chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. No medical history and current conditions were reported. The nurse reported that on an unknown date unknown number of patients were vaccinated with that doses of RECOMBIVAX HB (unspecified dose and route) lot K010216 expiry date 17-SEP-2016. On an unspecified date the vaccine had been improperly stored. The outcome of event was unknown. No adverse effects reported. Product quality complaint (PQC) was not reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Right lower leg swelling 1 week later with progressively worse swelling and redness.  Later began having left lower leg swelling as well.  Swelling is from knee to toes. Persists and has worsened since started (over 3 months ago)
8 days after getting the shot, my upper left arm  broke out in a red rash(hives) and itched. I called my doctor and she advised me to put and ice pack on it, take an antihistamine and put Calamine lotion on it.  After 4 days it seems to be getting better.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a unknown age female patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On or about 08-MAR-2011, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, dose, frequency, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related condition.  On an unknown date, the patient was treated for shingles. The event caused the patient hospitalization. As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff 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 event was unknown. The reporter considered herpes zoster to be related to zoster vaccine live(ZOSTAVAX).
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's relevant medical history and past drug history were unknown. On an unknown date recently, the patient was vaccinated with PNEUMOVAX23, (lot number and expiration date unknown), 1 dose in the arm for an unknown indication. The patient's concomitant medications were unknown. On an unknown date in the past week (approximately September 2013) the patient has edema at the injections site, the site swelled to the size of a silver dollar, some itching and then the whole arm swelled like a balloon. It was unknown if there was any laboratory data. As of 29-SEP-213 it was unknown if the patient would have another PNEUMOVAX23 injection and the outcome of the edema at the injection site, itching, and the whole arm being swollen were unknown. This report is linked with cases 1310USA000095, 1310USA000069 and 1310USA000376 via same reporter link. Additional information has been requested.
3 days after his vaccinations his skin color changed to a pale yellow and green tint, he didn't want to drink anything and started crying a lot day 3 night did not sleep well woke up every few hours day 4 woke up with a 101 temperature crying uncontrollably didn't want to eat or drink, gave him TYLENOL did not break his fever gave him MOTRIN did not break his fever would not eat or drink and cried all day for night did not sleep woke up screaming every few hours in pain day 5 woke up still had 101 temperature still trying TYLENOL and MOTRIN alternating nothing with break the fever still crying not wanting to eat or drink day five night woke up screaming every few hours in pain gut-wrenching screams by day 4 and 5 he was walking around glassy-eyed and it days just crying Non-Stop. I called the doctor's office day 4 and 5 both days talk to the nurse she told me to continue giving TYLENOL and MOTRIN she said this was normal day 6 I looked on the CDC website to find that it was not recommended to do MMR with flu shot and saw that it's not recommended to vaccinate when a child has an immune issue like C-diff. I called the doctor on day 6 talk to the practice manager and the doctor told them how frustrated I was scared to death my child did not act normal for 3 to 4 days finally by the end of the fourth day of running a temperature it broke and he began to eat and drink again.
Patient's mother has not contacted us for any adverse events following the administration of the Flublok vaccine to her 11 year old son.
