chrisvoncsefalvay/vaers-outcomes huggingface dataset:
D68.9 COAGULOPATHY, UNSPECIFIED TYPE 1/29/2022 HYPOTENSION I95.9 HYPOTENSION 4/29/2022 HYPOTENSION D68.9 COAGULOPATHY, UNSPECIFIED TYPE 1/29/2022 ADENOCARCINOMA, DUODENUM I95.9 HYPOTENSION 4/29/2022 ADENOCARCINOMA, DUODENUM D68.9 COAGULOPATHY, UNSPECIFIED TYPE 1/29/2022 HEMATEMESIS I95.9 HYPOTENSION 4/29/2022 HEMATEMESIS
Less than 1 mm papular rash on back, arms, legs with scattered 1-3mm mild erythematous papules, some with vesicular centers.
This spontaneous report was received from a register nurse concerning a male patient of unknown age who on 27-AUG-2012 was vaccinated with an expired dose, 0.65 ml dose subcutaneous ZOSTAVAX, lot number 670547/0659AA, expiration date 04-AUG-2012. No adverse events were reported. This is one of several reports received from the same source (other MAARS number 1209USA002305). Additional information had been requested.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild
Little pain on shoulder; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Little pain on shoulder) and FATIGUE (Tired) in a 120-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced ARTHRALGIA (Little pain on shoulder) and FATIGUE (Tired). On 06-Feb-2021, ARTHRALGIA (Little pain on shoulder) and FATIGUE (Tired) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 vaccine) was not applicable. No concomitant medication was mentioned. No treatment medication was mentioned.   This case was linked to MOD-2021-014536 (Patient Link).
Student complained of generalized itching to entire body one hour after receiving flu shot at her school flu clinic. No hives. No redness. No respiratory distress noted. Vital signs stable. BENADRYL was given IM. Student rested and informed itching less than before.
Woke up at 4am, 6/24/2019  to notice running fever 0f 100F together with tiredness headache
pt recv vax & devel a rash that was dx as chickenpox;reporter noted it was definitely attenuated & did not look as vesicular as nl;also noted pt had fever & malaise;pt still devel new lesions;
Within 10-12 hours post flu mist, pt noted onset of nasal congestion, headaches, body aches and nausea. Symptoms have not subsided and continue today. Also reports sinus congestion, dry cough, and decreased appetite. Stated nasal drainage is clear and denies any problems with seasonal allergies. has seen a provider and was treated with Cefzil, Flonase and Maxiphed, with no improvement. Was also given a Z pack. pt is concerned about feeling ill for so long. Nasal drainage start 11/09/2005, headache, general started 11/09/2005, Flu like symptoms 96 hours start 11/09/2005, nausea w/o vomiting start 11/09/2005.
Itchy rash on most of body, concentrated on feet, lower back, and back of legs. Includes swelling of feet and at lower, center, of back, just above and covering tailbone.
soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm). At the time of the report, PAIN IN EXTREMITY (soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is not under went for any treatment but he has concomitant drug like Simvastatin. Patient states that his second dose is due for exactly 18 days after his first dose (23March2021). He wants to know what date he should reschedule for and should they still be getting the second shot?  Concomitant and treatment information not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-053059 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-053059:CROSS LINKED WITH HUSBAND CASE
Hives 1 day after flu vaccine given. Controlled w/ Benadryl
Patient states that she started experiencing severe heartburn, profuse sweating, and was unable to sleep.
Pt received Hep-B (dose #3) at 10:13 on 9/20/01. Pt returned at 19:27, complaining of a rash and itching. Rash was on the abdomen, arms and back. Temperature was 98.2F. Pt was treated with Benadryl 25mg 1 po q6 hours X 5 days and Claritin 1 po q day X 7 days.
Hive type rash on abd, neck, face, and arms. BENADRYL 25 ml wght based with improvement.
After vx, acyclovir on hand in case I feel the tingling before an outbreak/ Suspected vaccination failure; Outbreak; keep acyclovir on hand in case I start to feel the tingling; Extremely sick; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, tingling of extremity and sickness. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, shingles, tingling of extremity and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, tingling of extremity and sickness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got extremely sick for at least 2 weeks after the shingles vaccine. The patient stated he/she would never get Shingles again. The patient was keeps acyclovir on hand in case he/she start to feel the tingling that always comes before an outbreak. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. This case has been linked to the case US2021AMR230926 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR230926:Same reporter.
patient received less than the full dose of Fluzone High-Dose due to the administering agent "squirted" most of the liquid out when they were removing the air from the syringe, no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 75 years old female patient who received yearly 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]  (lot number and Expiry date unknown) via unknown route in unknown administration site on 27-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was case of vaccine underdose.  It was reported that Received less than the full dose of Fluzone High-Dose due to the administering agent "squirted" most of the liquid out when they were removing the air from the syringe.  At the time of reporting no adverse reaction was reported.  Information on the batch number was requested.  List of documents held by sender: none.
