chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient woke up with achy arm, a small round area progressively got bigger until now . Area of angioedema  is about 6 inches long and 3 inches wide. Patient's arm still feels achy and sore.  Patient has had the 'flu immunization in previous years and nothing like this has happened before.
2 days after (2nd) Moderna vaccination patient developed loss of taste/smell, dizziness, and ear buzzing/tinnitus.  These have persisted, though some improving, after ~3 weeks.
Right (opposite) arm and hand felt a little numb; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 17:15 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took bupropion hydrochloride (WELLBUTRIN), itraconazole (SPORANOX) for an unknown indication on an an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 19:00, the patient experienced right (opposite) arm and hand felt a little numb a couple of hours after the vaccination, and still felt that way the next day, but to a lesser degree. The patient felt like the feeling when she get a limb "falls asleep". The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event right (opposite) arm and hand felt a little numb was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
1st syringe leaked, needle, not tight enough. Second flu vaccine given. None from 1st vaccine pt. received. Visually saw vaccine serum on pt. arm.
petechia rash on face,urticaria scalp and neck,. bilateral wheezing and cough with chest tightness. mom states symptoms started about 2 hours after immuniztions. Blood pressure and pulse stable Albuterol  for wheezing and chest tightness, improved breathing after treatment. Patient was discharged home with oral steroids
ocalized injection site discomfort, generalized fatigue, and a decreased sense of taste the following morning. The decreased sense of taste improved after 24 hours, but the generalized fatigue and injection site discomfort persisted over the next several days. She also experienced body aches, but notes these are fairly typical for her, so she didn't think much about it. She recalls having headaches and stomachaches around days 3-5 following her injection, and beginning on day 7, she also started to notice some injection site itching and induration.  The localized swelling and redness increased during days 7-10 following her COVID-19 vaccination, and over the last 6 hours, she also started to develop nausea. Her fatigue persists, but the headaches, stomachaches, and body aches have subsided.
71 yr old female with PMH of breast cancer, cirrhosis of the liver and brain lesions presents for evaluation of expressive aphasia. Patient was tested positive with COVID-19 on 10/18/21 and received the monoclonal antibody infection on 10/19/21. Denies chest pain, abdominal pain or SOB. .
pain that radiates down left arm, left shoulder blade, neck on left side, uncomfortable/painful to move arm after five days from recieving TD injection. causing headaches and discomfort, unable to sleep comfortably, pain keeps me awake in pm.
Runny nose; mild sore throat; Symptoms have reappeared 5 days after completing; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (mild sore throat) and SYMPTOM RECURRENCE (Symptoms have reappeared 5 days after completing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Drug allergy (unknown drug).   On 09-Dec-2021 at 7:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022 at 12:15 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 31-May-2022, the patient experienced RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (mild sore throat) and SYMPTOM RECURRENCE (Symptoms have reappeared 5 days after completing). At the time of the report, RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (mild sore throat) and SYMPTOM RECURRENCE (Symptoms have reappeared 5 days after completing) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication information provided. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. No treatment information provided. Patient previously received a COVID-19 Vaccine.    Device Date was 03-Jun-2022
Expired Hep B vaccine was given, Hep B #3 for child 0 adverse reactions, 0 treatment given.
pt states swelling started almost immed went to pvt MD started on medicine; arm swelled; pt large goose egg on lt deltoid & warm;
Creatinine levels above normal at 1.47 for the first time in my life EGFR  51 Creatinine clearance 44
left leg is swollen; headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left leg is swollen) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphedema (lymphedema class 2) and Thyroid disorder. Concomitant products included DULOXETINE and LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PERIPHERAL SWELLING (left leg is swollen) and HEADACHE (headache). The patient was treated with THYROID (NATURE THROID) at a dose of used for years and went off for 6 days and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (left leg is swollen) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included: T4 and T3 compounded.  The patient started experiencing headache about a week and half ago. She had taken Ibuprofen. The headache usually wakes up in the morning or comes later in the day, and she never get headaches. Patient also states she has lymphedema class 2 and forgot to put it down when she received the first dose, her left leg is swollen but she has gained some weight from her thyroid issues. She wants to know if there is any correlation with lymphedema and the vaccine.
