chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # reported as M011116, expiration date: 17-JUN-2017 and lot # reported as M022541 with expiration date: 23-FEB-2018 (dose and route of administration were not reported). It was also reported that sterile diluent (lot # reported as 00006430900; expiration date and exact dose were not provided) was used. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 48.6 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information has been requested.
Sharp pain on injection; consistent aching in shoulder and down arm limiting range of motion; currently in physical therapy. Injection given near top of left shoulder. Pain continues.
This is a spontaneous report from a contactable Physician via Pfizer sales representative. This Physician reported similar event for five patients. This is the 2nd of five reports. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced high fever on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016580735 as same reporter/drug/event, different patient.
Patient received second Moderna dose 1 week early.  Got first dose in series on 7/27/2021 and second dose in series on 8/17/2021.  Patient reported no adverse events.  Reporting as a medication error.
Dystonic Reaction- tremors of extremities and head/neck. Abnormal movements of the trunk.
Pancreatitis, Lipase 6686, amylase 1175, 81F, IV hydration, improved in 24 hours, lipase to 1008, amylase to 628.
t103.7 that evening, leg was sore & swollen from ankle to hip; pt was not given APAP; fever came down w/APAP; vomited x 1; had just cut teeth last wk; pt couldn't move leg from hip to ankle; had contact dermatitis; Dx: empetigo;
severe heartburn; Headache; Chills; joint pain; muscle aches and pains; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 03Feb2021 at 10:45 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included osteopenia, breast cancer in 2010, hearing impairment. The patient was allergic to NSAID. Concomitant medications included ibandronate (MANUFACTURER UNKNOWN), niacinamide (MANUFACTURER UNKNOWN) and vit D (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 13Jan2021 at 10:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 03Feb2021 at 22:00, the patient experienced severe heartburn, headache, chills, joint pain, muscle aches and fatigue. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events heartburn, headache, chills, joint pain, muscle aches and fatigue were recovered with sequelae on an unknown date.   No follow-up attempts are needed; Information about lot number cannot be obtained.
Sat at pharmacy for 10 min., no reaction. Drove to bank drive thru then hone - less than 5 miles. Mile before home, immediately thought I could not drive car home - felt totally drunk. Barely got the car in the garage, told husband I felt bad and went to bed and fell asleep. Later that day, got up to watch TV/sleep with ice pack on my head and eyes. Eyes were burning. Was like that for 2 days. No appetite, still had all senses but felt like the worse sinus attack and headache ever. Two days bad 3 days to fully recover strength. Mild loss of memory.
On the evening of 11/08/2021 a few hours after receiving his booster of Janssen, started having muscle aches, HA, and temperature of 100.2, and nausea.  Gradually his left arm, whole neck, mid-upper back and his thighs became extremely painful. HA became severe. Fever stayed present until 11/11/2021.  Went into the ER on 11/16/2021 due to severe pain persisting which has severely impacted his sleep. Tylenol and ibuprofen have not helped any symptoms. States "they did blood work, and gave me IV fluids and IV Toradol, and that finally gave some relief." He was discharged. Went into the ER this afternoon (11/17/2021) again via ambulance because it has been extremely difficult for him to walk due to the pain in his legs, back, and neck. Is still currently in the ER.
Pt received flu vaccine at work from pharmacy for a health fair. One and a half hours after vaccination, he started to get severe vertigo with nausea and vomiting, along w/profuse diaphoresis. His coworkers called 911 and he was taken to Hospital ER via ambulance. EMT's started code as he had abnormal EKG changes. He was evaluated in ER and multiple tests were completed (see list below). He was admitted from 10/25/18 - 10/27/18 for observation and to complete his stress test and was cleared for discharge after completion. EKG in ambulance showed sinus rhythm with prominent T waves and possible ST elevation which prompted STEMI code by EMS. EKG in ER. Echocardiogram stress test completed both being unremarkable. MRI stroke protocol was negative. CT angiogram of chest to rule out pulmonary embolism was negative.
