chrisvoncsefalvay/vaers-outcomes huggingface dataset:
None at time of Gardasil vaccine, but one year later adverse immunune system problems that included strep throat, urinary tract infections,treated for mono symptoms,rheumatoid arthritis and tonsillitis  2/16/09 Received PCP medical records of 3/20/07-6/2/08. FINAL DX: none provided Records reveal patient experienced irregular periods, menstrual cramps, acne, fever blisters.  Tx w/meds & BCP starting 5/2/07.  RTC 6/2/08 w/chills, fever, ear ache, sore throat.  Dx w/pharyngitis & tx w/antibiotics.  Referred to ENT after labs w/WBC increase.
A red line extends along a lymphatic drainage pathway in the left arm of the patient, with a slightly raised profile, from the overall contusion formed from the vaccination site.
I administered Tdap vaccine to the (R) deltoid then walked around pt and administered MENVEO to (L) deltoid. Pt was alert and talking when he suddenly went limp and quiet. I layed pt down when he began to have seizure like activity for about 30 sec.
The pt experienced a blotchy red rash to the cheeks and forehead. The pt also experienced diarrhea, lack of appetite, hot flashes, some blurred vision, evaluated by PCP. No treatment ordered. Used cold pack over rash to relieve itching.
Symptoms Reported: palpitation, hypertension, nausea, vomiting, tingling and numbness in limbs, and headache. About 30 minutes after receiving the vaccine, the patient started feeling dizzy, nauseous, and started vomiting. The patient was taken to the emergency room where she was diagnosed with Benign Paroxysmal Vertigo. The illness lasted for two days. She had a similar episode six years back, but takes no medication.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. Patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, patients were inadvertently vaccinated with improperly stored doses of PROQUAD (Merck) (dose, route of administration, lot number, expiration date and therapy type were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
The patient was seen in the ED on 10/17/23 for dizziness and generalized weakness. Additionally, in the ED she was found to be mildly febrile. A COVID PCR test performed in the ED resulted positive. Ultimately, she was admitted 10/17/23 - 10/20/23. Discharge diagnoses included generalized weakness secondary to COVID+; COIVD pneumonia ruled out; and leukopenia, moderate, likely secondary to COVID. During her admission, the patient was not started on steroids as she was non-hypoxic.   Of note, the patient has received four doses of the Moderna Monovalent COVID vaccine (given 2/12/21; 3/12/21; 11/16/21; and 4/27/22) and one dose of the Moderna Bivalent COVID vaccine (given 11/29/22).
a little soreness,arm was sore a little bit; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (a little soreness,arm was sore a little bit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diverticulitis and Irritable bowel syndrome. Concomitant products included MELATONIN for Sleep disorder.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a little soreness,arm was sore a little bit). The patient was treated with IBUPROFEN ongoing since an unknown date for Diverticulitis, at an unspecified dose and frequency and HYDROCODONE ongoing since an unknown date for Diverticulitis, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (a little soreness,arm was sore a little bit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-363553, MOD-2021-363555 (Patient Link).
vomiting, nausea, fever, chills, joint pain, aches, fatigue, headache
REDNESS, SWELLING, PAINFUL LUMP AT INJECTION SITE.  TREATED WITH BENADRYL, TYLENOL, AND ICE X 2 DAYS.  PAIN IMPROVED AFTER 2 DAYS BUT REDNESS AND LUMP REMAINED X 7 DAYS
Start date on 5/5/2021 Left arm and hand pain, Off balance. Left foot drags.Then Left leg,foot pain,numbness, pins and needles, aches,  4th week moved to torso, aches and pain. Alway daily Headaches on right side of head, extreme tireness, hard to walk with out using my cane.  3rd week moved to right leg and foot.Always  Brain fog, since the beginingg. Hard to remember things off and on. I need to rest and nap daily. Blurr vision 2nd week at home noticed. Wearing my eye glasses more. Ear pain and Dizziness/Vertigo on 5/16/2021 Doctor Prescribes Prednesone for 2 weeks. Helped somewhat. Taking Ibuprohen, CBD oil for pain, Doing stretches, yoga, PT exercises to strenght muschles, Chiropractic adjustments weekly and massage helps too. Going to try accupuncture next week. I think I have Gullian Barre Syndrom. I have all the symptoms due to the 2nd Moderma Vaccine on 5/5/2021. Cannot work. Missed a month of work now. May have to go on disability.
