chrisvoncsefalvay/vaers-outcomes huggingface dataset:
joint pain; runny nose with greenish thing coming out; This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCHARGE DISCOLOURATION (runny nose with greenish thing coming out) and ARTHRALGIA (joint pain) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006m20A and 031K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NASAL DISCHARGE DISCOLOURATION (runny nose with greenish thing coming out). On 21-Mar-2021, the patient experienced ARTHRALGIA (joint pain). On 21-Mar-2021, NASAL DISCHARGE DISCOLOURATION (runny nose with greenish thing coming out) had resolved. On 22-Mar-2021, ARTHRALGIA (joint pain) had resolved.            No concomitant medications provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Non significant follow up appended
Tingling in throat at time of injection lasting about an hour; tachycardia and sweating beginning in the early evening on the same day; awoken after midnight with severe tachycardia, weakness, confusion, and syncope; cough worsening the next day; general malaise.
This spontaneous report as received from a registered nurse refers to a 64 year old patient of unknown gender. The patients current conditions or medical history were not reported. On 12-JUN-2014, the patient was administered an expired dose of ZOSTAVAX (dose and route not reported) lot number H019042 expiration date 17-JAN-2014. No adverse effect reported. Additional information has been requested.
Information has been received from a consumer concerning her 20 year old niece with obesity who was vaccinated with a third dose of GARDASIL (lot# unspecified). On approximately 24-MAR-2008 the patient experienced insomnia and she had been very upset. The patient received the vaccinations at an other (unspecified) physician's office. On 31-Mar-2008, the patient went to see a therapist and she was diagnosed with "clinical depression". The patient was being treated with PAXIL. At the time of reporting the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Reporter needed to knowalternate dosing schedule per call they have a patient who will be coming in after the patient got the first dose in January of 2020 (2 years ago).; No other information provided.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  In 2020, the patient was vaccinated with the first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis.    The reporter needed to know alternate dosing schedule because the patient will be coming in after the patient got the first dose 2 years ago. No other information provided.
Patient's entire face turned red within two minutes of injection; gave 3/4 tsp of Benadryl PO per doctor's order. Patient's face was splotchy and red around circumference at hairline of face after a few.
Patient told us that she felt pain on left arm on 12/24/12 . Not able to reach patient for several try & left messages by pharmacist to follow up.
Dose # 1- Disseminated Nonpruritic rash  Dose # 2 - chills, myalgia  Both- Amenorrhea with negative preg tests.  This is atypical for me.
Swelling in neck which increased to golf ball size. Within a week period. Pt given Amoxicillin 200mg tid x 7days & blood work. Pt to f/u w/ us Tue. Sooner if any other problems.
Pronounced and sudden increase in dementia symptoms -- memory difficulties, agitation, confusion, disorientation on waking, rocking, using incorrect words, not recognizing people
Day after vaccine administered, awakened with stiff neck on left side. Unable to touch head, pain from back of head to deltoid went home from work, took Advil and slept. Next day improved, but not resolved. Symptoms for 3 days.
Minutes after the vaccination patient felt dizzy and  fainted and came back to consciousness  shortly after.  Patient felt much better just had a slight headache after regaining consciousness. Patient was given water and feet were lifted to help with circulation. Patient after additional 30 minutes of observation felt a lot better and was alert with no symptoms reported.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Bradycardia-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: After receiving vaccine, pt was sitting in waiting room; then family member alerted nurse that pt was feeling dizzy. Nurse & NP assessed pt; pt was alert, awake, conversant, diaphoretic, pulse in 40-50s, with low BP. Pt had vasovagal response, without syncope. Pt recovered after a few minutes & reported that he always has anxiety with needles/vaccines.