I received a Hepatitis A vaccine--the 2nd shot in the series--to complete a law requirement in order to serve food. I wanted to report my experience with VAERS, just to be safe, because I experienced very strange symptoms that I've never before experienced as a result of a vaccination. I received a vaccination, and the nurse left the room to get a cracker or juice. I fainted/became unconscious. When the nurse returned to the room and found that I had fainted, she and another staff person assisted me from the chair to the bed/table. I expressed that I had nausea, but was beginning to feel better. The nurse put an ice pack on my head because after fainting, I had 3 small knots with scratches with some blood trace on my forehead. I was feeling better and recovering. But a few minutes later, and all of a sudden, pain started to course through my entire body, and I told them things were getting worse, and I could feel it in my legs and body. Then, my body (especially my arms, hands, and fingers) became so abnormally stiff/rigid/contorted that I couldn't move them. I looked like someone with hypertonia. The nurse said the abnormal stiffness was the result of a panic attack--not the vaccination. This reaction was alarming to me because I feel that I was recovering from fainting, and then began to experience the body pain and abnormal stiffness, and then panicked as a result of that reaction. I do not feel I began to experience a panic attack prior to the abnormal stiffness, and I have never experienced muscle problems or such stiffness in conjunction with a panic attack. I do not believe the abnormal stiffness that I experienced is a symptom of a panic attack--I believe that only minor stress-related muscle tension is symptomatically associated with panic attacks. The other alarming experience I had as a result of the vaccination is that for 8 days following the vaccination, my cognition was affected: I would lose blocks of time during the day, experience forgetfulness, and had difficulty with basic comprehension of routine tasks such as running my business software. I did experience minor common side effects that could be expected--I lost my appetite and thirst drive, experienced tiredness, and full arm soreness.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered to a patient past the 30 day use by date/Dose was administered greater than 12 hours after the vial had been punctured), PRODUCT STORAGE ERROR (vaccine was punctured on 16JUN2022, stored in fridge post puncture and administered on 09Aug2022) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058A22-2A, 939906 and 021B21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered to a patient past the 30 day use by date/Dose was administered greater than 12 hours after the vial had been punctured). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was punctured on 16JUN2022, stored in fridge post puncture and administered on 09Aug2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered to a patient past the 30 day use by date/Dose was administered greater than 12 hours after the vial had been punctured), PRODUCT STORAGE ERROR (vaccine was punctured on 16JUN2022, stored in fridge post puncture and administered on 09Aug2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered to a patient past the 30 day use by date/Dose was administered greater than 12 hours after the vial had been punctured) and PRODUCT STORAGE ERROR (vaccine was punctured on 16JUN2022, stored in fridge post puncture and administered on 09Aug2022). No concomitant medications were provided by the reporter. The vial was initially stored in the refrigerator on 05-JUN-2022 and the use by date was 05-JUL-2022. The Moderna Covid-19 vaccine was punctured on 16-JUN-2022 15:10 (3:10PM) and the vial was stored in fridge post puncture. The dose was administered on 09-AUG-2022. The vial did not undergo any temperature excursions. The vial was not exposed to room temperature greater than 24 hours. No Adverse reactions or Side Effects were reported post first, second and first booster dose. No treatment medications were provided by the reporter.
Information has been received from the patient's mother, a Medical Assistant and a practice administrator concerning an 18 year old female patient with asthma, dyslexia and drug intolerance to BENADRYL and to AUGMENTIN who on 20-MAY-2011 was vaccinated with her first dose of GARDASIL (lot number 666597/0768Z) (dose, route and site not provided). On the same day the patient also received a dose of VARIVAX (lot number, dose, route and site not provided), a dose of MENACTRA and a dose of diphtheria toxoid (+) pertussis acellular vaccine (manufacturer unspecified) (+) tetanus toxoid. On 22-JUL-2011, the patient received the second dose of GARDASIL (lot # 0819Z; lot not valid for GARDASIL (dose, route and site not provided). The patient did not receive any other vaccinations that day. On 23-DEC-2011, the patient received the third dose of GARDASIL (lot # 670048/0963AA0 (dose, route and site not provided). The patient did not receive any other vaccinations that day. The patient was pregnant at the time she received her third and last dose of GARDASIL. It was reported that the office was not aware that the patient was pregnant when she received the third dose of GARDASIL, The patient had told the physician before the third dose of GARDASIL was administered that she was not sexually active. On 28-MAY-2012 the patient delivered a baby. The baby had hydrocephalia. The baby's events were captured in WAES# 1206USA02525B1. On 12-JUN-2012, the patient was in the office due to ear pain., The patient did not provide any information about her baby at that time. Follow-up information was received from office worker who reported that office had details for adverse event for the fetus that developed severe brain damage related to the patients vaccination with GARDASIL (WAES# 1206USA02525B1). Additional information is not expected.
Dizziness, headache, nauseousness to the point of having to sit still. Home treatment with Ibuprofen reduced symptoms that lasted approximately 24 hours.
