chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 83 year old patient of unknown gender. On 07-AUG-2014 the patient was vaccinated with 0.65 ml expired ZOSTAVAX, lot # J003805, expiry date: 03-JUL-2014, subcutaneously. No adverse effects reported. The outcome of events was unknown. Additional information has been requested.
-Covid vaccine: 8/1821 with adverse reaction, 9/08/21 2nd pfizer shot  -states immediately after 1st shot pain, swelling, hot to touch, nausea and didn't feel well but the arm kept getting worse when she got the second shot the person told her whoever did the first shot didn't do it in the triangle and that was the issue and she needed to see her pcm to get worked up. She said steadily hot to touch swollen but no magnet sticks to it
Pt came today for a triamcinolone cream. At counsel, she mentioned it was to treat a reaction on her shoulder and neck after the vaccine- she's had it since September, when she got the shot.  She is having these small "bubbles" appear in pairs on her shoulder and neck of the same side she had her vaccine. Pt says she thinks it is coming from deeper in the skin/muscle than a purely topical rxn.  Initially the doctor thought it was shingles, and gave her a course of acyclovir, which did nothing for the rash. Pt did not think it was shingles at the time, because she has had shingles before, and it did not feel like her previous eruptions.  Pt had triamcinolone at home for something else, and has been using that to help the rash, which has been intensely itchy. It has helped slow the reaction, so the doctor's office called in the triamcinolone today to continue helping.
Noted that approximately 10 days after she received her 1st COVID-19 vaccine, she developed a rash on her stomach, legs (inner aspect) and chest - little red bumps that were itchy. She applied topical cortisone 2-3 times/day for approximately 3 days. In speaking with her - the rash resolved and she doesn't have any concerns at this stage and is scheduled to have her 2nd dose of the COVID-19 vaccine within the next week. Noted that she had reported this experience to her PCP during a annual well-adult visit on 14Apr2021 - she did not make a special visit for this event.
Initial report received on 18 June 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 21-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; received on 08 October 2010, 08 December 2010, 11 February 2011 and 15 November 2011 (lot number, routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 23 May 2012, approximately six months after the dose. On 01 June 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 07 June 2012. Corrective treatments consisted of azithromycin starting on 07 June 2012 for 5 days. The subject was not hospitalized. At the final contact on 11 June 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Upper & lower lip swelling , blisters/cold sore on each side of mouth, few bumps on roof of mouth, severely chapped lips.  Lip swelling lasted 5 days,  bumps on roof of mouth lasted 1 day,  chapped lips lasted 2.5 weeks but are still very dry  and blisters/cold sores are not as visible but skin at corners of mouth are red and tender and opening mouth to eat causes discomfort
pt recvd vax; 30may95 exp fever of 106;devel shingles on lt side of torso;4dec95 still devel shingles
Tingling sensation; Numbness in his hand and fingers; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation) and HYPOAESTHESIA (Numbness in his hand and fingers) 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 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced PARAESTHESIA (Tingling sensation) and HYPOAESTHESIA (Numbness in his hand and fingers). At the time of the report, PARAESTHESIA (Tingling sensation) and HYPOAESTHESIA (Numbness in his hand and fingers) outcome was unknown.            No concomitant medication was provided. No treatment information was provided. It was reported that, over the weekend had some numbness in his hand and fingers,like a tingling sensation. It's the same arm where the lump was started to get bigger in the last few days too. Patient was reporting side effects of her daughters husband.  This case concerns a male patient, unknown age, with no known medical history, who experienced the non-serious, unexpected events of paraesthesia and hypoaesthesia. The events occurred  1 day after second dose of mRNA 1273 vaccine. The rechallenge is not applicable as there is no information regarding a third dose. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-380332 (Patient Link).; Sender's Comments: This case concerns a male patient, unknown age, with no known medical history, who experienced the non-serious, unexpected events of paraesthesia and hypoaesthesia. The events occurred  1 day after second dose of mRNA 1273 vaccine. The rechallenge is not applicable as there is no information regarding a third dose. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Extreme fatigue, fever, chills, and body and head aches and pains. The symptoms slowly began within a few hours of receiving the shot and peaked over night with the extreme fever chills and body aches.  They are still persisting but they improved a bit from over night.
