chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash developed 23Apr; Diagnosed with Shingles on 4-23-21; skin sensitivity on thigh on 18Apr; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0151, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 08Apr2021 14:30 at the age of 56-year-old as dose 1, single for COVID-19 immunization, at pharmacy. The patient medical history included DVT (deep vein thrombosis) and PE (pulmonary embolism) in 2014. The patient had known allergies to sulfa drugs and latex. The concomitant medications included Multivitamins. The patient was not pregnant at the time of vaccination. The patient received no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient was not tested for COVID post vaccination. It was reported that, the first symptoms appeared skin sensitivity on thigh on 18Apr2021 at 20:00. The patient was diagnosed with shingles on 4-23-21 and rash developed on 23Apr2021 at 20:00. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received antivirals as treatment for the events. The outcome of the events was reported as resolving.
had a hard time picking things up and doing things with his hands/had a problem with his hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 83 year-old male patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 83 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Psoriatic arthropathy" (ongoing); "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis, psoriatic arthropathy, start date: 18Mar2021. Past drug history included: Enbrel, start date: 2019, stop date: 2021, for Psoriatic arthropathy, reaction(s): "Weak and had abdominal pain and diarrhea/Was too weak without Enbrel"; Enbrel, start date: 2019, stop date: 2021, for Psoriatic arthropathy, reaction(s): "Weak and had abdominal pain and diarrhea"; Enbrel, start date: 2019, stop date: 2021, for Psoriatic arthropathy, reaction(s): "Weak and had abdominal pain and diarrhea"; Enbrel, start date: 2019, stop date: 2021, for Psoriatic arthropathy, reaction(s): "Pain in his hands, weakness, arthritis in back and hands was effecting him more without the Enbrel"; Enbrel, start date: 2019, stop date: 2021, for Psoriatic arthropathy, reaction(s): "Pain in his hands, weakness, arthritis in back and hands was effecting him more without the Enbrel"; Enbrel, start date: 2019, stop date: 2021, for Psoriatic arthropathy, reaction(s): "Pain in his hands, weakness, arthritis in back and hands was effecting him more without the Enbrel/Still has problem with his hands"; Enbrel, start date: 2019, stop date: 2021, for Psoriatic arthropathy, reaction(s): "Sedimentation rate increased". Vaccination history included: Bnt162b2 (dose1), administration date: 2021, for COVID-19 Immunization. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "had a hard time picking things up and doing things with his hands/had a problem with his hands". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around September 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as shortly after received zoster vaccine live (ZOSTAVAX), the patient suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not presented prior the used of zoster vaccine live (ZOSTAVAX). The patient was also experienced mental and emotional distress due to resulted physical limitations and seriousness of patient's condition. As a result of manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) conduct, the patient had suffered and incurred damages, included medical expenses, the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
J96.00 ACUTE RESPIRATORY FAILURE 12/10/2021 ADHESIVE CAPSULITIS OF LEFT SHOULDER J96.00 ACUTE RESPIRATORY FAILURE 12/10/2021 LEFT ARM PAIN J96.00 ACUTE RESPIRATORY FAILURE 12/10/2021 ADHESIVE CAPSULITIS OF LEFT SHOULDER J96.00 ACUTE RESPIRATORY FAILURE 12/10/2021 UNSPECIFIED ANXIETY J96.00 ACUTE RESPIRATORY FAILURE 12/10/2021 WEAKNESS OF LEFT ARM
approx 4days p/vax pt devel URI sx diarrhea initially dismissed as enterovirus. stools became mucousy & bloody & tested positive for blood & grew no enteric  pathogens.
Soreness in arm, decreased movement in arm (left). Patient called her place of employment on 11/30/15 to report she was having complications from the influenza vaccine from 11/24/2015. She went to her primary care physician for treatment. She reported that she was prescribed pain medication and allowed to go home.
Initial report received from a healthcare professional on 28 AUGUST 2013. A 34-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of ADACEL (lot number: U4655AA, expiry date: 12/13/2015 and exact dose number was not reported) intramuscularly in the left deltoid on 20 AUGUST 2013. As per the reporter, the patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects were not reported. On 26 AUGUST 2013, the patient had experienced local site reactions of redness, swelling, warm to touch at injection site of left arm. Corrective treatments and laboratory investigations were not reported. At the time of the report, outcome of the event was unknown. List of documents held by sender: none.
