chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild residual tingling numbness; mild residual tingling numbness; felt sick; body aches; fever; chills; nausea; This is a spontaneous report received from contactable reporter(s) (Physician).  A 25-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2023 as dose 2, single (Batch/Lot number: unknown) at the age of 25 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing), notes: prior Hx of possible Multiple Sclerosis with Brain MRI showes abnormal imaging 5 yrs ago but stable.; "abnormal EEG" (unspecified if ongoing), notes: Also has Hx of prior abnormal EEG.; "acid reflux" (unspecified if ongoing), notes: His only current medication is Omeprazole for acid reflux. Concomitant medication(s) included: OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: BNT162b2 (Dose 1, single), administration date: 07Mar2023, when the patient was 25-year-old, for COVID-19 Immunization, reaction(s): "numbness of bilateral distal arms and legs (forearms/hands & shins/feet)", "numbness of bilateral distal arms and legs (forearms/hands & shins/feet)", "numbness of bilateral distal arms and legs (forearms/hands & shins/feet)", "numbness of bilateral distal arms and legs (forearms/hands & shins/feet)", "felt sick", "Fever", "body aches", "chills". The following information was reported: PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), outcome "not recovered" and all described as "mild residual tingling numbness"; ILLNESS (non-serious), outcome "recovered", described as "felt sick"; PAIN (non-serious), outcome "recovered", described as "body aches"; PYREXIA (non-serious), outcome "recovered", described as "fever"; CHILLS (non-serious), outcome "recovered"; NAUSEA (non-serious), outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: A 25-year-old male patient received his first COVID-19 vaccine on 07Mar2023 and 13 days later developed severe numbness of bilateral distal arms and legs (forearms/hands & shins/feet) which dramatically improved after 10 days when he received his 2nd COVID-19 vaccination on 30Mar2023. He now only has very mild residual tingling numbness. Did have side effects and felt sick from both shots with fever, body aches, and chills lasting 24 hrs along with some nausea with 2nd vaccination. No imaging or other tests have been done yet, but plans to see his Neurologist in follow up. Optional Information included, Patient has prior Hx of possible Multiple Sclerosis with Brain MRI showing some abnormal imaging 5 yrs ago but has been stable since. Also has Hx of prior abnormal EEG. His only current medication is Omeprazole for acid reflux. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300063057 same patient/SD, different AE/dose;
Pt. received 3 injections, when leaving clinic, pt. got light headed, pale and fainted. She came to very quickly, was given cold rag to forehead. Sat for 10 min and was fine.
This spontaneous case reported by a consumer, describes the occurrence of erythema (redness), swelling, warm skin (heat of the rash) and rash in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Previously administered products included for an unreported indication: Rubella vaccine in 1984. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced erythema (redness), swelling, warm skin (heat of the rash) and rash. The patient treated with Bactine (benzalkonium chloride/lidocaine hydrochloride), 1 dosage form; twice a day. On May 12, 2021, erythema (redness), swelling, warm skin (heat of the rash) and rash resolved. No concomitant medications reported. This case linked to MOD-2021-090407 (patient link).
From initial information received on 04/04/2003 from a health department regarding an adverse event occurring in the US, it was reported that a 54 year old male patient received Typhim VI, Lot # U1157-2, given in his right deltoid on 04/04/2003.  Thirty to forty-five minutes later, the patient felt nausea and dizziness and felt faint.  The patient felt like vomiting, reportedly, not sure if this occurred.  About 15 minutes later, the patient felt better.  Within the past four to six weeks, the patient also received IPOL, MMR, RABIES VACCINE, HEPATITIS A AND B, AND TD ADS ADULT.  The lot numbers, manufacturers and route/site for all products were not reported.  Reportedly, the patient recovered from these events.
