chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sweated a lot; sore arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweated a lot), PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL, SIMVASTATIN, VITAMINS NOS, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), ASPIRIN [ACETYLSALICYLIC ACID], PROBIOTICS NOS and CELECOXIB (CELEBREX) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced HYPERHIDROSIS (sweated a lot), PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness). At the time of the report, HYPERHIDROSIS (sweated a lot), PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment details were not given. After the first dose, the patient experienced a sore arm, tiredness. and sweated a lot.   This case was linked to MOD-2022-466462, MOD-2022-466488 (Patient Link).
2 stents were put in; Tender arm; Tired; Difficulty breathing/trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of STENT PLACEMENT (2 stents were put in), DYSPNOEA (Difficulty breathing/trouble breathing), TENDERNESS (Tender arm) and FATIGUE (Tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Stent replacement (2 stents were put in) on 19-May-2021. Concomitant products included LOSARTAN for Blood pressure, EVOLOCUMAB (REPATHA) for Cholesterol, PRASUGREL and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing/trouble breathing) (seriousness criterion medically significant) and FATIGUE (Tired) (seriousness criterion medically significant). On 19-May-2021, the patient experienced STENT PLACEMENT (2 stents were put in) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced TENDERNESS (Tender arm) (seriousness criterion medically significant). At the time of the report, STENT PLACEMENT (2 stents were put in), DYSPNOEA (Difficulty breathing/trouble breathing), TENDERNESS (Tender arm) and FATIGUE (Tired) outcome was unknown.            Patient received the 2nd dose of vaccination on 21MAY202, she felt tired, had trouble breathing when going upstairs. The day after 22Apr2021, it increased, but was not gasping for air. She contacted to the doctor who told her to wait 2-3 days to see if her breathing improved. Patient reported that she made an appointment with her doctor and then Saw cardiologist on an unknown date. Patient reported that her breathing was better after the stents placements, but not perfect.  On unknown date, Lab tests included stress test and ultrasound and heart test on 19-May-21 with outcome unknown. Patient reported that she is in cardiac rehab. Treatment information was not provided.; Sender's Comments: Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded
This spontaneous report as received from a physician refers to a 12 year old female patient. On 07-JUL-2017 the patient was vaccinated with GARDASIL 9 dose 1, intramuscular for prophylaxis. On 07-JUL-2017, 1 day after onset of therapy the patient experienced syncope and contusion. The outcome of syncope and contusion was unknown.
It was reported that a female pt received a Fluzone SV '99-'00 vaccination on 10/26/99. Reportedly, on 10/27/99, the pt developed facial paralysis and difficulty speaking. The pt was seen by her doctor on 10/28/00 and was told that this is self-limiting. Correspondence received on 12/1/99, provided more complete pt and physician data, and DOB. The symptoms have resolved and the pt returned to work on 11/15/99.
Malaise beginning 18 hours after vaccine followed by Generalilzed Puritic skin rash 51 hours after vaccine.  Self treated with Tylenol, ibuprofen,  and Benadryl.
tongue swelled up and nothing would help the swelling at the same facility i was vaccinated at. i could not drink water or eveneat applesauce. the swelling did not go down for at 2 weeks until i demanded a referral to a better facility. i ended up being admitted to the hospital 3 times in 2 weeks. my tongue is still swollen as of today
Redness and swelling at injection site, aches, malaise and fever. All symptoms resolved on own in 6 days.
extreme soreness./ red patch painful to touch; red stripe on side of arm; This spontaneous report was received from a 56 year old female patient, who was also a company representative. The patient's concurrent conditions included hypersensitivity to "cillins and mycins". The patient's concomitant therapies included fluticasone propionate (+) salmeterol xinafoate(ADVAIR).  On 04-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0,5 milliliter, intramuscular with lot number S006777 with expiration date on 28-NOV-2020 for prophylaxis. On 06-NOV-2019,  by morning, the patient noted a red stripe on side of an arm 1" x 2" plus some additional spots not near the injection site with extreme soreness and a red patch painful to touch (erythema and pain). That day, the patient was started on methylprednisolone for 5 days and at the time of report was recovering from the events. No laboratory work was performed.  The causal relationship between pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the events were not reported.
Extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 88 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 04Mar2021 (Lot number: EN6202, Expiration Date: 30Jun2021) at the age of 87 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "thyroid doesn't work well" (unspecified if ongoing), notes: thyroid doesn't work well. Concomitant medication(s) included: IRON taken for thyroid disorder, start date: Dec2021; PRILOSEC [OMEPRAZOLE]; VITAMIN C [ASCORBIC ACID]. Vaccination history included: Bnt162b2 (1st dose:, Lot Number / Expiry Date: EL8982/ 31May2021, Route, Anatomical Location: Left Deltoid), administration date: 27Jan2021, when the patient was 87 years old, for COVID-19 immunization; Flu shot, administration date: Oct2021. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Extreme fatigue". The event "extreme fatigue" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had extreme fatigue that was lasted several months after receiving her Pfizer Covid 19 Vaccine. The caller had been advised to reach out to HCP and that Pfizer can't provided medical advise. Caller was asking if Pfizer had any additional information on fatigue to provide or guidance on what she can do. The caller was calling in regards to the COVID vaccine. The caller wants to know what could Pfizer do for the extreme fatigue that seems to be coming from the COVID vaccine. She had it for several months. She had been to her healthcare professional and they haven't given her any help. The caller received both shots and then a couple of months may be 3 months after that, she started experiencing fatigue. Her bloodwork seems to be okay. The fatigue hadn't improved, it's probably a little worse, she didn't remember exactly when it started. The caller stated that her thyroid doesn't work well. This was diagnosed years and years ago. She takes iron and just recently in the last week, she started taking Prilosec and Vitamin C. She stated that she saw 2 different doctors and neither one helped. She believed that the doctors didn't know what to do either. They did bloodwork and that was it. She just had the regular blood work taken from her arm so whatever they did from that was what she had. She mentioned that she had the flu shot in the fall, clarified as Oct2021. The patient did not received other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s).  No follow-up attempts are possible. No further information is expected.
Projectile vomiting, fever 102, eye rolling, prolonged crying, jerking movements in sleep (possibility dry heaving), refusing to eat.
Gave patient the vaccine approximately 9:50am. Shortly after giving the vaccine, patient fainted in her chair. Patient said she was fine, however, she fainted afterward again. We did get the patient to lie down on the floor while we call 911. EMS responders arrived and assessed her, patient did refuse to go to the hospital. We did monitor her for 45 minutes before she left our facility with her friend.
possible administration of invalid dose to patients; Never reached an acceptable range and was always warm by at least 2 degree C; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Never reached an acceptable range and was always warm by at least 2 degree C) and POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 011F21A) 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. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Never reached an acceptable range and was always warm by at least 2 degree C). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Never reached an acceptable range and was always warm by at least 2 degree C) and POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patients) 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.   Concomitant medication was not provided.  There were 4 days temperature data (between 01-Apr-2022 and 04-Apr-2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C. Between 22-Feb-2021 to 26-Apr-2022, there was no other temperature data available. Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period and LOT numbers were provided(057M21A, 025L21B, 066H21A, 069H21A, 027H21B, 032F21A, 011F21A, 004F21A, 025C21A, 017C21A, 002C21A, 042B21A, 031B21A, 027B21A, 026B21A, 016B21A, 008B21A, 045A21A, 001B21A, 029A21A, 025A21A, 001A21A).Some vials might had been moved to a refrigerator at some point. There was no temperature data for that storage unit.  Treatment information was not reported.
10 days after receiving the first shot my son noticed blurred, wavy vision in his Right eye.  We took him to the eye doctor the next day where his vision was 20/60 in that eye and they found a spot on the back of his retina.  We were referred to a Retina Specialist. We saw Dr. two times where they determined he had had inflammation in the back of his eye and scar tissue was now in the place where the inflammation had been.  We were told surgery would be needed to remove scar tissue and hopefully correct his vision a few lines.  We decided to get a second opinion since we still didn't have any answers regarding what caused this to happen, if it was going to get worse and if he could possibly get it in his other eye.  We just saw another Dr. where he confirmed that surgery was necessary to try to repair damage.  His vision at this appointment was 20/100.  They do believe it is stable but has fluctuated between 20/60 and 20/100.  Dr. mentioned that he has another patient about the same age who had the same thing happen at about the same time as our son's eye condition began.  I have since also found several cases around the world with similar experiences.