Patient brought the ED by EMS on 11/19 early morning for evaluation of a fall. Patient was laying in bed when she rolled off the side of her bad in an unwitnessed fall. Ultimately, she was discharged home however returned to the ED that day in the afternoon after another fall. Patient reports she felt dizzy and fell to the floor. During her second ED visit, she reported a mild headache and right sided neck pain, along with cough and sore throat. COVID-19 PCR test was done which resulted positive. Additionally chest imaging was concerning for suspected pneumonia. Ultimately, patient was admitted 11/19/22 - 11/22/22 for evaluation of recurrent falls and COVID-19 infection.
Tightness in chest about 3 to 4 hours after the vaccine felt very much like an allergic reaction that I?ve had before
March 20th I developed a sore throat. Today is 3/28/2022 and sore throat, cough, some sneezing in early morning is still present. I had to call out of work two times as I talk most of the day and could feel that I could lose my voice if I went to work. Today, day 9, is where I have actually used Tylenol hoping to decrease swelling which I believe has helped, drank Dayquil and had a Theraflu tea. Throat still feels congested but coughing is much less. I also have a lower back ache. I did not notice when this started but maybe around  March 23rd.   I have no other symptoms to where it can feel like a common cold.
Local-day 1, local spread-day 2 enlarged lymph nodes, skin red, itchy, day 3-headache, nausea, panic; day6-headache and nervousness remain (day reported); day 7-much better. Advised to check up with PMD.
11/8/2021  1. Community-acquired pneumonia 2. Severe sepsis 3. Acute respiratory failure 4. Acute on chronic kidney failure 5. Elevated LFTs and bilirubin
n/v extreme localized pain, localized heat & swelling, restricted ROM of rt arm, high fever, 24hr p/vax;
Pt. states that after receiving the 3rd Booster of Phizer 10/07/2021, started experiencing symptoms that evening of fever, chills, fatigue, weakness, and high Heart Rate (120). Cardiologist visit 11/19/2021 (High Blood-Pressure Follow-Up), advised to Report. No lingering side effects advised.
Menstruation in the middle of birth control pack 5 days after receiving final vaccine on 20Apr2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 10:00 (Lot number: er8734) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (a friend of mine who received her second dose on the same day had the exact same experience), for COVID-19 immunisation. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "Menstruation in the middle of birth control pack 5 days after receiving final vaccine on 20Apr2021".  Additional Information: Patient's friend reported about menstruation in the middle of birth control pack 5 days after receiving final vaccine on 20Apr2021 (PMS symptoms began 2 days after). Her periods are always precise/regulated by birth control, so this was very out of the ordinary. Didn't think much of it but a friend of reporter (patient) who received her second dose on the same day had the exact same experience. No COVID prior vaccination and COVID twas not tested post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021482005 same reporter/product/event different patient.
2 days p/vax pt devel severe cellulitis @ inj site;pt was hosp for 2 days & tx w/Ancef;tx w/ATB p/hosp d/c & recovered;this is 1 of 2 pt from this site to devel inj site rxn p/vax w/lot# 428497event was non-serious redness & swelling;
FOGGY MIND; COULDN'T MOVE; HAD TO SLEEP LONG PERIODS TO HAVE ENERGY; LIGHT HEADEDNESS; SEVERE COUGH; SHORTNESS OF BREATH; WHEEZING; CHEST TIGHTNESS; DIAPHORESIS/SWEATING BUCKETS; RHINORRHEA; PRESSURE AND DISCOMFORT IN EARS; EASILY FATIGUED MUSCLES; TREMBLING MUSCLES; PALPITATIONS; NECK PAIN; MUSCLE STIFFNESS; COUGH WITH CLEAR SPUTUM PRODUCTION; SLOWER SPEECH; PRESSURE AND DISCOMFORT IN NASAL PASSAGES; CHILLS; WEAKNESS; FEVER; NAUSEA; VOMITING; SEVERE HEADACHES; SEVERE FATIGUE; ACUTE MYALGIA/ACUTE MUSCLE PAIN; DIARRHEA; BILATERAL LYMPH ADENOPATHY/CERVICAL LYMPH ADENOPATHY; This spontaneous report received from a health care professional concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced foggy mind, couldn't move, had to sleep long periods to have energy, light headedness, severe cough, shortness of breath, wheezing, chest tightness, diaphoresis/sweating buckets, rhinorrhea, pressure and discomfort in ears, easily fatigued muscles, trembling muscles, palpitations, neck pain, muscle stiffness, cough with clear sputum production, slower speech, pressure and discomfort in nasal passages, chills, weakness, fever, nausea, vomiting, severe headaches, severe fatigue, acute myalgia/acute muscle pain, diarrhea, and bilateral lymph adenopathy/cervical lymph adenopathy. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy mind, couldn't move, had to sleep long periods to have energy, light headedness, severe cough, shortness of breath, wheezing, chest tightness, diaphoresis/sweating buckets, rhinorrhea, pressure and discomfort in ears, easily fatigued muscles, trembling muscles, palpitations, neck pain, muscle stiffness, cough with clear sputum production, slower speech, pressure and discomfort in nasal passages, chills, weakness, fever, nausea, vomiting, severe headaches, severe fatigue, acute myalgia/acute muscle pain, diarrhea, and bilateral lymph adenopathy/cervical lymph adenopathy. This report was non-serious. This case, from the same reporter is linked to 20210944355.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