1/1/21  itchy, red, warm at site. took benadryl and better. On 1/4 presented to EH. Large pale pink area about 3x5cm and larger red area outside it about 10x18cm. Outline marked w sharpie and date. sent her to pcp for eval.  She saw PCP 2/5 and dx as cellulitis and prescribed ABX. She took for one day and stopped.  Reaction completely gone 2/10/21. Likely will decline dose #2
I just tested positive for covid 3 weeks after my first dose; I just tested positive for covid 3 weeks after my first dose; This is a spontaneous report from a contactable consumer (patient) via the Pfizer sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EN6208), via an unspecified route of administration, on Mar2021 as a single dose for COVID-19 vaccination. The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient reported that: I got my first shot of your covid-19 vaccine 4 weeks ago. I was scheduled to get the second shot in 3 days. I just tested positive for covid 3 weeks after my first dose and was forced to cancel my second dose. patient underwent lab tests and procedures which included covid-19: positive, on Apr2021.  The clinical outcome of the events was unknown.   Information about the Lot/batch number has been requested.
Itchy palms on first night, developed more severe itching and hives on abdomen, back, thighs and neck over the next 24 hours.
SHE DEVELOPED BILATERAL HIP PAIN 2 DAYS AFTER RECEIVING 3RD DOSE OF HEPATITIS B VACCINE. THEN DEVELOPED LOWER EXTREMITY MUSCLE WEAKNESS 4 DAYS AFTER THE VACCINE. SHE WAS REFERRED TO HOSPITAL AND HAD AN MRI OF THE SPINE WITH CONTRAST AND THE LUMBAR PUNCTURE.
pt got vax 11AM & started crying when immun given & cried all day screaming; fell asleep @ about 2pM for about 15 mins; very unusual for pt to cry like that & usually sleeps for 2 hrs; leg rt was warm to touch & red;
Pt recvd vax 30JUN92 & 14JUL92 pt presented to physician's office w/cough, sl runny nose & bilateral parotitis; neck & cheeks were swollen; pt recovered in fourteen days; No further details were provided;
Arm swollen and warm. 1 day after getting flu shot and PNEUMOVAX in Left deltoid treated with MOTRIN, ZYRTEC and KEFLEX. Swelling went form lower chest to tip of hand all symptoms gone by 10/18/2009.
This spontaneous report as received from a registered nurse via a company representative, refers to a 15 year old male patient. Concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with a third dose of GARDASIL (dose, route, lot# and expiration date were not provided). Concomitant medication was not reported. On an unknown date, soon after administration of patient's third dose of GARDASIL, his lips turned blue and he felt faint. The patient sought medical attention in an office.  It was not known if the patient fainted or if he required medical treatment. The outcome of the events was not reported. Relatedness between the events and GARDASIL was not provided. Additional information has been requested.
After vaccine she waited and was ok to leave. 11am she begin to feel cold and weak and went to bed, by noon she was so cold and couldn't get warm we put a heat blanket on her and around 2pm she started feeling nauseated and I gave her some nausea meds and Tylenol. It all lasted for 24 hours but the symptoms were identical to the virus she experienced.
Patient received influenza quadrivalent High Dose P-free flu vaccine in the clinic on 9/16/22. On 9/28/22 Appointment was made to come get an influenza quadrivalent High Dose P-free flu vaccine during the drive through flu clinic that was done on 10/17/22. Patient received a second dose of the influenza quadrivalent High Dose P-free flu vaccine flu vaccine on 1017/22.
Very painful to touch. Red blotchy area started today (9/17/17) lower on arm and moving towards tricep area. After physician on call Dr. was told to apply ice. The following day swelling and redness down.
Moderate ringing in ears, more noticeable in last week or two. Started noticing about three weeks after last dose.
Client experienced malaise, achiness, and headache that lasted until the next day. Client also experienced a fever of 104 for approximately 5 hours; unrelieved by Tylenol.