Case number PHEH2013US013267, is an initial spontaneous report received from a nurse on 17 Jun 2013. This report refers to an 11-year-old male patient. He received only MENVEO conjugate component  (batch number: X1224), intramuscularly without being reconstituted with MEN A component on 07 Jun 2013. No adverse reaction was reported following this administration error.
Patient states she had flu type symptoms, with a fever of 101 degrees. Better after several days.
Approximately 7 minutes after vaccination I became lightheaded and dizzy. Felt like fainting. Heart rate jumped up to 179 BPM using a pulse oximeter to read and was breathing heavily. Was assisted to a wheelchair and spent a few minutes breathing in through my nose and out through my mouth and after a few minutes of this, my heart rate went back down and the symptoms subsided. As of today (1/27/2021) I am very exhausted.
At site of injection had 50 cent size redness & raised area, and itching. Sx started day after injection. On 12/4/12 called clinic & instructed per Dr. ZYRTEC 10mg nightly for several days. Pt notified had taken a CLARITIN that day & it had helped.
Contracted COVID; Contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: el3247), in left arm, on 12Apr2021 as dose 2, single (Lot number: el3247), in left arm and on 03Dec2021 as dose 3 (booster), single (Lot number: fg3527) at the age of 47 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolemia" (unspecified if ongoing); "gout" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant) with onset 02May2022, outcome "unknown", COVID-19 (medically significant) with onset 02May2022, outcome "not recovered" and all described as "Contracted COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Positive, notes: COVID test post vaccination COVID test type post vaccination: Nasal Swab,. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Afrin and Advil PM.  Clinical information: No known allergies. No other vaccine in four weeks. No COVID prior vaccination.
Initial unsolicited report received from a nurse on 15 October 2015. This case was linked to 2015SA165705 and 2015SA165706 (same vaccine, different events). This case involves 10 patients (age and gender not reported) who was vaccinated with first dose of FLUZONE QIV (batch number: UI444AB, Expiry date: 30 June 2016, dose, site of administration were not reported) intramuscularly on 14 October 2015. The patient's illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and any other vaccinations within 4 weeks of vaccinations were reported as none. Concomitant medications were not reported. On 14 October 2015, few hours following the vaccination, the patient had developed 3 to 4 inch raised red hot area and had discomfort. Laboratory data was not reported. The patients were prescribed antibiotics, cold compress and OTC medications. The patient was not recovered from the events. List of documents held by sender: none.
PATIENT REPORTS EXTREME PAIN ALL OVER, SEVERE HEADACHE, INJECTION SITE FEELS LIKE IT IS ON FIRE.  WORST PAIN SHE HAS EVER FELT, REPORTS BEING "BESIDE HERSELF" IN PAIN AND SORE AND TIRED. ALSO DIZZINESS
TIA - on April 22nd - that happened while I was having an anaphylactic reaction to the Metoprolol; And had another one on April 29th  - since they didn't know it was the Metoprolol I was reacting to the first time I had another anaphylactic reaction to it; May 1st - I had another anaphylactic reaction to Metoprolol again - since they had continued to keep me on it - that caused my AFIB to not stop and so they had to do Cardio Version for it to stop.   It took a couple more days - on May 6th - they discontinued the Metoprolol and started me to Diltiazem and on May 19th, I had an anaphylactic reaction to that drug and went to ER again and so then they switched me to Verapamil and I had an anaphylactic  reaction to that right away - after one pill - and so they took me off of that.  I had Atrial Bibulation surgery - for the AFib -  on June 3rd. Admitted for two days for that. Then things were good until August 12th - back to ER for another allergic reaction but they don't know what caused it. I had another allergic reaction on August 16th and they didn't know what caused that either. Ever since then, I have not had any allergic reaction but I have had trouble breathing every since. They are still trying to help me figure out what is causing that. They give me IV Benadryl when I'm in ER with the allergic reactions. I am only taking the cholesterol drug now so the last two reactions they are not sure what is causing it.  When my trouble breathing started - it would always start from 09:00 to 10:00AM and go away and then come back in the afternoon but go away before bed. But now it doesn't go away in the afternoon and it starts a little earlier now - with trouble breathing starting around 08:00 am. My oxygen levels are fine.  Note, I had a Flu Shot - January  2021
4/21 2p: 2nd moderna. 4/21 evening: mild tiredness 4/22 2am: high fever, extreme body chills 4/22 7am: same as above, with whole body muscular fatigue and pain. Took naproxen sodium at this time. 4/22 11:30am :woke up. still cold (room was normal temp, so fever). Muscular pain across body subsiding. Noticed visual tearing when looking at some things with horizontal bars in them. 4/22 2pm : chills completely subsided. Muscular pain mostly gone except at injection site. Visual artifacts completely subsided. 4/23 2pm: injection site still hurts like a 3 day old bruise.