Patient was given Pfizer for her second dose. Her first dose was Moderna. When asked if she was receiving her second dose of Pfizer she answered yes. Not discovered until after it was given that her first dose was Moderna.  No adverse effect noted 30 minutes after shot was given
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 20-JUN-2008 at public health department, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-FEB-2016, the patient was treated at hospital for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as shingles. The patient was prescribed acyclovir for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Vaccine received Thursday, April 1st.  Saturday, April 3rd, arm at injection site was red and below site was red, swollen  quarter size bumps.  No itching or pain, just red swollen bumps.  The redness and bumps went away the next day, Sunday, April 4th.  Then on Friday, April 9th, the red quarter size bumps are back, no redness at injection site, just the bumps below.  No pain, no itching, a little warm.
As soon as it was injected, I held back the pain I was experiencing on my arm. I thought that this pain was supposed to be normal because I was told that this was a side effect of the vaccination, that the arm hurt. But my arm hurt to the point I could not even move it. It wakes me up at night, I can barely move my arm. The further I can go is to the side, I can no longer lift it up. It hurts that much. It's so bad I can feel the pain on the shoulder. I still have this pain and it's been the same way since August. I tried pain relief, my doctor gave me Naprosyn, and nothing seems to be working. It takes away the pain but its not taking away the issue. I have no range of motion, and I can't even put on my coat on left arm first because my right arm will have a problem with me putting it on that way. I can't hug myself, I will defiantly feel it in the right arm. And I can't sleep with my arm above my head if I am belly up. When I lift my arm to put deodorant, I can't do it with the arm I was injected on. I received the booster but I needed it to be injected on the other arm. I am starting to think I have a shoulder related injury from taking this vaccine.
During the night starting feeling achy; Chills; Fever <100 degrees; This is a spontaneous report from a contactable consumer. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration on 13Apr2021 at 11:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 23Mar2021 as a single dose for COVID-19 immunisation. On 14Apr2021, during the night at 02:00, the patient felt achy, chills, fever of <100 centigrade. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. On 14Apr2021 at 02:00, the patient underwent body temperature test and the result was <100 degrees. No therapeutic measures were taken for the reported events. The clinical outcome of the events during the night starting feeling achy, chills and fever <100 degrees was resolved on an unknown date of Apr2021.  No follow-up attempts are needed. No further information is expected.
4/29 - Vaccine administered (Tdap) during pre-employment physical. Developed pain & decrease ROM afterwards 5/4 - spoke with PCP - conservative treatment. 5/11 - spoke with PCP again, was prescribed Nabumetone for pain. 5/15 - Seen at clinic and referred to ortho specialist for possible steroid injection & PT.
patient was supposed to receive the Moderna BIVALENT vaccine and received the Moderna MONOVALENT vaccine instead.
I had severe nausea, chills and a headache. I woke up at 5AM 1/16 and vomited. Then slept until 10:30 AM I had chills when I woke up and ibuprofen slightly helped. I vomited again at 11AM and then again at 11:15AM. I slept the rest of the day.
approximately 10 mins after receiving  the vaccine member complained of scratchy throat and difficulty breathing.  Member also began to hyperventilate.  O2 on RA 95%
heavy heavy period with lots of bleeding (soaked pad AND tampon at least every hour) and huge clotting for 2.5 days of a sox day period; I had just had a cycle start 18 days prior to this happening
p/vax pt exp severe muscle pain & joint pain;pt exp severe muscle aches & fatigue;fever;to ER;cannot walk, cannot sleep, fever cont;nails turned blue pt gray in color;r/o lyme disease;lost weight;poss systemic juvenile rheumatoid arthritis. The rheumatologist does not feel that there is a high likelihood that the arthritis was triggered by the pertussive component of her vaccination.
Upon arrival to the clinic ic for his shingles vaccination (with Zostavax, by MERCK), he was asked if he would want to receive a tetanus booster. Pt agreed and was administed Tdap (Adacel, by Sanofi-Pasteur).   Mr. Bettis received the Tdap (Adacel by Sanofi-Pasteur) vaccine instead of the TD-adult vaccine for his tetanus booster. This was reported as a medication error and submitted through PER. The patient was notified and reported no ADR or  problems with the Tdap vaccine. Mr. Bettis was instructed to give the facility a call if there were any apparent reactions to the vaccine.  Tdap (Adacel by Sanofi-Pasteur) is approved for patients between the ages of 11 to 64. TD-adult is indicated for patients greater than or equal to 65 years old. Mr. Bettis is 72 years old and should have received the Td-adult vaccine.
