chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had a high fever for a week (7 days), right after receiving the vaccination in question. Having a fever is very serious as a toddler with sickle cell anemia, because it can trigger a sickle cell crisis, or another adverse event. Sickle cell crisis could result in serious complications or death. This was a very scary time, watching to see what might occur due to the high fever. While patient had this fever due to the vaccination (Dr. also stated she had another young patient that also got a fever right after receiving the same vaccine), the doctor's office (as noted) stayed in contact with me on a regular basis while she was at home. They advised that I treat her at home, while keeping in close contact with them. They recommended to admit patient in the hospital (or take her to emergency) the very next day after the 7th day, but the fever started to drop at that time. So, while she did not go back to the doctor's office (per item 21 below), the doctor's office still communicated to me by phone and text on a regular basis.
This spontaneous report as received from a medical assistant refers to unknown patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with GARDASIL 9 (dosing details were not reported) which had undergone a temperature excursion of 51.7 degree Fahrenheit for 20 hours (incorrect product storage). No apparent adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Employee felt tingling and numbness down the arm that the vaccine was given in. Subsided in about 10 minutes.
Redness, heat, pain at injection site. Swelling, spreading of redness/rash over the course of three days. Advised patient to go to urgent care/ER.
Patient reported having a headache blister on upper lips and lower right  eyelid . Patient also reported having pain in the right eye redness.
FLUBLOK dose to a 15 month old with no adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2022SA381687(CLUSTER).  This case involves a 15 months old and unknown gender patient to whom INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] dose was administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for immunisation.  On an unknown date flublok dose was administered to a 15 month old with no adverse event (product administered to patient of inappropriate age) (same day latency). Physician said they received FLUBLOK by accident or they didn't order it but his staff is clearing that up. He wanted to know about safety issues and if it needs to be repeated.  Action taken: Not applicable.  Outcome: Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recvd vax & following the vax pt exp a local react; No further details were provided;
I started getting very very exhausted, I started falling asleep while talking to people, I fall asleep with food in my mouth, or during events. I could not choose when I was going to sleep, my body was choosing for me. My husband told me to seek medical advice. I went to the doctor and they did blood work. Then I fell asleep at my psychiatrist appointment and I told her what was happening. She did blood work too. I came down with stomach pain. My face was puffy before this. All my lymph nodes decided to swell up even in my stomach. I had nausea. I went to the doctor and they sent me to the ER. They said I had Epstein Barr, they said it was active and then my doctor said it was inactive. It has been confusing my blood work is changing up and is very inconsistent. They ran several tests for the Epstein Barr.
Patient suffered a hemorrhagic stroke in the right basal ganglia less than a week after receiving the vaccine.
Right upper thigh muscle spams/cramping and leg soreness. Headache on and off throughout week foollowing the second dose of vaccine.  Mild nausea on and off throughout week following the second dose of the vaccine.
This spontaneous report as received from a pharmacist refers to a 68-year-old female patient with allergy to sulfa drugs and history of vaccination with PREVNAR 13 on 23-NOV-2015. On 14-SEP-2016, the patient was subcutaneously vaccinated with a dose of PNEUMOVAX 23 injection (lot# M003027, expiry date 21-JUN-2017; exact dose was not reported) in her left arm. It was also reported that at the same time, the patient was vaccinated with an unspecified influenza vaccine (dose and route of administration were not reported). Concomitant therapies included CRESTOR. On 14-SEP-2016, the patient experienced an adverse effect described as a softball-size swelling at the injection site of the left arm and redness, which later spread to the elbow. On an unknown date in September 2016, the patient sought medical attention at an unspecified urgent care center and was prescribed KEFLEX 500 mg three times per day and unspecified steroid creams as treatment of the events by an unspecified provider. The pharmacist reported that the patient sought medical attention again on 16-SEP-2016, in an emergency room, because the redness had spread past her elbow into the forearm. It was reported that the patient was most likely going to be admitted into the hospital because of the events. No diagnostic lab studies were performed in regard to the events. The reporting pharmacist requested a lot check for PNEUMOVAX 23 (lot# M003027, expiry date 21-JUN-2017). The outcome of the events was reported as not recovered. The relatedness between PNEUMOVAX 23 and the events was not provided. Upon internal review, the events of softball-sized swelling at the injection site and redness were determined to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested.
On 4/27/2021 after administering this Modena vax it was discovered she had previously received the J&J covid vaccination on 3/6/2021. Pt was contacted and she stated she was fine with the exception of a sore right arm but had nothing else to report.
This case was reported by a healthcare professional and described the occurrence of nausea in a 21-year-old female subject who was vaccinated with Engerix B for prophylaxis. On 14 May 2007 the subject received primary course of Engerix B (unknown). Within 5 minutes of receiving vaccination with Engerix B, the subject experienced nausea, vomiting, sweating and weakness and was sent to the emergency room. The subject returned to the emergency room on 15 May 2007 with burning over the thigh, hands and legs associated with weakness. The subject was sent home and given steroids and Benadryl The subject returned to the emergency room again on an unspecified date with a rash on the ankle, legs and face. The subject also reported generalized weakness and abdominal pain. The subject was hospitalized. At the time of reporting the outcome of the events were unspecified.
headache, chills, injection site pain, feeling unwell, difficulty breathing, dizziness, weakness and imbalance
This spontaneous report as received from licensed practical nurse and refers to a 25 year old patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In March 2017, the patient was vaccinated with the first dose GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). In August 2017, the patient was vaccinated with the second dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). There were no adverse effects reported.
5 days p/the vax pt devel h/a, nausea, low grade fever, fatigue, hyperactive bowel sounds;
This spontaneous report as received from a registered nurse refers to a currently 81 year old female patient with drug reactions/allergies to tetracycline and CIPRO. On an unknown date in September 2011, the patient was vaccinated with PNEUMOVAX 23 injection (exact dose, anatomical location, route of administration, lot # and expiration date were not provided). There were no concomitant medications provided. The reported stated, that on an unknown date, the patient had an unspecified reaction to PNEUMOVAX 23. The outcome of adverse event was reported as recovered/resolved, on an unknown date. The reporter considered adverse event to be related PNEUMOVAX 23. Additional information has been requested.
THE NEXT DAY THAT HE RECEIVE THOSE VACCINES, HE COULD NOT WALK FOR 2 DAYS, HE WAS TIRED AND HIS EYES LOOK DIFFERENT AFTER THAT IN SEPTEMBER 2018 HE COULD NOT WALK AGAIN AND NOW I'M TAKING HIM TO THE CHIROPRACTIC AND THAT IS HELPING. I TALK WITH HIS DOCTOR AND SHE SAYS WAS A NORMAL REACTION, SHE DIDN'T LISTEN TO ME.
Pt said area below vaccine (inj site) was administered was swollen and hot to touch for almost 5 days.
This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles and chickenpox (both experienced at the age of 30 year old). On 7th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 7th September 2018, less than a day after receiving SHINGRIX, the patient experienced pain, feels awful, neck pain and pain in arm. On 8th September 2018, the patient experienced varicella-like rash. On 12th September 2018, the patient experienced sciatica. In September 2018, the patient experienced fever, ear pain, sound sensitivity increased, nocturnal headache and abnormal physical sensation. The patient was treated with ibuprofen (Motrin). In September 2018, the outcome of the fever, ear pain, sound sensitivity increased, nocturnal headache and abnormal physical sensation were recovered/resolved. On an unknown date, the outcome of the pain, feels awful and neck pain were recovered/resolved and the outcome of the sciatica and varicella-like rash were recovering/resolving and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain, feels awful, fever, sciatica, ear pain, sound sensitivity increased, nocturnal headache, abnormal physical sensation, neck pain, pain in arm and varicella-like rash to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. Around 4:30 pm, the patient received SHINGRIX on the left arm. The patient experienced neck pain more than arm pain. She started to feel achy. The patient babysat her granddaughter and by 10:00 pm, 5 hours 30 minutes after receiving SHINGRIX, at evening, she felt nasty and felt like she was coming down with something.  At 2:00 am, 9 hours 30 minutes after receiving SHINGRIX, she felt a fever and different sensations in her body and she could not lift her head off the pillow. The patient was down all day of vaccination. She took Motrin at 3:00 am which, helped her. On 8th September 2018, 1 day after receiving SHINGRIX, she took two Motrin. Days (less than a week) after receiving SHINGRIX, she experienced pain in her ear that was bothering her with sensitivity to sound and headaches at night for three days. The patient also reported that 1 day after receiving SHINGRIX, the patient experienced rash on her face that looked like pimples or chickenpox. The rash was resolving at the time of reporting and was not as noticeable. The day before reporting day (5 days after receiving SHINGRIX, she experienced sciatic nerve pain in the back of her right leg by her knee which was resolving at the time of reporting. The contact details of the physician were provided.
