chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gave the patient a dose of the Janssen vaccine instead of the second dose of the MODERNA vaccine; Wrong product administered; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Gave the patient a dose of the Janssen vaccine instead of the second dose of the MODERNA vaccine) and WRONG PRODUCT ADMINISTERED (Wrong product administered) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Gave the patient a dose of the Janssen vaccine instead of the second dose of the MODERNA vaccine) and WRONG PRODUCT ADMINISTERED (Wrong product administered). On 27-May-2021, INTERCHANGE OF VACCINE PRODUCTS (Gave the patient a dose of the Janssen vaccine instead of the second dose of the MODERNA vaccine) and WRONG PRODUCT ADMINISTERED (Wrong product administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment medication was not provided.   The patient was mistakenly given the Janssen vaccine instead of the second dose of the MODERNA COVID-19 vaccine. The Janssen dose was given on 27-May-2021 on left arm.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up information received on 9-JUN-2021, reporter stated that patient was doing fine with no adverse events.
vaccine was administered to a 15 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine was administered to a 15 year old) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine was administered to a 15 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine was administered to a 15 year old) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   injection into the deltoid muscle. No treatment medication was reported. No Concomitant medication was reported. No lab data was provided.
Left arm became sore on day of injection in the evening day 2 arm became warm to touch, red with some welts from shoulder to elbow. Instructed to ice area and take Benadryl 25mg every 6 hrs and report to Dr, Friday. Friday called redness was gone welts were gone had some soreness left. will continue benadryl over weekend and call Monday. All symptoms resolved by Monday.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-NOV-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
face started tingling; Swelling of lymph nodes in right arm pit; When she lifts her arm, she feels pain down to her wrist; All her skin became very sensitive / her blankets felt like burlap; Teeth chattering chills; Body pain; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (All her skin became very sensitive / her blankets felt like burlap), PAIN IN EXTREMITY (When she lifts her arm, she feels pain down to her wrist), PARAESTHESIA (face started tingling), LYMPHADENOPATHY (Swelling of lymph nodes in right arm pit) and CHILLS (Teeth chattering chills) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced SENSITIVE SKIN (All her skin became very sensitive / her blankets felt like burlap), CHILLS (Teeth chattering chills) and MYALGIA (Body pain). On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (When she lifts her arm, she feels pain down to her wrist) and LYMPHADENOPATHY (Swelling of lymph nodes in right arm pit). On an unknown date, the patient experienced PARAESTHESIA (face started tingling). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. On 06-Mar-2021, SENSITIVE SKIN (All her skin became very sensitive / her blankets felt like burlap), CHILLS (Teeth chattering chills) and MYALGIA (Body pain) had resolved. At the time of the report, PAIN IN EXTREMITY (When she lifts her arm, she feels pain down to her wrist), PARAESTHESIA (face started tingling) and LYMPHADENOPATHY (Swelling of lymph nodes in right arm pit) outcome was unknown.            No concomitant medication reported. Patient reported that she had the vaccine last Friday (2nd dose) 05-Mar-2021 at 10 AM in her right arm, lot 029A21A. That evening, patient had teeth chattering chills, body pain, all her skin became very sensitive, her blankets felt like burlap. Patient took acetaminophen. The symptoms subsided by Saturday. Sunday, patient started with swelling of lymph nodes in right arm pit. When she lifts her arm, she feels pain down to her wrist.. Patient still has a lot of swelling in her lymph nodes in that arm.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: follow up received on 19-Mar-2021. No significant information updated
Felt fine at time of shot, a little achy afterwards but nothing concerning. My legs ached some a few days after but got better. About 3 days ago I started getting a major headache on the right side that also arrived with blurry vision, mental fog and mild dizziness. Nausea yesterday and today except the headache was much worse. I cried from the pain and this is when I became more concerned. My eyes, mainly the right side and a pressure in my sinuses were very difficult to bare with, subsided some with multiple doses of ibuprofen and Advil sinus but not by much. The headache is unbearable, painful to stand out bend over or move.
Information has been received from a medical assistant, a 26 year old female patient with asthma, who on 15-FEB-2007 was vaccinated IM with a dose, 0.5ml, of Gardasil. There was no concomitant medication. On 23-FEB-2007 the patient reported that she couldn't breathe, her heart and chest were pounding, and she looked really pale. She also reported that she developed a rash at the injection site with "rectangular" hives. The MA added that she laid down when the events occurred, and the symptoms went away "after half an hour." The patient sought unspecified medical attention. Additional information has been requested.