Headache, body aches, prickly itching all over head to toe, tiny rash face, arms, chest, abdomen, etc. No whelps  or bumps similar to heat rash? Similar to when I had a morphine drip from a cesarean delivery.  Just started itching that progressed to all over. Not just injection site. No swelling. No fever. No trouble breathing, no throat closing, slight tenderness  in neck.
fever; body aches; severe nausea; This is a spontaneous report from a contactable healthcare professional reporting for self.  A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 02Jan2021 at 12:00 PM (Dose 1) as a single dose in the left arm  (age at vaccination: 45 years old) for COVID-19 immunization.  There was no relevant medical history.  She did not have COVID prior to vaccination. There were no allergies to medications, food, or other products. The patient's concomitant medications were not reported; there were no other medications taken in the 2 weeks prior.  The patient received the COVID vaccine at 12:00 PM on 02Jan2021. Exactly 12 hours later, on 03Jan2021 at 12:00 AM, she began having a fever, body aches, and severe nausea. This had continued all week. The patient was COVID tested post-vaccination on 04Jan2021 via nasal swab with a negative result. "Yesterday" (as of 08Jan2021) she went to immediate care (physician office)  and the doctor said that she had a bad reaction to the vaccine and shouldn't be having fevers every day and if they continue she may need to go to the emergency room. She was tested for other illnesses and everything was negative. Therapeutic measures were taken as a result of severe nausea and included ondansetron (ZOFRAN). The outcome of the events fever, body aches, and severe nausea was recovering. She reported the events as non-serious and confirmed there was no hospitalization.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
10:25 sz lasting 10 sec in school office EMT P48, R36, pale, loss of consciousness 15sec;feet elevated; 02;Bp 84/70, P60, R30;listless;dx vasovagal;fainting sz;MD felt rxn not d/t vax but a vasovagal episode;
Pt vaccinated with OPV/HIB 10-15 min after receiving injection, found apneic & cyanotic.
BACK PAIN; THROAT HURTING; SWALLOWING DIFFICULT; MUSCLE PAIN; HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced back pain. On APR-2021, the subject experienced throat hurting. On APR-2021, the subject experienced swallowing difficult. On APR-2021, the subject experienced muscle pain. On APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headaches, muscle pain, throat hurting, back pain and swallowing difficult was not reported. This report was non-serious.
Case reference number 1999026282 is a spontaneous report from a RPH. Allergies, medical history, and a concomitant medications are unspecified. On an unspecified date, the pt received the unspecified dose of Havrix. Subsequently, the pt experienced rash and fever. The most recent information, received on 09/30/99, reports the condition of the pt is unknown.
Post vax, the pt was difficult to arouse, body rash, swollen face. Went to ER and was discharged home. Returned to ER that evening because baby was unable to walk. Admitted to hospital. Discharged home, walking like a drunk/peg leg. Rash continued, falls on face when attempting to crawl. Returned to MD due to swollen left groin lymph node, continued rash, and uncoordinated ambulation.
10/14/08 8:00 AM  First noted hives on posterior aspect of both forearms and on anterior aspect of both thighs just above knees. At 3:00 PM hives are reduced to blotchy areas
chills; Second dose received on day 96; scheduled for third dose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), OFF LABEL USE (Second dose received on day 96) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (scheduled for third dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 011J20A.) for COVID-19 vaccination.     Concomitant products included METOPROLOL SUCCINATE (TOPROL XL), ALPRAZOLAM (AZOR [ALPRAZOLAM]), ATORVASTATIN CALCIUM (LIPITOR), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), LORAZEPAM (ATIVAN), ALLOPURINOL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication, MULTIVITAMIN & MINERAL.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced CHILLS (chills), OFF LABEL USE (Second dose received on day 96) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (scheduled for third dose). On 13-Apr-2021, CHILLS (chills), OFF LABEL USE (Second dose received on day 96) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (scheduled for third dose) had resolved.            No laboratory data was provided.   No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-083078, US-MODERNATX, INC.-MOD-2021-083133, US-MODERNATX, INC.-MOD-2021-083104 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Follow-up received on 03-May-2021 contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083078:Husband's first dose US-MODERNATX, INC.-MOD-2021-083104:Wife's 1st dose US-MODERNATX, INC.-MOD-2021-083133:Wife's 2nd dose
Patient did not take off his bandaid until today (10/5/21) after receiving vaccine on Thursday (09/30/2021).  When he took the bandaid off this morning, it was very red and the skin was broken open. He did report that he has gone swimming twice (Friday and Monday)and not showered since before last Thursday. He did not shower after swimming either and did not remove bandaid at any time between. Patient is going to try leaving the bandaid off and keeping an eye on it. He will contact his PCP if it doesn't look better in a day or so.
