chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Receiving SECOND Shot 73 days after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receiving SECOND Shot 73 days after the first shot) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receiving SECOND Shot 73 days after the first shot). On 30-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receiving SECOND Shot 73 days after the first shot) had resolved. Not Provided          No concomitant medications were reported.
1 day after injection of PrevnaR 13 (R) arm pain, swollen mass. 3 day after developed warm, red rash. No CP, SOB or itch.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 05-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5ml (lot # L038917, expiration date 20-FEB-2018, route unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 72 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 144 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from registered nurses refers to a 5 month old male infant. On 22-JAN-2014, the patient was seen in office for a "nurse visit" for vaccines and was vaccinated with his first dose of ROTATEQ (lot #H016249, expire date 27-MAR-2014), 2.0 ml once, oral. NO adverse effects reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Patient felt pressure in the chest, tingling in the right leg and watery eyes after receiving the vaccine. After drinking water the patient felt better. Heart rate and breathing were fine
PT c/o redness/rash To left A/z area after receiving vaccine in Left arm. PT. Treated w/some Benadryl and  ice pack. PT. observced for 30 mins. w/redness and rash  disappearing. PT. released to wife w/orders to call  911 w/ and other issues.
This is a spontaneous report from a contactable consumer reported for herself. A 66-year-old American female patient received PREVNAR 13 for Immunisation on 26Jul2016 on the arm and PNEUMOVAX on 13Jul2015 for immunization. Medical history included type 2 diabetes mellitus diagnosed in 2011 and blood cholesterol abnormal. Concomitant medicines included metformin at 500 mg, 2x/day, ongoing for type 2 diabetic and pravastatin at 40 mg, 1x/day  for cholesterol. On 13Sep2016 the patient experienced pneumonia. Consumer was not hospitalized for the event and received treatment with antibiotic azithromycin (ZITHROMAX Z-Pak). She just had a chest X-RAY and she was diagnosed with Pneumonia. The patient received the vaccine at pharmacy. The outcome of the event was unknown.
fever up to 103.3 erythematous macular rash on trunk and proximal extremities
Palpable, 2 inch diameter knot, warm to touch, appear on same arm as injection site 6 days after first dose of vaccine.  knot is approximately 3.5 inches below injection site.  No other side effects from vaccination until now.
24 hour fever; chills; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced on eyelid, forehead and scalp two years ago from the reporting date, at the age of 62 years) and eye swelling.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were recovered/resolved.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself/himself. The patient had the old shot and she/he did not understand at first why her/his eye was so swollen. The patient got it treated fast and it was not very painful. The age at vaccination was not reported. The patient received Shingrix shot which gave her/him 24 hour fever and chills and she/he stated that it was so far so good. The follow-up would not possible, as no contact details were available. For tolerance of 2nd dose, refer case US2021AMR039337.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR039337:Same reporter
broke out on his chest and back, like pimple; allergy; broke out on his chest and back, like rash; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (broke out on his chest and back, like pimple), HYPERSENSITIVITY (allergy) and RASH (broke out on his chest and back, like rash) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B214) for COVID-19 vaccination.     No medical history was reported by  the reporter.  Concomitant products included LOSARTAN and SIMVASTATIN for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACNE (broke out on his chest and back, like pimple), HYPERSENSITIVITY (allergy) and RASH (broke out on his chest and back, like rash). At the time of the report, ACNE (broke out on his chest and back, like pimple), HYPERSENSITIVITY (allergy) and RASH (broke out on his chest and back, like rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient mentioned that patient received a steroid shot for allergy possibly on the same day as his Moderna COVID 19 vaccine.    This case was linked to MOD-2021-237502 (Patient Link).
Case number PHEH2014US004303 is an initial spontaneous report received from a pharmacist on 27 Feb 2014. This report refers to a 35-year-old male patient. Past medical history and concomitant medications was not reported. He was inadvertently administered only Men A lyophilized conjugate component of MENVEO (batch number: A12098), reconstituted with a sterile diluent instead of MenCYW-135 liquid component, intramuscularly on 27 Feb 2013. Reported stated that, the patient is a physician, who will be traveling. No adverse reaction was reported following this administration error.
Inconsolable for 2 hours approx. 4 hours after immunizations calmed with comfort measures and TYLENOL.