Pneumonia, hypoxemia, Dyspnea, Tachycardia,SIRS, increased lactic acid level, dehydration,fever, HTN, hypomagnesemia
Due to administrative member/ electronic documenter being late, two members received their second dose of Pfizer one week earlier than the 21 Days.
Immediately following my shot, which was a booster as I was fully vacinnated with Moderna back in January 2021, I developed hypertension and extreme anxiety. I also began to have panic attacks and had great difficulty sleeping. All of these symptoms are highly unusual for me. I am now seven weeks since receiving the Pfizer Booster and I am still suffering these symptoms and don't know what to do as my numerous doctors' visits since the shot have not been able to conclusively identify a reason.
Day of vaccine, no adverse symptoms.  The 2nd day had chills, fever of 99.6, muscle aches, cramps, fatigue,   3rd day, temp back to normal, still fatigue, mild muscle aches.
This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022 12:13) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022 12:13) in a 61-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2022 at 12:13 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 18-Feb-2022 at 12:13 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022 12:13). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022 12:13). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022 12:13) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022 12:13) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Census ethnicity reported as White. No concomitant medications were reported. Vaccine administration time was reported as 12:13:29. No treatment medications were reported.
This case was reported by a physician via sales rep and described the occurrence of Bell's Palsy in a 13-year-old female patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, 1 day after receiving BEXSERO, the patient experienced Bell's Palsy (serious criteria GSK medically significant and other: As per reporter). On an unknown date, the outcome of the Bell's Palsy was not recovered/not resolved. It was unknown if the reporter considered the Bell's Palsy to be related to BEXSERO. Additional details were received as follows: BEXSERO was the only vaccine administered to the patient. The patient was seen in the emergency department for the symptoms. The sales rep had limited information but other health professional had additional information which could be obtained by follow up.
Myalgia, Arthralgia & Fever Narrative:  Other Relevant History:
Pt recvd DTP/HIB/OPV on 4NOV91 @ 4 1/2 hrs later seen by MD to onset of crying & swollen, hard area rt upper thigh; no temp; Rx w/antihistamines & Advil; Admitted to hosp 18NOV91 w/t103.8 R w/inc WBC;
69 patients had recieved expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 patients had recieved expired vaccine) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 patients had recieved expired vaccine). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 patients had recieved expired vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided by reporter. No concomitant medication was provided by reporter.
herpes blisters; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (herpes blisters) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Blister.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced BLISTER (herpes blisters). On 10-Feb-2021, BLISTER (herpes blisters) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information not provided. Treatment information not provided   This case was linked to MOD-2021-031239 (E2B Linked Report).; Sender's Comments:  MOD-2021-031239:Sister case
2 cm patch of erythema and induration, slight tenderness on the anterior (R) thigh. Cellulitis (R) leg. Treated with KEFLEX.
Patient with hx of palpitations of unknown etiology. Last episode was in Jan 2020 where she was in ED for monitoring. She was then evaluated by a cardiologist. Holter was done. She was told that she had "SVTs".  No treatment.   She tolerated Pfizer dose #1 without problem. Today, 15 min post vaccination, she started to feel her heart "palpitating" and feeling "chills" and shivering. Presented with high HR in the 160s, decreased to 104 and 112. She felt better 10 min after observation. Her HR dropped to 98. Shivering stopped. After 25 min, palpitations and shivering recurred.  She started to c/o "chest tightness". Denies difficulty breathing, dizziness, HAs, blurred vision. She was cold to touch. Then, she started to sweat and felt warm.  Temp was 98.1. Throughout the episode, she was alert and oriented x 4. Given O2 2L nasal cannula, push fluids, and OJ. Taken to ED.
The patient, who has no significant past medical history including diabetes, presented with very severe diabetic ketoacidosis  one week after receiving the vaccine.  He  developed severe metabolic encephalopathy, aspiration pneumonia, and was placed on mechanical ventilation.  At the time of this reporting, he is brain death (awaiting apnea test confirmation).  He is expected not to survive.
Large erythema extending 6" x 2" warm and tender to touch. Some burning around injection site about 1 cm.