After COVID shots hands broke out; Eczema; Allergies; This spontaneous case was reported by a consumer and describes the occurrence of RASH (After COVID shots hands broke out), ECZEMA (Eczema) and HYPERSENSITIVITY (Allergies) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic).   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) in pre filled pen. On an unknown date, the patient experienced RASH (After COVID shots hands broke out), ECZEMA (Eczema) and HYPERSENSITIVITY (Allergies). The patient was treated with DUPILUMAB (DUPIXENT) at an unspecified dose and frequency. At the time of the report, RASH (After COVID shots hands broke out), ECZEMA (Eczema) and HYPERSENSITIVITY (Allergies) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication list was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for Humira with respect to the events, eczema, rash and allergies were not provided.   This case was linked to MOD-2022-645284 (Patient Link).
Over the next 24 hours, severe chills, headache, fatigue & temperature of 101.6 F.   The next 24 hours, fever subsided, chills subsided & headache became moderate, gradually easing.  Body aches & fatigue present. Today, body aches present & fatigue has lessened somewhat.
I had the covid vaccine of 12/29 and I  had a little bit of an allergic reaction; Well on 12/30 I had some peanut butter and within 5 minutes I had an extremely itchy palm of hand.; my palm was bright red and a little tingling; my palm was bright red and a little tingling; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient medical history included allergic to peanuts. The patient concomitant medications were not reported. Patient had the covid vaccine of 29Dec2020 and had a little bit of an allergic reaction. As a child patient was very allergic to peanuts but have out grown it as an adult. Well on 30Dec2020 patient had some peanut butter and within 5 minutes patient had an extremely itchy palm of hand. Patient immediately looked and palm was bright red and alittle tingling. Patient went and washed hand. It went completely way after about 30 minutes. Other then that feel fine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
PATIENT STARTED TO EXPERIENCE A SWELLING IN THE ARM WHICH HASN'T GONE AWAY, THE LUMP IS STILL PRESENT AFTER 2 WEEKS,
Shots were 13 weeks apart and we are 10 days away from the second shot; Headache; Fever; Muscle ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Shots were 13 weeks apart and we are 10 days away from the second shot"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; MYALGIA (non-serious), outcome "unknown", described as "Muscle ache".  Additional Information: Reporter stated, "Reporter just had a question, reporter mom and reporter both received, both of the shots for the Pfizer vaccine (not clarified), the shots were 13 weeks apart and we are 10 days away from the second shot. Reporter mom was having symptoms of headache, fever and muscle ache. So, reporter was just calling to see if that was a normal reaction 10 days out of the second shot. She was having symptoms for two days now." (Vaccine name not clarified, hence suspect captured as Unspecified Vaccine and is this a Pfizer product tab checked-Yes). Reporter was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department and provided with the number. In response to further probing for safety report, reporter stated, " just talked to somebody and gave them all of reporter age and medical and everything, reporter just did that (not clarified further). reporter will try that number again." (further clarification unknown if reporter called in Pfizer Drug Safety earlier, hence report type captured as initial report. Further probing could not be done as reporter was unwilling to further answer the questions and hung up abruptly. Hence, product details (LOT#, expiration date, NDC#, UPC#), purchase details and other details were unknown and limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Urticaria - hives, on legs, trunk, face. Unknown if vaccine reaction, vaccinated 1/7/13 mother noticed hives on legs, trunk, face on 1/8/13.
