chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 14 year old daughter who on 13-JUL-2007, was vaccinated IM with a first dose of Gardasil. "Almost immediately" after the injection, the patient experienced extreme injection site pain which lasted for about 4 hours. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Vomiting with in 48 hours, dizzy. Continued fatigue.  11/16 episode of vomiting/blacking out/dizzy As of yesterday, muscle aches/pain in legs and arms
Weakness lower extremities 3-25-13 to present. Heart racings 3-25-13. Concentration needed to walk 3/25/13 to present.
Information has been received from a consumer concerning her daughter who in August 2006, was vaccinated with MMR II (dose, route and lot number unspecified).  The mother stated "her daughter received a dose of the vaccine in August 2006 and then about a week (approximately in August-2006) after receiving the vaccine, the patient had a febrile seizure that lasted about a minute or less.  The patient did see a physician regarding this but was not hospitalized.  The patient's mother, also reported about a year after receiving a second dose (approximately in 2007) of MMR II (dose, route and lot number unspecified), the patient had another febrile seizure and also her mother reported that the patient had recovered".  Upon internal review, febrile seizure was determined to be an other important medical event.  Additional information has been requested.
Patient had rash that began on leg then spread to neck and all over rest of the body with fevers. The rash lasted about 7-9 days per mom of patient.
I felt ill when I awoke on Wednesday morning. Flu like symptoms and low grade fever, body aches, headache. I had some itching and discomfort on my abdomen. However, when I went to check Thursday morning, I noticed I had a pretty severe shingles rash. I have had shingles in the past, I am 37 years old. I have not received the shingles vaccine. I have actually had shingles more than once, and had it the first time at 12 years old.  I am currently experiencing the worst break out I have ever had. I have seen a physician who is helping me manage my symptoms as well as possible.
pt became diaphoretic and light headed after the COVID shot. no LOC. Did not fall. Did not hit his head. pt monitored and released.  13:37 120/77 p58 r18
Began with fatigue on day 2 and sore arm, day 3 temp of 101.6, chills, body aches, continued through day 5.
chills; aching; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and MYALGIA (aching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 23-Dec-2021, the patient experienced CHILLS (chills) and MYALGIA (aching). At the time of the report, CHILLS (chills) and MYALGIA (aching) outcome was unknown.            Concomitant medication of the patient was not reported.  In the evening of 23-Dec-2021 or early morning of 24-Dec-2021, the patient had chills and aching.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Supected vaccination failure; now dealing with the shingles; pain is overwhelming; 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, 2 years 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 was unknown and the outcome of the shingles and pain were not recovered/not resolved.   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 shots 2 years ago from the date of reporting. After receiving Shingles vaccine, the patient was dealing with shingles at the time of reporting. The patient stated that, the pan was overwhelming, and the shots did nothing for him/her. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation were not provided.
Pt recv vax on 10/05/98; on 10/09/98 pt exp headache, fever (101), near syncope, imbalance; pt imp 25 day
Patient was given an intradermal FLUZONE shot indicated in patients over 18 years old. No adverse event occurred, this is just a proactive report.
fever of 102 F that lasted for two days; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (fever of 102 F that lasted for two days) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020. Concurrent medical conditions included Hypothyroidism. Concomitant products included VITAMIN D NOS, VITAMIN E NOS, CALCIUM and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PYREXIA (fever of 102 F that lasted for two days). On 06-Feb-2021, PYREXIA (fever of 102 F that lasted for two days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 102 f High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Throat swelling, pressure, heat, difficulty swallowing, raspy voice. Difficulty breathing when laying down. Lungs clear. Benadryl 50 mg. ER Solumedrol injection. Still taking Benadryl next day symptoms less but persisting.
Patient received Fluzone, lot 1383AA, on 10/20/204 via IM injection into the left Deltoid muscle. Later the same day, she developed frontal headaches, nausea, dizziness and left sided numbness of her arm and leg. She states she was so dizzy that she had to lie down on the kitchen floor and had to be assisted to the bedroom. She did not have loss of use of her left extremities, did not confusion or other mental status changes, and did not have slurred speach. The symptoms resolved after several hours.
This case is one of a cluster of two patients who experienced adverse events following administration of FLUZONE, lot number UH476AB. The events for the other patient were captured in case 2011-09914. Initial report was received on 12 October 2011 from a patient. A 57-year-old female patient had received on 08 October 2011 an intramuscular injection in right deltoid of FLUZONE. On 11 October 2011, the patient experienced clammy feeling, generalized body aches, diarrhea, vomiting profusely and very sore on right deltoid and complained of headache. She reported that when her symptoms occurred, they came on suddenly and progressed quickly. The patient has been feeling a little better. No further informational was available at the time of the report. The patient's outcome was reported as not recovered/not resolved. Follow-up information was received from a healthcare professional on 30 January 2012. Verbatim: "Upon future exploration we found that other people we know (work with/associate) were hit with the same symptoms in the month before and since October they did not have a flu shot, so we tend to believe that our illness was not related to the shot, but the intestinal bug that has been prevalent. Ours just coincidentally occurred following the flu shot". The patient outcome was reported as recovered/resolved on 13 November 2011. Documents held by sender: none.
received a dose that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received HBV (Engerix B) (batch number unknown, expiry date 30th April 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th May 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 25th May 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-Jun-2022 Reporter's comments: Medical assistant reported that the patient received Engerix-B that had expired. The consent to follow up was given. Additional Supportive Information: The patient received expired dose of Engerix B, which led to expired vaccine used.
