chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Autonomic Neuropathy; orthostatic intolerance; Headache; Fatigue; dizziness; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 23-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced autonomic neuropathy, orthostatic intolerance, dizziness, headaches, and fatigue. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of autonomic neuropathy was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Angioedema Narrative: Employee presented to ER for right sided facial swelling 9 days following PFIZER injection. Employee did not experience any SOB or chest pain. ER provider administered steroid injection for treatment. Employee returned to work on the day of discharge and states she will follow up with private allergist for further disposition.
Then I had singles under my breast/Suspected Vaccination failure; Then I had singles under my breast/Since then I've been having mini patches of shingles each time different spot Chest, elbow, thigh.; The second dose I got so sick; was in pain for 2 days/Painful; Swollen arm; Arm that was red; Pain in arm; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Then I had singles under my breast/Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Then I had singles under my breast/Since then I've been having mini patches of shingles each time different spot Chest, elbow, thigh.), sickness (Verbatim: The second dose I got so sick), pain (Verbatim: was in pain for 2 days/Painful), swelling arm (Verbatim: Swollen arm), erythema of extremities (Verbatim: Arm that was red) and pain in arm (Verbatim: Pain in arm).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the sickness, pain, swelling arm, erythema of extremities and pain in arm were resolved (duration 2 days).   The reporter considered the vaccination failure, shingles, sickness, pain, swelling arm, erythema of extremities and pain in arm to be possibly related to Shingrix. The reporter considered the vaccination failure and shingles to be possibly related to Shingrix.     The company considered the vaccination failure, shingles, sickness, pain, swelling arm, erythema of extremities and pain in arm to be possibly related to Shingrix. The company considered the vaccination failure and shingles to be possibly related to Shingrix.   Additional Information: GSK Receipt date: 08-SEP-2023 This case was reported by patient via interactive digital media. The patient reported that she took her vaccine last year.  The second dose she got so sick and was in pain for 2 days with swollen arm very red and painful.  Then she had singles under her breast it stayed for 2 months and Since then she had mini  patches of shingles each time different spot Chest, elbow and thigh.  The patient stated that she learned that even with vaccine you might had shingles, if you're not vaccinated and had shingles, you could start meds in the first 72 hours, you would be fine. The patient would never get any vaccine ever. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Diagnosed with COVID-19/ She experienced sore throat, headache, chills and breathing issues when lying down flat; Pain in the back of her legs; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Pain in the back of her legs) and COVID-19 (Diagnosed with COVID-19/ She experienced sore throat, headache, chills and breathing issues when lying down flat) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003H21A, 008C21A and 008C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Diagnosed with COVID-19/ She experienced sore throat, headache, chills and breathing issues when lying down flat). In September 2022, the patient experienced PAIN IN EXTREMITY (Pain in the back of her legs). At the time of the report, PAIN IN EXTREMITY (Pain in the back of her legs) and COVID-19 (Diagnosed with COVID-19/ She experienced sore throat, headache, chills and breathing issues when lying down flat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2022, SARS-CoV-2 test: (Positive) Positive.   No concomitant medications were provided. The patient went to the emergency room where they recommended paxlovid, however patient did not take that injection. Instead, patient drank orange juice. No treatment medications were taken by the patient.
I felt fine for several hours after receiving the shot until about 10PM when I got into bed.  As soon as I got into bed, I started shivering and my teeth were "shaking."  A few minutes later, I went to the bathroom and had to vomit, then had diarrhea.  I then went back to bed.  The next morning I felt fine, but just really tired.
The area of the injection site had a circular red area appear 6 days after the shot.  The area was about 3/4" in diameter.  Over the next 7 days, the redness continued to spread along arm until it was 5" long and 3" wide, down my forearm.  It was slightly itchy one or day days, but otherwise just a red splotch, like a sunburn or similar to a mild allergic reaction.  It faded after the 7th day and has not reappeared. The lymph node of the arm also hurt for two days after injection, and hurt again on the 6th day when the red area appeared.  The discomfort subsided after one day.
