chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosed with Reynaud's; This case was reported by a consumer via(Shingrix GSK Chatbot) interactive digital media and described the occurrence of raynauds in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included covid-19 vaccine (Covid19 Vaccine).   On an unknown date, the patient received Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced raynauds. On an unknown date, the outcome of the raynauds was unknown.   It was unknown if the reporter considered the raynauds to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient stated that last December or this January, he/she received the Covid vaccine and 1 month later received shingrix vaccine because the healthcare provider was concerned the patient was vaccinated. Since then patient diagnosed with Reynaud's. The patient asked if the GSK (GlaxoSmithKline) had any reports of having Reynaud's after Shingrix.
This spontaneous report was received from a health care professional refers to an approximately 13 month old female patient. Drug reactions/allergies were none. On 27-MAY-2015 the patient was vaccinated with M-M-R II (lot # K021952; expiry: 10-NOV-2016), 0.5 ml, intramuscular injection. Concomitant medications and medical history were reported as none. On 27-MAY-2015, the nurse reported that a patient developed a welt, redness, and swelling at the injection site within five minutes of receiving the vaccine. The nurse reported that the patient received the M-M-R II intramuscularly (inappropriate route of vaccination). The nurse stated that the patient will be coming back today on 27-MAY-2015, at an unspecified time to see if the welt, redness, and swelling were resolved. No lab tests done. Patient sought medical attention and the physician instructed that the patient take unspecified antihistamines and to apply an ice pack to the injection site. The outcome of all the events at the time of this report and medication error was unknown. Causality assessment for the events was not reported. This case is linked to: 1506USA012544 (same reporter link). Additional information has been requested.
Redness around the injection site; Itchiness at the injection site; Warm to touch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE PRURITUS (Itchiness at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch at the injection site) and VACCINATION SITE PRURITUS (Itchiness at the injection site). On 09-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around the injection site). At the time of the report, VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE PRURITUS (Itchiness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant products included medications for blood pressure and diabetes. Treatment information was not provided.
Despite taking proper medications and having adequate sleep, my husband had a sudden influx of seizures (over a dozen) starting a few hours after getting the vaccine. His seizures are more convulsatory in nature than normal and take longer to recover from than his average seizures.
developed severe shingles 3 months after first RZV dose given with no prior history of any prior shingles. Therefore should second dose be given under there circumstances?
08:20 am Received 2nd dose of Moderna. Hx of facial swelling to sulfa, so pt was to remain for observation for 30 minutes. At 08:45 am complained of feeling like her eyes were swelling. Pt's daughter was in the car with her and did not notice patient looking any different. No distress noted nor obvious swelling of face, eyes, lips, etc. O2 sat 98%  pulse 72. Administered 25 mg benadryl chewable tablet and observed pt for another 30 minutes. At 9:30 am pt reported feeling better, no other problems noted. Pt was discharged to home and told to take benadryl q 6 hrs for the next day and seek emergency care if condition worsened. Call to pt on 03/26/21 revealed that pt had no further problems.
Pt sts 4-5 hours after injection developed pain, redness, swelling at site, T max 102. Pt presents to office no fever, 5 inch diam erythema to post upper (L) arm w/ 1 inch center hard area. Provider advised ibuprofen prn.
Pt received 3 rd dose of MMR and should have received 1st dose of varicella
Wednesday and Thursday: headache, low grade fever,  chills, fatigue, slight nausea, very sore arm. Arm still very sore and red today on Friday.
Information has been received from a physician concerning a 60 year old female office employee who "about 3 weeks ago" on approximately 23-APR-2007 was vaccinated with a 0.65 ml dose of ZOSTAVAX vaccine (Merck). Subsequently, "soon after receiving the shot" the patient experienced a hematoma on her arm, swollen arm, and a bruise around the injection site. Unspecified medical attention was sought. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 6/14/2007. Information has been received from a physician and a 66 year old (also reported as 60 year old) female employee (adm) who on 30-MAR-2007 (also areported as "about 3 weeks agao") was vaccinated with a 0.65 ml (also reported as 0.7 ml) dose of ZOSTAVAX vaccine (Merck). Additional information has been requested.
The skin at the injection site feels warmer than the skin around; Feeling tender; Larger and swollen; Small red area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (The skin at the injection site feels warmer than the skin around), VACCINATION SITE PAIN (Feeling tender), VACCINATION SITE ERYTHEMA (Small red area) and VACCINATION SITE SWELLING (Larger and swollen) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LOSARTAN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Small red area). On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (Feeling tender) and VACCINATION SITE SWELLING (Larger and swollen). On 12-Mar-2021, the patient experienced VACCINATION SITE WARMTH (The skin at the injection site feels warmer than the skin around). At the time of the report, VACCINATION SITE WARMTH (The skin at the injection site feels warmer than the skin around), VACCINATION SITE PAIN (Feeling tender), VACCINATION SITE ERYTHEMA (Small red area) and VACCINATION SITE SWELLING (Larger and swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included body lotion on  the injection site.
On 12NOV90, pt exp itching & swelling over entire body w/in minutes of receiving Influenza vax; Pt was given DPH; As of 15NOV90, sx have not subsided & the pt has severe swelling of the face & lips;
Fever, Fatigue , weakness Sore Arm, Muscle Ache  Lasted for 4 days
This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 65-year-old patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On 18th May 2018, less than a year after receiving SHINGRIX, the patient experienced localized erythema and tenderness. On an unknown date, the patient experienced skin discoloration. On an unknown date, the outcome of the localized erythema, tenderness and skin discoloration were unknown. It was unknown if the reporter considered the localized erythema, tenderness and skin discoloration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had red spot and this spot was described as tender and red. After a month, the spot changed to a color of purple but no increase of tenderness. The caller reported prior to her second vaccine for advice.
Mother reports 24 hrs post shots, pt crying, vomiting,staring spells. 36 hours post shots crying, high pitched abnormal inconsolable crying for 5-6 ours. 48 hours post shot, fussy but normally fussy. 56 hours post shots, normal for her. No fever,no redness or soreness at injection site.
A non-serious spontaneous report of administration of expired product has been received form a Registered Nurse concerning a 15 year old male who received FLUMIST. Medical history and concomitant medications were not reported. On 29-Dec-2008, this child was administered FLUMIST which expired on 28-Dec-2008. There was no adverse event associated with this error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information received on 13-jan-2009 confirmed the child has not experienced any adverse events.  Follow-up information received on 27-Mar-2009 included Product Complaint Investigative results. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customer not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.
C/o pain, swelling & redness at site of starting 6/24/11. I viewed her left arm 6/27/11 & noted a large red & swollen area at least 3" x 3" at the injection site. She c/o chills, fatigue, & general malaise 6/25/11-6/26/11.
Narrative:  Following vaccine administration, patient became dizzy. No fall or LOC was experienced. Patient remained in observation area for 30 minutes. Patient and family departed clinical area with no distress noted.
pt c/o sob and CP since the second dose of COVID vaccine on 3/17. labs showed elevated D-dimer. Pt was called and left msg. Plan is to send her to ER.
Arm Pain; Fever; tiredness; body aches; diarrhea; upset stomach; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 44-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on an unknown date in May2021 at 18:15 (at the age of 44-years-old) as dose1, single for COVID-19 immunization. Medical history included anemia. The patient was not allergic to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in May2021 at 20:00, the patient experienced arm pain, fever, tiredness, body aches, diarrhea and upset stomach. Therapeutic measures were not 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 event arm pain, fever, tiredness, body aches, diarrhea and upset stomach was resolved with lasting effects on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mom called 23JUN93 reporting rt leg has swollen purple welt from inject site to halfway a back of leg; instructed to use ice & APAP; t99-100; crying, cranky;
patient says dizzy/headache the first few days, but then arm swelling started.  at first just a hive that she put ice on and it helped.  now its an itchy rash that has spread down to elbow.  and it's 5 days after shot given
8 days after shot, itchiness and red swollen area on arm near injection site. Warm to the touch.
Client had a vasovagal response, became diaphoretic, cool and clammy.  Lips were pale.  Client never lost consciousness.  Client recovered within 15 minutes.  Administered ammonia inhalant.  Pt. was bradycardic which resolved within 10 minutes.  Client movd to holding/observation.
Cough, URI symptoms which persisted when patient evaluated by provider March 2004, noted new murmur and subsequently diagnosed with MVP and moderate MR and borderline LVE
I contracted COVID-19 on 07/12/2022 with symptoms of dry cough, chills, fever of 100, headache, runny nose, congestion, fatigue, and lack of appetite. I was prescribed Paxlovid on 07/14/2022. I was ill for 4 to 5 days before my symptoms began to resolve. I am still experiencing lingering congestion, but my other symptoms have fully resolved.
Baby never really stopped screaming and fussing after vaccines. About 4pm same day a low grade fever set in. The next day and for the following week she would hardly eat and when she actually did eat, about 1/3 came back up. This lasted for a little over a week. Treated with Tylenol, called office and they said it sounded like typical reaction and wouldn't last.
stomach discomfort 5NOV93; fever 6NOV-9NOV, stomach cramps/diarrhea (NOV-11NOV; treatment-bedrest & APAP;
This spontaneous report as received from a consumer (the patient's mother) refers to a female patient of unknown age. No information on her medical history or concurrent conditions was provided. In approximately March 2014, reported as in the Spring 2014, the patient was vaccinated with her first dose of GARDASIL (1 single shot, route, lot# and expiration date were not reported). In approximately 2014, reported as 12 days after vaccination with GARDASIL, the patient began to get very sick. On an unknown date, the patient had been hospitalized (specific reason and duration were unknown), the patient's hair had been falling out, hemoglobin levels were declining (values and units were not reported) and the patient was diagnosed with autoimmune hemolytic anemia. On an unknown date, the patient was treated with steroids (dosage and frequency were unknown). At the time of the report, the outcome of the events was not recovered. The relatedness between the events and GARDASIL was not reported. No PQC (product quality complaint) was involved. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX. On 20th April 2018, the patient received SHINGRIX. On 20th April 2018, less than an hour after receiving SHINGRIX, the patient experienced pain in arm and erythema of extremities. On 1st May 2018, the patient experienced ALT high, hemoglobin A1C increased, cholesterol low and monocyte count increased. On an unknown date, the outcome of the pain in arm and erythema of extremities were recovered/resolved and the outcome of the ALT high, hemoglobin A1C increased, cholesterol low and monocyte count increases were unknown. It was unknown if the reporter considered the pain in arm, erythema of extremities, ALT high, cholesterol low and monocyte count increased to be related to SHINGRIX. The reporter considered the hemoglobin A1C increased to be unrelated to SHINGRIX. Additional details were provided as follows: Within an hour and a half to two hours after receiving the SHINGRIX vaccination, the patient experienced tenderness and redness that extended from his shoulder ultimately down to his elbow after approximately two days. On 1st May 2018, eleven days after receiving vaccination, the patient had laboratory work and his monocytes, HA1C (Glycosylated haemoglobin), ALTs (Alanine aminotransferase) were high, and cholesterol was low. The patient felt that he was responsible for most of the numbers being off but was concerned that the SHINGRIX vaccine might have affected the monocytes. The patient had denied permission to contact their physician. The reporter wanted to end the call and would not provide additional information. The reporter referred to health care professional.
Information has been received from a registered nurse concerning a 32 year old female employee with allergies to flowers, molds and pollens, and a history of prior vaccination with measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live who on 08/10/2004 was vaccinated with a dose of measles virus vaccine.  On 08/14/2004 she experienced muscle and joint pain, headache, and developed a rash on the palmer surface of her hands.  On 08/17/2004 the patient was seen, and her hands were very itchy, no pustules, and bumpy rash continued, and was also noted on the soles of her feet.  The patient was seen in emergency room, and diagnosed with a reaction to measles virus vaccine.  No laboratory or diagnostic studies were performed.  The patient was placed on therapy with diphenhydramine cream for treatment of the rash.  At the time of this report the outcome was unknown. Additional information has been received from the nurse.  The nurse reported the patient was sent to the emergency room to rule out any infection.  The emergency room doctor ruled out infection and reported that he felt the symptoms were a reaction to the vaccination measles virus vaccine.  The patient was treated with topical diphenhydramine, and subsequently, recovered within three days, without incident.  The nurse indicated that she did not feel that the patient's events would have progressed to a serious event had they gone untreated. No further information is expected.
Vaccine given subcutaneously; A spontaneous report was received from a pharmacist concerning an 89-year old, female patient who was participating in the mRNA-1273 Emergency Use Program and vaccine was administered subcutaneously.  The patient's medical history was not provided. The patient current conditions included ulcers and high blood pressure. Concomitant medications was not specified.  On 18-Jan-2021, approximately 0 days prior to the onset of the event, the patient received a dose of mRNA-1273 subcutaneously for prophylaxis of COVID-19 infection.  On 18-Jan-2021, the patient received the vaccine subcutaneously. The reporter noticed from a picture that it was not administered intramuscularly.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event vaccine administered subcutaneously was considered resolved on 18 Jan 2021.  The reporter did not provide a causality assessment of the event incorrect route of product administration.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
SARS-CoV-2 RdRp Resp Ql NAA+probe~COVID-19 rapid diagnostic test (nucleic acid amplification test NAAT) performed at pharmacy. Case investigation interview with client has not been performed at time of this note.
Came to the emergency room with a headache, fever, and chills and was diagnosed with COVID-19 pneumonia.  Patient was started on remdesivir and steroids.  Patient was breathing on room air.  Since the patient completed remdesevir course, the patient is feeling better.  Patient also has a positive D-dimer,  probably secondary to COVID-19 pneumonia.  CTA chest was negative for PE.  There was a question of CHF.  Echo shows EF of 55% to 60% and left systolic function normal.  Patient had a complaint of lower extremity swelling.  The patient was given oral Lasix, also given 1 dose of IV Lasix.  The lower extremity swelling resolved.  Since patient was stable enough, patient was discharged to a group home.
Fever or chills; cough; fatigue; new loss of taste or smell; congestion or running nose.
Swollen eyelids and face; Swollen eyelids and face; This is a spontaneous report from a contactable consumer reporting for herself  A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6202) on 25Feb2021 at 14:45 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. The patient didn't have medical history. Concomitant medications included multivitamin, ascorbic acid (VITAMIN C) and calcium. The patient received first dose of BNT162B2 on 04Feb2021 at 14:45 on left arm. On 04Mar2021 at 06:00 am the patient experienced swollen eyelids and face. At the time of the reporting the patient had not yet recovered from the events.   No follow-up attempts are possible. No further information is expected.
everyone there seems to have COVID in various symptoms in the house; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported similar events for 2 patients (Self and Boyfriend). This is the 2nd of 2 reports.   This consumer reported for a 71-year-old male patient (Boyfriend) received first dose of BNT162B2(Formulation: Solution for injection, Batch/Lot number: EN6198), via an unspecified route of administration, administered in Arm Right on 04Mar2021 as single dose for COVID-19 immunisation. Medical history included diabetes and blood pressure high. There were no concomitant medications.  On an unknown date, the patient experienced unknown if they have covid/she says that they never got tested, but everyone there seems to have covid in various symptoms in the house. Consumer reported that patient had their first Pfizer COVID-19 vaccine shot 04Mar and are due today for their second shot in. She says that patient got their first shot, but since then their household has come down with COVID and her daughter has it, yesterday she tested positive. She says she was supposed to get her second dose today, but she has not been tested, so she wants to know how long she can go with not getting the second shot, like if she needed to isolate or if she could go the site masked and get it, she has heard there is no effect on having COVID when you get the vaccine, whether you get it or not. She says a couple of days after they got the shot her boyfriend went to his clubhouse and was there a couple hours, that same day, he was out masked the rest of the day but he took it off to eat. She says that they never got tested, but everyone there seems to have COVID in various symptoms in the house and her daughter tested positive yesterday after she didn't feel well at all. She says her daughter did not have vaccine. Consumer reported that patient had first dose injected in their right arms, probably closer to 03:00 PM though their appointments were at 02:00 PM, there was a long line. Caller says that her boyfriend were diabetic, he was diagnosed last year and he has had high blood pressure for a while. Patient did not on insulin or anything for it. Consumer reported patient did not had any other recent vaccinations or started any new medications. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021333120 same reporter/product/event, different patient