chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information was received from a healthcare professional on 23 May 2013. A 40-year-old male patient had received a dose 1 intramuscular injection in the left arm of ADACEL, lot number C4328AA on 23 April 2013 at 10:00 AM. On 28 April 2013 (also reported as 2 days post-vaccination), the patient experienced severe pain the left arm (upper arm). The pain in the arm became worse and worse so that he could not focus on anything else and was unable to sleep. The patient went to the emergency room twice. Treatment included acetaminophen-hydrocodone, TORADOL and VALIUM. He was admitted to the hospital from 29 April 2013 to 01 May 2013. He had an MRI and was started on IV ANCEF. At some point he developed some swelling and redness described as 4cm in size. This resolved and the patient had pain which he described as 1/2 of 1 on a scale of 10 and some tenderness with palpation of the arm. Some faint redness on the back of the arm came today after he applied heat to the area. Of note is that his symptom was pain, which was severe, and involved the entire upper arm and he felt pain into the shoulder. He had no rash or redness at the site of injection, he had no swelling initially and no numbness or weakness. Diagnosis was pain after injection and was presumed to be associated with the vaccine. Discharge diagnosis was myalgia and myositis, unspecified; cellulitis and abscess of unspecified sites. Treatment included CELEBREX, TRAMADOL, KEFLEX and DILAUDID. The patient had no illness at the time of vaccination, no adverse events to prior vaccines and no past medical history. The patient had allergies (not specified). Outcome was reported as recovered. Documents held by sender: Medical Records.
the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up; the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up; the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up; the red area started to "spread like rash ( around where the injection was); the red area started to "spread like rash ( around where the injection was); a little red spot; This is a spontaneous report received from a contactable consumer. This consumer reported for herself (patient) that dose 2 via an unspecified route of administration on 24Apr2021 as SINGLE DOSE for covid-19 immunisation .The patient medical history was not reported the patient's concomitant medications were not reported.The patient experienced a little red spot on 25Apr2021 , the red area started to "spread like rash around where the injection was on 26Apr2021,the red area started to "spread like rash around where the injection was on 26Apr2021,the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up on the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up on 27Apr2021 Therapeutic measures were taken as a result of a little red spot (the red area started to "spread like rash the red area started to spread like rash the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up , the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up The events were assessed as Non serious by health authority and outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Swollen glands, sore throat, (lasted one week) chills, aches, headache (one day).
light fever in late evening, went to bed around 11:00 pm, fever began to peak by midnight  sever shaking for several hours, mild headache did not sleep much until ca 4 am, exhausted the following day shoulder somewhat swollen, redness over much of outer shoulder persisted for 3 days, with pain and redness gone by Saturday 29
received an extra dose of MENACTRA with no reported adverse event; Initial information received on 24-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old female patient who received an extra dose of menactra with no reported adverse event while receiving vaccine meningococcal a-c-y-w135 (d conj) [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Jun-2021, the patient received a  dose of suspect Menactra vaccine Solution for injection dose: 0.5 ml frequency: once lot U6920AA and expiry date: 15-Apr-2022 (strength: unknown) via intramuscular route in the left arm for immunisation. On 23-Jul-2021 she also received a dose of the same vaccine 0.5 ml once.  On 23-Jul-2021 the patient developed a non-serious event "received an extra dose of menactra with no reported adverse event" (extra dose administered) (latency: 1 month 1 day).  It was reported that when the patient returned for a wellness check this year, it was discovered that they had received the extra dose of Menactra.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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.; Sender's Comments:  01116793:
Left upper arm sore after first injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: EP7534) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "stroke" (unspecified if ongoing), notes: about 10 years ago; "anxiety" (unspecified if ongoing), notes: After having stroke; "depression" (unspecified if ongoing), notes: After having stroke; "Severe indigestion" (unspecified if ongoing); "Burping all the time" (unspecified if ongoing); "sleep" (unspecified if ongoing); "immune system was compromised" (unspecified if ongoing), notes: 10 years ago. Family history included: "Alzheimer's" (unspecified if ongoing), notes: Her mother had Alzheimer's and breast cancer and passed away; "breast cancer" (unspecified if ongoing), notes: Her mother had Alzheimer's and breast cancer and passed away. Concomitant medication(s) included: PAXIL CR taken for anxiety, depression; PRILOSEC [OMEPRAZOLE MAGNESIUM] taken for dyspepsia, eructation; TRAZODONE taken for sleep disorder. Vaccination history included: Flu vaccine (Probably was about 4 months ago or something). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24Mar2021, outcome "not recovered", described as "Left upper arm sore after first injection". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: She had been on Prilosec for over 10 years. Since COVID she had not been working that much. When she first got the shot she was nervous because she was on a wait list. The soreness started probably within 24 hours, they gave two Tylenol and had her take them. She adds that the arm soreness from the first vaccine pretty much had gone away but she is a side sleeper and she stayed off of it. In the middle of the night, she rolled over on it and said it was still sore so she got the second dose in her right arm. She confirms she received her 2nd dose on 14APR2021, ER8737, given around 10:30 am this morning. She clarifies she would take a quarter of the pill because she could not take a full one, it drugs her and if she does not get at least 8 hours of sleep, it will be in her system. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Approx 10 minutes after injection, she reports she had beginning of numbness and tingling of L arm and L leg. She was able to use them but the feeling persisted. She also felt some "nerve tingling" feeling in her back. By 28 hours later, most of the feeling returned to arm and leg.
Information has been received on 31-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 14-OCT-2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician as recommended for routine adult health maintenance for the prevention of shingles. 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 12-JUL-2010, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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.
Next day post vax, the pt developed a red, rash-like area at injection site. On 9/6/00, pt's mother noticed coughing. The pt continued to cough for three weeks, very hard and forceful. He also ate very little during this time and looked exhausted. He also became very clingy. He constantly wanted to be held and wouldn't go outside to play, was always very tired. On 9/22/00, he was taken to doctor and they could not find anything wrong with him.
Still having issues regarding red rash; Ring worm; Blotches that look like reddish brownish dry scaly skin patches on patient's stomach; Blotches are itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (Blotches that look like reddish brownish dry scaly skin patches on patient's stomach), PRURITUS (Blotches are itchy), RASH ERYTHEMATOUS (Still having issues regarding red rash) and TINEA INFECTION (Ring worm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced RASH MACULAR (Blotches that look like reddish brownish dry scaly skin patches on patient's stomach) and PRURITUS (Blotches are itchy). On an unknown date, the patient experienced RASH ERYTHEMATOUS (Still having issues regarding red rash) and TINEA INFECTION (Ring worm). At the time of the report, RASH MACULAR (Blotches that look like reddish brownish dry scaly skin patches on patient's stomach) and RASH ERYTHEMATOUS (Still having issues regarding red rash) had not resolved and PRURITUS (Blotches are itchy) and TINEA INFECTION (Ring worm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information were reported.    Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Additional information received on 31-Mar-2021 was updated with additional event of red rash, ring worm, treatment received and outcome of the events.
Dizziness; weakness; felt like I was going to pass out/I felt a little crummy for about the first 24 hours/I felt like my blood sugar was low/vasovagal response; an allergic reaction; This is a spontaneous report from a non-contactable other health care professional (Patient). A (Age: 44; Unit: Unknown) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 23Feb2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Feb2021, patient experienced dizziness, weakness, a vasovagal response, my blood sugar was low, i felt a little crummy for about the first 24 hours/i felt like i was going to pass out, but didn't, an allergic reaction. Caller read that dizziness and weakness was an allergic reaction. She experienced dizziness and weakness a minute after the vaccine. Caller stated that the patient had received many vaccines, practiced blood draws and never had a vasovagal response from a needle or shot. The patient felt like my blood sugar was low, felt a little crummy for about the first 24 hours and thought that was normal. The patient concerned because they talked about these symptoms as an allergic reaction. It was not severe, it lasted a long time, felt like was going to pass out, but did not and was very dizzy and weak. Caller wanted to know if this was an allergic reaction or not.The outcome of all events was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be requested. No further information is expected.
