chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site lump in a 50-year-old female patient who received HAVRIX adult (batch number MB3Y2, expiry date 10th June 2018). On 3rd August 2016, the patient received the 1st dose of HAVRIX adult (intramuscular) 1 ml. In August 2016, 14 days after receiving HAVRIX adult, the patient experienced injection site lump. On an unknown date, the patient experienced injection site pain and injected limb mobility decreased. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site lump was recovered/resolved and the outcome of the injection site pain and injected limb mobility decreased were recovering/resolving. The reporter considered the injection site lump, injection site pain and injected limb mobility decreased to be possibly related to HAVRIX adult. Additional details were provided as follows: The patient received numerous vaccines in the past without issues. The patient received HAVRIX adult on left arm, which was her non-dominant side. On 15th August 2016, the patient received a flu vaccine in her right arm without incidence. It was reported that the patient was concerned about receiving the 2nd dose, as she was unsure if that was specific to the vaccine, the person's technique or what can she do to prevent the issues from occurring with the next vaccination. The patient had spoken with her physician, who referred her back to the facility where she received the vaccination from. It was reported that serious criteria questions not addressed. Caller became upset when GlaxoSmithKline was not able to answer her specific questions.
The test was positive for Covid 19 infection; The test was positive for Covid 19 infection. Sneezing and a runny nose were his symptoms; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administration date 08Nov2021 (Lot number: FG3527) as dose 3 (booster), single, administration date 23Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 08Nov2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant) with onset 24Nov2021 14:45, outcome "unknown", described as "The test was positive for Covid 19 infection"; COVID-19 (medically significant) with onset 24Nov2021 14:45, outcome "unknown", described as "The test was positive for Covid 19 infection. Sneezing and a runny nose were his symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) positive, notes: at 14:45. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2014JUS001214 is an initial spontaneous report received from a nurse on 13 JAN 2014 with a follow up information received from a nurse on 13 FEB 2014 and a follow up received on 17 FEB 2014. This report refers to a 17-years-old female patient. Past medical history and concomitant medications was not reported. Her vaccination history included administration of MENVEO (batch number: not reported) on 03 APR 2009 which was  well tolerated. She was vaccinated with MENVEO (batch number: A12099) at a dose of 0.5 ml subcutaneously in the left upper arm on 10 JAN 2014 at 16:21 PM. No adverse reaction reported following this administration error.  Follow up information received from a nurse on 13 FEB 2014. Patient demographics (initials, age, date of birth, gender, height and weight) vaccination history, batch number of MENVEO, vaccination date, dose and site of suspect vaccine administration updated.   Follow up information received from a nurse on 17 FEB 2014. Updated vaccination history.
Information has been received from a nurse practitioner for the Pregnancy Registry for GARDASIL concerning a 15 year old female with asthma and seasonal allergy who on 30-OCT-2007, 19-MAY-2009 and 08-SEP-2009 was vaccinated intramuscularly with first, second and third dose, respectively of GARDASIL (lot number not reported). Concomitant therapy included albuterol, hydrocortisone cream and NASONEX. The nurse practitioner stated that the patient stated that her last menstrual period was in June 2009, and also told her that she had not had intercourse in the past three years. On 08-SEP-2009, when the patient was seen in the office, she was given a dose of FLAGYL for a trichomonas infection. The patient is going to be having an ultrasound completed on 15-SEP-2009 for prenatal evaluation and dating. She denied any difficulties with the pregnancy. Lab test performed included pregnancy urine at office (positive), "PAP smear", Gonorrhea and Chlamydia culture (results not provided). The patient sought medical attention at the office. Follow up information was received from a nurse practitioner. The patient's date of birth was reported. The nurse practitioner reported that the patient gave birth to a baby boy on 27-FEB-2010 at 38 weeks of gestation. It was a vaginal delivery with no complications and no sexually transmitted infections (STI). The patient is breastfeeding. The nurse practitioner has since seen the mom and baby in passing. It was noted that the patient was seen on 23-MAR-2010 by a resident. She mentioned that the baby is "very cute and sweet." She said as far as she knows everything looked normal with the baby but there was nothing specific mentioned in the resident's note in the patient's chart. Additional information is not expected.