This spontaneous report as received from a physician via representative refers to a 17 year old male patient. On 07-AUG-2012 the patient was vaccinated with his first dose of GARDASIL (injection, strength, lot#, dose and route were unspecified). On 29-JUL-2013 the patient was vaccinated with his second dose of GARDASIL (injection, strength, lot#, dose and route were unspecified). Physician reported that patient received his third dose of GARDASIL (injection, strength, lot#, dose and route were unspecified) "too early", on 08-OCT-2013. HCP planned to give the fourth dose of GARDASIL per CDC protocol. This fourth dose has not occurred yet. Patient had not had any side effects from receiving a third dose early. Patient did not seek medical attention as this was paperwork identified event. No lab diagnostics studies were performed and not treatment was given for the event. Therapy was continued and outcome was unknown. Additional information has been requested.
Patient contacted pharmacy to report that the site of injection was red and warm to touch.  Inflamed area was "about the size of a quarter".  She also indicated that area was sore.
Pt. presents in office 5/16/08 with low grade fever, <15 erythematous maculovesicular lesions on post neck & face.  Vaccinated with VARIVAX on 5/6/08.  Rx BENADRYL, calamine & AVEENO baths.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified date, the GARDASIL 9 vaccine had a temperature excursion of 24 hours. The lowest recorded temperature was 34 F. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". On 21-JUL-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 "0.5mL-10 Pk SD PFD-Luer-Lok" which had a lot number of M003659 and expiration date on 20-SEP-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Shortness of breath, itching right thigh, dizziness, nause, flushing, headache
sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day at the age of 60 years as dose 1, single and (Batch/Lot number: unknown) for 1 day as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The reporter states she had a sore arm after receiving both doses of the Pfizer COVID vaccine. She states she was 60 at the time she received the doses and she is now 61. No information in PI regarding if someone who administered the vaccine had COVID and still had antibodies is able to pass COVID on to other people.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Per pt, within 2h, she started to experience achiness & inability to move her arm. Now she still having trouble raising her elbow to shoulder height. Not sure if pt is seeing Dr.
Slight pain at the injection site; muscle and joint aches (mostly in shoulders and  back) which caused difficulty sleeping at night; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; Slight nausea; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 26Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ethinylestradiol, norgestimate (ESTARYLLA), valacyclovir, cyanocobalamin (B12), iron, and colecalciferol (D3). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021, the patient experienced slight pain at the injection site, muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night, and slight nausea. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Local swelling and hardness to injection site x1 week. Unusual high pitched crying for several days. Diarrhea. Behavior changes at one week, (agitation, poor eye contact, manic episodes which appeared as though he was in some sort of delirium). SEIZURES on the 12th day after vaccine, generalized in nature. To this date he has had 15 such seizures in approximately 1 month. He is on 2 anticonvulsants. (tegretol, phenolbarbitol) Additionally, he has developed upper airway wheezing, which occurs intermittently. Per follow up- Intractable epilepsy, developmental delay. Other symptoms attributable to his anticonvulsants such as hair growth and gum problems. He has been hospitalized 12 times, with episodes of life threatenting status epilipticus. His physicians state it is unlikely this will ever go away.
11/19/21 "Patient covid + transferred off IPR to general medical floor". PMHx of "a.fib, COPD, and dementia".
"COVID Arm" - Redness, swelling, warm to touch, round in shape.  Appeared near/at injection site 10 days after dose.  No change in size for 24 hours, reduced/gone within 24 to 48 hours with faint discoloration lasting approximately 5 days total
arm pain; This is a spontaneous report from a contactable consumer. A 25-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunization. The patient's medical history was reported as none.  There were no concomitant medications. It was reported that in the first dose, the patient just had arm pain. The outcome of the event was unknown. The patient received treatment for the event.   Information on the lot/batch number has been requested.
Narrative:  92 year old male that presented to the ER on 12/13/21 with cough and  SOB. Symptoms had began 2 days prior to ER visit. Grandson he lives with tested positive for COVID that morning of 12/13/21. Admitted for observation. Patient declined monoclonal antibody treatment. Patient was discharged 12/14/21. PMH of chest pain at rest, atrial fibrillation, HTN, BPN , GERD, CKD , and  osteoarthritis.