became hot, clammy, (nausea w/ results for over 15 hours), entire body aches, shortness of breath, it was like doing all over again, has been over 40 hours now better but not quite there
difficulty breathing, fast heartbeat 125bpm, low grade fever, lower back pain, headache, body ache, tightness of the chest
Information has been received from a physician concerning a male who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # 657143/0380U).  Subsequently, the patient developed erythema at the injection site within one day.  The erythema was described as swollen, painful and warm from the injection site to the elbow.  The pain and swelling prevented the patient from using his arm.  Unspecified medical attention was sought.  At the time of the report the outcome was unknown.  The physician requested a lot check.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the center and was released.  Additional information has been requested.
This spontaneous report was received from a pharmacist refers to multiple unspecified patients of unknown gender and age. Information regarding medical history, concurrent conditions and drug reactions/allergies were not reported. On multiple unspecified dates, these patients were vaccinated with improperly stored ZOSTAVAX (lot # L011533, expiry date: 03-JUL-2016). No adverse effects were reported. Additional information has been requested.
Information has been received from a physician concerning a 14-15 year old female.  On an unknown date, the patient was vaccinated with her first dose of GARDASIL 0.5ml (route and site not reported).  After vaccination, the patient experienced a pain in her hip.  The pain went away and then the patient received her second dose of GARDASIL and the pain in her hip reappeared.  Patient went to physical therapy however she did decline to receive the third dose.  No lot number was provided.  The patient recovered from pain in her hip.  Additional information has been requested.
Two raised red lines emanating from deltoid area of injections laterally around front of arm to underarm. Patient said they did not itch but were painful. Recommended emergency room.
Fully vaccinated with Covid vaccine x 2. Tested positive for Covid on 01/22/2022. Admitted to the Hospital in on 01/27/2022. Expired on 02/01/2022 while still hospitalized.
Crohn's; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Crohn's disease (In 2019, the patient was in the hospital due to Chrohn's. She was recovered from hospitalization).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's) (seriousness criteria hospitalization and medically significant). At the time of the report, CROHN'S DISEASE (Crohn's) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was recovered from hospitalization. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medication information was reported. No treatment medication information was reported.  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.  Company Comment:  This spontaneous case concerns an elderly female patient with relevant medical history of Crohn's disease, who experienced the unexpected, serious  (hospitalization and medically significant) event of Crohn's disease on an unknown date in the context of  receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of vaccination and onset date of the event was not provided. No information on any other doses of COVID-19 vaccination was provided. The relevant medical history of Crohn's disease remains a confounder as the disease itself is known to recur. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly female patient with relevant medical history of Crohn's disease, who experienced the unexpected, serious  (hospitalization and medically significant) event of Crohn's disease on an unknown date in the context of  receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of vaccination and onset date of the event was not provided. No information on any other doses of COVID-19 vaccination was provided. The relevant medical history of Crohn's disease remains a confounder as the disease itself is known to recur. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Right deltoid - redness, swelling, warm to touch & tenderness (22 mm).
I was uncontrollably tremoring inside and outside my body. This began at 6:00 am after the shot. My heart felt as if it was palpitating. I had extreme body aches and chills. 6:00 am two days after shot I broke out on hives which began on my torso and spread to my face and extremities.
Pt called the office stating she had received the first dose of Moderna's COVID vaccine around 0830. Pt called at 0941, c/o band-like headache with significant pain, a metallic taste in her mouth, and feeling like parts of her mouth were numb similar to when she has dental work done and is numbed with lidocaine.
received her first dose over a year ago / not / received her second dose.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in left arm, over a year ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
4 year old with a history of asthma and a cochlear implant came into our office for a Pneumovax vaccine. 3 hours later mom called and said she was febrile 101, increased respiratory effort and chills.