Increased BP and fever up to 101.8 degrees. Sent to ER at approximately 10PM on October 16th.  Was released the next morning around 4AM with resolved BP and fever symptoms.
After 2nd dose of vaccine (Jan 8, 2021) I had body aches and fatigue for 2 days. On January 30th I saw urgent care for respiratory symptoms including cough and nasal congestion, had negative covid test done. On Feb 3rd awoke with headache, nausea, and vomiting was seen in ER and released. On Feb 4th saw PMD diagnosed with probable meningitis. On Feb 5th was admitted to hospital for overnight stay. Symptoms included dizziness, headache, nausea, vomiting, tests included labs, ct, and lumbar puncture. Was prescribed acyclovir at discharge. Continued to have symptoms for 2 weeks. Unsure if it was related to the vaccine or not.
Patient started to feel tingling sensations on back starting about 01/11/09. These symptoms continued to manifest until blotches appeared on the skin (along nerve tract) and one spot nearly blistered. Patient experienced the pain and tingling throughout. As of 02/07/2009, still slightly visible and mild pain. 2/9/09 TC to patient who stated DX of Zoster made by pcp.
MILD GENERALIZED RASH ON TORSO AND FACIAL AREA STARTING ON 1/6/05.
Pt stated injection site was hot to touch, red and swollen. Pt went to walk in clinic. Pt states she has a small  lump at injection site.
Vaccine was put in refrigerator 74 day prior to being administered making it expired by 4 days.  Patient did not have any adverse effects from vaccine but did test positive for covid 3/25.
This is a spontaneous report from a contactable pharmacist via a Pfizer-sales representative. This pharmacist reported similar events for two patients. This is the first of two reports. A 7-decade-old (reported as sixties) male patient received PREVNAR 13, via an unspecified route of administration, on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe rash and irritation at injection site on an unspecified date. The outcome of the events, severe rash and irritation at injection site was unknown. Information on batch number has been requested. Sender's Comments: Linked Report(s): PFIZER INC-2018223202 same reporter, events, drug, and different patients.
unbearable pain in his arm; he doesn't feel good; tenderness; swelling and his arm; when he breaths it feels like something is stabbing him; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (unbearable pain in his arm), FEELING ABNORMAL (he doesn't feel good), TENDERNESS (tenderness), PERIPHERAL SWELLING (swelling and his arm) and DYSPNOEA (when he breaths it feels like something is stabbing him) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (unbearable pain in his arm), FEELING ABNORMAL (he doesn't feel good), TENDERNESS (tenderness), PERIPHERAL SWELLING (swelling and his arm) and DYSPNOEA (when he breaths it feels like something is stabbing him). At the time of the report, PAIN IN EXTREMITY (unbearable pain in his arm), FEELING ABNORMAL (he doesn't feel good), TENDERNESS (tenderness), PERIPHERAL SWELLING (swelling and his arm) and DYSPNOEA (when he breaths it feels like something is stabbing him) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported  No treatment medication was reported