I developed a rash from my shoulder to my elbow. I had a fever for 24 hours, weakness in the legs, nauseated, went into AFIB. Went to hospital.
Patient had one dose of Janssen and was presenting for a Moderna booster. Vaccinator gave a full 0.5 mL dose of  Moderna on accident, instead of the 0.25 mL booster dose. Client aware of mistake.
I experienced a lot of fatigue, muscle pain, headache that progressively got worse during the day, body aches, chills. This lasted from 9am through the entire day. The headache became a lot worse around 3pm that day and I noticed a peak in these symptoms around 1pm.
Received influenza vaccine at 7:30, pain in arm began at 12pm. Severe pain in shoulder, arm and radiating into neck area continued for 5 days. Swelling on day 1-3. No redness at injection site.
Immediate neck pain that is not relieved with any pain pills. I hope this is not permanently damaged. I have no idea when this is going to go away. Turning neck either way is painful. Sleeping on stomach is difficult. Have not been able to sleep for the past 2.5 weeks. Have had to quit job due to this. This is substantially impacting my life for the worse. And no idea when this symptoms will go away. Can not sleep. Even with sleep pills.
Patient received dose #3 only a week after dose #2 after telling clinician that they did not receive dose #2 and it was entered into system by mistake. Found administration forms showing they did receive dose #2.
This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a adult female patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received the 1st dose of Hepatitis B vaccine and the 2nd dose of Hepatitis B vaccine. In August 1998, the patient received the 3rd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. Additional details were provided as follows: The health care professional was the father of the patient, a cardiologist. The health care professional shared adverse event information to Regulatory Authority via health care professional chat. The age at vaccination was not reported. The health care professional stated that a patient was vaccinated with Hepatitis B vaccine series that was completed in August 1998 and was recently tittered for Hepatitis B surface antibody and the results were shown as not detectable. The health care professional did not have information on which Hepatitis vaccine was administered for the three dose series, and wanted to know how to dose ENGERIX B to provide a booster. The health care professional did not respond to the question if that was the initial contact with Glaxosmithkline.
Late in the evening on day of vaccination,  patient's (L) arm began to swell, become red and warm to touch, and was painful.  She used ice, Tylenol, and Aleve.  Came to the office the morning of 08/18/23 for us to see her arm.  Dr. examined her arm and instructed her to continue to use ice, Tylenol, Aleve, and Benadryl as needed.  Also instructed her to keep her arm elevated.
Complained of lightheadedness and dizziness. Blood sugar and vitals signs taken. Transported to ER.