Patient presented to vaccine clinic for first dose of Janssen. Patient received dose at 3:02 pm. At 3:07pm patient stated he felt anxiety in his stomach, felt like he was going to pass out and slowly proceeded to the floor with the assistance of the nurse. Patients legs were raised on chair and head supported by sweater. Patient did not lose consciousness. BP 102/72, P51 O2 99% RA, R 17. Patient denied H/A, C/P, or SOB. Patient was diaphoretic and bradycardic with no labored breathing. After a few mins, patient was raised to a seated position and given a bottle of water. P 98, 99% O2 stat. Patient reported that he was feeling bettter and safely brought to a standing position. BP 130/74, P80, 99% RA. Patient walked to observation area, reported feel better and continued to be observed for an additional 15 mins. Patient denied further medical treatment.
A delayed reaction around injection site.  After no initial soreness, several days after the injection the area became painful with a large hot red area.  It seemed to be progressively getting worse and on the evening of 1/12/21 when becoming very uncomfortable, the patient drew a circle around the red area and the next morning noted that it had grown significantly.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case contains information for the 70th of 190 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
This spontaneous report as received from a registered nurse refers to a male patient who is currently 4 years old. Information regarding his pertinent medical history, concurrent conditions, drug reactions/allergies, and concomitant medications was unknown. On an unknown date, the patient was vaccinated with GARDASIL 9 (which had a lot # of L043214 with and expiration date of 30-AUG-2017; the dose, dosage number, and anatomical location were unknown), intramuscularly. This was an error and it occurred because two of his siblings were also receiving vaccinations during the same sessions and GARDASIL 9 was intended for the older sibling. However, the patient, at the time reporting, had not exhibited or reported any adverse effects. Notably, no product quality complaint was involved. Additional information has been requested.
pt received booster on 1/24/22. Called hospital on 1/25/22 to report she woke up the middle of the night with arm pain, chest pressure radiating to her back.  She  had chills and headaches.  PMH - hx of PE on blood thinners  and total knee replacement. Sees external PCP.   Pt was advised to go to ED for further evaluation of symptoms.
Fever up to 101 F Degreefrom the day vaccination; Urinating frequently (10 times in aday); Heavy body pain; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male 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 26Apr2021 at 12:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within two weeks of COVID -19 vaccine. On 26Apr2021 at 17:00, the patient experienced "fever up to 101 F Degree from the day vaccination till now, urinating frequently; 10 times in a day, heavy body pains". The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 26Apr2021, the patient underwent Body temperature and the result was fever up to 101 F Degree. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events "fever up to 101 F Degree from the day vaccination till now, urinating frequently; 10 times in a day, heavy body pains" was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Received injection at 2:30ish.  By 4pm I was cold and couldn't warm up.  Then I got very tired and had to rest.  By 7pm I was getting very hot, like I was on fire, alternating with cold.  I also developed a sore arm near the injection site.  By 7pm I also very painful all over.  By the next morning my body was swollen which made it difficult to sleep and move.
Information has been received from a physician concerning a 10 year old female who on 11-APR-1997 was vaccinated with a dose of Varivax. On 10-MAY-2006 the patient developed breakthrough, there was no lesion count. The patient received no treatment and was not hospitalized. No further information was available. There was no product quality complaint involved. Additional information has been requested.
Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 78 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 20-MAY-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a pharmacist concerned a 68 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. Patient was not pregnant at the time of reporting. 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, 1 total, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  As of end of MAY-2021, the patient was tested for antibodies and no detectable antibodies to the spike protein present in the body which was reported as inadequate immune response (coded as confirmed immunological vaccine failure). Patient reported that ,she didn't experience any symptoms after the vaccination (no arm pain, fever, chills, etc.), so she was worried that she received an expired or inadequate product per the pharmacist. Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) No detectable antibodies to the spike protein. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210663889- covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Fever to 104 for 4 days post vaccination. Left upper arm large, red knot.