I had cough, low fever, sinus congestion, running nose, dizzy, anxious feeling, and fatigue. I talked to a doctor for reassurance. I went to the a center to get tested and a couple days later I got notified that I was positive for COVID-19. I was sleeping 12 hours of the day.
PATIENT REPORTED HAVING A SORE,RED AREA AROUND VACCINATION SITE 1 DAY AFTER HER VACCINATION. PATIENT STATES SHE TOOK BENADRYL FOR 3 DAYS WITH NO RELIEF. PATIENT SOUGHT MEDICAL ATTENTION AND WAS PRESCRIBED AN ANTIBIOTIC. HER CONDITION WAS RESOLVED
Pts father was given VIS, vaccine was verified by LVN, waited 10-15 minutes with no reaction
Trunk: approximately 10 lesions on anterior chest/abdomen: small 2-4mm red papules with tiny white centers, 2 on back; Extremities: one on each calf, one on medial buttock, 1-2 on each arm. Rash began on arms at daycare earlier today 6/23 followed by rapid appearance of the truncal lesions. Otherwise well, no oral or genital lesions, afebrile.
3 hrs post vax, diarrhea, "hot brain, feels like I am dying." Pt at work. Stated that flu like sx last 1 wk. Didn't see primary dr as advised by nurse.  Telephone call only.
FAINTED, THROAT TIGHNESS, DIZZINESS, HARD OF HEARING
High blood pressure up to 170/100 and angina. I have no history of high blood pressure. I went to the ER yesterday and had to be placed on blood pressure medication.
THE DAY FOLLOWING THE MODERNA INJECTION #2, BREASTS WERE EXTREMELY TENDER (FOR 6 WEEKS).  WHEN THAT SUBSIDED I WAS EXTREMELY FATIGUED FOR A FURTHER 6 WEEKS.  I WAS CONCERNED ENOUGH THAT I RISKED GOING INTO A HOSPITAL SETTING FOR A BLOOD TEST TO ENSURE THERE WERE NO UNDERLYING ISSUES.  (NONE WERE FOUND).  CONSIDERING THE REACTION I HAD TO THE VACCINE, LIKELY, SHOULD I HAVE CONTRACTED COVID, SYMPTOMS WOULD BE MUCH WORSE.  NEVERTHELESS, I AM HESITANT TO RECEIVE THE BOOSTER AS I CANNOT AFFORD TO HAVE FURTHER EXTREME FATIGUE FOR A LONG PERIOD.  I AM CONSIDERING TAKING THE PFIZER BOOSTER, AND WOULD APPRECIATE ANY MEDICAL FINDINGS YOU CAN IMPART.  THANK YOU!
Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K209) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.            Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up information received on 30-JUN-2021. No new information.
Sore arm; I had a little bit of a rash on my shoulder; Back is full of pimples, red pimples, like red marks; Back is full of pimples, red pimples, like red marks and they itch; This is a spontaneous report from a contactable consumer (patient). This 83-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiry date unknown), via an unspecified route of administration on 18Jan2021 at a single dose for COVID-19 immunization. Medical history included high blood pressure, gout, and rash on the penis area. Concomitant medications included tacrolimus for rash on the penis area, allopurinol for gout, amlodipine for blood pressure, benazepril, hydrochlorothiazide, metoprolol, and unspecified vitamins. The patient has not had laboratory in the past two weeks but last month, and the everything was fine. On an unspecified date in Jan2021, the patient had sore arm. On an unspecified date in Jan2021, the patient noticed that he had a little bit of a rash on his shoulder but then he looked at his back and it is full of pimples, red pimples, like red marks and they itch. It is on the upper part of the back, around the middle. The patient did not take anything for said events. As they were on his back, he didn't notice them until last night (unspecified date in Jan2021), they started to itch a little bit. So, they could have been there for 2 or 3 days.  The patient stated that the only thing he can think of is that it might be from the vaccine. Due date for the next shot is on 08Feb2021. Outcome of the events was unknown.
STOMACH ACHE; HEADACHE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. patient did not take any medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced stomach ache. On 14-MAR-2021, the subject experienced headache. On 14-APR-2021, Laboratory data included: CT scan (NR: not provided) Not reported, Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach ache, and headache. This report was non-serious.
This spontaneous report was received from a medical assistant referring to a 6 month old male patient. The patient had no known pre-existing physician-diagnosed allergies, birth defects, nor medical conditions. On 15-NOV-2017, the patient was vaccinated with improperly stored doses of ROTATEQ orally, dose 3, for prophylaxis (lot # M039061, expiry date: 28-APR-2018, dose not reported); and LIQUID PEDVAXHIB, intramuscular in the left thigh, dose 3, for prophylaxis (lot#N012119, expiry date: 06-FEB-2020, dose not reported). Other vaccines administered on the same date included: PEDIARIX, intramuscular in the right thigh; and PREVNAR 13 intramuscular in the left thigh. No adverse effects were reported and the patient did not have any illness at time of vaccination. The doses of the vaccines were exposed to a temperature of 9°C to 25°C (15.2°C) for a time frame of 1 hour and 48 minutes. There was no previous temperature excursion. A digital data logger was involved. Furthermore, no product quality complaint (PQC) was involved.
Initial unsolicited report received from a nurse on 29-Sep-2017. This case involves a female patient (age was not reported) who was vaccinated with 0.5 ml single intramuscular dose of INFLUENZA FLUZONE QUADRIVALENT (Batch number: UT5911KA, expiration date, dose in series and site of administration were not reported) on 29-Sep-2017. Patient's medical history and concomitant medications were not reported. On 29-Sep-2017, immediately after the vaccination, the patient's right deltoid became red, hot to touch, swollen and itchy and the reddened area was the size of a tennis ball and in the center she developed a hive about the size of a quarter. The patient was seen in the emergency room (ER). Laboratory investigations were not reported. As corrective treatment, the patient was given ALLEGRA. The outcome of all the events was reported as recovering (reported as symptoms were subsiding). List of documents held by sender: none.
Mom did Reading on GARDSIL and thinks childs Medical problems may be related to GARDASIL. Last GARDASIL 4-16-07. Back pain started Dec-2006, FX Vertebrae - Dec 06, Jaw pain July 07, FX jaw - Sept 07; GARDASIL #1 - 10-10-06, #2 - 12-19-06, #3 - 4-16-07. Dx with JRA spring of 09. Seeing Rheumatologist. Has been Tx for multi focal osteomyelitis.  8/19/09 PCP Medical records received DOS 10/10/06 to 4/16/07. Patient 'gets burps that smell like rotten eggs', then stomach cramps, vomiting when stressed. Abdominal pain.  9/24/09 Infection Disease Consultation medical records received DOS 3/10/08 to 11/27/08.  Assessment: Ganglion Cyst Right Hand. Proliferative Periostitis Mandible and L-4 Vertebral Body. Chronic Osteomyelitis of Garre.  Patient presents with history of right sided mandibular pain preceeded by use of braces and orthodontic manipulation. Facial assymetry with swelling area of right mandible. After several weeks of no symptoms, new onset right sided jaw pain and swelling. Lump/swelling on back on hand. Back pain.  9/25/09 Rheumatology consult received DOS 2/12/09 to 5/28/09. Assessment: No unifying diagnosis. Chronic recurrent multifocal osteomyelitis. Patellofemoral syndrome. Ganglion cyst - wrist. Back pain. Sledding injury resulting in L4 vertebral Fx dx'd several months later (May 2007) by MRI.  Wakes up in morning with severe pain in wrists with limited range of motion. Synovial thickening wrists. Knee pain. Jaw pain. Mandible, fibrous dysplasia. Vertebral body sclerosis. Fell off bicycle and injured knee. Otitis media. Marked improvement with naprosyn.
Patient received both her flu and RSV shot on Friday around 4:15pm.  Patient states the next morning that she felt sick to her stomach, had a headache and felt dizzy.  Before her husband could get her to the restroom, she passed out and broke her metatarsal bone.  Patient did go to the ER where she states that they couldn't find any reason why this would have happened.  She then attributed it to her vaccination.  Her husband had the same two shots and was just tired.