chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHHY2012US105247 is an initial spontaneous report received from a pharmacist on 19 Nov 2012: This report refers to a 42-years-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: not reported) on 15 Nov 2012. After vaccination on the next day, he complained that, he woke up in the middle of the night with hives and itching all over trunk, arms and legs. He was treated with BENADRYL. On 17 Nov 2012, he also experienced lips and hands swelled up. The outcome and causality of the events was not reported.
3RD DOSE PFIZER COVID VACCINE GIVEN 11/29/21, #FF2593;  8/17/22 pt admitted to hospital after EMS being called due to pt falling out of recliner at home; c/o cough, fever, congestion; positive COVID test; given Remdesivir, Decadron, ABX; ICU for hypoxemia and hypotension; family decided on comfort care and hospice after pt did not make improvements; dc'd to a local hospice where he passed away
My sister got them with the shot/suspected vaccination failure; My sister got them with the shot; Few and small amount of pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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 and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. After receiving shingles vaccine, the patient experienced shingles, which went away in a few weeks and only had a few and small amount of pain which she does not have afterward. The reporter stated believe me you would rather have them with the shot than without.
This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. On an unspecified date, the patient was vaccinated with the full series of RECOMBIVAX HB doses (Lot #, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date, the patient had a negative titer now for hepatitis B antibodies. Blood test were performed (results not provided). No treatment was given for the event. The status of the patient had not changed since the titer. The relatedness for negative titer for hepatitis B antibodies was unknown for RECOMBIVAX HB. This is one of several reports from the same source. Additional information has been requested.
Initial unsolicited case received from a nurse on 25 May 2018. This case involves a patient (age and gender not reported) who received only DTaP/IPV component of PENTACEL (Batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unspecified date. Without the ACTHIB component of PENTACEL. Patient's medical history and concomitant medications were not reported. It was of actual medication error due to inappropriate reconstitution technique. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
PATIENT STARTED COUGHING SO HARD AROUND 8PM THE EVENING OF HER FIRST MODERNA COVID VACCINE THAT SHE WAS SHORT OF BREATH AND WHEEZING SAYS SHE FELT LIKE HER LUNGS WERE FILLING WITH FLUID OVER THE NIGHT AND SHE FEALT SO SHORT OF BREATH SHE CONSIDERED GOING TO THE HOSPITAL. THE NEXT DAY SHE FELT ABOUT 70% BETTER BUT EVEN NOW THAT SHE IS DUE FOR HER SECOND VACCINE (TODAY IS DAY 25) SHE SAYS THERE IS STILL ABOUT 10-15% RESIDUAL SIDE EFFECTS THAT IT FEELS LIKE BRONCHITIS.
pt began to be febrile to 102 on adverse onset date & temp to 104 inthe PM; mom administering APAP advised to contact MD: MD felt it was a viral infect per mom;
pain around the area of vaccine; pain in arm; pain in shoulder; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was allergic to sulphur. On 24Mar2021, the patient experienced pain around the area of vaccine and pain in shoulder and arm. Therapeutic measures were not taken as a result of the events. The clinical outcome for the events pain around the area of vaccine and pain in shoulder and arm was unknown at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN608) via an unspecified route of administration in the left arm on 14Apr2021 as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
tiredness/ body fatigue; woke up in the middle of the night; was tossing and turning and couldn't sleep; headache; chills; like really really cold; body aches / whole body was achy; lethargic; stuffy nose; muscle pain; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 20:00 (Lot number: ER8730) at the age of 52 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 29Mar2021 21:00, outcome "recovered with sequelae" (31Mar2021), described as "nausea"; FATIGUE (non-serious) with onset 30Mar2021 02:00, outcome "not recovered", described as "tiredness/ body fatigue"; MIDDLE INSOMNIA (non-serious) with onset 30Mar2021 02:00, outcome "unknown", described as "woke up in the middle of the night"; INSOMNIA (non-serious) with onset 30Mar2021 02:00, outcome "unknown", described as "was tossing and turning and couldn't sleep"; HEADACHE (non-serious) with onset 30Mar2021 02:00, outcome "not recovered", described