chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness returned to both quads again/ entire right quad was sore and then it settled proximal & lateral; This is a spontaneous report from a contactable other healthcare professional (patient). A 56-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number CZ3302), via an unspecified route of administration (left arm), on 20Jan2021, at a single dose, for covid-19 immunization. Medical history included GERD, osteoarthritis, spinal stenosis, allergies: penicillin, covid prior vaccination, and covid-tested post vaccination of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via nasal swab PCR and Rapid tests on 06Jan2021 with results of negative. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140) on 30Dec2020 14:00 intramuscularly on the left arm for covid-19 immunization at the age of 55 years and experienced on 31Dec2020 08:00 waking up with muscle soreness in both quads (4/10 pain) that lasted for 24 hours in the left and since 31Dec2020, still having in the right quad - initially it was the entire muscle and then it settles proximal and lateral to hip - the pain level was 2/10. The vaccine was received at the nursing home/senior living facility. The patient's concomitant medications were not reported. The patient stated that after the 2nd dose, on 20Jan2021 the soreness returned to both quads again. Today, 25Jan2021, it continued in right. The patient woke up and the entire right quad was sore and then it settled proximal & lateral. The outcome of the adverse event was unknown. The patient had no other vaccines in four weeks.
Information has been received from a healthcare worker (office manger) concerning a 13 month old white male with "NKA" who on 05-OCT-2007 was vaccinated with a second dose of PROQUAD (lot number: 658032/0985U) in the left thigh. On 05-OCT-2007 at 7:00 the patient's mother stated that the patient laid around and started. The patient had an elevated temperature of 102-104. There was no relevant diagnostic tests and laboratory data. There was no illness at time of vaccination (health child). The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested.
Information has been received from a registered nurse concerning a 15 year old female who was vaccinated with a dose of GARDASIL (Lot # 654885/1424F). Concomitant vaccination given at the same time included MENACTRA. On 18-FEB-2007 three days after vaccination the patient experienced swelling of the face. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/12/2007.  Initial and follow-up information has been received from a registered nurse concerning a 15 year old female with no pertinent medical history who was vaccinated intramuscularly into the left arm with a first dose of GARDASIL (Lot #654885/1424F).  Concomitant vaccination given at the same time included an intramuscular injection into the right arm with a first dose of MENACTRA (Lot #U2108AA).  On 18-FEB-2007 three days after vaccinatio the patient experienced swelling of the face.  An allergist performed tests that revealed negative for GARDASIL.  Subsequently, the patient recovered.  The patient received the second dose of GARDASIL without problem.  Additional information is not expected.
Mistakenly took 3rd shot; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st and 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, 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-OCT-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. Patient reported that he/she mistakenly took third shot of Shingrix. Patient wanted to know what side effect he/she might have. Additional supportive information: As patient received extra dose of Shingrix mistakenly which led to extra dose administered.
Same day post vax, the pt's arm swelled at site of injection to tennis ball size. Pt's physician reported that he saw petechiae, thumb-print size rough skin at site of injection. He stated that he did not see any infection or swelling.
T103-104 yesterday & today; acting tired, not irritable or fussy 22SEP92; 23SEP92 given APAP; On PE there was sl induration @ inject site;
Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2013 the patient was inoculated with ZOSTAVAX vaccine at a pharmacy for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-MAR-2016 the patient was treated by a physician for a vesicular rash which was diagnosed as herpes zoster. The patient was prescribed KENALOG for her painful symptoms and chronic pain. On or about 11-MAR-2016 the patient again sought treatment by the physician for peripheral facial neuropathy which was diagnosed as Ramsay-Hunt Syndrome, a peripheral facial nerve palsy secondary to herpes zoster infections. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Upon internal review Ramsay-Hunt Syndrome was determined to be a medically significant event. Additional information has been requested.
15 cm x 15 cm raised, swollen, and red area on R deltoid.  Also reddened posterior deltoid red area and under arm and anterior bicep reddened area.
pt recvd vax 26SEP95 & 28SEP95 fever, joint ache, diff breathing & fear; crying, shakey, t100;no pharnyngeal or uvula edeam;resp w/o wheezing; red & swollen inj site w/9x9cm area of erytheam
Local 5x7 cm redness - SL warm to touch. Minimal swelling.