He has dementia and started to improve after Pfizer covid vaccination. Went from being incontinent to saying he had to go to the bathroom, getting up, and going; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Dementia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "He has dementia and started to improve after Pfizer covid vaccination. Went from being incontinent to saying he had to go to the bathroom, getting up, and going".  Additional information: Patient is Father-in-law of friend. It was unknown if patient had tested for covid prior and post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swollen lymph node; Aching body; Sore arm; Dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 02Dec2021 16:30 (Lot number: FJ8762) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: sulfa medication" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 12Apr2021, when the patient was 46 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 22Mar2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 16:30, outcome "unknown", described as "Dose number: 3"; LYMPHADENOPATHY (non-serious) with onset 03Dec2021, outcome "recovering", described as "Swollen lymph node"; PAIN (non-serious) with onset 03Dec2021, outcome "recovering", described as "Aching body"; PAIN IN EXTREMITY (non-serious) with onset 03Dec2021, outcome "recovering", described as "Sore arm". Therapeutic measures were not taken as a result of lymphadenopathy, pain, pain in extremity.  Additional information: Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Small group of vesicles on Left upper outer arm. No redness, no edema. Was given varicella vaccine on 5/10/12. Pt's father called. On 5/11/12 d/t itching. Came in on 5/14/12 & Rx'd hydroxyzine and BACTROBAN ointment for rash.
Broke out in generalized vesiculo-papular rashes 1st noted on chest and face.
Approximately 8-10 hours after receiving the vaccine on 9/22/21, the patient developed sudden onset testicular pain, 6 -7 on pain scale. Pain persisted throughout the night until patient was taken to the emergency room at 0800 on 9/23/21. Patient was subsequently diagnosed with a varicocele on ultrasound. Patient had no prior history of testicular pain or varicocele diagnosis.
Injection site felt itchy; Swollen to about the size of a quarter; the swelling is now about 4'" in diameter, fiery red, and still itchy; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 04Mar2021 at 16:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis multiple joint, spinal stenosis and allergy to nickel since an unknown date and knee replacement on an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN), vitamins and venlafaxine (MANUFACTURER UNKNOWN) on an unknown date ,for an unknown indication and unknown if ongoing.  On 12Mar2021 at 10:00, the patient felt injection site itchiness, and when examined, was swollen to about the size of a quarter. By the time the patient got home from work, it was also red. On 13Mar2021, in the morning, the swelling was about 4 inch in diameter, fiery red, and still itchy. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site felt itchy, swollen to about the size of a quarter and fiery red was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt broke out w/rash 3-4hr p/vax;rash noted mainly on buttocks & interior thighs;pruritus present;instructed by MD to give DPH;15JUL96 rash & itching given by 11JUL96;no further problems;
Swelling and bruising noted at site. Over the course of three months soft mass formed at vaccination site and became painful. Surgical excision of mass to be done on 13 December 2010
had 3 lyophilized parts of the vaccine and no "diluents" / suspect /patients got the liquid adjuvant only; had 3 lyophilized parts of the vaccine and no "diluents" / suspect /patients got the liquid adjuvant only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The reporter was a pharmacy student. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The reporter stated that the patient might had been administered only the liquid adjuvant portion of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that they had lyophilized part of the vaccine and no diluent, so they suspect that patient got the liquid adjuvant only. The reporter consented to follow up by email as HCP had no details at time of reporting. This case had been linked with US2021084246 and US2021AMR084959, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021084246:same reporter US-GLAXOSMITHKLINE-US2021AMR084959:same reporter
Been feeling unwell for more than 24 hours. Very fatigued and this is day 3; Been feeling unwell for more than 24 hours. Very fatigued and this is day 3; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration in the left arm on 10Feb2021 (at the age of 30-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications ("other medications in two weeks") were reported as none. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration in the right arm on 24Jan2021 (at the age of 30-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Feb2021 the patient experienced "been feeling unwell for more than 24 hours. Very fatigued and this is day 3." The patient did not receive treatment for the adverse events. The clinical outcome of the events "been feeling unwell for more than 24 hours. Very fatigued and this is day 3" were recovering/resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Rash developed 8 days after injection just below injection site, felt itchy, hot, and sore. Lasted 2 days. Experiencing frequent diarrhea.
