chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A quarter-size red spot under the right armpit with a rash spreading out from it; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in the arm left on 21Mar2021 at 16:15 (at the age of 74-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient was allergic to penicillin. Concomitant medications included aspirin (MANUFACTURER UNKNOWN) at a dose of 81 mg started on an unspecified date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021, the patient developed a quarter-size red spot under the right armpit with a rash spreading out from it. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event a quarter-size red spot under the right armpit with a rash spreading out from it was not recovered.  No follow-up attempts are needed. No further information is expected.
Bi-Lateral Pulmonary Embolisms, Left Leg Deep Vein Thrombosis  Noticed Symptoms on 5/28/2021 Hospitalized on 6/2/2021
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches), CHILLS (chills), PYREXIA (low grade temp) and MYALGIA (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced HEADACHE (headaches), CHILLS (chills), PYREXIA (low grade temp) and MYALGIA (body aches). At the time of the report, HEADACHE (headaches), CHILLS (chills), PYREXIA (low grade temp) and MYALGIA (body aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported.
This spontaneous report as received from a registered nurse refers to an 11 year old female patient. On 26-MAY-2017 the patient was inadvertently vaccinated with an expired dose of GARDASIL lot # L035105, expiration date 14-MAY-2017 for prophylaxis. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006828.
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 31Mar2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient tested positive for COVID-19 on 15Apr2021 and the patient was scheduled to receive the second dose of the vaccine on 23Apr2021. The patient had zero taste and smell at the time of report. The patient wanted to know if it was necessary to receive the second dose of the vaccine after contracting COVID-19 after the first dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective / COVID-19 cannot be ruled out.
pt recvd vax & 6 days later exp shoulder pain, stomach pain, elevated SGOT, elevated LDH; treated w/Zantac;
Administer expired vaccine to 450 patients after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. Number of doses administered was 102 doses. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non significant information.
Information has been received from a physician concerning an 8 week old male, with no medical history and no allergies, who on 10-JAN-2007 was vaccinated with a first dose of Rotateq vaccine (human-bovine) (lot#655406/1114F). There was no concomitant medication. It was reported that, "after receiving his first dose of Rotateq vaccine (human-bovine)", on approximately 10-JAN-2007, the patient developed diarrhea. The diarrhea persisted two days after the vaccination then the diarrhea slowed down. On 15-JAN-2007 the stools became formed again and the patient's mother noticed "red speckles" in the stool, which were determined to be specks of blood in the stool by a test in the physician's office. At the time of the report there was no treatment. It was noted that the physician was awaiting the lab cultures that were taken on the stool samples on 16-JAN-2007. It was noted that the child was not vomiting or having any other symptoms. The patient was eating and acting normally. At the time of the report the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Upon internal review, the patient's specks of blood in the stool was considered to be an other important medical event. Additional information has been requested.
This spontaneous report as received from a healthcare worker (certified medical assistant) refers to an unspecified number of patients of unknown age and gender. On an unknown date, those patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX dose and route of administration were not reported (lot # K010337, expiry date 22-JUL-2016). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sporadic whelps erupting and receding on various parts of body. No SOB. Pt takes chlortabs routinely at night. Last dose was 10/31/12 at approx. 1800 hrs. Receives annual Flu vaccines. 1st time pt has reactions.
OV 6/17/10 - red, edema. 0930 Mother had called office on 6-16-10 she spoke with office to inform us of rt posteria arm has about 2" annular reddened area with warmth at site tenderness - I instructed mother to be told to given BENADRYL 25 mg po (OTC) with 4 degrees - RTC in am if area enlarges.
Monovalent mRNA vaccine administered for a bivalent mRNA dose. Patient was given the monovalent mRNA vaccine, as I was not aware at the time, that the EUA had been withdrawal by the FDA.  My supervisor received noticed on 05/01/2023 from Health Department with a link to the DHHS which announced updates to Covid-19 vaccines.  That the Bivalent Moderna & Pfizer BioNTec vaccines were to be used for all doses administered to those 6 months of age and older.  In the announcement, NO where did it state that this change had gone into effect the month prior. I was forwarded the email announcement  on 05/02/2023 and it was read on 05/03/2023 as soon as I returned to the clinic office from doing vaccinations I destroyed all remaining doses of our Pfizer monovalent mRNA FP7136 vaccine.   The patient suffered NO adverse affects and had NO adverse events following his vaccination. This patient was released on 04/21/2023 (the evening following his vaccine).
