the event was not cancer and that the patient did not overdose.   The outcome of rotavirus infection and haematochezia was reported as not recovered.  The causal relationship between Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ)and the occurrence of the events, was not reported.  Upon internal review, haematochezia was determined to be a medically significant event.
Pt became dizzy/lightheaded after receiving his covid vaccine and then watching his mother receive her covid vaccine. Pt was instructed to lie down on exam table, mother brought patient juice, cold compress applied to head and neck. Pt mother notes pt last ate around noon. After 15-20 min patient felt better. Was able to leave clinic with mother as escort without incident.
Headache x 3 days (very uncommon for patient) with only minimal relief from naproxen and acetaminophen dosed multiple times Fatigue (slept more than normal)
poor oral intake and fatigue, found to have acute kidney injury, hematuria and proteinuria.  Renal function progressively worsening.  kidney biopsy performed on 3/30/21 showed granulomatous ANCA glomerulonephritis+ anti-GBM nephritis
On  4/17/2021 after my hot yoga class at 930am I noticed a red circle on my left arm where the injection site was. It became bright red, hot to the touch, puffy. It grew to about 2.5inchesx2.5 inches.  I took a generic Allegra, put ice on it for 20min off an on, marked the site to track if it grew.  The evening of 4/17 the redness was not as bad  but still hot to the touch and hadn't grown in size. Sunday 4/18 by 2pm it was completely back to normal. There were no other symptoms.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided    For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant product use was not provided by the reporter.  190 patients (9 different lot numbers) received a vaccine past the beyond used by date.  Treatment information was not provided.  This case contains information for the 114th patient out of 190 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER CASE
a lesion on her leg; Information has been received regarding a case in litigation from a lawyer and referred to a female patient (pt) of unknown age. No information was provided regarding the pt's medical history, allergies, drug reactions, concurrent conditions or concomitant medications.  On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, lot number and expiration date were unknown) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).   On unknown date (reported as after receiving suspect vaccine), the pt suffered a lesion on her leg. As a result of those symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of suspect vaccine, the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of suspect vaccine, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of suspect vaccine, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered as not recovered. The causality assessment between the event and suspect vaccine was related.  The event was considered to be disability by the reporter.