TINGLING AND UNCOMFORTABLE FEELING IN UPPER BACK, ITCHING IN THE REGION OF THE INJECTION
Gradual increase in Sjogrens symptoms (muscle aches and pains, muscle stiffness, unable to get comfortable, unable to sleep, heavy limbs)
No adverse effect; Patient received improperly stored VARIVAX; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/ allergies were not reported. Concomitant therapies included sterile diluent which was used for reconstitution of vaccine was stored properly. On 05-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), lot # S005078 and expiration date 19-FEB-2021 or R019237 and expiration date 04-JUL-2020 (strength, dose, frequency, route and anatomical location not reported) for prophylaxis (product storage error). It was reported that both lots of varicella virus vaccine live (oka/merck) (VARIVAX) underwent the temperature excursion, but the reporter did not know which lot was given to the patient. The storage temperature was reported as minus 9.74 degree Celsius for an unknown time frame. There was no previous temperature excursion. Digital data logger was involved. No adverse effect reported. No product quality complaint (PQC) present.
She stated that the sides of her tongue felt "fat" within sev. minutes of vaccination. BP 138/102 P 70 O2 - 100% alert, at 3:25. BP 142/98 P 78 at 3:40 and she said she felt fine. Stated she has had many flu vaccinations in the past with no problem. After 20 minutes she said she still was ok and left.
THE PATIENT DEVELOPED RASH AND WAS GIVEN DIPHENHYDRAMINE 50MG/ML VIA IM ROUTE
3rd dose administered; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number LG374, expiry date 28th May 2024) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 06th June 2022) and Shingrix (2nd dose received on 14th October 2022).   On 16th January 2023, the patient received the 3rd dose of Shingrix. On 16th January 2023, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comment: The reporter was a practice administrator. The reporter reported that the patient inadvertently received third dose of Shingrix vaccine. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Additional supportive information: The patient received extra dose of Shingrix in error, which led to extra dose administered.
Information has been received from a physician concerning a female pediatric patient who was vaccinated subcutaneously with a 0.5 mL dose of varicella virus live (Oka/Merck). On a unspecified date, the patient developed a rash of less that 50 flat lesions, after vaccination. The patient sought unspecified medical attention. The patient's outcome was not reported. There was no product quality complaint. Additional information has been requested.
Headache, inability to concentrate, and red rash approximately the size of a quarter over the injection site. Pain on left side of body from head to left foot. No pain on right side of body.