I went to bed feeling perfectly fine, and woke up 2 hours late with blood 9 blood blisters in my mouth. I went to ER, they sent me home with an appointment with an NP. the following day I wake up with petichae and bruises all over my body and was voiding blood. I had bloodwork drawn and my plateless came back less than 1. I have no history of blood disorders or auto immune diseases in my family and was perfectly healthy up until now. The doctors have not identified a cause for this episode of ITP, nor do we know if this is a chronic issue. I received 2 plateless transfusions, a couple doses of IVIG, and am now on steroids and getting weekly bloodwork. As a nurse, I am 98% sure this is a vaccine reaction. I nearly died.
HEART ATTACK; This spontaneous report received from a consumer via a company representative concerned two patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 (a month prior to this report) for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, two patients' suffered a heart attack and died. It was unknown if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked. Sender's Comments: V0: COVID-19 VACCINE AD26.COV2.S - Heart Attack. This event is considered Unassessable. The event 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.; Reported Cause(s) of Death: HEART ATTACK
Beginning late afternoon the day of injection, I had a few intermittent chill sensations and my injection arm began to hurt worse than any other injection I've ever experienced.  Then, about 10 PM that evening, while in bed, I started experiencing more frequent chills, worsening injection arm pain, and muscle pain throughout my body, making it difficult to sleep or move. The following day, by about 8:30 AM in the morning, the injection arm pain had lessened to be consistent with an IM injection, and the chills and muscle pain were gone. No further adverse symptoms were experienced.  I did take 400 mg of ibuprofen the morning after the injection.
7:09 patient received COIVD 19 vaccine after vaccination patient monitored by medical staff 7:20 patient c/o lightheadedness, dizziness, SOB and difficulty swallowing. patient brought into exam room at that time.   Sp02 at 7:25 was 99% on RA, pulse 133 patient assessed by RN, shaky, clammy skin, no visual swelling of neck or mouth, tachycardia noted.     50 mg benadryl IM given by RN at 7:25 vitals retaken at 7:30 pulse:99 SpO2:98 on RA, BP: 140/96 Patient D/C at 8:09  with VSS. NP states continue dosing 2-4 hours with benadryl 50 mg for the first and depending on how she feeling 25 to 50 mg there after.
erythema, induration, swelling of lt upper arm around site of DT inj, T38.7 16x16in;
the patient was administered the 2nd dose of PROQUAD; developed a 100.7 fever/ fever for approximately 4 hours; This spontaneous report was received from a consumer referring to her granddaughter as a 3 years 9 months old female patient. Information about medical history and current conditions was not provided. Information about concomitant medications was unknown.   On an unknown date, the patent was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, route, lot # and expiration date were not reported). On 05-AUG-2019, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, lot # and expiration date were not reported, route reported as injection) for prophylaxis (inappropriate schedule of vaccine administered). On an unspecified date in August 2019 (reported as over the past weekend), the patient had the fever for approximately 4 hours and recovered on the same day. Her temperature was 100.7 (unit unknown). The patient didn't seek medical attention or have any laboratory rests. It was unknown if treatment was given for the event. Causality assessment was not provided.
pt recvd MMR vax live as a child; pt currently exhibited a lack of response to mumps; no further details were provided;
muscle soreness/mild pain at injection site (deltoid muscle) fo 24-36 hours after injection. Resolved spontaneously without requiring analgesics. No other adverse events noted.
Nauseous, light headed, Headache, runny nose Body Aches, then passed out unable to walk on own, fever Admitted to hospital on October 30
Patient presents emergency department 3-day history of progressive worsening shortness of breath.  Patient reports significant exercise intolerance and inability to ambulate around his house due to severe shortness of breath.  Patient reports fevers chills body aches as well as a productive cough bringing up yellow-greenish sputum.  Patient denies any chest pain or abdominal pain.  Patient states he has been tolerating p.o. food and fluids normally no change in bowel or bladder habits.  Patient denies any falls or other types of trauma.  Patient has no additional medical or trauma complaint.