Right thigh - 14.5 x 10.5cm area red, hot, itching, painful
Splinter hemorrhage appeared on thumb of left hand the morning after vaccination Patient had no history of splinter hemorrhages
4-2-21) Injection site soreness and feverish, headache, intermittent runny nose. Took Tylenol. Headache and soreness abated after taking Tylenol. Runny nose lasted about 6 hours. 4-3-21) Dizzyness/vertigo that lasted 5 minutes, intermittent headaches. Called ambulance. EMTs checked vitals, but vertigo had abated, so did not transport to medical facility. Tylenol for headaches. Headaches abated after taking Tylenol. 4-4-21) Headaches. Took Tylenol. Headaches abated after taking Tylenol. 4-5-21 and 4-6-21) No headaches, but slept a lot.
Localized site reaction to (R) arm. 6 x 4 cm warm to touch, pain with palpation.
following adm of MMR/TD pt went into immed grand mal sz; blood sugar accu check 108; BP 138/86;
Approx. 5 hours after vaccine administered, bad headache and fatigue. Injection site and all upper arm became very sore to the touch Approx. 6 hours after vaccine, face became very flushed, hot and inflamed. Lips began to slightly swell                - both upper arms became red and hot, skin flushed                 - headache  and fatigue persisted                 - fever of 99.9  Benadryl taken 8 hours after vaccine, which helped with hot feeling in face and hands, lip swelling went away
redness and "warm to touch" at injection site; redness and "warm to touch" at injection site/red patch; It is swollen and tender to touch/injection site swelling; It is swollen and tender to touch; Red patch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 86 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 11:00 (Lot number: EP6955) at the age of 86 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (unspecified if ongoing), notes: Verbatim: Thyroid. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (1st Dose,first dose lot# EN6204), when the patient was 86 years old, for COVID-19 IMMUNIZATION. The following information was reported: VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "redness and "warm to touch" at injection site"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness and "warm to touch" at injection site/red patch"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "It is swollen and tender to touch/injection site swelling"; TENDERNESS (non-serious), outcome "unknown", described as "It is swollen and tender to touch"; RASH MACULAR (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Red patch".  Additional information: Patient states that with the regular flu shot used to get the symptoms of the flu, but it didn't last long. The patient hasn't had her flu shot for a couple of years. History of all previous immunization with the Pfizer vaccine considered as suspect: no. Additional Vaccines Administered on Same Date of the Pfizer Suspect: no. The adverse event did not required to visit the Emergency Room and Physician Office. Prior Vaccinations (within 4 weeks): no, just the two COVID vaccines.  No follow-up attempts are possible. No further information is expected.
This patient was given a booster dose of 0.25 mL out of the original Moderna vial that was no longer under the Emergency Use Authorization. I hadn't read my e-mail received the day before that it was discontinued and to wait until the bivalent vaccines arrived so I helped a co-worker administer this vaccine. I attempted to call this patient on 9/2/2022 to let them know that they are eligible for a bivalent Booster dose in two months but the patient did not answer and I was unable to leave a voicemail. I e-mailed all of the Primary Care and EMS workers at facility to let them know not to give any boosters until the Bivalent booster vials arrive. I e-mailed facility that I had helped a co-worker administer a booster and they let me know that I needed to fill out a VAERS report on 9/8/2022. I haven't had time to do it but I have time today.
This spontaneous report as received from a physician refers to a 18 month old male patient with none medical history and drug allergies. On 06-MAR-2013, the patient was vaccinated with a dose of VARIVAX (Merck) lot # H016911, expired date 01-SEP-2014, 5 ml, subcutaneous for recommended immunization (dose unspecified). Concomitant medication was reported as none. On 06-SEP-2013, the patient developed an unspecified rash. On 09-SEP-2013, 185 days after onset of therapy, the patient was seen by the physician and was diagnosed by the physician with shingles. Lab diagnostic studies were not performed. The physician prescribed the patient ZOVIRAX for the shingles.  The outcome of unspecified rash and shingles was reported as not recovered. The causality between VARIVAX (Merck) and the events was not reported. Additional information has been requested.
