chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a nurse and describes the occurrence of POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS) in a 46-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS). At the time of the report, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The reporter did some research and found a case report of postural orthostatic tachycardia syndrome in a patient after being the administration of the 1st dose of the Moderna Covid-19 vaccine. No treatment medications were reported. The publication was Unknown. Company Comment: This spontaneous case concerns a 46-year-old male patient with no medical history reported, who experienced the unexpected non-serious AESI of Postural orthostatic tachycardia syndrome that occurred in the context of first dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2022-633799 (E2B Linked Report). Sender's Comments: This spontaneous case concerns a 46-year-old male patient with no medical history reported, who experienced the unexpected non-serious AESI of Postural orthostatic tachycardia syndrome that occurred in the context of first dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-633799: Reporter's case (Female Patient).
2 days after Fluzone was given I developed severe chills and fever and severs uncontrolable shaking of my head, upper limbs, and headache.  the next day the symptoms were gone. I am a retired physician and in good health and feel the the above was directly related to the fluzone.
p/vax pt c/o swelling in arm to the wrist & pain in the underarm;
Swollen lymph nodes; Chills; Soreness at injection site; This is a spontaneous report from Non-Contactable consumer(patient).A 44-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EW10161), via an unspecified route of administration in right arm on 28May2021 at 16:15 as a single dose for COVID-19 immunisation at doctor office.  Medical history included Acid Reflux and COVID-19 from an unknown date. Concomitant medication(s) included omeprazole taken for an unspecified indication, start and stop date were not reported and elderberry taken for an unspecified indication, start and stop date were not reported.  The patient previously took Erythromycin, flu vaccine, flexeral and experienced allergy. On 29May2021, patient experienced swollen lymph nodes, chills, soreness at injection site. No treatment drug was given for the event. Patient was not hospitalized for the events. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19.The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Apr2021.Since the vaccination, the patient had not been tested for COVID-19. The reporter assessed the event as non serious. The outcome of the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Information has been received from an office administrator referring to an unspecified number of patients of unknown age and gender. The patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # M015926, expiration date 28-JUN-2017, dose and route not provided) on unspecified dates. No adverse effects had been reported. Temperature and Time frame: 9.7F for 1 hour and 18 minutes. Was it administered (AE)? Yes. Was previous temperature excursion? No. Was call because of a "data logger"? Yes. This is one of several reports received from the same reporter. Additional information has been requested.
3 days Post 2nd Pfizer shot gallbladder area and stomach became painful. Contacted clinic, received a call from nurse, I explained symptoms, nurse told me essentially to wait it out and if it gets worse go to the ER. Here we are 9 days later and pain is still there sometime an 8 on pain level at night.