I receive my flu shot every year. I always have a severe headache after the flu shot and have one this time as well. However, that is listed as a normal side effect, so I just expect that will happen every time. This time I am experiencing numbness and tingling in my feet and lower legs. There is a tingling/burning sensation that has moved into my upper thigh. It is Friday night so I will contact my primary care physician on Monday. If the symptoms becomes worse I will seek medical attention.
raised red spot at injection site; tender spot at injection site; raised spot where the vaccine was given; raised spot where the vaccine was given; 1st dose of Shingrix subcutaneously; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema, injection site tenderness, raised rash, injection site reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema, injection site tenderness, raised rash, injection site reaction and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema, injection site tenderness, raised rash and injection site reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient, received the dose of Shingrix subcutaneously on an unknown date, which led to incorrect route of vaccine administration The patient developed a large, raised, red tender spot where the vaccine was given about 5 inch by 3 inch in size.  The reporter consented to follow up.  The HCP did not have the vaccination information (date, lot number, expiration date, etc).
Initially site of injection marked redness, tenderness, indurated lasting 3 weeks. Area remained red, tender. Dr prescribed BENADRYL, cold packs - not effective. Then prescribed Methylpred 4mg pak for 6 days - on 10-17-13. Today 11-8-13 area still pink, slight tenderness persists.
rash just around the injection site; itchy that comes and goes just around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash just around the injection site) and VACCINATION SITE PRURITUS (itchy that comes and goes just around the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE RASH (rash just around the injection site) and VACCINATION SITE PRURITUS (itchy that comes and goes just around the injection site). At the time of the report, VACCINATION SITE RASH (rash just around the injection site) and VACCINATION SITE PRURITUS (itchy that comes and goes just around the injection site) outcome was unknown. Not Provided      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.   Treatment and concomitant medicines were not reorted Action taken with mRNA-1273 in response to the event was unknown
chills; fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd March 2020, the patient received the 2nd dose of Shingrix. On 4th March 2020, 1 days after receiving Shingrix, the patient experienced chills and fever. On 5th March 2020, the outcome of the chills and fever were recovered/resolved.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient himself. The reporter did not consent to follow up.
Starting about 48 hours of the injection, I begin to develop a fever and chills, my bllod pressure increased, I begin to get chest and sinus cogestion, and about hour 54 my fever had spiked up to 101.5, by Pulse Ox had dropped to between 80% and 85% my blood pressure was at 145 over 110 with raipd and shallow breating for about two hours, I was close to going to the ER because of such sustained low oxygen levels.  I took 1000 MG of tylenol around hour 55 and the fever begi to break, the blood oxygen levels went back up over 95% and the my blood pressure normalized
his arm was sore; kinda tired for 3 days; Nosebleed; This spontaneous case was reported by a patient and describes the occurrence of EPISTAXIS (Nosebleed), VACCINATION SITE PAIN (his arm was sore) and FATIGUE (kinda tired for 3 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced EPISTAXIS (Nosebleed). On an unknown date, the patient experienced VACCINATION SITE PAIN (his arm was sore) and FATIGUE (kinda tired for 3 days). On 10-Apr-2021, EPISTAXIS (Nosebleed) had resolved. At the time of the report, VACCINATION SITE PAIN (his arm was sore) outcome was unknown and FATIGUE (kinda tired for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient had nosebleed that just started spontaneously, it lasted for 10 to 15 minutes . Patient did not receive any medication for nosebleed and patient just put pressure on  his nose  with a Kleenex and overtime it clotted.   This case was linked to MOD-2021-297968 (Patient Link).