Pt who was approx 15 mon of age at time of vax, devel a 3 day partial paralysis of lower extremities described as a muscle weakness. Pt had trouble getting up from a chair. Lab eval revealed lack of seroconversion for measles.(titer 0.76)
Got his vaccine, and he was told to sit in a chair for about 15 minutes to see if he would have a reaction.  At first he did not have any reaction.  As time went on he developed a slight headache, then his body felt warm.  When he went to bed he tried to sleep and he could not and turned from side to side, and still could not rest, very restless, insomnia.  Then he noticed a pain in his right leg at the bottom by his ankle.  He then noticed that his right side was sort of numb and tingling, which went on for about 15 minutes and then it stopped.  The headache has subsided.  He has the soreness in the arm, but not like it was before.   All of his symptoms are subsiding.  He did not take anything for these symptoms.
On 8/13/2021 patient was given Pfizer following a first dose Moderna on 7/19/2021. No adverse reactions.
swollen tongue (20 minutes after, subsided after taking allergy medicine) chills, headache, body aches, tiredness  (lasted 4-5 hours, some symptoms improved after taking Ibuprofen)  sore arm near injection (immediately and lasting 3 days)  Was within 90 days of testing positive from COVID (January 2, 2021 was positive test)
Patient's daughter called the pharmacy back roughly 3 hours post-vaccination stating that the patient was experiencing diarrhea and vomiting. These could be possible side effects from vaccination, or they could be unrelated. Either way, I felt it was important to report this event. I counseled the patient's daughter on the importance of hydration while experiencing diarrhea/vomiting and recommended a trip to the ER if the patient cannot tolerate fluids or appears to be dehydrated.
Redness and swelling of the left upper arm secondary to PNEUMOVAX. Patient was given Keflex and lab work.
40 minutes after second dose of Pfizer started with severe head pressure, tunnel vision, dizziness. Saw pcp office multiple times. 7 days later started with bilateral lower extremity weakness. 10 days after the vaccine right leg started to drag. Seen pcp for weakness and decreased reflexes and was admitted to local General Hospital 11/8/21-11/12/21. Improved with IV steroids was discharged with home PT and OT which failed. Symptoms returned morning I was discharged and progressively worsened. Have severe sound sensitivity, severe head pressure continues even 18 months later. Intermittent tinnitus, nausea, vomiting. Started with memory and concentration problems within first month of injection. Started having seizures May 2022 and continue to have 3-4 per week. Have been admitted to hospitals 4 times since the n. January 2022- left leg started to drag as well and have been completely wheelchair bound since then. Have been diagnosed with severe immune response to Covid vaccine, incomplete paraplegia. Continue with memory loss, concentration issues, intermittent blurry vision and intermittent loss of vision in right eye. Swallowing difficulty, severe muscle cramps, intermittent tingling and numbness in lower extremities, weakness goes up to core, worsening constipation,
Body ache; Aches in the leg; Aches in the arm; Headache; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), PAIN IN EXTREMITY (Aches in the leg), PAIN IN EXTREMITY (Aches in the arm), HEADACHE (Headache) and FATIGUE (Fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN (Body ache), PAIN IN EXTREMITY (Aches in the leg), PAIN IN EXTREMITY (Aches in the arm), HEADACHE (Headache), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, PAIN (Body ache), PAIN IN EXTREMITY (Aches in the leg), PAIN IN EXTREMITY (Aches in the arm), HEADACHE (Headache), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is taking other medication. No treatment information was provided. No relevant concomitant medications reported.
Immediately following the vaccination the patient was bleeding and told the immunizer she felt dizzy. She then instantly slumped over in her seat and blacked out. She was unconscious for a very short period of time (Only long enough for the immunizer to call the RPh for assistance). 911 was called when Madison regained consciousness she asked what had happened, explained her anxiety and then vomited twice . The paramedics arrived and evaluated her and a ride was called so she would not have to drive. She waiting in the pharmacy for around 40-45mins after the vaccination before leaving with her parents.