***adverse events continued through 2nd vaccine dose and are included below. Day of 1st vaccine (1/29/21): that evening, sore arm, extreme fatigue, diarrhea 1/30/21: extreme fatigue, headache, body aches, chills 1/31/21: body and muscle aches, diarrhea 2/1/21: migraine, agitation, fatigue, joint aches, chills, feverish, weak 2/2/21: severe neck, head ache, body/muscle pain, joint aches, chills, weak 2/3/21: symptoms easing up some 2/4/21: symptoms continue easing 2/5/21: very achy - especially hands and knees (arthritis spots) 2/6/21: mildly achy, almost normal, no Tylenol needed for first time in a week 2/7/21: mildly achy 2/8/21: mildly achy, took Tylenol 2/9/21: mildly achy, extreme fatigue, p.m. chills, diarrhea 2/10/21: mildly achy, mild headache, diarrhea 2/11/21: mildly achy - especially hands and knees (arthritis spots) 2/11/21: virtual doctor appointment with my Rheumatologist; she said all the symptoms I was having was due to the vaccine, which was also causing a Fibromyalgia flare and aggravating my Arthritis; ordered bloodwork (done on 2/16/21: cbc, tested for RA and Lupus) to confirm there was nothing else new going on with me; recommended palliative care, given prescription for Flexeril (muscle relaxer); advised waiting as long as possible before getting vaccine dose #2 2/12/21 - 2/17/21: mildly achy - hands and knees 2/18/21: achy, extreme fatigue, chills 2/19/21: feeling "normal"  2/24/21: knee pain (both)/burning, difficulty walking 2/25/21 - 3/2/21: knee pain (both)/burning, stiffness, difficulty walking took Tylenol and Flexeril, icepacks 3/2/21: in-person doctor appointment with Rheumatologist; she assured me my knees were not in fact swollen, pain was related to Fibromyalgia and Arthritis; bloodwork was all normal and I was cleared to get the 2nd vaccine dose on 3/5/21 (5 weeks after 1st dose) 3/3/21 - 3/5/21: knees improved. new symptoms: right chest/arm muscle aches (lymphatic reaction [I had lumpectomy and sentinal lymph node biopsy, chemo, and radiation for right-breast cancer in 2011-2012])  3/5/21: vaccine dose #2, lot EN6198 @ same place/location as dose #1, and also in left arm 3/5/21: sore arm, p.m. tingling/burning sensation in whole torso, fatigue, nausea; took Zofran and Tylenol 3/6/21: extreme fatigue, headache, arm pain, achy, diarrhea, nausea; took Zofran and Tylenol 3/7/21: extreme fatigue, headache, sore arm, increasing achy, diarrhea, sore all over, back/neck ache, mild nausea, felt feverish; took Zofran and Tylenol 3/8/21: migraine, nausea, achy muscles, felt feverish, diarrhea; took Zofran and Tylenol 3/9/21: migraine worse, extreme fatigue (slept all day), weak all over, nausea improved; took Tylenol 3/10/21: woozy, bad headache, extreme fatigue, achy, diarrhea with severe cramps,99.0 fever with flush/burning sensation in cheeks 3/11/21: extreme fatigue, no restful sleep, sore "guts", headache decreased, felt feverish 3/12/21: headache, fatigue, diarrhea 3/13/21: felt "normal"  Since March, my Fibromyalgia and Arthritis have flared more frequently, I often get under arm lymph node aches, and have more frequent headaches
left side of face got swollen, 5 lb weight gain on 1/8/21, resolved on 1/12/21
Information has been received from a nurse practioner (NP) concerning a student who received two doses of MMR II and had a negative mumps titer. No further was provided. Additional information has been requested.
Influenza vaccination administered on 10/29. Client began feeling "achy all over" on 10/31. Has a history of osteoarthritis, under care of orthopedic and pain management MDs, but stated that "this was more intense". Somewhat relieved by Tylenol Extra Strength. No fever or any other local or systemic symptoms. Still felt achy as of 11/11.
Extremely painful swelling in left armpit lymph node. The swelling then moved into my neck/collar bone area as the selling in my armpit eased. I was unable to wear a bra for 2 and 1/2 days because it was so painful. I am on day 4 post injection and the swelling in the armpit is almost gone but I still have some swelling in my neck.
Married 10/13/07.  11/5/07 menstrual cycle 3-4 days vs 5-6 but has irregular cycles since off BCP x several months.  AVA vaccine #1 9/7/07 with 2nd about 2 wks later (estimated 9/21/07 as not in DEERS).  Third AVA, primary ACAM SMPX, flumist given 11/7/07.  No adverse events and normal take for SMPX with foreation at left arm site.  Missed menstrual cycle in Dec with pregnancy test positive 12/20/07.  Normal pregnancy w/o complications, normal vag delivery.  Healthy newborn female born 7/15/08 - needs trensturn released, scheduled for 7/17/08.