Mild pain on left leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild pain on left leg) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Mild pain on left leg) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Mild pain on left leg) had resolved.            It is stated that patient was taking regular prescribed medications. Treatment information was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-280250 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Edema at the injection site, "the size of a golf ball", Cellulitis of the lymph nodes in left axilla-Primary care Physician prescribed Levaquin for 10 days. That was changed to Biaxin after 2 days due to Hyperemesis. Double Vision and pressure in eyes and ears, mostly on Left side-Retina specialist diagnosed it as 4th degree ophthalmic nerve damage (Palsy), not related to Diabetes, ENT specialist diagnosed Post Immunization Reaction, Ophthalmologic Neurologist diagnosed eye condition as 6th Degree Optic Palsy Treatment involves Prisms for eyeglasses to correct the double vision. Hopefully the prisms can be altered as the vision improves. As of 11-16-07, there has been no improvement in vision. The left arm is still sore, PCP to evaluate next week. Employee missed 2 days of work when symptoms first began, and has spent many hours visiting medical specialists.
Injections site red and warm to touch. Swelling and redness all the way down to his elbow. Low grade fever.
Some hearing loss; Tinnitus; A spontaneous report was received from Consumer concerning himself, a 71 years old male patient who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced some hearing loss/deafness and tinnitus/tinnitus.  The patient's medical history was not provided. Concomitant product included Warfarin.  On 1 Feb 2021, prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 007m20a) by intramuscular route for prophylaxis of COVID-19 infection.   On 01 Feb 2021 he had some hearing loss and tinnitus. Patient stated he canceled second Moderna vaccine until he receives more information on his side effect. Patient was concerned about scheduling second Moderna vaccine.   Treatment was not reported.  Action taken with mRNA-1273 in response to the event was withdrawn.  The outcome of the event some hearing loss and tinnitus was unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
Redness, swelling, hot and itchy.  Tylenol and cool compress.  Dr prescribed antibiotics if redness area increases.
Subsequently post vax, the pt experienced joint pain in middle fingers of both hands spreading to whole hand.
positive COVID-19 test; positive COVID-19 test; administered with Moderna vaccine as booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 39 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 03Apr2021 as dose 2, single (Lot number: ER8737), in left arm and on 08Nov2021 as dose 3 (booster), single (Lot number: FG3521), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Jun2022 as dose 4 (booster), single (Lot number: 058A22-2A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative Colitis" (unspecified if ongoing). Concomitant medication(s) included: REMICADE, start date: 24Jan2022. Past drug history included: Minocycline, reaction(s): "Known allergies: Minocycline". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 08Jun2022, outcome "unknown", described as "administered with Moderna vaccine as booster dose"; VACCINATION FAILURE (medically significant) with onset 05Feb2023, outcome "unknown", COVID-19 (medically significant) with onset 05Feb2023, outcome "unknown" and all described as "positive COVID-19 test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Feb2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19; patient was treated with PAXLOVID.
5PM on the 31st my injection site was very painful. The next day I was extremely fatigued and had a headache as well.
Autoimmune/ inflammatory syndrome; Primary ovarian failure; Autoimmune/ inflammatory syndrome; Secondary amenorrhea; Low estradiol levels; Increased FSH and LH; Increased FSH and LH; Specific autoantibodies were detected (anti-ovarian and anti-thyroid); This spontaneous report was received from a physician via social media and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.      On an unknown date, the patient was vaccinated with human papillomavirus (HPV) vaccine (manufacturer unknown) (lot#, expiration date, dose, route of administration and anatomical location were not reported). On an unknown date, the patient experienced primary ovarian failure, autoimmune/ inflammatory syndrome, blood follicle stimulating hormone (FSH) and blood luteinising hormone (LH) increased, low estradiol levels, secondary amenorrhoea; and specific autoantibodies were detected (anti-ovarian and anti-thyroid). The outcome of the events unknown. Causality assessment was not provided.       Upon internal review, the event of autoimmune syndrome was considered to be medically significant.
received two of the three dose regiment in "2017."; no additional AE was reported; This spontaneous report was received from a 37-year-female patient referring to herself. Concomitant medication and drug reactions/allergies were none. In 2016, she was diagnosed with an unidentified type of human papillomavirus (HPV) infection, it was recommended by her healthcare provider at the time that she got the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine to "prevent future infections."   On unknown dates in 2017, the patient was vaccinated with two of the three dose regiment of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for future infections (strength, lot #, expiry date, and route of administration were not provided) in another unidentified country (inappropriate schedule of product administration). She was just made aware of the benefits regarding the prevention of cancer in receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and wanted to know if getting a third dose was recommended. No further information or additional adverse event was reported (no adverse event).