Red area 2 inches x 1 1/2 inches about 3 1/2 inches below the injection site with slight rash around red area intermittently in a few areas.  No redness or swelling has occurred at the injection site.  Area of rash does not itch, is not hard, is not painful.
lost a considerable amount of weight; stomach pain; diarrhea; vomiting; malaise; Nausea; they found something with his heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 63 year-old male patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "kidney transplant", start date: 1998 (unspecified if ongoing), notes: kidney transplant 23 years ago, so he is immunocompromised. The patient's concomitant medications were not reported. The following information was reported: WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "lost a considerable amount of weight"; ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "unknown", described as "stomach pain"; DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "diarrhea"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "vomiting"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "malaise"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Nausea"; CARDIAC DISORDER (non-serious) with onset 2021, outcome "unknown", described as "they found something with his heart". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal pain upper.  Additional information: Reporter said that the stomach pain and vomiting started right after the vaccine but she did not know when, they were talking to his doctor and she had not realized that he started having these things after his vaccine. She says his weight dropped a lot, which she started seeing as alarming and contacted a GI doctor. Reporter said they gave him a new medication as a treatment to try three weeks ago that was helping, then it stopped helping him. She says it is called Bentyl. She says they gave him that medication for stomach pain and it helped like a week and a half. The patient did not start any new meds. She said he was a kidney transplant patient and had been on the same meds for a long time, other than two years ago they had him start some other medication for common things people take. No further details provided this other medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swollen Lymph Nodes in Neck; Painful Swallowing; Fatigue; Swollen Lymph Nodes in Neck; Condition aggravated; Fatigue aggravated; low titer of 2 of 3 components in MMR; This case was reported by a consumer via call center representative and described the occurrence of lymphadenopathy cervical in a female patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 2020) for prophylaxis.   Co-suspect products included MMR (MMR vaccine) for prophylaxis and MMR (MMR vaccine) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received MMR vaccine. In May 2019, the patient received MMR vaccine (intramuscular) .5 ml. On an unknown date, 2 days after receiving Shingrix and not applicable after receiving MMR vaccine and MMR vaccine, the patient experienced lymphadenopathy cervical, swallowing painful, fatigue, lymphadenopathy cervical, condition aggravated, fatigue aggravated and therapeutic response decreased. The patient was treated with non-drug therapy (Heat Therapy). On an unknown date, the outcome of the lymphadenopathy cervical, swallowing painful, lymphadenopathy cervical and fatigue aggravated were not recovered/not resolved and the outcome of the fatigue, condition aggravated and therapeutic response decreased were unknown.   It was unknown if the reporter considered the lymphadenopathy cervical, swallowing painful and fatigue to be related to Shingrix. It was unknown if the reporter considered the therapeutic response decreased to be related to MMR vaccine. It was unknown if the reporter considered the lymphadenopathy cervical, condition aggravated and fatigue aggravated to be related to MMR vaccine.  Additional details were provided as follows: The age at vaccination was not reported. On an unknown date, the patient received MMR vaccine. Approximately 3 weeks ago (from the reporting date), the patient received the dose of Shingrix in right arm. The following week, she received booster MMR vaccine in left arm. Lot number was unknown but the patient remember Shingrix expiry date as year 2020. The Booster dose of MMR vaccine was administered due to low titer of 2 of 3 components in MMR, this led to therapeutic response decreased.  Roughly 2 days after receiving Shingrix vaccine, the patient complained of fatigue and swollen lymph node glands in neck. The patient reported that the swelling occurred intermittently. She felt okay in the morning, but not so well in afternoon or evening. The patient also experienced pain when swallowing due to the pain from swollen lymph nodes in neck.  After 1 day of receiving booster MMR vaccine, the events fatigue and swollen lymph node glands in neck were worsened.  The physician recommended her to drink a lot of hot liquids and apply heat for relief. The patient believed this can also be attributed to weather, this included an unusual amount of rain and also lots of pollination. She termed this as triple whammy (Shingrix, MMR, and allergy season). The patient did not consent to follow-up due to feeling like she would get someone in trouble. The patient did not want to receive follow-up.