Pain started on inside of right calf on 3/23/2021, but continued to spread up and down from just above ankle to groin area. Three areas were extremely painful to touch. Diagnosed as blood clots in the saphenous vein. Put on ibuprofen, keflex and famotidine on 3/29 and advised to elevate and use moist heat to help clots resolve. Pain started subsiding on 4/3 but is still there, just not as bad. Referred to vascular surgeon, on 4/6/2021. He recommended following advice from  since they seem to be resolving and are not in the deep femoral vein. As of today, 4/13/2021, pain is still there although somewhat improved.
Vaccine given Approx 6pm on 5/12/09 on 5/13/09 L arm has area 3x3cm redness, swelling.
The Bivalent Booster was accidently given as first dose of Pediatric series.
cold sore on her top lip and on top of the pallet; Caller said like herpes simplex; allergic reaction; looks more red and extended out, nothing she now has 3 dots on her for head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 22Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: ORAL HERPES (non-serious) with onset 25Sep2021, outcome "unknown", described as "cold sore on her top lip and on top of the pallet"; HERPES SIMPLEX (non-serious) with onset 25Sep2021, outcome "unknown", described as "Caller said like herpes simplex"; HYPERSENSITIVITY (non-serious) with onset Sep2021, outcome "unknown", described as "allergic reaction"; ERYTHEMA (non-serious) with onset Sep2021, outcome "not recovered", described as "looks more red and extended out, nothing she now has 3 dots on her for head". Additional information: The patient had the second dose of the Pfizer covid 19 vaccine this past Wednesday, 22Sep2021. Patient stated on Saturday, 3 days after the vaccine, began to have like a cold sore on her top lip and on top of the pallet. Patient said like herpes simplex noting she has never had this. It was bothersome. The patient stated that today it looks more red and extended out, noting she now has 3 dots on her forehead. Patient has had this for 2 to 3 days and asked could this be an allergic reaction to the vaccine. Also asked should she go to the hospital.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
my left hand, hip and toward my back, from a scale of 1-10 felt like an 8-9 for the last 24 hours; my left hand, hip and toward my back, from a scale of 1-10 felt like an 8-9 for the last 24 hours; injection site is tender and the tenderness seems to be lasting longer than other vaccines; my left hand, hip and toward my back, from a scale of 1-10 felt like an 8-9 for the last 24 hours; A spontaneous report was received from a consumer, who is a male patient of an unknown age that received Moderna's COVID-19 Vaccine and experienced pain in left hand, hip, toward his back, and vaccine injection site tenderness.  The patient's medical history included an unspecified disorder related to back pain. Concomitant product use included unspecified pain medication.   On 22-Dec-2020 at around 2 o'clock, the patient received his first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in his left upper arm for prophylaxis of COVID-19 infection.    That day, at around 4 o'clock, the patient had experienced pain on his left hand, hip and toward his back, pain intensity 8-9/10 for the last 24 hours.  The vaccine injection site was tender which had seemed to last longer than any other vaccines that he had received in the past.   Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events were unknown.   The events, back pain aggravated, pain in hip, pain in hand and vaccination site tenderness, is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-JUN-2008, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided), for the long term prevention of shingles and zoster related conditions. Subsequently, the patient was treated for shingles on unspecified date. As a direct and proximate result of the patient's use of zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would 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 (on an unknown date), 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 the event was considered as not resolved. The causality between shingles and zoster vaccine live (ZOSTAVAX) was considered as related.