Had COVID the month of December- no hospitalization. Had first moderna April 3, 2021.  Second moderna shot May 4. I have had low platelets for a few years  but not any lower than 43,000.  Went for blood work on May 3 2021 for Dr. for check up  and my platelets were 17,000. She prescribed me a steroid and brought them back up to 156,000 by May 10. She told me it was from COVID . My vaccine was very close to my appointment.
felt fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (felt fatigued). At the time of the report, FATIGUE (felt fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Additional Details: PATIENT reports feeling dizzy right after vaccination and felt pen and needles from shoulder to finger and groin to ankel. Felt a little nausea but felt better soon. He experienced a little dry mouth and was given Gatorade and asked to stay longer. Before leaving he said he felt fine
Patient reporting within 24 hours of receiving Men B vaccine having left arm site redness, swelling, warmth, tenderness that increased over several days with discomfort and pain to arm. Patient scheduled appointment to be seen in office 02/17/2022 with concerns on exam for more exaggerated response compared to normal vaccine response seen, and concerns for cellulitis. Patient treated with 5 day course of cephalexin, and did well with full recovery.
Left thigh red, hot and swollen x 6 days measured 10cm x 6cm. ZYRTEC given and started on 3/10.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 9HM59, expiry date 30th September 2023) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 9ZK5T, expiry date 7th October 2024) for prophylaxis, dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR) for prophylaxis and INFLUENZA VACCINE (FLUBLOK) for prophylaxis.   On 15th September 2022, the patient received the 1st dose of Shingrix, Boostrix, Boostrix Pre-Filled Syringe Device, PREVNAR and FLUBLOK. In October 2022, less than 3 weeks after receiving Shingrix and Boostrix and less than a month after starting Boostrix Pre-Filled Syringe Device, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix, Boostrix and Boostrix 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: 20-OCT-2022 Reporter's Comment: The reporter stated that, a patient received the Shingrix along with 3 other vaccines (Boostrix, Prevnar, and Flublok) and got shingles within the month.  He received the first dose of Shingrix, along with the mentioned vaccines.  A prescription for Valtrex was sent over to the pharmacy on 4th October 2022, but she stated that, other medications (that were not named) were sent on 3rd October 2022 (diagnosis could have been on 3rd October 2022 or 4th October 2022). It was unknown if the reporter considered the shingles to be related to Prevnar and Flublok. The reporter consented to follow up via postal.
Morning after injection, pt complained of diarrhea, sweating, chills 4-5 hrs, fatigue lasting greater than 3 days.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 30-year-old female patient 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) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported. No adverse reactions were reported by patient.
Diagonised with  a form of Mastocytosis.  Never taken any medication other than the vaccine. Only trigger described from this disease is medication ie Covid Vaccine.; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 82-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6207, expiry date was unknown) dose 1 via an unspecified route of administration arm left on 11Mar2021 12:00 PM (at the age of 82-years-old) as a single dose for COVID-19 immunisation. Facility type vaccine was other. Medical history included asthma (asthma as a child) from an unknown date and unknown if ongoing, allergies: tree nuts from an unknown date and unknown if ongoing. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient had no other medications in two weeks. On 31Mar2021, the patient experienced being diagnosed with a form of mastocytosis, never taken any medication other than the vaccine, only trigger described from this disease is medication i.e., covid vaccine. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care; and patient had hospitalization for 3 days. No treatment was given for event. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7533 expiry date was unknown) via an unspecified route of administration at arm left on 01Apr2021 12:00 PM as a dose 2, single for COVID-19 immunisation. Outcome of the event was not recovered.  Information has been requested in follow up.
It started with a scratchy throat and head congestion. I ran a fever for less than a day, but chills, fatigue, and cough for a couple of days. I took an at-home COVID-19 test on 03/30/2023 which came back positive. My doctor was on leave so I contacted my insurance telehealth line where I told a doctor about my positive test and was prescribed Paxlovid via my primary care doctor's office. I started my treatment the next day. As of now, I'm doing well with a residual cough and finally tested negative on 04/03/2023.
Two days after injection (L) arm turned red, warm and swollen. Seen by provider dx with mild cellulitis of (L) upper arm and treated with oral antibiotic.