It was brought to our attention that there was an immunization error made on a patient. The patient had an injury on Friday, July 20th and came to the walk-in clinic Saturday, July 21st to see about updating her tetanus status. The walk-in provider ordered a Td to be administer red. In error, a PENTACEL was given. This came to light during an audit that was being performed by one of the nurses. She did call the patient and informed her of the error. At that time, it was thought that the patient would need additional tetanus coverage since the patient was given a pediatric dose. The patient came in this morning and said she was having a reaction to the vaccination. In the meantime, agency contacted and asked about giving a Td for coverage. One of the nurses informed us that she does not need additional immunizations. She is covered with the Dtap. She also said the HIB and Polio in the PENTACEL would not cause the patient any problems. Two nurses went and visited with patient about her reaction at 9:30 this morning. She has not had any respiratory symptoms. She stated that her left arm (where she received the vaccination) was very sore and it also hurt up into her left shoulder and her neck. She did have a warm, red area from the injection site down to about 3 to 4 inches above her elbow and she said it itches. It is blotchy in nature and the patient said it is actually a little improved. We advised Tylenol and ice. It was explained to the patient that a Td was ordered for her and that she was given a pediatric vaccination that also contained Hib and Polio. I told her this was an error. She was given VIS sheets on these vaccinations for her information. We went over the information with her that we received from agency and explained that she is completely covered for tetanus with the vaccine she received. She said she was satisfied with the information she was given, and she was very understanding about the error. She was instructed to call us with any concerns she may have regarding this issue. An incident report was filed. We were also advised by agency that we will need to complete a VAERS form for the state, a Vaccine Adverse Event Reporting System. This will be completed as requested.
Patient has a history of coronary artery disease status post CABG.  He has has been "feeling unwell" for the past week, with fevers, headache, shortness of breath, and multiple other complaints.  Pt was admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia.
lt arm pain-same arm as flu shot;supra? deltoid atrophy;EMG affected on axillary suprascapular, median nerve;
she tested positive for covid also; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated that her daughter and she got the first dose of the Pfizer covid 19 vaccine three weeks ago. She stated that three days after getting the shot, her daughter tested positive for covid. She also tested positive for covid. She asked if they do not have symptoms and whether they were able to get the second shot. She had no symptoms and completed isolation. She also stated that she did not consider this an AE, stating that she just got exposed to a relative. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
SLIGHT HEADACHE, ACHY, COLD AND FATIGUE STARTED AROUND 8:00PM, 11/13/20.  OF COURSE, INJECTION SITE WAS RED, SWOLLEN AND WARM. WENT TO BED AT 9:30 WITH EXTRA COMFORTER AND CLOTHES. NEVER REALLY SLEPT, COULDN'T GET WARM, EVEN WITH THE ADDED HEATING PAD ON HIGH.  RIGHT HAD HURT BADLY.  GOT OUT OF BED AT 2:00AM TO USE BATHROOM AND GET MORE CLOTHES AND BLANKETS. TEETH CHATTERING, TOOK TEMP. NORMAL IS 96.6-97.8, IT WAS 100.6. FINALLY GOT LESS COLD AFTER HOT TEA.  STAYED IN BED UNTIL 11/15/20. GOT UP ONLY TO SIT IN RECLINER THE ENTIRE DAY.  FINALLY....MONDAY MORNING, WOKE UP FEELING 100% ME!