Narrative: Patient got covid-19 vaccines on 3-22-2021 and 4-13-2021. Patient tested positive on 10-6-2021, admitted to the hospital on 10-9-2021 for chest pain. He was discharged on 10-12-2021 and monitored in quarantine at home. He was readmitted to the hospital on 10-26-2021 after coming to a pain appt already scheduled and complaining of chest pain that was constant. He was treated and discharged on 10/29/2021
Patient came in with generalized weakness and cough. Patient medicating with tylenol. Admitted to Hospital
Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-NOV-2016, the patient was vaccinated with a dose of ZOSTAVAX as permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, dose, route of administration, anatomical location,, lot # and expiration date were not reported) due to a health care professional recommendation. On an unspecified date in 2016, the patient was treated by a health care provider for uveitis. On an unknown date, the patient experienced shingles (herpes zoster) and other zoster-related injuries despite being inoculated with the ZOSTAVAX vaccine (vaccination failure). It was also reported that the patient suffered serious physical, emotional and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering (Emotional distress and pain), extensive 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 including 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 pre-existing conditions and activations of latent conditions, lost wages, loss of earning capacity and other losses and damages. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased, uveitis and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Mass of right thigh, granulomatous reaction to vaccine as determined by dermatologist (benign growth) Occurred a few weeks after vaccine given, no treatment or intervention deemed necessary at this time
Swelling & hot, painful skin at injection site; heat & swelling & pain grew worse over few days. Flu-like symptoms (fever, headache, body ache & lethargy) for few days. TYLENOL & ZYRTEC, on Dr's advice, improved symptoms.
Pt experienced 3 episodes of difficulty breathing, shaking and rapid respirations. No color change or loss of consciousness or high fever. Pt was hospitalized and was in no apparent distress.60 day follow-up dated 7/10/00 provided no additional data.
pain; bleeding; This is a spontaneous report received from a contactable consumer or other non hcp (patient herself) via medical information team. A 21-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 05Jul2021 as dose 2, single (at the age of 21-years-old) for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date for COVID-19 immunization. Medical history included endometriosis Treatment: BCP unspecified start date and ongoing. The patient's concomitant medications were not reported. On unspecified date of 2021 the patient experienced pain, bleeding. Patient wants to know anyone else reported these side effects and information is available regarding menstrual changes. The patient underwent lab tests and procedures which included pain: 10/10 on unspecified date. The outcome of events was unknown.    The lot number for the vaccine, [Pfizer COVID-19 Vaccine], was not provided and will be requested during follow up.
Wednesday morning he started to feel a lot of muscle soreness in the back of his neck and shoulders and could not put his head back to drink water. Wednesday evening put muscle rub on achy areas and took a couple of Aleve. Thursday morning was  feeling better and Thursday evening a lot better. Friday just a slight tight feeling to remind him it is still there.
20 yo healthy male with onset of severe urticarial reaction, swelling of face, hands and feet, fever on 4/11, hospitalized 4/16/2021, resembles serum sickness.
Patient developed severe chills in the afternoon after getting PCV-23 he was shivering uncontrollably, his teeth were chattering, shortness of breath. Next day seen in the office, no fever, and advise to take ibuprofen.
No adverse effect; improperly stored doses of ROTATEQ were administered; Route of Administration: intramuscular; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 24-JUN-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R033255, expiration date 26-JUN-2020, intramuscular (dose, frequency and anatomical location were not reported). The vaccine was stored in temperature above 47 Fahrenheit degrees for 2 hours. The temperature was measured by "data logger". There was no previous temperature excursion. No adverse effect was reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA009902: US-009507513-1906USA009882: US-009507513-1906USA009880: US-009507513-1906USA009914: US-009507513-1906USA010076:
This is a spontaneous report from a contactable pharmacist. A 70-year-old female patient received PREVNAR 13 (lot number: S31255, expiration date: Jul2018) intramuscular on arm left at the age of 70-year-old on 21Aug2017 at 0.5 ml, single for immunization. Patient medical history included high blood pressure and high cholesterol. Concomitant medications included atenolol and amlodipine both for high blood pressure; and simvastatin for high cholesterol, all from unspecified date and ongoing. The patient previously received PNEUMOVAX 23 for immunization. The pharmacist mentioned that patient was given PREVNAR 13 vaccination on 21Aug2017 (reported as several days ago) and patient had an allergic reaction to her arm on unspecified date. On 22Aug2017, patient experienced itchy, beet red, warm to the touch and it was not just only on the local site, down the arm to the elbow was also red, itchy, and warm to touch. Patient took some BENADRYL as treatment for the events. No lab work was done. Outcome of the events "it was not just only on the local site, down the arm to the elbow was also red, itchy, and warm to touch" was recovering, while "allergic reaction to her arm" was unknown. She said it actually had improved today but still itchy but not as bad as it was. Patient stated that the itching was what was driving her crazy. It was reported that itching has actually improved since she was here on the weekend. Pharmacist asked her if it was still warm to touch and patient said a little bit not like it was the day before. The reporter (pharmacist) provided causality for the events as related to the vaccine and mentioned "I would say yes, that's the only thing it could. I looked to see if there was bite on her arm, or she got bitten by something but I did not see anything."
Arm edema, erythema extending from injection site in deltoid distally beyond elbow.