dizziness, hives, red face, swollen eyes, itchy tongue, itchy throat, swollen lips, brain fog
This literature marketed information has been received from a published literature article refers to a 2-year-old boy with  known beef, pork, and milk allergy. The patient developed on an unspecified date in approximately 2011, disseminated urticaria, shortness of breath, difficulty swallowing within an hour of receiving M-M-R II (dose, route, vaccination site, lot# and expiration date were not provided) and VARIVAX (dose, route, vaccination site, lot# and expiration date were not provided), for prophylaxis, and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) and haemophilus influenza B (manufacturer unknown).  Physician diagnosis of anaphylaxis. The patient received diphenhydramine hydrochloride (BENADRYL), prednisolone sodium phosphate (ORAPRED), and intramuscular 0.15 mg of epinephrine with resolution on an unspecified date. The author considered the event as a reaction associated to M-M-R II and VARIVAX. Upon internal review, anaphylactic reaction was determined to be medically significant. This is one of several reports from the same reporter (Case # US-009507513-1809USA011156, US-009507513-1809USA012060, US-009507513-1809USA012063, US-009507513-1809USA012064, US-009507513-1809USA012065, US-009507513-1809USA012066, US-009507513-1809USA012062); Sender's Comments:  US-009507513-1809USA011156:
One week post injection, experiencing loss of skin pigmentation or whiteness at injection site, hard bump and above average soreness. By noon, whole shoulder muscle swollen, location is warm, mild redness, and feels like a bee sting.  3 days post injection, every joint in the arm (Shoulder, elbow, wrist) was aching, Injection site pain was nominal.  RE #21 - Will monitor and visit Dr if condition worsens.
Same day- started hurting couldn't lift (R) arm with pain. Couldn't lay on (R) side. Muscle ache
Systemic: Lymph Node Swelling-Medium, Additional Details: pt reporterted swelling of lymph nodes in both arms eventually swelling to baseball size before returning to normal by the saturday (07-31-21) following injection (07-23) pt experincenced in shot arm (left) 1st (07-24) before observing in opposite (right) arm the following day (07-25) pt reported to physician and was told it should resolve in about a week; pt was not advised against second shot by MD
RAPID ONSET DIZZINESS (DIZZY); SOMETIMES NAUSEA (NAUSEOUS); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAR-2021, the patient experienced rapid onset dizziness (dizzy), and sometimes nausea (nauseous). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rapid onset dizziness (dizzy), and sometimes nausea (nauseous). This report was non-serious.
Within an hour I experienced rapid heartbeat and elevated blood pressure, I don't have blood pressure problems. This lasted about 8 hrs afterwards.
This case was reported by a nurse via call center representative and described the occurrence of injection site fat atrophy in a elderly female patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020). On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site fat atrophy and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site fat atrophy and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site fat atrophy to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported this case via click to chat forum. The age at vaccination was not reported but could be 68 years or 69 years. The patient received a dose of SHINGRIX in the gluteal muscle, which led to vaccine administered at inappropriate site. The patient developed subcutaneous fat atrophy at the site of injection. No further information was reported.
Gave the Bivalent , instead of the (second) monovalent  I administered the wrg vaccine
NO ADVERSE EVENT/NO ADVERSE REACTION REPORTED  COVID19 (PFIZER) 03/06/2021 COVID19 (MODERNA) 04/10/2021
A non-serious spontaneous report of influenza B with symptoms of fever and cough has been received from a health professional concerning a 31-month-old male, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. The patient's medical history included gestation period of 41 weeks. Concomitant medications were not reported. The patient received 0.2ml FLUMIST nasally on 09-Nov-2010 for protection against flu. The patient started with fever and cough in the evening of 18-Jan-2011. He tested positive for influenza at the doctor's office on 20-Jan-2011. The sample was sent to the stat lab and it came back B positive. The patient was treated with oseltamivir 45 mg twice daily for five days from 20-Jan-2011 to 23-Jan-2011 and ibuprofen 100 mg one tsp from 18-Jan-2011 to 23-Jan-2011 for fever. The events resolved on 22-Jan-2011.
Initial report received from a healthcare professional on 21 November 2014. This is a linked case of 2014SA163350. A 08-year-old male patient, whose medical history and concomitant medication were not reported, received a dose of FLUZONE batch number, dose, route and site of vaccination were not reported) on an unspecified date in 2013. On unspecified date in 2013, patient had severe local reaction. In 2014, patient received 0.25 ml dose of FLUZONE quadrivalent (half dose) and had severe but manageable local reaction (swelling, redness). Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the events was reported as unknown. Follow-up information was received from the healthcare professional on 25 March 2015. The vaccine administered in 2013 was known to be quadrivalent Influenza, however it was administered at another facility and the lot number was not available to the reporter. The patient was taken to the emergency room at that time to rule out cellulitis (previous report stated that the patient was hospitalized). No additional information was known regarding this event. List of documents held by sender: none.