Myalgia, Arthralgia, Fever, fever; body aches; chills; joint pain; back pain (around/in kidneys) Narrative;
BlurredVision, Headache, Bell's Palsy, numbness started in lips then tongue, then face and ear and right side of face; still issues with blinking eyes, pain radiates shoulder down her back Narrative:  Did CT and given 5 days of prednisone and them provided cefdinir for right eardrum bulging out;
chest pain, shortness of breath, dizzy, exhaustion, tingling in rt leg and arms, hoarse voice, difficulty walking,
Itching all over the body (Both Arms and Legs); Rash became visible on both arms but mainly on Injected Arm; Itching Right Arm Injection Site; Bad Rash Right Arm Injection Site (Baseball Size); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over the body (Both Arms and Legs)), RASH (Rash became visible on both arms but mainly on Injected Arm), VACCINATION SITE PRURITUS (Itching Right Arm Injection Site) and VACCINATION SITE RASH (Bad Rash Right Arm Injection Site (Baseball Size)) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced RASH (Rash became visible on both arms but mainly on Injected Arm), VACCINATION SITE PRURITUS (Itching Right Arm Injection Site) and VACCINATION SITE RASH (Bad Rash Right Arm Injection Site (Baseball Size)). On 20-Jun-2021, the patient experienced PRURITUS (Itching all over the body (Both Arms and Legs)). At the time of the report, PRURITUS (Itching all over the body (Both Arms and Legs)), RASH (Rash became visible on both arms but mainly on Injected Arm), VACCINATION SITE PRURITUS (Itching Right Arm Injection Site) and VACCINATION SITE RASH (Bad Rash Right Arm Injection Site (Baseball Size)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15-7-2021 contains no new information
Pt reports body feeling "tingly and off"      By received water and stated "the tingly was less" at 1210. Pt stayed for 30 minutes
Myalgia, Fever, Pain at injection site Narrative:  Other Relevant History:
Information has been received from a nurse referring to a patient of unknown age and gender. The patients medical history, concomitant therapy and concurrent condition were not provided. On 01-SEP-2016, the patient was vaccinated with (Oka/Merck) VARIVAX (strength, dose and frequency were unknown; lot number M010482 with expiration date 01-MAR-2018). (Oka/Merck) VARIVAX was improperly reconstituted with "0.5 ml, from a separate, 10 ml, single dose vial of Sterile Water for injection, for drug diluent use, manufactured by Hospira, lot # 54-152-DK with expiration date 01-JUN-2018" instead of the Merck supplied diluent. No adverse effect reported. This is one of the twelve reports that received from the same source. Additional information has been requested.
This spontaneous report as received from a Registered Nurse refers to multiple unspecified patients of unknown ages and gender. On an unspecified date the multiple unspecified patients were administered VAQTA (Lot# unspecified) (dose, frequency, route and location unspecified) that was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects were reported. Follow up information has been received from the registered nurse via telephone call indicating that she did not have the information available at that time and she might be able to fax it early the following week. This is one of several reports received from the same source. Follow up has been received from the registered nurse. The nurse provided lot numbers, expiration dates and a list of patient identifier representing patients given affected vaccine from 16-APR-2014 through 23-APR-2014. On unspecified dates in April 2014, 11 (eleven) patients were given affected VAQTA (lot # J011629, expiration date: 20-SEP-2015). The 11 patients included: (MARRS# 1404USA014966), (MARRS# 1405USA013228), (MARRS# 1405USA013233), (MARRS# 1405USA013234), (MARRS# 1405USA013235), (MARRS# 1405USA013236), (MARRS# 1405USA013232), (MARRS# 1405USA013231), (MARRS# 1405USA013237), (MARRS# 1405USA013229), (MARRS# 1405USA013230). Additional information is not expected.
A week after my first injection, there was swelling, firmness, hives (itchiness) and heat at the injection site. After initial injection, I experienced soreness, inflammation at the injection site as well as fatigue. Swelling went down  1/20  and reappeared worse than before along with other symptoms  1/23.
Other Seizure; Literature Report:   Information has been received from the authors of a published literature article, title as stated above regarding to a child patient of an unknown gender. No information was provided regarding the patient's medical history, concurrent conditions and concomitant therapies.  On an unknown date, the patient was vaccinated with at least the first dose of M-M-R II to prevent measles (dose, vaccination scheme, route of administration, anatomical injection site, lot number and expiration date were not reported).  On an unknown date, the patient experienced other seizure. At the time of the report, the outcome of the event was not reported.  The authors considered that the event seizure was considered to be related to suspect vaccine as this event was considered a rare consequence of routine childhood M-M-R II vaccination.  Upon internal review, the event seizure was determined to be medically significant.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same reporter.  Sender's Comments:  US-009507513-2010USA001144:
Shoulder and arm area swollen (left). Low grade fever 100.5 treated with TYLENOL, down to 99 degrees this afternoon.