Pt received RECOMBIVAX September 2011, November 2011, February 2012 and March 2012. Information was received on 24-OCT-2016 from a consumer/mother regarding her child. Medical history, concurrent conditions and concomitant medications were not reported. On September 2011, November 2011, February 2012 and March 2012 the patient was given a dose of RECOMBIVAX HB (specific dated were not reported). The patient's mother explained that in September 2011 the patient was actually supposed to receive GARDASIL instead of RECOMBIVAX HB which was administered (due to clerical error). The patient did not have an adverse reaction to RECOMBIVAX HB. It was unspecified if the patient ever received his intended GARDASIL vaccinations. No further information was provided. Additional information is not expected as contact information was not provided.
4 hours post vaccination, experienced injection site pain,  body aches, chills, dizziness, shakiness and weakness. Took NSAID and went to bed. That night, experienced extreme body pain - including sole of feet. Cramping in thigh and calf. Extreme chills and severe headache. Weakness and shakiness continued.      The next day, aches continued but chills improved some. About 2:00 pm, experienced visual abnormality - shiny bubble-like image filled roughly 25% of visual field of both eyes. Was not a "floater." Image was translucent with jagged edges. Headache continued to be severe. Took more NSAID's and rested in a dark room for several hours. Visual abnormality ceased but vision blurry for about an hour.      It is now 4 days later (Tuesday). Injection site (and entire right arm) still quite tender. Weakness and shakiness continue. Headache still present but not as severe (3 to 4 on a scale of 1-10). Chills have subsided. No further visual problems to date.
Patient began having sudden weakness, leg swelling, abdominal pain, dyspnea.  Placed on 4L NC in ER.   Chest xray showed "ground glass" appearance.  CT chest showed no PE.  BNP level 8472.  Stress test show no ischemia, Ejection Fraction 66%, no chest pain but did have shortness of breath.
large broken blood vessel in his left eye on outer edge of the iris; He felt terrible/He felt emotionally terrible for 5 to 10 minutes; He felt depressed; His right arm was sore on that day after 2nd dose/He had body aches; chills on next day; At night, he sweated a lot.; His right arm was sore on that day after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (large broken blood vessel in his left eye on outer edge of the iris) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (His right arm was sore on that day after receiving 2nd dose). On 22-Aug-2021, the patient experienced MYALGIA (His right arm was sore on that day after 2nd dose/He had body aches), CHILLS (chills on next day) and HYPERHIDROSIS (At night, he sweated a lot.). On 24-Aug-2021, the patient experienced FEELING ABNORMAL (He felt terrible/He felt emotionally terrible for 5 to 10 minutes) and DEPRESSED MOOD (He felt depressed). On 25-Aug-2021, the patient experienced EYE HAEMORRHAGE (large broken blood vessel in his left eye on outer edge of the iris) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EYE HAEMORRHAGE (large broken blood vessel in his left eye on outer edge of the iris), MYALGIA (His right arm was sore on that day after 2nd dose/He had body aches), CHILLS (chills on next day), HYPERHIDROSIS (At night, he sweated a lot.), FEELING ABNORMAL (He felt terrible/He felt emotionally terrible for 5 to 10 minutes), DEPRESSED MOOD (He felt depressed) and PAIN IN EXTREMITY (His right arm was sore on that day after receiving 2nd dose) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Approximately 60-90 minutes post injection noted swelling in the face and lips as well as the injection site. Antihistamine taken with little relief. As time progressed, low grade fever around 100 degrees Fahrenheit. Intense pain approximately 8 hours post injection in the left axillary area in conjunction with increasing swelling. Facial swelling resolved within 12 hours, but swelling of the lymph nodes and fever still present 48 hours post injection at time of report submitted. Will seek medication attention with PCP when in office tomorrow.