Patient developed numbness, tenderness and pain left thoracic region radiating around to the front of chest on July 12 start mild very painful by July 15 and on July 16 Herpes Zoster rash present following the dermatone. We have photographs if needed
Information has been received from a Registered Nurse concerning a 21 year old female patient with a chronic yeast infection an no drug reactions/allergies, who in 2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot # 655327/1287U). On 26-MAR-2010, the patient was vaccinated with the second dose of GARDASIL (lot # 663559/1178Y). Concomitant therapy included ESTROSTEP. On 28-MAR-2010, the patient experienced dizziness, loss of appetite, was achy, had a high temperature, minor nausea, cough and congestion. The patient recovered from these symptoms. On 05-APR-2010 the patient developed a rash. At the time of the report, the patient had not recovered from the rash. The patient sought medical attention (office visit). No laboratory diagnostics studies were performed. Follow up information has been received from a licensed practical nurse who indicated that the patient with no illness at the time of vaccination and no medical conditions (previously reported as chronic yeast infection) who was vaccinated IM with a dose of GARDASIL in her right deltoid. On 28-MAR-2010 the patient experienced achy muscles. On 05-MAY-2010 the patient developed rash on her trunk. On an unknown date the patient recovered. Additional information is not expected. Additional information is not expected.
Mainly cold symptoms, sore throat, headache. At one point, dizziness and cold sweat. I did a home COVID-19 test and it was positive and I called my doctor on the phone and they prescribed PAXLOVID and I began taking it that same date.
mild chills and shocks during early morning hours. 100.3 temp About 8 hours of nerve contractions Extreme sleepiness about 12 hours
Soreness in injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in injection site arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness in injection site arm). At the time of the report, VACCINATION SITE PAIN (Soreness in injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant Medications were reported. No Treatment Information Provided.
Herpes zoster - rash on left leg consistent with shingles (focal erythematous rash with multiple small vesicles)
One week later experienced redness, warmth, inflammation and tenderness at and around injection site.  Symptoms include fatigue and chills. Began slowly and increased in severity over 2 to 3 days. Resolved in 5 days.
Enlarged, tender submandibular lymph nodes (both sides); Mild, normal pain at the injection site area that lasted 2 days and resolved; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Enlarged, tender submandibular lymph nodes (both sides)) and VACCINATION SITE PAIN (Mild, normal pain at the injection site area that lasted 2 days and resolved) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis since 2018. Concomitant products included CERTOLIZUMAB PEGOL (CIMZIA) for Rheumatoid arthritis.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE PAIN (Mild, normal pain at the injection site area that lasted 2 days and resolved). On 13-Jan-2021, the patient experienced LYMPHADENOPATHY (Enlarged, tender submandibular lymph nodes (both sides)). The patient was treated with TRAMADOL at an unspecified dose and frequency. On 31-Dec-2020, VACCINATION SITE PAIN (Mild, normal pain at the injection site area that lasted 2 days and resolved) had resolved. At the time of the report, LYMPHADENOPATHY (Enlarged, tender submandibular lymph nodes (both sides)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
it was more red, a little bit scaly, kind of a dryness on the splotches; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration, in the left arm on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. on an unknown date, the patient experienced more red, a little bit scaly, kind of a dryness on the splotches, not raised after the first dose. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
pt had her 2nd covid vaccination dose on wednesday past. she has a blister like rash in her nose, outside her nose/nares, and on the left side of her face, with swelling and pain.  has been taking tylenol for pain, without experiencing any relief. pt denies having shingles previously, admits to having chicken pox as a child. pt reports 1 day after the 2nd immunization dose, she had a fever with aches and chills. those symptoms lasted 1.5 days. "late last night my face was red, and then this morning it (blistery rash) appears and this is the outcome."
Whole body aches and fatigue beginning at 7pm day of vaccination lasting til 1pm following day, Severe Chills beginning at 8:30pm lasting til 12pm, Headache starting 12pm relieved with Tylenol, Mild-Moderate Nausea starting at 4am until 5am
30 sec seizure reactivity with urinary incontinence. 911 called. Took vital signs and gave ice pack in back of neck.