Menstruation issues/menstrual cycle issues; irregular menstrual periods and other menstrual changes; abnormal bleeding; painful menstruation; new or worsening symptoms related to menstruation (cramping, heavy bleeding, changes in mood, etc). Onset was sometime in May or June.  Issue(s) is ongoing.
a rapid heartbeat, felt like a scratchy feeling deep down in my throat on left hand side, felt some pressure between my breasts symptons that I have never had in my life and weak
raised red bumps began on lt arm around inj site 13OCT97;rash is spreading up neck to face recommended pt see PMD;
Red, raised rash at the injection site; warm to touch and itchy.  Appeared 12 days after the vaccination.
Got the shot around 2pm, and then the next morning at 3am I was severely sick and could not walk due to severe pain in my left sciatic nerve, went to the er three times and couldn?t get relief, lasted severely for about 3 months and still have pain to this day
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 12:07 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 12:07 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 42.86.  Concomitant medication of the patient was not reported.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature of 34 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 06-Apr-2021 and beyond use date for the vials was reported as 09-May-2021. The vaccines moved to clinic on 15-Apr-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.
I keep extensive records of my period, especially since my surgery (uterine ablation). I was supposed to start on 4/14/2021. After my 1st shot on 3/17/2021, I started my period as normal. After the 2nd shot, I felt no symptoms that I generally have (cramps/headache). Around 9 pm on 4/14/2021, I began to experience the symptoms of the 2nd shot, which I expected. The symptoms (sore arm, headache, nausea, extreme fatigue) lasted until 4/16/2021. When I woke up on 4/16/2021 at 7 am I felt great and I started my period within the hour. I am not sure if receiving the shot and not getting my period for 2 days is related. Possibly stress. Not sure but thought it was worth noting for future studies.
no AE; Caller is a pharmacist reporting an AE for VAQTA. Caller states an infant patient age 2 months 12 days inadvertently received pediatric VAQTA on 9/27/2022. Caller did not provide lot/exp at time of call. Caller states it was unknown at time of call i; Caller is a pharmacist reporting an AE for VAQTA. Caller states an infant patient age 2 months 12 days inadvertently received pediatric VAQTA on 9/27/2022. Caller did not provide lot/exp at time of call. Caller states it was unknown at time of call i; Information has been received from a pharmacist, referring to a 2 months-old and 12 days infant patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 27-SEP-2022, the patient was inadvertently vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 ml (lot number, expiration date and administration route was not provided) for prophylaxis.  The reporting pharmacist stated that it was unknown at time of call if the administration was related to a medication error, stating it was possibly mistaken for hepatitis b vaccine (manufacturer unknown). No adverse effects were reported.
Hives; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.            No concomitant medications reported by the reporter.    No treatment medications provided by the reporter.
Started with itching, redness, swelling and warmth in (L) arm where varicella vaccine given on 8/20/13. Redness, swelling and discomfort increased and pt was seen by Nurse Practitioner on 8/22/13. Pt was placed on cephalexin 250 mg 3 capsules in AM and 3 capsules in PM x 10 days.
This spontaneous report as received from a pharmacist refers to an unspecified patients of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unknown date, an unspecified patients were vaccinated with a dose of improperly stored PROQUAD (Merck) (dose, route, lot number and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Awful body aches, fever, headache, eye pain, dizziness, feeling like a truck hit me. Started about 8 hours after the vaccine, continuing up until today 2/14/21
Information has been received from a registered nurse concerning a 17 month old female with no allergies and no reported medical history who in May 2005, was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (lot # 648750/0446P). There was no concomitant medication. On 10/11/05 the patient presented with shingles. A culture is being sent for lab diagnostics. The adverse event did not improve and the patient is not recovered. There was no product quality complaint reported. Follow up information received on 11/23/05 from a health professional reported that the results to the PCR diagnostic test was vaccine type. The patient sought unspecified medical attention. Additional information has been requested.
Pt woke up 9/12/13 with redness and slightly swollen area on inside of upper arm on the same arm vaccination given in. Pt felt flu-like symptom with no fever and all over body soreness. As of 9/13/17 redness has not spread and the other symptoms have gone away.