PT reported leg swelling, redness, bruising to DTaP vax inject site 6 hrs post injection. Tx warm heat to leg, overnight and recheck if still swollen. V'd to seek good perfusion tertoes? warm to touch, can move leg and feet.
having "a reaction"; felt like she had the flu; feeling sick for 3 days; Face started feeling really hot; Facial redness; Facial swelling; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (having "a reaction"), INFLUENZA LIKE ILLNESS (felt like she had the flu), MALAISE (feeling sick for 3 days), FEELING HOT (Face started feeling really hot) and ERYTHEMA (Facial redness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history provided.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced ADVERSE REACTION (having "a reaction"), INFLUENZA LIKE ILLNESS (felt like she had the flu), MALAISE (feeling sick for 3 days), FEELING HOT (Face started feeling really hot), ERYTHEMA (Facial redness) and SWELLING FACE (Facial swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Redness, at an unspecified dose and frequency. On 28-Feb-2021, FEELING HOT (Face started feeling really hot), ERYTHEMA (Facial redness) and SWELLING FACE (Facial swelling) had resolved. On 03-Mar-2021, ADVERSE REACTION (having "a reaction"), INFLUENZA LIKE ILLNESS (felt like she had the flu) and MALAISE (feeling sick for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Following vaccination patient developed worsening soreness and redness on her left upper arm.  At visit had a erythematous warm clearly demarcated area on her left upper arm that measured 15 x 13 cm.
fever; Abnormal sensation of limb; Nausea; Eye Headache; Headache in eye; She doesn't have any energy; Rash; Underneath the skin It is sore and hard; exhausted; Pain in extremity; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318; Expiration Date: May2021), via an unspecified route of administration, administered in Arm Left on 21Mar2021 15:15 (at the age of 56-years-old) at dose 1, single for covid-19 immunization. Medical history included blood pressure. Concomitant medication included hydrochlorothiazide taken for blood pressure abnormal. After vaccination, on 22Mar2021, patient had a rash, the rash was underneath the actual place where she was shot and she put some alcohol on the area, she feels it did not help. Rash was growing, was persisting, underneath the skin was sore and hard and was spreading. She got an eye headache on 25Mar2021. It felt like she has been punched in the eye. She was also noticing some nausea on 25Mar2021. She had just eaten. She mentioned she went with her sister to get the shot and she had no problems. Caller went on to mention, after she got the shot, she started to feel sensation at her elbow and went all the way around up to the shot, the area where the shot was given. At night her arm was extremely sore on 21Mar2021. The next day around evening time she was on the prail line and it shot down to her finger, she has never had arthritis before, it went down her finger. She also felt exhausted, as if she doesn't have any energy. She felt better yesterday but today she is like she was on Monday (at the time of report). She first noticed it on Monday (22Mar2021) evening when she tried to walk. Soreness happened Sunday night (21Mar2021), it was spreading and when she touches it, it was like sit has a fever in it. Eye headache, it was like a headache in her eye. This started today before her conference call, maybe 10 or 10:30. Now at the time of report it was not as agitated. Nausea she tried to eat around 12:40, she ate and she felt like she was getting sick to the stomach. Vaccine was not administered at Military Facility. The adverse events was not resulted in Physician Office. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events Rash, Underneath the skin it is sore and hard and Soreness was not recovered; Exhausted, does not have energy was unknown; Eye Headache, Nausea was recovering.  No follow-up attempts are possible. No further information is expected.
Janssen COVID-19 Vaccine EUA Severe pain developed about 6 hours following injection in central region of upper back, and at lowest ribs.  Moderate pain developed in mid-abdomen.  Duration of pain 8-12 hours.  Unusual fatigue developed about 6 hours following injection, duration of fatigue about 5 days.
Extreme Headaches; Ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Extreme Headaches) and PAIN (Ache) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 20-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced HEADACHE (Extreme Headaches) and PAIN (Ache). At the time of the report, HEADACHE (Extreme Headaches) and PAIN (Ache) had resolved.            Concomitant product use was not provided by the reporter.  The patient took two vaccines of moderna and with the first vaccine he had bad side effects of extreme headaches and aches. He had recovered since then just worried now about getting a refill from the pharmacy.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.  The reporter's causality for the events of extreme headaches and ache with Humira was not provided.  The reporter's causality for the events of extreme headaches and ache with Moderna COVID-19 vaccine was reported as possible.   This case was linked to MOD-2022-627433 (Patient Link).