Shot given at 2:45 pm.  At 4:45 pm itching of breast, rash bright redd on neck, ears arms and shoulders blotchy, no resp distress, no difficulty swalling.  At urgent care at 7 pm rash and itchiness mostly gone. some blotches remained given cimetidine 300 mg 1 po q 8hrs x 3 days, prednisone 20 mg 1 po bid x 3 days, benafryl 2 caps po q 8 hrs.
Information has been received from an 83 year old female with "stomach problems," depression, cholesterol high, fibromyalgia, sulfonamide and iodine allergies and a history of being shot in her knee and open heart surgery two years ago, who on 14-JAN-2008 was vaccinated with a "single dose of series" of zoster vaccine live (Oka/Merck). Concomitant therapy included DIGITEX, simvastatin (MSD), DIOVAN HCT, famotidine, LORAZEPAN, OS-CAL and glucosamine. Subsequently, "about a month ago" in Feb 2008 after receiving zoster vaccine live (Oka/Merck) she started to have muscle pain in her upper arms, shoulders, thighs and bottom. The patient also stated her left arm where she received the vaccination hurt and had a red spot for about a week. In addition, she stated she had little red pimples appear at her hair line and on her face that itch, but stated she would put cream on them and it would go away. About two weeks ago, the patient stated the pain had gotten so bad that she had trouble getting out of bed, combing her hair, brushing her teeth, and when lifting her arms to get things out of her cabinet. Medical attention was sought in the physician's office, "blood tests" were performed, and the results came back normal. The patient's physician told her to take extra strength TYLENOL, which she stated has not been helping. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow up information from the physician indicated that this 83 year old female consumer also had hypertension. There was no illness at the time of vaccination. On 31-MAR-2008 the patient recovered. Additional information is not expected.
Upon receiving his second shot, he also experienced fatigue and reportedly felt awful 22Apr2021 with his whole body aching.; Upon receiving his second shot, he also experienced fatigue and reportedly felt awful 22Apr2021 with his whole body aching.; body aching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 21Apr2021 (Lot number: EW0172) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot number=ER2613,, lot unknown=False,, administration date=27Mar2021,, dose number=1), administration date: 27Mar2021, when the patient was 51 years old, for Covid-19 immunisation, reaction(s): "joint pain". The following information was reported: FATIGUE (non-serious), MALAISE (non-serious) all with onset 22Apr2021, outcome "unknown" and all described as "Upon receiving his second shot, he also experienced fatigue and reportedly felt awful 22Apr2021 with his whole body aching."; PAIN (non-serious) with onset 22Apr2021, outcome "unknown", described as "body aching". Therapeutic measures were not taken as a result of fatigue, malaise, pain.  Additional information: No other vaccine in four weeks. On 21Apr2021, (name withheld) reported to me (name withheld) that he has had joint pain since his first shot 27Mar2021. Upon receiving his second shot, he also experienced fatigue and reportedly felt awful 22Apr2021 with his whole body aching. I believe he got vaccinated in left arm but unsure.  No follow-up attempts are possible. No further information is expected.
This patient states one hour after the vaccine was given she started having " hot and cold sweats", her temperature was 100.5, and she was tired. She felt like she had "a really bad flu". The patient went to bed and slept the rest of the day. That evening she stated she was stiff across her shoulders and down both arms. The next day, her temperature was 99.7 and her hand and arm were jittery. She states "she felt better that afternoon".
Patient stated via phone that on 5/14/2021, his upper lip began to swell while driving.  The night of the 14th, he awoke with itching and hives on the left side of his body.  On the 15th, his bottom lip swelled.  On the evening of the 16th, the itching became more intense. Patient has taken benedryl and applied calamine lotion. Both provided temporary relief as symptoms returned later.  Patient is in our county indigent care program and will hopefully get to see a nurse practitioner about his condition.
Headache, fever, chills, started within 8 hours of injection and lasted for 48 hours  Headache continued for 3-4 days after that  In addition, for the next 30-60 days, I had periodic pain in my lymph nodes; it was unspecified, and unpredictable,  but it would occur randomly some time after the 2nd vaccine shot