as "headache"; MYALGIA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "muscle pain"; CHILLS (non-serious) with onset 30Mar2021 02:00, outcome "not recovered", described as "chills"; FEELING COLD (non-serious) with onset 30Mar2021 02:00, outcome "not recovered", described as "like really really cold"; PAIN (non-serious) with onset 30Mar2021 02:00, outcome "unknown", described as "body aches / whole body was achy"; LETHARGY (non-serious) with onset 30Mar2021 02:00, outcome "not recovered", described as "lethargic"; NASAL CONGESTION (non-serious) with onset 30Mar2021, outcome "not recovered", described as "stuffy nose". Therapeutic measures were taken as a result of nausea, fatigue, headache, myalgia, chills, feeling cold, nasal congestion.  Additional information: It was further reported that nausea started on 29Mar2021 an hour after vaccine and then it stopped and started back up again on 30Mar2021. Patient stated that on 30Mar2021 at 02:00, she woke up in the middle of the night with a bad headache and was tossing and turning and couldn't sleep because the headache was so bad. She was getting the chills, like she was "really really cold". The lethargic part got worse this morning (day of the report). Patient treated the symptoms (nausea, tiredness/body fatigue, headache, and muscle pain) with an allergy pill, fexofenadine (ALLEGRA). For the headache she took Advil, the pain goes away but then comes back.   No follow-up attempts are possible. No further information is expected.
An MD reported the occurrence of a 62 y.o. male who did not respond to 2 series of Hep A vax inactivated for prophylaxis. The subject's medical history included gastroesophageal reflex disease and an unspecified collagen vascular disease. Concurrent medications include omeprazole (Prilosec), finasteride (Proscar), fluvoxamine maleate (Luvox) and alendronate sodium (Fosamax). The subject consumes one glass of wine per day and denies tobacco use. Approx 4 yrs ago, in 98, the subject completed one dose of Hep A vax inactivated and his titer (NOS) revealed he had "not developed an antibody response." Beginning in Jan 02, the subject initiated a 2nd series of Hep A vax inactivated. A titer (NOS) was drawn on 3/4/03 and revealed that he had not developed an antibody response.
Vaccine expired 10/13/2021, vaccine given 10/22/2021.
Vomiting, redness, and warmth at site - patient returned for follow up next day.  No treatment required. Per follow-up: Pt had local reactin to DTaP of flu shot. Reaction 2 1/2 x 2 1/2 inch L thigh. Area warm to touch.
2nd dose not received between day 25-35 of the 1st dose/COVID 19 vaccine about 3 months ago/ Patient didn't receive 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose not received between day 25-35 of the 1st dose/COVID 19 vaccine about 3 months ago/ Patient didn't receive 2nd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose not received between day 25-35 of the 1st dose/COVID 19 vaccine about 3 months ago/ Patient didn't receive 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose not received between day 25-35 of the 1st dose/COVID 19 vaccine about 3 months ago/ Patient didn't receive 2nd dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The concomitant medications were not reported. The treatment information was not provided. It was reported that patient wanted to get the second dose now. And the first dose was received two to three months before. Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Follow-up information included addition of additional reporter. On 23-Aug-2021: Follow-up received included additional reported details.
first night had strange vivid dreams, extremely fatigued/sleepy, muscle aces all over, joint pains all over (arthritis is only in a few joints), runny nose, sore throat.  2nd day felt better but still very sleepy, fatigued, muscle cramping.  3rd day still extremely sleepy, muscle soreness, joint pain.  4th day fatigue, weakness, nausea.
"exactly 12 hours from the shot I developed body aches and chills.  Muscle pain and fever.  I was on the plane home and it hit the last hour.   When I got home temp was 103.1.   It lasted for about 8 hours - 10 hours"
Since receiving the Johnson and Johnson Covid vaccine, my blood  pressure continued to go up each consecutive day. On Saturday, March 20, 2021 my blood pressure was 195/95. Obviously my husband took me to ER where I was given a prescription to hopefully lower my blood pressure. The medicine that I was give is Amlodipine. My blood pressure typically runs 120's over low 70's. I know this issue is not listed on your list of side effects. My husband has also experienced the same issue, just not to the extreme that it affected me. His has been up around 20 points.
