chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was not sure if this could be at all related.  I had my anatomy scan Monday the 14th of June and I am 20 weeks pregnant.  Had my second pfizer vaccination in January.  They found out I have a placenta with multiple lobes and I am now high risk.  I was just very curious if there was anyone else out there that had a similar story.
Dose administered from expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from expired vial) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from expired vial). On 27-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered from expired vial) had resolved.        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 concomitant medications were not reported. No treatment medications were not provided.   Reporter did not allow further contact
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 84 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 09-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 09-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
Developed hive on RAT next to injection site of varicella.  It was about 2cm in diameter.  It happened right away after injection.  Placed cool pack on and gave Benadryl.  Physician notifiied.  Advised parents to keep an eye on it.  Talked to mom on 7/27/05 and no further adverse reactions noted.
Erythema, swelling, tenderness, warmth starting 1-2 days after vaccination, has persisted for 1 week and is now starting to regress.
Mild fever 8 hours, Chills for 2 hours, Right arm pain/soreness and muscle pain/body ache for 48 hours, Constipation and Small bruise at injection site for 4 days.
This spontaneous consumer report (initial receipt 07-Nov-2014) concerns a female patient. The patient had a medical history of back pain but no known allergies. This was the first time that the patient received flu shot. In January 2013, the patient caught the flu. On an unspecified date, during the week 12-Oct-2014 to 18-Oct-2014, the patient received intramuscular AFLURIA (batch number not reported) at 0.5 ml. On an unspecified date, approximately 3 days after vaccination, the patient experienced extreme fatigue and severe muscle aches in shoulder, neck and middle and upper back. The patient was confined to the bed for couple of weeks. The patient had tried resting, massages and rubdowns to help control the aches but nothing helped. The muscle aches were similar to the aches she had when she caught the flu. Outcome was reported as not yet recovered. Reporter's comments: The patient insisted that the muscle aches are due to AFLURIA alone and could not be linked to her pre-existing back pain. The reporter assessed the case as non-serious and considered the events as related to AFLURIA (caused by vaccine).
suspected vaccination failure; shingles; worst pain; This case was reported by a consumer via interactive digital media ( and described the occurrence of suspected vaccination failure in a 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received shingles the shot and still had the shingles. The patient reported that it was worst pain ever. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation shingles was not reported.
Full body rash on 8/4 resulting in ER visit. Treated with prednisone. Swollen and tender lymph nodes 8/5
My face swelled up for 5 days. On March 5 I woke up and started to sneeze violently with a runny nose. I took 2 benadryls to alleviate the nasal symptoms and swelling.
Patient received the adult pfizer 0.3ml instead of the children's dose  per mom 7-14-22 child has no side effects except for a sore arm which has gone away.
Initial misuse information received from another manufacturer (service request number 1-6084621271) on 28 January 2013. The information was originally provided to the other manufacturer from a healthcare professional. An adult patient, whose age, medical history and concomitant medications not reported, had received a dose of MENACTRA (batch number, site and route of administration were not reported) on January 2013 (date not specified). The reporter stated that the patient received vaccine 5 days after the expiration date. The vaccine was expired at the end of December 2012 thus leading to expired vaccine used. As per reporter the patient did not experienced any adverse event. Documents held by sender: None.
Severe dizziness , numbness in right arm tightening in chest was diagnosed with vertigo prescribed meclizine 25 mg
Stroke symptoms. Complete loss of function of left side of body, slurred speech, confusion. Outside of window for treatment. Partially resolved. Still having some trouble with speech, left hand still "tingly." Able to walk now.
Fainted; A spontaneous report was received from a consumer, who was an 82-year old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and fainted.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 07 Jan 2021, approximately 6 hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 07 Jan 2021 at 19:30, the patient fainted. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, fainted, was unknown.; Reporter's Comments: This case concerns a 82 year old female patient who experienced a serious unexpected event of Syncope. The event occurred 6 hours after first dose of mRNA-1273. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
forearm hives; itchy body rash of "pustules, vesicles, that look like tiny chicken pox"; itchy body rash of "pustules, vesicles, that look like tiny chicken pox"; itchy body rash of "pustules, vesicles, that look like tiny chicken pox"; Flu like symptoms; headache; chills; fever; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (for tolerance of 1st dose refer case US2020018229).   On 22nd January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd January 2020, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms (serious criteria clinically significant/intervention required), headache (serious criteria clinically significant/intervention required), chills (serious criteria clinically significant/intervention required) and fever (serious criteria clinically significant/intervention required). On 24th January 2020, the patient experienced hives (serious criteria clinically significant/intervention required), vesiculopustular rash (serious criteria clinically significant/intervention required), varicella-like rash (serious criteria clinically significant/intervention required) and itchy rash (serious criteria clinically significant/intervention required). The patient was treated with benadryl (nos) (Benadryl). On 25th January 2020, the outcome of the influenza-like symptoms, headache, chills, fever and hives were recovered/resolved. On an unknown date, the outcome of the vesiculopustular rash, varicella-like rash and itchy rash were recovering/resolving.   Additional details were provided as follows: The age at vaccination was not reported. The patient developed flu like symptoms of fever, chills and a headache which lasted for 2 days and resolved. The patient developed hives on her right forearm and a full body itch rash of pustules and vesicles that look like tiny chicken pox. The patient's rash had improved, but still remained. The patient stated that she had been to see her physician about this rash and had treated it with benadryl. Emergency room visit was required. The reporter consented to follow up.  It was unknown if the reporter considered the influenza-like symptoms, headache, chills, fever, hives, vesiculopustular rash, varicella-like rash and itchy rash to be related to Shingrix.
Rash, hives - started approximately 3 to 4 hours after administration of vaccine.
The patient came in to receive booster shot.  She stated that she did not experience any side effects with the first 2 shots.  In the middle of the night, post booster dose, the patient woke up in the middle of the night sweating profusely.   She called me this morning complaining of the injection site itch, warmness to touch and feeling it being bumpy.
Heart racing; tooth extraction; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing) and TOOTH EXTRACTION (tooth extraction) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia.    Concurrent medical conditions included Chronic lymphocytic leukemia, Heart rate abnormal (reported on 06-Nov-2019 that heart rate was in the 40s on an unknown date), Dizziness (reported on 06-Nov-2019 that he was experiencing some dizziness on an unknown date), Heart rate increased (reported by the patient on 24-Jun-2020; again reported on 30-Jun-2020 that he had been having episodes of the fast heart rate around every 3-4 weeks where it gets up to around 128 to 135 and lasts for about 3-4 minutes; again reported periodic heart rate increased by patient on 14-Jan-2021), Fatigue (reported by the patient on 24-Jun-2020), White blood cell count decreased (reported by the patient on 24-Jun-2020), Glare (reported on 30-Jun-2020) and Difficulty focusing eyes (reported on 30-Jun-2020). Concomitant products included METOPROLOL SUCCINATE, LEVOTHYROXINE SODIUM and ATORVASTATIN CALCIUM for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and IBRUTINIB (IMBRUVICA) (Oral) 420 mg once a day. On an unknown date, the patient experienced PALPITATIONS (Heart racing) and TOOTH EXTRACTION (tooth extraction). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) ongoing since an unknown date for Heart racing and Tooth extraction, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Heart racing) and TOOTH EXTRACTION (tooth extraction) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that his heart rate was in the 130s and normally he runs in the 50-60s. He thought his heart racing was due to having large meals.   Reporter did not allow further contact
Moderna COVID-19 Vaccine EUA.  About 15 minutes after the shot, felt slight difficulty in breathing. It's more of a discomfort than pain. Stayed in the pharmacy for about 45 minutes. Felt the breathing difficulty going away so decided to drive home. The breathing difficulty came back when I reached home (a 5-minute drive).  Feel asleep; woke up after about an hour and the breathing difficulty is completely gone. Have not felt it again until this report date (1/22/21 1:16am).
9/30/02 Rec'd telephone call from client's aunt. Client is staying with her while his father is out of town on business.  Reports client developed rash on 9/29/02 in appearance of "white pimple-like bumps" over abdomen, chest, back, shoulders and under arms.  C/O itching.  Bumps were not fluid filled.  She gave him an Aveeno bath and applied Calamine lotion.  Denies fever or other s/s. Client went to school 9/30/02 and school nurse examined him. School nurse unsure of what rash was per client report. Client remained in school.  10/01/02 Telephoned aunt.  Client in school today. Rash looks better, has appearance of reddened bumps. Appears more sparsely scattered today.  Aunt reports client's father to return end of week and will be taking him to primary physician if rash still present.