Fever of 103.7, chills, weakness, lethargy, body and joint aches, severe arm soreness, lightheadedness, headache, shortness of breath, phlegmy cough
Developed blood clot in heart -- > went into Atrial Fibrilation with no prior history of A FIb -- > Large clot was thrown from the heart into the brain splitting into two clots, one blocking brain stem and one blocking right hemisphere -- > Death on 2/10/21
Severe reaction around injection site, 8.5 cm in diameter. Bright red, severe swelling, hot to touch and very tender to touch. 3 days later symptoms slowly decreasing, now 7 cm in diameter with treatment. Cause may have been inappropriate administration by pharmacist into subcutaneous tissue instead of muscle. Prior to injection, pharmacist pinched arm to elevate fat layer, did not inject needle completely into muscle layer and when removing needle the vaccine dripped out of injection site. It was also injected too low on the arm to be in the meat of the deltoid muscle.
BIL EYE SHAKING, UNABLE TO FOCUS, EYES PULLING TO THE LEFT, HIGH BLOOD PRESSURE, DIZZINESS, UNABLE TO BALANCE WHILE WALKING, NAUSEA, EMESIS. I WENT TO THE ER BY AMBULANCE. MY EYES RETURNED TO NORMAL AFTER APPROXIMATELY 4 HOURS. I AM STILL HAVING DAILY HEADACHES, AND MY BLOOD PRESSURE CONTINUES TO BE HIGH.
G62.9 PERIPHERAL NEUROPATHY 4/10/2023 DIVERTICULITIS DIVERTICULOSIS OF COLON
shortly after receiving the Gardasil 9, dose 1, He felt dizzy, then nauseated. Felt pins and needles down the  left side of his body to his toes. He was laid flat, then offered Capri Sun, then 5 mins later he got a headache, that worsened . Very weak , unable to walk up steps to home, mom was supporting him to walk. Currently, at 409 pm, he is lying in bed, drinking water , unsteady on his feet , still needing assistance when walking .Nausea comes and goes per mom
Arm is Swollen; Arm is Itchy; Arm has Huge Knot; Arm feels Hot Like Sun Burn; Arm is Red all the way down; Fatige; Joint Pain; Chills; Fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is Swollen), PRURITUS (Arm is Itchy), INJECTION SITE MASS (Arm has Huge Knot), LIMB DISCOMFORT (Arm feels Hot Like Sun Burn) and INJECTION SITE ERYTHEMA (Arm is Red all the way down) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Hypertension.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm is Swollen), PRURITUS (Arm is Itchy), INJECTION SITE MASS (Arm has Huge Knot), LIMB DISCOMFORT (Arm feels Hot Like Sun Burn), INJECTION SITE ERYTHEMA (Arm is Red all the way down), FATIGUE (Fatige), ARTHRALGIA (Joint Pain), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body aches). At the time of the report, PERIPHERAL SWELLING (Arm is Swollen), PRURITUS (Arm is Itchy), INJECTION SITE MASS (Arm has Huge Knot), LIMB DISCOMFORT (Arm feels Hot Like Sun Burn), INJECTION SITE ERYTHEMA (Arm is Red all the way down), FATIGUE (Fatige), ARTHRALGIA (Joint Pain), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.            Treatment informations was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up information was received from initial reporter: New event Myalgia and second dose information was added
Event - resumption of menstrual cycles/bleeding after menopause Treatment - prescribed low dose progesterone-only birth control pills daily Outcome - still having menstrual cycles 5 months post vaccination
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hyperventilation-Medium, Additional Details: patient laid down in minute clinic exam room while feeling ill
PT RECEIVED VACCINE AT OUR PHARMACY TODAY. SHE WAS FINE A FEW MINUTES LATER WHEN I CHECKED ON HER.  HER FATHER REPORTED AT APPROXIMATELY 4:41PM THAT SHE FELT DIZZY AND NAUSEUS.  SHE WAS SITTING ON THE FLOOR, BUT SAID SHE DID NOT FALL.  WE GAVE HER AN ICE PACK.  BP CHECKED AT 4:47PM (112/89).  PT STATED SHE WAS FEELING BETTER, JUST A LITTLE NAUSOUS.  SHE WAS STILL A LITTLE NAUSEUS AT 4:55PM, BUT WAS SITTING IN A CHAIR.  SHE FELT WELL ENOUGH TO LEAVE WITH HER FATHER AT APPROXIMATELY 5:07PM.
13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is 11th of 13 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient