chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Meningococcal Conjugate vaccine and the Inactivated Influenza vaccine. The patient sat and was monitored for the recommended 15 minutes after the immunizations and did not show any symptoms of adverse reactions.  As the patient was getting ready to leave, she began to feel lightheaded and was assisted to lie in Trendelenburg position, the patient's symptoms began to resolve after about 5 minutes. The patient drank 6 ounces of apple juice and was then able to sit up, without return of lightheadedness or any other symptoms.  Vital signs were stable (blood pressure 136/82, pulse 73), and patient's condition returned to the same as it was prior to vaccination. Patient was then discharged to home. Patient was advised to get plenty of rest, drink adequate oral fluids and refrain from over-exertion and strenuous activities for the next several hours. Patient was advised for future vaccination, she should lie down prior to and for 15 minutes after the vaccinations.
Very strange dreams during the night. Waking up several times slightly confused as to where I was.
Fatigue, headache, neck pain (posterior), chills-unknown if fever-no thermometer. Glandular swelling L & R into cheeks, cervical lymph nodes. All started on 4/7/06.
had pretty much the same reaction they did; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had pretty much the same reaction they did(Vaccination site reaction).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  Patient had pretty much the same reaction they did.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), had pretty much the same reaction they did,  was unknown.
This spontaneous report was received from a nurse refers to a male patient of unknown age. No concurrent condition or medical history was reported. On 02-AUG-2015, the patient was vaccinated with improperly stored M-M-R II (lot # K016153, Exp. 24-SEP-2016, dose and route of administration not provided) (Incorrect product storage). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. Product quality issue was not involved. This is one of the two reports from the same reporter. Additional information has been requested.
Pt c/o baseball size rash around the site of the injection. Pt also c/o soreness for 5 days following the shot and spiking a temp of 101.1 at some pint after the vaccine was given
suspected vaccination failure; he got the shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The reporter was patient's wife. The age at vaccination was not reported.  The patient received Shingles vaccine and got the shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset were unknown.
Pain, fevers, difficulty moving right arm days 1-2 after receiving vaccine followed by localized swelling, hives and itching of right arm treated with oral antibiotics starting 11/3/18 by clinic for concern of cellulitis treated with oral antihistamines, NSAID's and acetaminophen by clinic and our office for pain, fevers, itching and hives.
1 hour after the shot I experienced colorful floaters of different shapes  This lasted about 45 minutes. 2 hours later chills and nausea. This lasted about 3 hours    Approximately 12 hours after the shot feeling normal with no nausea or colorful floaters
Developed temp to 103 same night.  Next night temp to 105 & was irritable three days later vesicles on lips & white plaques in mouth.
No adverse event; First dose on 18-May-22 and second dose on 07-Jun-22; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-May-22 and second dose on 07-Jun-22) and NO ADVERSE EVENT (No adverse event) in a 26-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Drug allergy and Drug allergy.   On 18-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Jun-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-May-22 and second dose on 07-Jun-22). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-May-22 and second dose on 07-Jun-22) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-May-22 and second dose on 07-Jun-22).    No concomitant medication information was provided. No treatment medications were provided   This case was linked to MOD-2022-673503 (Patient Link).
swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 011A21A) for COVID-19 vaccination.     No medical history information was provide by the reporter.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pruritus and Vaccination site swelling, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site) was resolving. The swelling has gone down a bit at the time of the call (13Apr2021) but the itching is still ongoing. She took Tylenol.          Patient reported that swelling was gone at the time of call on 13Apr202 but itching is still ongoing from dose 2.  No concomitant medication was provided.   This case was linked to MOD-2021-075001 (Patient Link).
pt devel fever, nausea, sore throat, earache; c/o swelling @ inject site & pain;
Information has been received from a registered nurse referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On an unspecified day, these patients were vaccinated with improperly stored PNEUMOVAX 23 single dose vial (SDV) (lot # K006681, expiration date: 21-OCT-2015; strength, dose and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
PT. SPOUSE STATES SHE HAS SEVERE LOCALIZED STOMACH CRAMPS, VOMITED ONCE, NAUSEA, AND DIARRHEA 2-3 EPISODES
The pt became SOB, tongue and lips were swollen, had difficulty swallowing and had a rash and itching all over, about 30 to 45 minutes, post vax. She was given Allegra 180mg, 0.2 epinephrine without relief. She was sent to ER and admitted to the hospital. Diagnosed with allergic reaction to injection.
40 year old received anthrax vaccine #5 in his right triceps area on 04AUG04. Within 24 hours he had progressive right arm edema, erythema and pain approximately >120 cm, but not below his elbow. He also reports having some localized "itching" and a "mild headache" that began the following day. He denies SOB, chest pains, fever, lymphedema, generalized rashes, arthralgias or myalgias.
left side of tongue pain and swelling which began a few hours after shot. redness and bumps also developed on the side of her tongue spreading down her throat. made difficult to swallow for 3 days. now on Day 5 is improving
Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 56-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 56-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
Information has been received from a nurse practitioner concerning a 23 year old female with mild cervical dysplasia with colposcopy and no known allergies or adverse drug reactions reported. On 26-SEP-2006, the patient was vaccinated with the first dose of 0.5 mL of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication reported. It was reported that the pre-filled syringe had been stored at 34F. On 26-SEP-2006 the patient developed severe pain during administration with lightheadedness and dizziness. The patient was laid on the exam table and given ibuprofen (MOTRIN) for pain. The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the events. Additional information has been requested.
The patient received both FluzoneHD and Pneumovax23 vaccines on same date.  The patient experienced mild flu-like symptoms, including a mild fever, for 24 to 36 hours after vaccine administration. The main adverse reaction was a red, warm welt the appeared around the injection site of the Pneumovax23.  The welt lasted for 3 to 4 days before subsiding.
Mother states patient took first dose of oral typhoid at 8 AM and waited 1 hour to eat, then exactly 2 hours after dose became nauseated and had abdominal cramping. Denies any fever or diarrhea. Felt better the evening of 02/20/05.
Extreme fussiness & crying which started about 2-3 hours after vaccines, lasted 3-4 hours followed by hives about 3 hours after vaccination. Hives gradually worsened, becoming more generalized. Treated with BENADRYL. Hives still present 48 hours later then put on prednisone.
Fever; Body aches; Chills; Headache; Injection site pain; Muscle soreness; Fatigue; Minimal sore throat; Stuffy nose; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 21Apr2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and fibromyalgia. 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 vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), calcium (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3) and ibuprofen (MANUFACTURER UNKNOWN) not 48 hours before; all taken for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER0735) via an unspecified route of administration in the left arm on 31Mar2021 at 13:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient previously received erythromycin (MANUFACTURER UNKNOWN), clarithromycin (BIAXIN) and experienced drug allergy. On 22Apr2021 at 01:00, the patient experienced fever, body aches, chills, headache, injection site pain, muscle soreness, fatigue, minimal sore throat and stuffy nose. On the same time, the patient underwent body temperature test and the result was found to be less than 102 (unspecified units). The adverse events 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events fever, body aches, chills, headache, injection site pain, muscle soreness, fatigue, minimal sore throat and stuffy nose were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Aching pain in right armpit; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 at 13:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). The patient had no known allergies to medications, food and other products. Concomitant medications included ethinylestradiol, norelgestromin (XULANE); from an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021 at 08:30, the patient experienced aching pain in right armpit. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of reported event. The clinical outcome of the event aching pain in right armpit was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Thrombosis leg; Heart attack; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4113473-00 (AbbVie).  A 60 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Sep2021 (Batch/Lot number: unknown) at the age of 60 years as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. Relevant medical history included: "BLOOD CLOT IN LEG" (unspecified if ongoing); "HEART ATTACK" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: THROMBOSIS (hospitalization, medically significant) with onset Sep2021, outcome "recovered" (2021), described as "Thrombosis leg"; MYOCARDIAL INFARCTION (medically significant) with onset 2021, outcome "unknown", described as "Heart attack". The action taken for adalimumab was unknown.  The patient suffered a heart attack but there was no damage. In Sep2021, he received covid vaccine, two days after the vaccine he developed a blood clot in his leg, and was hospitalized. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of Thrombosis leg, and Heart attack with adalimumab (HUMIRA) was no reasonable possibility. Causality as per AbbVie's opinion is that there is no reasonable possibility that the events of Thrombosis leg, and Heart attack are related to adalimumab (HUMIRA). The reporter's causality for the event(s) of Thrombosis leg and Heart attack with PFIZER BIONTECH COVID-19 VACCINE was not reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case, the causal association between the events thrombosis, myocardial infarction and the suspect drug BNT162B2 cannot be excluded.The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Three hours post vax, the patient began not focusing at preschool, not listening, standing up and throwing chairs, screaming, and running around the room yelling.