Right sided body numbness, brain fog, anxiety, tremors, memory loss, panic attacks, headaches, dizziness, heart racing,
This spontaneous report as received from a nurse refers to a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On 21-JUN-2016, the patient was inadvertently vaccinated with a dose of PROQUAD (dose, route, and Lot# not provided) instead of an intended dose of M-M-M II, concomitantly with a dose of VARIVAX (dose, route, Lot# not provided). Nurse was uncertain why the error occurred but did not felt it was due to product confusion. No adverse effect was reported. Additional information has been requested.
Information has been received from a licensed vocational nurse concerning her 16 year old daughter. The patient was allergic to macrolides. She had no pertinent medical history. On unspecified dates, the patient received 2 doses of unidentified Merck human papillomavirus (HPV) vaccine (name and lot number not provided) (dose and route not provided). There was no concomitant therapy. The nurse stated she picked up her daughter from school and noticed her neck was swollen and she was having difficulty breathing. On 13-AUG-2015, the nurse took her daughter to the emergency room where blood work was performed and the patient was diagnosed with hyperthyroidism. It was also reported that the patient also had irregular periods with extreme cramps, headaches, numbness in her legs and extreme fatigue (onset dates unknown). The patient was a competitive cheerleader and she had to stop cheering since starting treatment with levothyroxine sodium (manufacturer unknown). Because she had extreme fatigue and difficulty breathing, she could not do anything upside down anymore. The outcome of all the events was reported as not recovered. The relationship between the events and the vaccination was not reported. The reporter considered the events of extreme fatigue and hyperthyroidism to be disabling. The reporter considered all the events to be life threatening. Upon internal review, the event hyperthyroidism was considered to be medical significant. Additional information has been requested.
Very bad skin rash on lower extremities; This non-serious case was reported by a consumer and described the occurrence of rash in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus. Concomitant products included sitagliptin (Januvia).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Very bad skin rash on lower extremities). The outcome of the rash was resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-JUN-2023 This reporter was submitted via online direct entry reporting system. The patient had for Very bad skin rash on lower extremities. The seriousness for Very bad skin rash on lower extremities was Intervention required. Shingrix manufacturer and expiry date was unspecified. The reporter consented to follow up.
26 minutes after receiving the vaccine I started to get a metallic taste in my throat. I felt my tongue from the back of my throat to the tip of tongue was very tingly. I difficultly swallowing, every time I went to swallow it felt like something was stuck in my throat. Due to me bad allergic reactions in general I took 25 MG of Benadryl prior to be vaccinated. I was instructed to go over to ER, I went to the ER. I was given 50 MG IV of Benadryl they watched me for a few hours and then sent me home. I went home and sleep and was told to take Benadryl every 8 hours. I woke up cause I couldn't breath right. My face and tongue was swollen at this time. There was redness on my face as well. I woke my husband up and he took my back to the hospital. I went back to Hospital. They said it was acute reaction I was having and gave epi-pen in my left thigh. I received Decadron IV push and said it would last 72. I was told to take Benadryl every 6 hours instead of 8 like told the day before. I went home and have been doing that. I have been okay today so far.  A week before getting the vaccine anti-inflammatory diet to help prevent the an allergic reaction.  I am having my tithers drawn in a month
This spontaneous report was received from a physician and healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VAQTA, lot # K007791, expiration date 22-AUG-2016 (strength, dose and route of administration were not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
vomiting; like having the flu; severe rash; swelling; fever; chills; aching in my stomach; gut wrenching; been sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 73-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   The patient's past medical history included measles (had red measles). Previously administered products included Shingrix with an associated reaction of malaise (1st dose received on unknown date and had sickness).   On 19th September 2019, the patient received the 2nd dose of Shingrix and Influenza vaccine Quadrivalent 2018-2019 season. On 22nd September 2019, 3 days after receiving Shingrix and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced stomach pain and gut wrenching. On an unknown date, the patient experienced sickness, vomiting, influenza like illness, rash, swelling, fever and chills. On an unknown date, the outcome of the sickness and vomiting were recovered/resolved and the outcome of the influenza like illness, rash, swelling, fever, chills, stomach pain and gut wrenching were unknown.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm and flu vaccine in the left arm. After vaccination, the patient had sickness for 2days after each dose. The patient laso had vomitting but not diarrhea and crunching on ice and having like flu. After vaccination, the patient had severe rash, swelling, fever and chills and contacted with doctor's because of more concern for heart. After vaccination, the patient had gut wrenching, aching in stomach before bed time. Less than a week, after vaccination with dose of shingrix and Flu vaccine, the patient had sickness, vomiting, influenza like illness, rash, swelling, fever, chills and adverse drug reaction.  It was unknown if the reporter considered the sickness, vomiting, influenza like illness, rash, swelling, fever, chills, stomach pain and gut wrenching to be related to Shingrix and Influenza vaccine Quadrivalent 2018-2019 season.