15minutes post vaccination of the 1st dose  the  back of the throat begun to itch throat swelling had to use inhaler due to chest tightening after 35mins  post vaccination, my thumbs turned bright blue Same symptoms occurred after 2nd dose except there was no chest tightening and participant  didn't have to use my inhaler.
HANDS FEEL SUNBURNED; SENSITIVE TO TOUCH; ITCHY HANDS; RED BUMPY SPLOTCHES ON  PALMS OF BOTH HANDS AND FINGERS; HANDS RED; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid disorder, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no known medical conditions. The patient is a farmer and is very healthy and had nothing like this in the past. On an unspecified date in AUG-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, for prophylactic vaccination. On 13-NOV-2021; 13:15, the patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on right arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included levothyroxine 125mcg sodium for thyroid disorder. On 16-NOV-2021; 16:00 Tuesday, the patient awaken by her hands becoming itchy and started to show red bumpy splotches on the palms of both hands and fingers and On 17-NOV-2021 She states that they seemed to get worse and that her hands feel as if they have been sunburned that they were sensitive to touch and were puffy. The patient states that it is currently ongoing and still with both hands equally.  On 17-NOV-2021 13:00, treatment medications included: diphenhydramine hydrochloride (2 Benadryls) for red and itchy hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hands feel sunburned, itchy hands, red bumpy splotches on palms of both hands and fingers, sensitive to touch, hands were puffy, and hands red. This report was non-serious.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
COVID 19 Treatment; COVID 19 Treatment; Dose 1 with Moderna vaccine, dose 2 with Pfizer vaccine and dose 3 with Moderna vaccine; Dose 1 with Moderna vaccine, dose 2 with Pfizer vaccine and dose 3 with Moderna vaccine; 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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 as dose 2, single (Lot number: FJ1620) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Mar2021 as dose 1, single (Lot number: Mod011A21A), in right arm and on 31Mar2022 as dose 3 (booster), single (Lot number: Mod017B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: PCN" (unspecified if ongoing), notes: known allergies PCN; "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 08Dec2021, outcome "unknown" and all described as "Dose 1 with Moderna vaccine, dose 2 with Pfizer vaccine and dose 3 with Moderna vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 10Sep2022 to 16Sep2022.
At around 4 pm the day I got the vaccine, I started feeling drowsy. I didn't think anything of it. However, about an hour later I was experiencing full body aches. This was eventually followed by chills, aches and pains, a cough, and a fever. These symptoms went away around 1 am that night of April 10, 2021. Then they returned around 3 pm the following day. Then went away again around 8 pm.
This spontaneous report was received from a physician via a company representative and refers to a 17 year old male patient. Concurrent conditions, medical history and allergies were not reported. On 08-MAY-2015, the patient was vaccinated with the third dose of GARDASIL, intramuscular injection, (strength, dose, frequency, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. The same date, the patient experienced loss of consciousness described as passed out, was non-responsive and experienced "tightening in the chest". The patient sought medical attention in the office, no treatment was given for the adverse event and it was unspecified if lab diagnostics studies were performed. The outcome of loss of consciousness, unresponsive to stimuli and chest discomfort was reported as recovered/resolved on an unspecified date in May 2015. The relatedness between loss of consciousness, unresponsive to stimuli and chest discomfort and therapy with GARDASIL was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 08-MAR-2016, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 22-MAY-2016, she was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster keratitis. The patient was prescribed instill brinzolamide (AZOPT), acyclovir, and hypromellose (GENTEAL) gel for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Upon internal review, herpes zoster keratitis was determined to be medically significant. Additional information has been requested.
Headache, Myalgia, Fever, injection site pain and swelling Narrative:  Other Relevant History:
Moderna booster shot was given following J&J  which was administered on 4/12/21. I had a  ?Covid arm? reaction to the J&J which showed up after about a week, and lasted for about as long. Moderna booster has caused as similar reaction, however it is not localized like the J&J rash was. I have red, itchy, and sometimes painful rashes on my arms, legs, upper pelvic area, lower abdomen, and ear. The rash showed up about four days ago and has not begun to reduce in size or severity. I have started taking Benedryl today, but am not seeing anything improve as of yet.
Parent noted a large bump in area of injection on left thigh. Patient was seen in our office today 4/13/18 and palpated a small nodule type bump. Parent states it is much smaller than the day after the injection.