Initial case received on 09 February 2010 from a health professional. A 15 year old female patient received an intramuscular deltoid (arm unspecified) injection of MENACTRA (lot number not reported) on 22 December 2009. Within 24 hours on 23 December 2009, the patient  experienced involuntary tremors in the vaccinated arm. The patient had no illness at the time of the vaccination. She had no known allergies and no concomitant medications. Her medical history included headache, joint pain, allergic rhinitis and nasal polyps. As of this report the tremors had not resolved. Documents held by sender: None.
Mild dizziness; being tired; headaches; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Mild dizziness), FATIGUE (being tired) and HEADACHE (headaches) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included BISOPROLOL, CALCIUM and RISEDRONATE SODIUM (RISEDRONATE) for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Mild dizziness), FATIGUE (being tired) and HEADACHE (headaches). In February 2021, DIZZINESS (Mild dizziness), FATIGUE (being tired) and HEADACHE (headaches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that the patient experienced mild dizziness and headaches that would last a minute and disappear and recur in a few hours. This lasted for a week and half. The patient also reported being tired which lasted for two and a half weeks.  No treatment details were reported.
This spontaneous report was received from a physician regarding a female patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 06-JUN-2018, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, strength, frequency, lot#, expiration date and route of administration were not reported). In approximately June 2018, the reporter stated that the patient was prescribed a corticosteroid injection for an unspecified reason. At the reporting time the outcome of the event was unknown. The causal relationship between ZOSTAVAX and the event was not reported. No product quality complain was present.
Patient came to clinic and request Covid vaccine.  She was ask by intact person if was first vaccine and voiced yes, then at registration again ask if was first vaccine and again answered "yes".   Then when she came to vaccine office I ask her again if this was her first Covid vaccine and she voiced "yes".  I then advised that would be receiving Moderna and she acknowledged.  It was not until went to enter the vaccine report that noted had a Johnson and Johnson vaccine already entered from 05/12/2021. I went to inquire to her but she did not remain the 15 minutes as recommended therefore I called her to inquire and she voiced "if I did, I don't remember".  I also contacted the Pharmacy he remembered he was the person that gave it to her.  At time of reporting this which is little over one hour that she received no reactions.  Only reporting as had received Johnson and Johnson and now Moderna over 28 days.
large red area on arm; blotchy area on arm; didn't feel well; This case was reported by a other health professional via sales rep and described the occurrence of erythema of extremities in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced erythema of extremities, blotchy and feeling unwell. On an unknown date, the outcome of the erythema of extremities, blotchy and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, blotchy and feeling unwell to be related to Shingrix.  Additional details were received as follows: The age vaccination was not reported. The reporter stated that an acquaintance of hers experienced a large, red, blotchy area on her arm after the first dose of Shingrix. The patient was feeling unwell after getting the vaccine. The symptoms lasted about 2 weeks before resolving. This is 1 of the 2 cases reported by the same reporter.
Patient  did not have any reaction, however an expired vaccine was administered. Moderna Vial was punctured on 9/13/21 a little after 1:13 PM. Dose was given  a little after 6:12  PM on 9/14/21