Moderna COVID 19 vaccine #1 on 3/23/21 via Department of Health Services outreach event,. Second dose administered  too soon on  4/6/21 during clinic event.  Moderna dose #3 given on 4/20/21 via different outreach event. In total patient received 3 vaccines.
Had immunization at 11AM on 3/5/21. At 11PM chills started, by 11:30PM worst chills and teeth chattering. On 3/6/21 at 3AM fever of 101.2, extremely hot. She felt tired and achy all day. In the evening on3/6/21 she had nausea and vomiting for a short time. On 3/7/21 she remained tired, sore and achy. Feeling better today on 3/8/21.
Within an hour of the test, I became extremely ill - chills, 102+ fever, headache, cough, asthma problems, and loss of appetite/stomach problems.  This lasted 5 days and on the 4th, i was hospitalized with myocarditis.
About 4 hours after PREVNAR 1, she got feverish, sleepy, fussy, ate less, for 1 1/2 days. Burping a lot 2nd day. While breast feeding, about 52 hr. after PREVNAR, had a 30 sec clonic AE's synchronous rhythmic SZ, then cried a minute, then slept all night. Normal today 6-15-17.
My arm became red at the site of the injection and my leg became very shaky and this lasted for the next three days like  I had the flu. To this day of the report I have shortness of breath and numbness, tingling down my left arm and leg. My immune system seems to be compromised. I am having auto immune conditions now and my legs spasm and cramp. When I take my bike out to ride I have severe spasms in my chest and lack the ability to breath and pain like someone is sitting on my chest, to this day I cannot function in any capacity at all, I have had to take a leave of absence from my medical education and I am unable to work. In addition I have burning and numbness of my tongue and nose bleeds daily, my eyes are continually burning and watering of the eyes.
Severe pain in left leg. Couldn't walk. Went to urgent care . Did blood work and x-ray.  A week later, severe in right shoulder blade and upper back. Had to leave work. Took pain medication. The next day, woke up with severe pain in right calve, felt tingling in numbness in both legs. Went to ER.  Given pain medication. Did Dopler untrasound on right leg to rule out blood clot. Still have severe pain  in different locations. Still having numbness and tingling in arm and legs. Went to a neurologist.  Feeling discomfort in throat. Feeling aniexty. Can't do activities like before.
thigh feels warm to touch, red, swollen 11:05 21AUG98 per mom;
This spontaneous report as received from a nurse practitioner refers to a group of unspecified patients. The patients were vaccinated with GARDASIL (date, route and lot number unknown). No other co-suspects were reported. No concomitant medications were reported. On unknown dates the patients received vaccine doses that were exposed to temperature above 46 F to 45 minutes, with the highest temperature of 78 F for 15 minutes. No adverse effect reported. No treatment information was reported. Information about PNEUMOVAX 23, RECOMBIVAX, PEDVAXHIB and VAQTA that were exposed to temperatures above 46 F for 45 minutes, with the highest temperature of 78 F for 15 minutes is also reported. This is information is processed in the linked cases: 1211USA001296, 1211USA001297, 1211USA001298 and 1211USA001299. Additional information has been requested.
Pt wanted to stand while he received 0.25 cc of Fluvirin IM to left arm, within 5 seconds of administering this, pt passed out. Eyes somewhat rolled back and body went limp. I laid him down and began calling out his name for a response. Within 5 seconds pt blinked his eyes and responded to me, alert and laughing. Pt laid down for at least 30 minutes and was checked by doctor then released, oriented without complaints. Some redness to injection site but cleared up within 10 minutes.
Left arm: local reactin, mild 4x5 cm redness, mild induration-no blisters.
Initial misuse report received from a healthcare professional on 28 May 2013. A 50-year-old patient was administereed ActHIB instead of ADACEL. No adverse event was reported. Documents held by sender: None.