Intense pain in left arm for 2 days (42-72 hours) after vaccine starting at 3 AM. Arm knotted up and pain from shoulder to elbow. Patient had skin cancer surgery on left neck/ear on same day he got vaccine. One earlobe was red and enlarged and possibly infected not sure if earlobe symptoms tied to vaccine.
Pt 12 years of age was given Pfizer, 5 to 11 dose 0.2ML. Outcome, monitor for an additional 30 minutes, no adverse reactions noted,  mom and dad notified on incident. Vaccination station chief (NP) notified at time of event. Follow up discussion with parents by Nurse  practitioner immediately followed up with patient and parents.
This spontaneous report as received from a consumer refers to her son, a 11 year old male patient. Patient had no pertinent medical history and no drug reactions/allergies. On 19-JUN-2008 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # 658422/1030U, Exp date: 27-JUN-2009) (dose and route unspecified). No concomitant medication reported. On 20-JUN-2008, less than 24 hours later the patient started throwing up and became ill while at a soccer game. The consumer reported that her son left the soccer game and when her son got home he "passed out" and fell asleep. The consumer reported that her son slept for the next 24 hours. The consumer reported that when her son was sleeping she noticed that there was an injection site reaction at the site of the VARIVAX (Merck) vaccination that was described as a red, raised oval about 4 inches by 4 inches at the site of the VARIVAX (Merck) vaccination. The consumer reported that when her son woke up he felt better and within 4 or 5 days the injection site reaction resolved and her son was recovered (date unspecified). No treatment was given for the events and no lab diagnostics studies performed. Additional information is not expected.
Pt recvd 2nd dose of Hep B vax on 22FEB91; Pt devel severe itching & swelling @ site of inject; scratched the inject site, & it became infected but later healed; sx persisted for approx 2 months & then remitted;
I started experiencing a severe migraine, chills, and body aches. For the past few days, the symptoms have not gotten better. I now have GI symptoms as well, such as nausea, abdominal pain, and diarrhea. My migraine has not gone away, and it has been almost 4 days now. During the first two days, I was taking tylenol, but I didn?t want to take too much tylenol so I stopped taking it, which is when the migraine got worse because I no longer had pain relief. The pain in my body is pretty bad, but my legs feel the worst.  I am not an antivaxxer. I was excited to get the vaccine. However, I am feeling seriously ill with not many answers and it is very concerning. The CDC says the side effects should only last a day or two. I am now several days in with no relief and it feels like i?m just getting worse.
Information has been received from a physician concerning a 3.5 year old female who was vaccinated with Varivax. It was reported that she got 75 chickenpox lesions and a 101 F fever. There was no use of prescription drugs and no hospitalization for this experience. At the time of this report the patient had not recovered. Additional information has been requested.
Patient woke up around 5:00 am on March 16, 2021 with her left hand swollen to 3x Its normal size and in terrible pain. She went to the ER@ Medical Center and was told that it was sooriatic arthritis and sent her home. The next day she went to the ER again because she was still hurting bad and was told the second day that she had an infection, but they never specified what it was. They gave her antibiotics through an I.V. for 2 hours, and then sent her home with 2 more prescriptions for 2 more antibiotics , augmentin and dloxycycline and a steroid pack, and naproxen 500 mg.  Two days after that, she saw Dr., who proceeded to give her 2 more antibiotic shots on that day and the next. Dr.'s office scheduled her for an ultrasound finally that Friday and that is when they found the blood clot in her hand/wrist. Dr. was not there that day, so his associate saw her instead. Dr. took her off of all her  medications and put her on Xarelto to try and dissolve the clot. He said he had never seen a blood clot in someone's hand, but that he had no reason to believe that it had anything to do with the shot. Patient has no conditions that cause blood clots, nor does she have any family history of blood clots. There is no other reason for the blood clot in the same arm as her vaccine the next morning.