What happened a few days after vaccine I started feeling an itch in my ear for like a week or two then I noticed a little bump and I had my wife look at she said this is strange there is something there. Then a few days after I started feeling pain like an ear infection and I went to the ER, I had to go twice to ER. I was treated poorly at first visit. At this point my face was a little swollen and my lymph nodes. They gave me antibiotics I took them for a day or 2. I had my wife take a picture of ear. It looked like herpes, so I started taking an antiviral. That week, I had to go to ER again because I feel so much pain I could not sleep, and it was annoying. They gave me a better anti-viral and I was treated for herpes. It cleared up a few days later.
Projectile vomiting and diarrhea until 10/30/13 at 12:00 PM.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown dates, the patient was vaccinated with unspecified number of doses of unspecified varicella vaccine reported as either VARIVAX (Merck) (lots#, expiry dates, routes and sites of administration, doses were not reported) or PROQUAD (Merck) (lots#, expiry dates, routes and sites of administration, doses were not reported). On an unknown date, the patient experienced "full case" of shingles an unspecified amount of times. The outcome of the event was unknown. The relatedness between the event and unspecified varicella vaccine (either VARIVAX (Merck) or PROQUAD (Merck) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received booster dose of Pfizer Covid 19 vaccine. He fell from his seat while at his 15 minute observation. He had a syncope episode which lasted less than 2 minutes. VS WNL. RRT arrived in 3 minutes of being called. Patient was assessed by MD. Patient declined to go to the ER for further evaluation. He remained in the clinic for another 30 minutes and was escorted to his ride home.
Red, oozy rashes all over face within hours of first shot. Persisted. After 2nd dose condition worsened: Itchy red hives progressed to throughout body concentrated on lower back.   Condition progressed to needing a round of prednisone 40mg. Symptoms significantly decreased.  Allergist and derm prescribed Dupixent. I have taken the loading 600mg and then 300mg (two weeks later). Second dose of Dupixent coincided with tapered dose of prednisone and symptoms are starting to return.    Biopsy  suggest eczema and eosinophilic pustular folliculitis. However treatment is currently not resulting in recovery.
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 2nd July 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 5th July 2018, 3 days after receiving SHINGRIX, the patient experienced injection site rash. In July 2018, the patient experienced extensive swelling of vaccinated limb, general body pain, fever, injection site lump, injection site erythema and injection site itching. The patient was treated with ALEVE and BENADRYL. In July 2018, the outcome of the general body pain and fever were recovered/resolved. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site lump were recovering/resolving and the outcome of the injection site rash, injection site erythema and injection site itching were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, general body pain, fever, injection site lump, injection site rash, injection site erythema and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. The patient also experienced injection site reaction that included swelling of an area about the size of her palm around the injection site with a knot. Then on 5th July 2018, the patient noted a rash on her arm around the injection site. The patient reported that, at the time of reporting, the injection site reaction had improved greatly but still had small knot, pink in color and little itchy. The patient reported that she was seen by her physician's office on Friday, 6th July 2018 and the patient was advised to take ALEVE and BENADRYL to help with the reaction. The contact details of the physician was provided.
About 35 hours after the Moderna booster injection, the area around the injection site turned warm and slightly swollen. The swelling and heat subsided over the larger area and then centralized  into a smaller, aching, red patch below the injection site. The patch is about 3 inches below the injection site. The patch's size is horizontal on a slight angle, about 3 inches wide by 1.5 inches deep. The patch is red, warm, slightly raised, with an ache, and harder to the touch than the skin around it. As of about 10 hours after the eruption of this reaction, about 11 a.m. Dec. 18, the symptoms have slightly subsided, but the ache continues, to the touch, with an added itch. This reaction did *not* occur with the first two Moderna doses in April and May of 2021.