Swelling of right hand with severe redness like a burn. C/O itching and burning sensation. Knot at injection site grew to approx 1" diameter. Today makes 5 days and knot is approx 1/2" in diameter. Right hand is dry with crusty scabs, itching and unable to tolerate ointment due to stinging.
zoster like rash in her R breast after shingrix vaccine; This case was reported by a other health professional via interactive digital media and described the occurrence of vesicular rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. It was reported that the patient reacted with a zoster like rash on her right breast day after Shingrix vaccine.
4hrs p/vax 9NOV95 pt woke up crying;high pitch scream cont for 12 hrs lt thigh warm red swollen 5" lenghth; did not have high fever;gave APAP q 4 hrs starting @ onset 1PM;
@3hrs injection site soreness, @12hrs chills, @ 18 hrs fatigue, @20 hrs general malaise, headache nasal congestion, armpit nearest injection site mild pain, fever 100°f, 24 hrs all symptoms persist and intensify. @32hrs fever peak 102°f, injection site pain decreases. Headache increases. 500mg aceteminophen taken. Nasal congestion increases, @40hrs chills, malaise and congestion decrease, fever99.9°f , throat soreness appears, Kidney pain appears. Headache increases. @48 hrs kidney pain persists,  armpit pain persists. All other symptoms decrease.
lt upper quad pain sx began approx 2-2 1/2months p/vax; no other known exposure; no routine medications; ultrasound spleen 9FEB94; enlarged spleen;
shakes sweats  severe pain in injected arm felt pusling and still have pain and pusling foggy cant sleep
feeling "funny"; Dizzy; gurgling felt in gut; pain in kidneys; This spontaneous report was received from a 73-year-old female patient referring to herself. The patient's medical history was reported as none. The patient's drug reactions/allergies included codeine allergies and phenothiazines allergies. Concomitant therapies included "symbostatin" (5 mg) and supplements (unspecified).  On an unknown date in May 2023 (reported as recently), the patient was vaccinated pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for as prevention of pneumococcal disease (route was reported as injection; strength, dose, lot #, expiry date and anatomical location were unknown).  On an unknown date in May 2023, the patient was feeling funny afterwards (feeling abnormal), experienced dizzy, did not pass out, gurgling felt in gut (gastrointestinal sounds abnormal), pain in kidneys. Experienced symptoms very briefly while still shopping. It was reported that had not sought medical attention and did not received treatment for the events. The outcome of all events of feeling abnormal, dizzy, gastrointestinal sounds abnormal and pain in kidneys was reported as recovered.  The causal relationship between all events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Fatigue, malaise, low fever (100+), frontal headache for 36 hours.
patient whose arm had to be kept in a sling for 2 weeks due to an unspecified reason; This spontaneous report was received from a medical assistant via company representative referring to a female patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy details were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route, lot# and expiry date were not reported) for prophylaxis.         It was reported that the patient's arm had to be kept in a sling for 2 weeks due to an unspecified reason (adverse event) after receiving with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The patient recovered from the event, 2 weeks after with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was received. No further information was reported. No product quality complaint was reported. Causality assessment was not provided.
REDNESS AND SWELLING AT SIGHT OF INJECTION, WARM TO TOUCH, NO FEVER OR SEVERE PAIN BUT SORENESS IN ARM
i had covid 19 in March of 2020. it lasted over 3 weeks and it left me with pain during and long after covid. Orthopedic doctor took x ray scans and all were normal. They treated me with methylprednisolone and meloxican which cleared it up. !2 hours after covid vacine , the sharp shooting pain is back with sharp pain like electric shocks.
I received my Moderna booster on Friday, January 14th. Heart palpitations lasting between 3 and 10 seconds began on January 17th. Palpitations would occur about four or five times a day, most noticeable at nighttime. Wednesday, January 19th was the peak of the palpitations, meaning that they were the strongest and lasted the longest. The night of January 19th, they occurred continuously for 5-7 minutest before I fell asleep. Last palpitations were felt Monday January 24th. There may have been one very small one on Wednesday January 26th after a heart monitor was placed on me, and at which time I pressed the monitor to trigger a mark in their system. No other symptoms occurred.
pt verbalized started having pain @ inj site, itching, & hives on 12APR99;denies other s/s or any prev s/s prior to 12APR99;pt verbalized didn't take any meds, apply anything to site, did not f/u w/MD;
shot given 29JAN96 afternoon 30JAN96 pt woke up in AM w/redness around site (lt deltoid), tenderness to touch, swollen, fever 101; seen @ MD office 31JAN96;tx Duricef
Severe local rxn @ inject site on lt thigh, fever 105F, fretfulness, vomiting, anorexia; poss encephalitic component; pt not eating, talking;
Has had several instances of numbness, dizziness, passing out, paralysis, shaking, chills, nausea, back pain, muscle weakness and more. Symptoms started back in 2013 with the first fainting spell around August 2013.