Within 48 hours post vax, the pt experienced scintillating scotoma with severe migraine. It was indicated that her symptoms occurred several times per week for a two week period. At the time of the report, the pt had not experienced the symptoms for a week.
Extreme chills, fever (102), body aches, vomiting, diarrhea, extreme fatigue, strange taste in mouth, and headache. This lasted for 8 days and I'm still dealing with the fatigue and lack of energy.  I took alternating doses of tylenol and motrin and drank lots of fluids.  I had to miss 6 days of work because I was too sick to teach.
lymph nodes of her knees are swollen/Swollen lymph nodes inguinal; Swollen lymph nodes in arms/swollen lymph nodes knee; Lymph nodes in her both arms were swollen and tender/ inguinal lymph nodes are swollen and tender; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes in arms/swollen lymph nodes knee), LYMPH NODE PAIN (Lymph nodes in her both arms were swollen and tender/ inguinal lymph nodes are swollen and tender) and LYMPHADENOPATHY (lymph nodes of her knees are swollen/Swollen lymph nodes inguinal) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic disease (Multiple chronic diseases).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes in arms/swollen lymph nodes knee). 11-Mar-2021, the patient experienced LYMPH NODE PAIN (Lymph nodes in her both arms were swollen and tender/ inguinal lymph nodes are swollen and tender). On 12-Mar-2021, the patient experienced LYMPHADENOPATHY (lymph nodes of her knees are swollen/Swollen lymph nodes inguinal). The patient was treated with KETOROLAC for Lymph node pain, at a dose of UNK dosage form. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes in arms/swollen lymph nodes knee), LYMPH NODE PAIN (Lymph nodes in her both arms were swollen and tender/ inguinal lymph nodes are swollen and tender) and LYMPHADENOPATHY (lymph nodes of her knees are swollen/Swollen lymph nodes inguinal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was on unspecified concomitant medications. It was reported that on 11-Mar-2021, patient's lymph nodes in her both arms were swollen and tender. On 12-Mar-2021 she felt the lymph nodes of her knew are swollen and inguinal lymph nodes were swollen and tender.
Swollen lymph nodes throughout neck area and around ear on the left side as well as a bright red left ear lobe (injection was given on the left arm). All of these symptoms last approx 5-6 days.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received DTPA vaccine. Concomitant products included MOTRIN and LEVSIN. On 9th April 2013, the patient received DTPA vaccine. On 9th April 2013, less than a day after receiving DTPA vaccine, the patient experienced injection site pain, injection site nodule and neck pain. On an unknown date, the outcome of the injection site pain, injection site nodule and neck pain were not recovered/not resolved. The reporter considered the injection site pain and injection site nodule to be related to DTPA vaccine. It was unknown if the reporter considered the neck pain to be related to DTPA vaccine. Additional details provide were as follows: This case was reported by the patient herself. The reporter stated that, she received what she thinks was the BOOSTRIX vaccination in her healthcare professional office over 2 years ago in her right arm. The reporter was only able to provide the components of the vaccine which she received but recalls seeing GlaxoSmithKline on the bottle the nurse was holding (Tetanus, Diphtheria and Whooping Cough or Pertussis). In addition she stated her healthcare professional would not provide her with the name of the vaccine. She has informed her healthcare professional about her right arm. The patient experience soreness, stinging (pain) and a small knot (nodule) at the injection site. She had pain from her right elbow all the way to the back of her neck. Her arms felt like she just got the injection. The reporter also stated that, she thinks the nurse hit a nerve when giving the injection with a very long needle because of her height and weight.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. At the time of the patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not reported and the lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
BlurredVision, Myalgia, Arthralgia, Fever, fatigue, injection site -knot, redness and itching  Narrative:
patient received it after excursion; The patient should have received the Prevnar 13 at four months, but he was behind; it was a rash, a diaper rash; The total excursion was for 8 hours and 30 minutes. The lowest temperature reached was 35.6 degrees Fahrenheit.; This is a spontaneous report from a contactable other healthcare professional (HCP). A 6-month-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, pre-filled syringe pen), on Feb2020 (0.5ml injection pre-filled syringe) (lot number: AL8456, expiry date: Jul2021, NDC number: 0005-1971-01) in right thigh at 0.5 ml, single; (lot number: W33489) on Feb2020 at a single dose; on 16Jun2020 14:30 at a single dose, all via an unspecified route of administration for immunisation. There was none of medical history. Concomitant medication included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP, lot Number: C5611BA, Manufacturer: Sanofi), hib vaccine (HIB, Manufacturer: Sanofi, Lot Number: UJ09944), polio vaccine inact (IPV, Manufacturer: Sanofi, Lot Number: P1E70), all for immunisation. It was stored out of range patient received it. There were two excursions, one in May and one in June. The total excursion was for 8 hours and 30 minutes. The lowest temperature reached was 35.6 degrees Fahrenheit. It was after the Jun2020 excursion when administered after the excursion. She confirmed it was administered after the excursion, but clarified it was only one patient who received after the excursion. This patient received it after it was involved in the excursion for 5.5 hours. It was a few days later where the excursion continued for 2 hours. She clarified and explained the patient had received the Prevnar 13 in between the excursion total time frame. The patient was behind on receiving the Prevnar 13. The patient should have received the Prevnar 13 at four months, but he was behind. He was behind on all his vaccines due to the virus. She stated they did not have many patients coming in at this time. It was a rash, a diaper rash on an unspecified date in 2020. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
Due to mis-communication with pharmacists 1.0 mL dose was administered instead of 0.5 mL dose - no reaction noted
A non-serious spontaneous report of received two separate doses of H1N1 on the same day was received from a non-health professional concerning a 44-month-old female. The relevant medical history was not reported for this patient. On 18-Nov-2009, the patient received two separate doses of H1N1, Intranasal. There as no adverse event associated with the medication error; therefore, treatment and reporter causality assessments are not applicable and the event is considered resolved.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 2:28 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported. It was reported that patient(s) were given dose(s) from vial(s) that were stored in an ultracold freezer which was colder than they should have been. Caller was on her way to work & did not have details on how many patients, vials etc. She stated that she would call back when she got to work & had more information. They were going to want to know what to tell the patients & what they should do about this.   This case was linked to MOD-2021-402935 (Patient Link).
The patient presented for COVID-19 booster, therefore nurse gave him a Moderna booster. Patient reported no adverse side effects.
Pt received DTaP-Hep-B-IPV (Pediarix,PCV-7, & HIB on 1-25-07. Three hours after vaccination pt got very fussy, crying for several hours.  In the middle of these crying spells, pt had several isolated jerking movements of the upper extremities only, which eventually subsided.  Pt taken to ER and no specific therapy done. Sib has a history of myoclonic epilepsy.
Redness and swelling at the injection site and redness and swelling further down the arm the following day.
Post vax, the patient developed tingling in her fingers and numbness, swelling and pain of arm.
A 6 month old patient received 2 doses of the Moderna COVID-19 Vaccine primary series 8 days apart instead of one month apart.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A 6 month old patient received 2 doses of the Moderna COVID-19 Vaccine primary series 8 days apart instead of one month apart.) and NO ADVERSE EVENT (No adverse event) in a 6-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A 6 month old patient received 2 doses of the Moderna COVID-19 Vaccine primary series 8 days apart instead of one month apart.) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A 6 month old patient received 2 doses of the Moderna COVID-19 Vaccine primary series 8 days apart instead of one month apart.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (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 (A 6 month old patient received 2 doses of the Moderna COVID-19 Vaccine primary series 8 days apart instead of one month apart.).    Concomitant medications were not reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that a 6-month-old patient received 2 doses of the Moderna COVID-19 Vaccine primary series 8 days apart instead of one month apart. The HCP would like to know if they need to repeat the second primary series dose or if they can move on to give the Moderna COVID-19 Vaccine, Bivalent booster.  No treatment information was provided.
Breakthrough COVID-19 Case: I had traveled overseas and tested negative on May 24th. The night I flew in on May 25th, I did not feel well. I called my primary to be prescribed Paxlovid. Once I got home I used an At Home COVID-19 test and tested positive. I still have a lingering cough but I feel great.
1:00am - Ate Entire Bag of Lemon Cough drops 4:00am - 8:00am = Intense IBS