WEAKNESS IN LEGS (WOBBLY LEGS); This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced weakness in legs (wobbly legs). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of weakness in legs (wobbly legs) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211107853.
11/11/22 presents to ED for "fever, fatigue, n/v". PMHx of " renal transplant in 2003, paroxsymal atrial fibrillation on Eliquis, ischemic cardiomyopathy s/p ICD placement, prostate cancer, type 2 DM, adrenal insufficiency.
The vaccine was mixed using a multi-dose vial of diluent.  The diluent vial was punctured twice and used to mix two vials of vaccine. The injection was given IM but a 5/8 inch needle may have been used.
pt stated a few day after getting the vax she developed headache, muscle aches and pain, nauseated, swollen lymph nodes, chills, dizziness, weakness, and had anxiety.  Pt called ambulance and transported to  ER.  She was tested for covid w/ negative results.  Had blood work w/ abnormal results (mild leukopenia).  She was prescribed Benadryl.  Her DX ; Dizziness, uncertain, mild medication reaction to the Covid vax.  She was released and told to FU w/ PCP.  Her FU appt is 3/12/2021.
Dark urine 5 days Tinitus ongoing Low grade fever hot feeling inside ears resolved 3 days Lymph node swollen R armpit and both sides of throat resolved 5 days Pain overall intense off the charts body pain I had to take medication resolved 3 days
COVID-19 symptoms started 06/06/22; tested positive the same day with a home test. I thought it was allergies until a friend of mine texted and said they tested positive and I was around him the night before. I tested positive same day and went to doctor to verify. I felt like I had a mild cold, felt clammy, and sweaty on and off, a little tired maybe. Symptoms lasted 2 days. I felt better the 3rd day and I took a home test and it was negative.
Patient developed a fever of 99.3 and a headache. On the morning of 9/22/2014 patient still complained of a headache and had a fever of 99.7. On the evening of 9/22/2014 at 7:00 PM patient had pink spots on his chest and behind his ears. On 9/22/2014 at 1:30 PM patient went to his doctor as his chest/back/ and part of his face/neck had more pink spots and his fever was 99.2. He was diagnosed with chicken pox. As of today 9/23/2014 patient still has a temp of 99.7 (which we alleviate with Tylenol) and his entire face/neck/chest/stomach/back and legs are covered with chicken pox (at least 50-60 spots on each area of his body).
I had cut my hand a week ago, and noticed it wasn't getting any better so after church I went to the emergency room. Because I'm Diabetic and it wasn't healing, so they gave me a tetanus shot. And pain shot , antibiotic shot. I go home and two hours later, my throat was closing I couldn't breathe, heart racing my arm was red. Itching.
Experienced the typical headache one or two days after the first dose, which I knew would be expected, so I decided to continue with the second dose sometime during the week of November 21, 2017. After the second dose, my reaction became severe. I could barely get out of bed because of how painful my head felt. In addition to the crippling headache, I also experienced severe dizziness and nausea that continued for almost a week. I refused the third dose, even though I explained my symptoms, I still felt extreme pressure from my employers that doing so could affect my employment. A titer was performed on January 9, 2018 and the result came back at 1.1 IU/mL. I was hoping over time that whatever was causing the headaches would eventually decrease; unfortunately, this has not happened. Any time I am overly stressed or catching a cold (immune system becoming overly active), I develop the same all encompassing, fiery headache I had after the second rabies dose. My head feels warm to the touch, every lobe and the cerebellum feels intense pain and pressure, and my upper neck is sore. Sometimes the pain becomes so intense I become dizzy and nauseous. I've described it to people as though my brain is melting'. It's difficult to think while having these headaches and OTC painkillers do nothing to alleviate the pain. I also want to note I have no history of migraines.