11/4/2013 - fatigue 11/05/2013 - fatigue, headache, red and warm-to-touch circle at point of injection 11/06/2013 - red and warm-to-touch circle at point of injection 11/07/2013 - severe pain in shoulder 11/08/2013 - severe pain in shoulder radiated up into left side of neck, back into shoulder blade and down into arm 11/09/2013 - severe pain in shoulder, weakness in left arm, tingling in left fingertips, on 7-8 on scale of 10 11/10/2013 - severe pain in shoulder, shoulder blade and neck continues, weakness in left arm, tingling in left fingertips 11/11/2013 - pain in shoulder decreased, fever, chills, congestion, coughing, sneezing, severe headache began early hours 11/12/2013 - continued discomfort in left shoulder, congestion decreased with medication, headache decreased in severity with medication
Based on the follow-up information on 8 June 2015, this case became medically confirmed. Initial unsolicited report received from a non-healthcare professional on 30 April 2015. A 18-year-old female patient had received a dose of MENACTRA (batch number: U5068AB, dose, dose in series and expiry date were not reported) intramuscularly in left arm on 20 April 2015. Number of previous doses for MENACTRA was reported as one. The patient had medical history of asthma. Concomitant medications were not provided. On 20 April 2015, four hours after vaccination, the patient developed nausea and vomited. After 28 hours of vaccination, the patient had developed migraine headache. On 29 April 2015, the patient had second occurrence of migraine headache. Patient required ER/doctor visit. Laboratory investigations were not reported. The patient was seen in Urgent Care setting for first incidence of migraine headache where the patient was treated and released. For second occurrence of migraine headache, the patient was prescribed (RX) IMITREX. At the time of report, the outcome of the event was unknown. Documents held by sender: none. Follow-up information received from a physician on 8 June 2015. Patient name was corrected. Patient had received 0.5 ml dose of MENACTRA. Name of person who administered the vaccine was corrected. Vaccine was administered at private doctor's office/hospital. At the time of report, the outcome of the events was reported as unknown. List of documents held by sender: None.
MUSCLES FEEL LIKE JOINT PAIN; MILD HEADACHE; MUSCLE ACHES/SORENESS AT THE CALVES, QUADS AND RIGHT ELBOW (INTERMITTENTLY); EXTREME FATIGUE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included: radical cystectomy, and hysterectomy, and concurrent conditions included: non-alcohol user, non-smoker, penicillin allergy, sulfa allergy, and high grade bladder cancer, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: UNKNOWN) dose was not reported, administered on 02-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-OCT-2021, the patient experienced muscles feel like joint pain, mild headache, muscle aches/soreness at the calves, quads and right elbow (intermittently), and extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme fatigue on 04-OCT-2021, and had not recovered from mild headache, muscle aches/soreness at the calves, quads and right elbow (intermittently), and muscles feel like joint pain. This report was non-serious.
Breakthrough symptomatic case with onset 9/24/21, symptoms include cough and shortness of breath, worsening. presented to Emergency center on 10/5/21  after testing positive at an outside clinic on 9/24 and 9/30. CXR on 10/5 was negative. no fever.
4/5/2021 8 p.m. feeling lethargic, body discomfort 4/6/2021 3 a.m. having trouble sleeping, shoulders and neck are feeling stuff, feeling hopeless. I've only been able to sleep in small increments. 1 p.m. still feeling lethargic, was able to sleep, however woke up covered in sweat. 4/6/2021 2 a.m. Was awoken due to excessive sweating. Was able to get back to sleep without to too much effort.
[Moderna Covid Vaccine] use for COVID-19 under Emergency Use  Authorization (EUA): pt developed covid pneumonia after receiving moderna covid shot
This spontaneous report as received from a licensed vocational nurse refers to a 13 year old male patient. The patient had no illness at time of vaccination. No information on patient's medical history or concomitant medications was provided. On 25-AUg-2015 at 8:54 a.m., the patient was vaccinated with the second dose (reported as #1 given elsewhere) of VARIVAX (Merck) (subcutaneously, in right arm , lot # L010145; dose and expiration date were not reported) that was improperly stored. At the same time, the patient was concomitantly vaccinated with the first dose of MENACTRA (intramuscularly, in right arm, lot # 0502CA; dose and expiration date were not reported) and with the first dose of ADACEL (intramuscularly, in the left arm, lot # 05095AA;dose and expiration date were not reported). No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected as all scheduled correspondence was already received.