2 minutes after injection, patient became dizzy and could not walk. eventually she collapsed, was sweating, flushed, said she lost her hearing, and right arm was numb. she stayed this way at least half an hour. paramedics came to assist about 15 min. after onset.
Purple band around my arm; Covid hands; Skin began to peel/down to the 3rd or 4th layer of skin; Weird bumps on my hands; low grade fever; really bad reaction on my arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (really bad reaction on my arm), SKIN DISCOLOURATION (Purple band around my arm), VACCINATION COMPLICATION (Covid hands), RASH (Skin began to peel/down to the 3rd or 4th layer of skin) and VACCINATION SITE RASH (Weird bumps on my hands) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eczema. Concomitant products included CORTISONE for Rash.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced VACCINATION SITE REACTION (really bad reaction on my arm) and PYREXIA (low grade fever). On 12-Sep-2021, the patient experienced RASH (Skin began to peel/down to the 3rd or 4th layer of skin) and VACCINATION SITE RASH (Weird bumps on my hands). On an unknown date, the patient experienced SKIN DISCOLOURATION (Purple band around my arm) and VACCINATION COMPLICATION (Covid hands). At the time of the report, VACCINATION SITE REACTION (really bad reaction on my arm) and PYREXIA (low grade fever) outcome was unknown and SKIN DISCOLOURATION (Purple band around my arm), VACCINATION COMPLICATION (Covid hands), RASH (Skin began to peel/down to the 3rd or 4th layer of skin) and VACCINATION SITE RASH (Weird bumps on my hands) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was provided by reporter. She has tried multiple different lotions and creams for her hands including cortisone, eczema medication and psoriasis medication. She has an appointment to see a dermatologist on Thursday.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Significant followup appended-Start date, medical history, new events added.
2 hours, post vax, pneumococcal vaccine, pt experienced pain, swelling and itching of left shoulder, upper arm, forearm and wrist. Treated self with Claritin (which pt also uses for rhinitis). Symptoms slowing abating. Treatment today with Benadryl in clinic and is improving, "recovering at present".
Patient was administered the influenza vaccination on 11/27/12 and induration occurred at the injection site the next day.
Shot given on left side, severe swelling of lymph nodes under arm & clavicle area, could not lift or use arm for 48hrs.  Took Benadryl 3 times daily as well as ibuprofen.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-FEB-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5 ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time for the first time was 9120 hours with lowest recorded temperature of 27 Fahrenheit degree. The total cumulative excursion time for the second time was 3468 hours with lowest recorded temperature of 20 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.
Left deltoid swelling/warmth extending to left subclavicular chest wall. Swelling and warmth to left axillary as well. Advil prescribed and follow up with primary recommended.  Per patient "symptoms are improving."
PT. PresenTed wiTh Funny/MeTallic TasTe In her mouTAh. Pt was A/o x 4. ViTal signs wer taken x 3. PT. was given waTer TO Drink and moniTored. PT. STaTed ThaT The Funny TasTe wenT away aFTer 20 min PT. was MoniTord For addiTional 10 Min and discharged
previously received the full primary immunization series of BNT162b2 and received a third/booster dose; previously received the full primary immunization series of BNT162b2 and received a third/booster dose; fever; This is a spontaneous report from a contactable pharmacist received via medical information team. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 29Mar2021 as dose 3 (booster), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 13Feb2021 as dose 1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 06Mar2021 as dose 2, single for COVID-19 immunization. The patient was previously received the full primary immunization series of BNT162B2 and received a third/booster dose on 29Mar2021 and fever on an unspecified date in Mar2021. Patient was currently experiencing fever. Pharmacist wanted to know when patient can receive his shingles vaccine. Outcome of fever was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Awoke with fever of 102.  Continued with fevers ranging intermittently from 101 to as high as 104 through 7-11-13.
After vaccine I experienced vomiting, dizziness, fatigue achy, soreness in arm. About a week later my arm was very sore and eventually lead to lost of mobility in my left arm.
The shot was very painful with pain immediately at the injection shot. The pain continued down my arm to my fingertips. Pain was consistent for about 2 weeks. Now pain is intermittent and usually when picking up heavy items.