Patient received her covid vaccine at 9:50am. She was in the observation area. She stated she couldn't breathe at 9:55am. She showed no signs of any breathing difficulty. Patient reported a past history of anaphylaxis to bee stings. At 9:57am 50mg of Benadryl was given. 9:58 am she reported she was sweaty,  had blurred vision, and was hot. At 10:05, patient said she started to feel better. We asked that she wait the full 30 minutes. By 10:20am, she was feeling fine and the symptoms had resolved.
Client received TDAP on 8/21/10 at R deltoid IM. Client reports on 8/22/10 that area of injection site with redness, swelling, warmth and mild pain. The swelling was extensive at area of R deltoid. Ice Pack applied without reduction in swelling. Client will follow-up with Primary Care Physician for further evaluation.
Nausea; vomiting; diarrhea; excessive sweating; irregular heart rate; long QT; Elevated WBC 19; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm right on 14Sep2021 at 17:30 (Batch/Lot number was not reported) as dose 1, single (at the age of 55 years old) for COVID-19 immunization. Medical history included depression, thyroidectomy and hysterectomy from an unknown date. Concomitant medications included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported. No other vaccine in fourweeks. On 15Sep2021 at 15:00, the patient experienced nausea, vomiting, diarrhea with excessive sweating irregular heart rate, long QT wave never had before. Stated "Coincidence or an issue caused by the vaccine AAA (as reported)". Elevated WBC 19. Adverse events (AE) resulted in hospitalization for 4 days. Therapeutic measures were taken as result of the events, treatment included IV fluids, IV antibiotics heart monitoring continue. No covid prior vaccination. Covid tested post vaccination. The patient underwent lab tests and procedures which included QT: long QT wave never had before, heart rate: irregular, WBC 19: elevated on unspecified date; Nasal Swab: negative on 19Sep2021. The outcome of the events was not resolved.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient was receiving vaccinations at a school based clinic.  After she received her HPV vaccination she went to stand in line to get her Hepatitis A vaccination.  While standing in line she was noted to have tonic/clonic seizure activity, fluttering of her eyes, and she fell to the floor on her left side.  She was attended to immediately and was awakened within seconds.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the patients were vaccinated with doses of M-M-R II (dose, lot number and expiration date were unknown), which were following a temperature excursion. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 55-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th November 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 30th November 2022, 30 min after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-Feb-2023: Reporter's comment: This case was self reported by the patient. The patient received dose of Fluarix. After a half hour later, the patient experienced a headache.  The headaches vary in intensity but had headaches since dose and it had not resolved.  The reporter consented to follow up.
This spontaneous case reported by a consumer, describes the occurrence of nasal congestion (nose is stopped-up) and fatigue (very tired) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced nasal congestion (nose stopped-up) and fatigue (very tired). At the time of the report, nasal congestion (nose stopped-up) and fatigue (very tired) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Two weeks early menstrual bleeding; Two weeks early menstrual bleeding, including clotting and mucus; two weeks early menstrual bleeding, including clotting and mucus accompanied by cramps; Fatigue; headache; body pain; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old-non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6208) via unspecified route of administration in the left arm on 13Mar2021 at 15:30 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient medical history included autoimmune disease. The patient was allergic to morphine, gluten and dairy. Concomitant medication included thyroid (ARMOUR THYROID) medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021, the patient underwent nasal swab test and tested negative for COVID-19. The patient was not diagnosed with COVID-19 prior to vaccination. On 14Mar2021, the patient experienced two weeks early menstrual bleeding, including clotting and mucus accompanied by cramps, fatigue, headache, and body pain lasted for more than 7 days. The patient did not receive treatment for the reported events. The events resulted in the doctor or other healthcare professional office/clinic visit. The clinical outcome of all events was unknown at this time of report.   No follow-up attempts are needed. No further information is expected.