Information has been received from a 60 year old female occupational therapists with allergic reaction to corn, wheat, eggs, milk, thimerosol, penicillins, sulfa, doxycycline, CRESTOR, LIPITOR, IVP dye, BIAXIN, amoxicillin, erythromycin, BACTRIM, CEFTIN, CIPRO, AUGMENTIN, FLAGYL, "TROZAN", CLARITIN, ALLEGRA, ENTEX IA, HISMANAL, SELDANE, CORTISONE IV, RHINOCORT, BECONASE, NASOCORT, VANCENASE, ADVIL, BENADRYL, LEVAQUIN, AVELOX, TEQUIN, prednisone, alendronate sodium (MSD), MIACALCIN, flu shot, diesel, perfumes, fragrances, RESTASIS, ALOCRIL, PATANOL, walnuts, Brazil nuts, kidney beans, pinto beans, malt, hops, cats, yard allergies, certain molds, timolol (caused insomnia) who on 22-FEB-2010 was vaccinated with a dose of ZOSTAVAX (Merck), IM in the right arm. Concomitant therapy included BETOPIC S, vitamins (unspecified), omega-3 marine triglycerides and ACIDOPHILUS. On 27-FEB-2010 the patient began to develop overwhelming fatigue to the point that she was not sure if she could complete the activities of daily life like driving; severe headache to the point that she required 3 generic MIDRIN and 3 halves of DARVOCET N-100; muscle/bone/joint pain which "felt the same as when she took LIPITOR and CRESTOR; bladder urgency; a randomly occurring strange feeling while walking--like walking on ice; ears that felt full; and a swollen right hand upon waking in the morning. The "finger pads" were also numb in that hand. The patient would have lab work and urine analysis on Monday (possibly on 14-MAR-2010). These symptoms had not improved, but had gotten "a little worse." Physician stated that the adverse effect with the feet was possibly viral syndrome. The adverse events were considered to be disabling and other important medical events. The patient had a history of allergy to alendronate sodium while on prior therapy with alendronate sodium (MSD, WAES 1003USA02705). This is one of several reports received from the same source. This is one of several reports received from the same source. No further information is available.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 16-year-old male patient  who received BEXSERO. In July 2016, the patient received the 1st dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were provided as follows: The healthcare professional who was the patient's mother stated her son had pain in arm following administration of BEXSERO. The healthcare professional did not have vaccine information and did not recall any details of the pain such as duration as the vaccination was back in July. This did not result in any doctor's visits. The healthcare professional stated  that the patient was hesitant to get 2nd dose due to arm pain.
There is bumps in perimeter of my tongue; There is bumps in perimeter of my lips; Swollen cheek; Head was foggy; Dry mouth; Muscle soreness; Tiredness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Head was foggy), DRY MOUTH (Dry mouth), LIP DISORDER (There is bumps in perimeter of my lips), SWELLING FACE (Swollen cheek) and TONGUE DISORDER (There is bumps in perimeter of my tongue) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced PYREXIA (Fever). On 09-May-2021, the patient experienced FEELING ABNORMAL (Head was foggy), DRY MOUTH (Dry mouth), MYALGIA (Muscle soreness) and FATIGUE (Tiredness). On 11-May-2021, the patient experienced LIP DISORDER (There is bumps in perimeter of my lips) and SWELLING FACE (Swollen cheek). On an unknown date, the patient experienced TONGUE DISORDER (There is bumps in perimeter of my tongue). On 10-May-2021, FEELING ABNORMAL (Head was foggy), DRY MOUTH (Dry mouth), PYREXIA (Fever), MYALGIA (Muscle soreness) and FATIGUE (Tiredness) had resolved. At the time of the report, LIP DISORDER (There is bumps in perimeter of my lips), SWELLING FACE (Swollen cheek) and TONGUE DISORDER (There is bumps in perimeter of my tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
7/15/22 I had been traveling out of town. I woke up with a little bit of a sore throat. I went to the gym, came out, showered, went about my day and left that evening. Throughout the plane ride I did not feel well, began to cough, chills. I made an appointment for a COVID test. I went home and slept. I tested positive for COVID that afternoon. I went next door to the urgent care, they prescribed PAXLOVID, something for cough, an oral steroid, a Z-PAK for an ear infection. I felt better in a couple of days. I had a bit of a bounce back. And got through it. After 11 days, I went about my usual business.
Patient said she felt real weak. She broke out in a profuse sweat and had heart palpitations. These symptoms lasted about 10-15 minutes. She said she sat real still until they subsided. She stated that she felt real weak for the rest of the day but felt normal the next day and since that time.
about 5-10 mins after the covid shot, patient felt dizzy, sweaty, vision blurred and itchy and hot(breathing was ok and normal) called 911 and emt came to check him out . They did not give him any treatment and told me to observe him for 30 mins and he can leave if feeling better. patient waited a few more minutes and felt better and left pharmacy
This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. The reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of SHINGRIX and had two days worth of flu like symptoms following administration. Nurse did not recall lot number or date of administration. The reporter did not agree to follow up. The reporter did believe the adverse event to be related to the product and resolved with no further complications.