5PM mom noticed pt T103 & entire lt leg had turned a purplish/bluish color & was cold to the touch;able to move leg & wiggle toes;pt very fussy & crying;mom called ER & was instructed to alternately give APAP & Ibuprofen;had knot inj site
This is a spontaneous report received from a contactable consumer (patient). A 70-year-old female 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. On an unspecified date, the patient reported experiencing some palpitations, lower back pain and pelvic pain that totally incapacitated her to do her daily routines. The patient added that she also experienced neck pain that has subsided. The patient reported that the pain has been so severe that she cannot bend over, could not sleep, it was just constant that nothing like ADVIL or ALEVE do not help. The patient reported that she has already seen various doctors (gynecologist, orthopedic and rheumatologist) none of which knew what was going on. The patient searched information on the internet where she found that this was a reported side effect with the vaccine. The patient added that a doctor wanted to inject her with medication to alleviate pain. The outcome of event 'neck pain' was recovered on unspecified date; all other events was not recovered. Information on the batch number has been requested.
Varivax was given 12/12/05 inadvertently.  The varivax was ordered for 12/27/05 and given instead today.  DPH was notified and was told probably not harmful-watch for rash-mom aware. The pt had no adverse reaction to the second dose of varicella thate he received on 12/27/05.
Starting 02/25/2023 and lasting through 03/01/2023, I had a fever of around 102 to 103 degrees. I was only able to control the fever with Tylenol. I was taking 2 Extra strength Tylenol every 8 hours. I also had a sticky sort of phlegm, mostly right behind the nose. I had a little bit of coughing and sore throat from around Tuesday to Wednesday. For the most part, it felt like a really bad postnasal drip. As a result of all of this, I was very tired and lethargic. I was tested for COVID-19 and twice for Strep throat, all were negative. Everything seemed to resolve on its own. I am basically back to normal at this point, with the exception of a little congestion.
Pt developed pericardial tamponade after 2nd dose.  Pt reports intermittent symptoms that started about 2 weeks after 2nd dose.  He was hospitalized about 6 weeks after and initially thought he had a pulled muscle.
Severe pain in head, Had inflamation in eyes that required holes made eith laser in  both eyes. this happened after first dose in jan. Second dose was feb 8 2021. I began feeling pain in both legs and weakness about a week later. It became worse, my dr. recommended I go to hospital. Bllod test revealed high inflamation. I have been under the care of a rhumatologist since . He did extensive blood test from lymes desease to rhumatois arthristisr. I tested negative for all. He prescribed diclofenac for pain and later added enbril for inflamation. I am still under his care.
7-14-15 Japanese encephalitis vaccine administered 7-15-15 Mom calls reporting sore legs and fever 100.3 F.
Headache/headache feels like migraine; Headache/headache feels like migraine; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 (19:00) (Lot number: EH9899; Expiration date was not reported), and then the second dose on 12Jan2021 (18:45) (Lot number: EK4176; Expiration date was not reported), both intramuscularly on the left arm at a single dose for COVID-19 immunization at the hospital. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On an unspecified date, after the first dose of vaccination, the patient had a headache/headache that felt like migraine. The patient had experienced a similar headache (headache that felt like migraine) on 17Jan2021, after the second dose of vaccination. The patient had received bultalbital, acetaminophen, caffeine (FIORICET) as treatment for the events. The outcome of the events, headache/headache that felt like migraine, was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination.  No follow-up attempts are possible. No further information is expected.
The day after the vaccine was received, pt felt extremely exhausted. She never ran a fever, but the exhaustion lasted 3 days.
Infant with h/o allergic proctocolitis & was doing well but after 2 months old shots had increase blood in stool.