This spontaneous report was received from a Medical Assistant referring to an unknown number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis. It was reported that, LIQUID PEDVAXHIB, was stored to a temperature of 1 °C for 12 hours. Data logger was involved. Furthermore, it was reported that no adverse effects occurred and that no product quality issue was involved. Additional information has been requested.; Sender's Comments: US-009507513-1705USA002381: US-009507513-1705USA002380: US-009507513-1705USA002383: US-009507513-1705USA002382: US-009507513-1705USA002384:
No additional AEs; HBP called in and reported that the improperly stored vaccine was administered.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 13-OCT-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W011622, expiration date: 06-APR-2024, administered for prophylaxis (dose, anatomical location, and route of administration were not provided). Administrated varicella virus vaccine live (oka/merck) (VARIVAX) was stored at -14 Celsius degrees up to -10 Celsius degrees (-11.9 Celsius degrees) for 42 minutes, no previous temperature excursion were reported (product storage error).  There were no adverse events reported (no adverse event).; Sender's Comments:  US-009507513-2210USA005958:
administer expired vaccine to 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 patients, after the manufacture date of expiration) in a 72-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. Number of doses administered was 173 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
I've had palpitations in the past. I saw the same cardiology provider office. But those palpitations were small in quantity. I'm talking 30-40 per day. After the vaccination, I was counting, every few seconds, and was having about 2,000 or 3,000 over a 24 hour period. This went on for about 6 weeks before I decided to see a cardiologist. It was still going on in the office. They caught it on an EKG and he heard it with the stethoscope. He ordered an echocardiogram and a 72 hour monitor. I think I had the echocardiogram 2 weeks later and the monitor was a few weeks later. By the time I got the monitor, they slowed down by like 90%. The echocardiogram was normal, too. They came back a few weeks later but not as intense. They were on a lesser level and I think I've been OK ever since.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 02/17/2021, 03/17/2021, and 12/29/2021. They tested positive for COVID-19 on 08/25/2022, when they presented to emergency department for assessment after a fall.  They were admitted to hospital. They were found to be severely hypoglycemic and to have suffered a head injury with loss of consciousness, subdermal hematoma, and a subarachnoid hemorrhage. Their condition declined and they died in the hospital on 09/04/2022.
Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. Concurrent condition and medical history were not reported. On unknown dates the patients were vaccinated with improperly stored VAQTA (lot # L015460, expiration date 20-JUL-2017; Lot# L028666, expiration date 04-NOV-2016 (the nurse could not identify the lot numbers which had been administered to the patients) strength, dose, frequency and route were unknown) (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Administration of Expired Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported   This case was linked to MOD-2021-237307, MOD-2021-237412, MOD-2021-237346, MOD-2021-237347, MOD-2021-237474, MOD-2021-237480, MOD-2021-237697, MOD-2021-237470, MOD-2021-237417, MOD-2021-237428, MOD-2021-237440, MOD-2021-237445, MOD-2021-237451 (Patient Link).
8-year-old patient was vaccinated with 2nd dose of Hep A at 10:50. Mother stated that she had eaten breakfast prior to appointment. The vaccine was administered and she waited for 15 minutes before leaving. Patient said that she felt fine and did not appear to be in any sign of distress or sign of any adverse reactions. Approximately an hour later patient and her mother walk into office stating that patient had fainted at school and was called by the school nurse. Her mother assumed that we had medical services available and returned to the office. Patient was asked if she knew her name and where she was, to which she responded correctly. However, when asked who her mother was, she appeared disoriented and was not able to vocalize who she was. Patient was given some juice and cookies and appeared to gain more consciousness after. Patient then was able to explain, that as soon as she walked into class she began to see blurry and dark and experienced ringing in her ears. Her teacher assisted her as she fainted and regained consciousness at the nurse's office. As she was recalling what happened, the color returned to her lips and eyes appeared to focus a bit more while making eye contact. Patient and her mother were advised to go to the emergency room.
Intermittent dizziness that has lasted 7 days thus far. She is being treated with increased hydration and a trial of antihistamine. She is avoiding driving for now.
Significant Chills, sweats, nausea, vomiting, fatigue. Gradually decreasing in severity over five (5) days.
This spontaneous report was received from a medical assistant referring to multiple unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot # L042846 with expiration date 15-SEP-2017, lot# N002922 with expiration date 30-SEP-2018, lot# N011851 with expiration date 19-DEC-2019, and lo# N002202 with expiration date 04-NOV-2019 for prophylaxis.  No adverse event was reported. The doses of RECOMBIVAX HB, were exposed to a temperature excursion of 47 degrees Fahrenheit (°F) to 77 °F during a time frame of 2 hours 45 minutes which was detected by the data logger. Previous temperature excursion was reported as 47 °F to 77 °F for 45 minutes. This is one of several reports from the same reporter; Sender's Comments: US-009507513-1708USA002992: US-009507513-1708USA002994: US-009507513-1708USA002995: US-009507513-1708USA002863:
Information has been received from a female consumer concerning her one year old female niece who recived her first vaccination of mealses virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) date not reported.  Sebsequently, the patient experience light case of measles.  The experience of the reporter is described in waes # 00080474  Additonal information has been requested.
Adverse Events  1. Cardiac arrhythmia (premature atrial contraction, premature ventricular contractions) 2. Brief Supraventricular Tachycardia episode  Treatment: TBD