Swelling of legs; Osteoarthritis; Paresthesia lower limb; Pain legs; Headache; Fatigue; Nausea; Vomiting; Urination frequency of; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Urination frequency of), PERIPHERAL SWELLING (Swelling of legs), OSTEOARTHRITIS (Osteoarthritis), PARAESTHESIA (Paresthesia lower limb) and PAIN IN EXTREMITY (Pain legs) in a 48-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.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and GABAPENTIN for an unknown indication.    No Medical History information was reported.   On 20-Jul-2021, the patient started GABAPENTIN (unknown route) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate Free. On 20-Jul-2021, the patient experienced POLLAKIURIA (Urination frequency of). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of legs), OSTEOARTHRITIS (Osteoarthritis), PARAESTHESIA (Paresthesia lower limb), PAIN IN EXTREMITY (Pain legs), HEADACHE (Headache), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, POLLAKIURIA (Urination frequency of), PERIPHERAL SWELLING (Swelling of legs), OSTEOARTHRITIS (Osteoarthritis), PARAESTHESIA (Paresthesia lower limb), PAIN IN EXTREMITY (Pain legs), HEADACHE (Headache), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test: abnormal. On an unknown date, Platelet count: Low. On an unknown date, Thyroid function test: High(abnormal). On an unknown date, White blood cell count: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs and treatment medications were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Headache, NauseaVomiting, HYPERglycemia, Cold sweats, weakness, fatigue, high blood sugars mid to high 300's Narrative:
Narrative:  Pt was a 75 YO male with PMH of BPH, HTN, and CAD whose death was reported to facility by the agency.
pt rcvd vax; pt exp fever; t 4degree/shot; pt irritable; leg pain; joints seemed hot; tx: APAP; benadryl; ice;
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 72-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 Celsius. On 18-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported]. At the time of this report, no adverse event was reported. This case 201805517 was crossed linked to original case 201804863 due to same reporter.
Aching in shoulder at rest, sharp pain and limited range of motion in shoulder especially when crossing midline in front or back (dressing, driving, showering, reaching, etc), pain when trying to sleep... pain is deep within shoulder joint, not in the muscle tissue where injection given.  At the 4 week point I started doing some research and discovered others who had the same symptoms after being given an IM injection too high (the Pharmicist who gave mine was not comfortable with what he was doing - had not given any mercury free vaccines needing an IM needle...only the new prefilled subQ ones.  He did not seem to know what he was doing...couldn't find the needle on the vial (wasn't one on there, had to get one), then didn't know what needle to use (someone else found one for him), didn't know to expel the very large air bubble in the vial, etc.  After realizing what my shoulder issue was I called my health insurance company to report it and followed up with a Dr. visit.  I am almost done with a 10 day course of NSAID therapy and cold pack treatments.  Still having pain, but seems to be lessening and range of motion is slowly improving.
This spontaneous report as received from a company representative refers to a female patient of unknown age with history of lower back pain and unspecified nerve pain. The primary reporter stated that a physician had two patients who experienced a vaccine failure of ZOSTAVAX. Other case (MARRS # 1303USA000448). On 21-FEB-2013 "about three weeks ago" The female patient received ZOSTAVAX 19400 PFU, 0.65ml subcutaneously (lot# and exp date were unspecified). On 21-FEB-2013 two weeks after ZOSTAVAX injection, the patient developed outbreak on her thigh and was diagnosed with shingles. It was reported that vaccine failure and shingles did not cause hospitalization or prolonged and were not life threatening. The relatedness of shingles was unknown. The outcome of vaccine failure and shingles was unknown. Additional information has been requested.
The patient said she felt dizzy after receiving the Moderna vaccine.  It was her first immunization.  This occured at 4:42pm.  She did not feel better after 30 minutes so we offered her to come into the pharmacy and lay down.  We took her blood pressure and blood sugar.  Her BP was 113/73.  Her BS was 108.  After about 20min, she said that she felt cold.  Shortly after this, she said that her throat felt strange.  She said that she thought it was swelling.  She began to have difficulty breathing.  At that time, an epinephrine 0.3mg auto injection was given at 6pm.  The pt began to breathe easier within a minute of the injection.  The pt said that she felt tingling in her legs and hands.  After about 10 minutes, she said that feeling in her throat was coming back.  At that time, the ambulence attendants arrived.  We told them about giving one injection of the epi-pen.  The ambulence attendents were able to walk the pt to the gurney.