Went to get up to get ready for work and instantly collapsed-scraping up knee. Became extremely nauseous, weak, excruciating headache and dizzy. Unable to stand, had to crawl to nearby chair and call for wife. Thought might be dehydrated, extremely pale, tried to drink water, but began vomiting. BP was elevated, but no temperature. Tried to eat crackers and drink more water, but continued to violently vomit. Never felt so badly in entire life. No strength to stand or get up the stairs to be taken to ER, so had to call paramedics. When they arrived, BP had come down, but they felt needed to be transported to ER, so they took to healthcare facility at about 1:30 pm.
08/30/2022: Runny/congested nose, sore throat 08/31/2022: Runny/congested nose, sore throat, coughing, muscle/joint pain 08/01/2022: Runny/congested nose, sore throat, coughing, headache 08/02/2022: Runny/congested nose, sore throat, coughing, throat tightness/coldness, chest tightness/coldness All days: DayQuil
Shivering, sweating, headache, lymph node soreness, extremely tired, nausea, loss of appetite. Tylenol, ginger ale, saltine crackers, Body Armour drink, water. Slept 1 complete day following the vaccination.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. A few years ago, the patient was vaccinated with the first dose of GARDASIL (lot #, dose, route and indication was not reported). This licensed practical nurse reported that the patient did not receive their third dose of GARDASIL. At the time of reporting, the patient was in the office to receive the third dose but the time between the second dose and third dose, that patient would receive today (20-SEP-2013), it was outside the dose schedule recommendations of the product insert. No adverse effects reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
A week later, my sensitivity to fragrances became much more severe causing my skin to crack. Last Friday the 21st it got much worse by the 24th It was like a 7 or 8 on the pain scale. It became so severe I was not able to operate my vehicle properly. The provider recommended that I use LIDEX topical ointment and moisturizer. She diagnosed me with dyshidrotic eczema. After applying the treatment for about 2 days, my symptoms improved. I am about 80% recovered with the skin no longer being broken but there are still some issues.
Pt called advice line on 3/31/15 to report event from 2/11/15 PREVNAR vaccine which he stated last 10 days. No medical intervention needed. Pt used ice with response. Rash, urticaria, pruritus and swelling at site.
Prt had facial redness due to a hair dye treatment PRIOR to vaccine.  After vaccine, left side of face and left ear was observed by staff to be swollen and increasingly red.  Vital signs stable; prt was not in any distress and prt had no complaints.  Prt was evaluated by medical provider and given dose of benadryl and observed in clinic after for 2.5 hours with some improvement.
High fever for 12 hrs? 104.5 was highest. Body aches, soreness, fatigue
This spontaneous report received from a health care professional concerned a non Hispanic or Latino 3 month old white male. The patient's height, and weight were not reported. No concurrent conditions were reported. The mother had medical history of COVID infection in April 2021, and was vaccinated in August the same year. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number: 1808982, expiry: unknown) dose was not reported, 1 total, administered on AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced fetal exposure during pregnancy. The patient was born in NOV-2021. On 12-FEB-2022 the patient's parent noticed there was swelling in the leg situation that prompted them to take patient to the hospital. On 15-FEB-2022, the patient was diagnosed with deep venous thrombosis and was hospitalized on the same day and on 22-FEB-2022 the patient was discharged. The number of days of hospitalization were 8 days. Doctors had been wondering whether there might had been a relationship between the vaccine administration while in utero and the subsequent development of DVT (Deep vein thrombosis) in an infant born to a vaccinated mother. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from deep venous thrombosis in infant, and the outcome of fetal exposure during pregnancy was not reported. This report was serious (Hospitalization Caused / Prolonged). This parent/child case is linked to 20220449140. Sender's Comments: V0- 20220440088- Covid-19 vaccine ad26.cov2.s- Deep venous thrombosis in infant- The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220440088-COVID-19 VACCINE Ad26.COV2.S- Fetal exposure in pregnancy. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
None with first shot.  Just tender arm at injection site.  After the noonday second shot 2/25/2021 , within 24 hrs. I was awaken with ringing in my ears which still continues today.
The evening of the vaccine swelling developed at injection site. The next day she developed a headache, chills, nausea and sweating. Today (day 3) she continues to have left arm swelling with chills and sweating.