Pt c/o dizziness and numbness in head initially but resolved.  BP 105/49, HR 56, RR 16 -- > 108/56, 62, 16.  Pt given water, juice.  Recommended pt f/u with their healthcare provider.  Pt stable and released from the vaccination site.
About 1 week after receiving vaccination, redness, itching, swelling appeared just below injection site.  Skin felt hot, firm, and visible raised lump
Child had left facility when mom noticed left-sided facial swelling and left-sided itching. Child and mom returned to facility where epinephrine and benadryl were administered.
Dermal Fillers in lips increased in size. Swelling happened during the night. Reduced slightly over the course of the next day, but then swelled up again the second night.
Got COVID in December of 20022 then got a diagnosis of Multiple Sclerosis in March of 2023. Questioning if connected.
A physician reported the occurrence of fever in a 5-year-old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The medical history, concurrent conditions and concurrent medications were unknown. The pt had not experienced any adverse events following previous immunizations. On 05/20/2002 the pt received her 5th injection of Infanrix (lot DTPA524A2). On 05/23/2002 she returned to the physician's office with a fever and an injection site reaction characterized by swelling and redness. The physician prescribed paracetamol (Tylenol) and applications of ice. These events resolved on 05/23/2002.
0904 Pt feels light headed/dizzy, 15 min post vaccine  0910 BP 120/80, 02 99%, HR 91,  0915: Pt eating pretzels and drinking water, feels the same.  0920 sitting in chari-no change- talking  0930 ambulated to restroom.  0935 feels light head still.  Some better BP 130/88, )2 99%, HR 88.  0937 Pt req. to lie down on cot.  0940 Pt states feels smuch better.  BP 118/78, O2 99%, HR 78.  0950 Sitting up on cot -some better- finished pretzels of water still slightly diaay.  Pt encouraged to find a ride phone call her husband. they are down to one car.  Pt husband offered to call UBER.  0955 Pt states she wants to stay a bit longer rather than her husband come since she is feeling a bit better.  1000 Pt sitting chair.  Not feelin as dizzy.  1005 Pt walked up and down hallway and states she is feelin much better, to restroom no difficulty.  1015 Pt states feeling much better BP 110/85, O2 99%, HR 82,  1020 BP 120/88,  pt insists on driving stating she is feeling much better.  Refusing to have anyone come and drive her.  1025 Pt ambulated to her car with escort and states she feels ok to drive home.  Pt instructed to call PCP and report her dizziness and instructed to seek medical assistance should symptoms redevelop.
I noticed 2 small spots on my inner right thigh that were very itchy.  At first, I thought it may have been a misquito bites, but I was wearing pants.  The next day, I noticed several more similar itchy spots on my right arm, left arm around elbow, and my left ankle.  The next day after that, I woke up with similar itchy spots along my jaw line.  The spots are raised, itchy, small about the size of a pea, and seem to be in clusters of 2 or more.  I have been outside this weekend, but did not notice any mosquitos or other bugs.  These are bothersome only because they itch.  And I've been treating with Cortoizone 10.
fever after 12hrs 99. to 102.7 Local redness, warmth, pain Lasted 24HRS.