Found in crib non responsive by sitter later that afternoon. Asystole on admission to ER.  Added from Discharge summary rec'd 12/12/2005: Cardiopulmonary arrest and apnea./sr
patient got very sick; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a social media.  This case is linked to case 2020SA291942 (same reporter).   This case involves a patient [unspecified demographics] who got very sick (illness), while patient received INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [batch number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got very sick (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, patient took flu shot twice.   Details of laboratory data not reported.    It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Body aches; Shaking; Muscle soreness; Redness at injection site; Vomiting; Dose 1 on 31May2021 and Dose 2 on 06Jun2021; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Jun2021 at 11:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) and ethinylestradiol; norgestimate (SPRINTEC) both 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: UNKNOWN) via an unspecified route of administration in the right arm on 31May2021 at 11:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation and took rizatriptan (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced the drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jun2021 at 22:00, the patient experienced body aches, shaking, muscle soreness, redness at injection site and vomiting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measure was not received for the reported events. The clinical outcomes of the events body aches, shaking, muscle soreness, redness at injection site and vomiting were resolving, at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My sugar was higher; Arm was sore for 2 days; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 Vaccine, and who experienced arm was sore for 2 days and sugar was higher.   The patient's medical history included diabetes. Concomitant product use was not provided by the reporter.   On 23-Dec-2020, approximately 1 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection.   On 23-Dec-2020, patient had no side effects expect for sore arm and sugar was higher. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events arm was sore, and sugar was higher was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Shoulder hurts; muscle pain; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 25Mar2021 as a dose 1, single and the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 15Apr2021 as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the caller named (withheld), already got the first and second dose of the Pfizer vaccine. Stated that, she received the first dose last on 25Mar2021 and got the second dose last on 15Apr2021. (Withheld) told that, she lost her vaccination card and wanted to get a copy of it. (Withheld) also mentioned that, on an unspecified date in 2021, her shoulder hurts after getting the first and second dose, she cannot straight her arm up and whenever she's trying to straighten her arm she's having muscle pain on an unspecified date in 2021. Stated that, the call was not transferred as the call got disconnected. Any medical questions addressed by this program forwarded/referred to Medical Information (live operators only) was reported as no: customer and/or medical inquiry was not forwarded or referred to MI. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient falsified DOB when registering for vaccination, stating the minor was4/6/2017. Guardian consented to the vaccination.  Department of Health verified with statistical records that the patients actual DOB is 2/5/2017 which made the vaccine a contraindication. No known adverse reactions noted.
Approximately 12 hours after injection, began having weakness, fatigue, chills, nausea. At 14 hours developed dizziness, loss of balance, sensitivity to light, exceptionally painful headache, cycle of shivering and chills to extreme fever, full body pain and feeling as though I were being scalded with hot water. Symptoms continued through the entire night. Arose in the morning at 10:30 am feeling extreme weakness, nausea, loss of balance, fatigue, severe headache, extreme sensitivity to light (which compounded headache pain). Symptoms began subsiding around 1:00 pm. Finally felt normal at approximately 8:00 pm this evening with exception of high level of soreness of right arm at injection site. In short, this was the most horrible feeling I have ever experienced, and I came very close to dialing 911. I did not take anything to try and alleviate any of the symptoms, as I was fearful that it exacerbate some of the conditions.
Multiple side effects such as headache, tiredness, muscle pain, rapid heartbeat, and swollen lymph nodes throughout. On evening of the third week after second shot, severe abdominal pain in lower right. Next morning went to urgent care, and was tested for appenditicitis.
This spontaneous report was received from a other health professional refers to a 24 year old female patient. On 17-SEP-2014 the patient was vaccinated with GARDASIL dose 1, 0.5 ml (milliliters), intramuscular (lot # unspecified). On 17-SEP-2014, the same day of vaccination the patient experienced upper abdominal pain, muscle weakness and widespread muscle tenderness. The patient was evaluated at a local emergency room on 17-SEP-2014. No details of the emergency room visit and treatment were provided. The patient was not admitted to the hospital. The outcome of upper abdominal pain, muscle weakness and widespread muscle tenderness was reported as recovered/resolved on 18-SEP-2014. There was no product quality complaint (PQC) involved. Patient sought medical attention visited the emergency room. Causality assessment was not provided. Additional information has been requested.
Received MMR right arm on 1/22/2013. Patient noticed itching to area around 5pm (1 hour after injection) and noticed redness and swelling. Came to clinic at 1/23/2013 at 12:30pm because of itching. Redness 6 cm x 6 cm area, warm, itching. Given BENADRYL & ice pack.