chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Post menopausal hot flashes every day; Post menopausal hot flashes every day; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 59-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8731, Expiration date not reported), via intramuscular in right arm on 13Apr2021 14:45 (at the age of 58-year-old) as single dose for COVID-19 immunization at hospital. The patient medical history included: high blood pressure and thyroid from an unknown date and unknown if ongoing. The patient was allergic to stone fruit. The patient concomitant medication included thyroid (ARMOUR THYROID), metoprolol tartrate (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL [IBUPROFEN]). The patient previously received codeine and experienced allergy on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported as unknown whether the patient had COVID prior vaccination. The patient was not COVID tested post vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number ER8727, Expiration date not reported), via unspecified route of administration in right arm on 23Mar2021 14:45 (at the age of 58-year-old) as single dose for COVID-19 immunization. On 20Apr2021 16:30, the patient experienced Post-menopausal hot flashes every day. The patient did not receive any treatment for the event. The outcome of event was not resolved. Follow-Up (16Jul2021): Follow-up attempts are completed. No further information is expected.
Fever, severe shaking, muscle aches, severe headache, pain in chest and abdomen, nausea, vomiting.  Started around 10pm 12/26, mostly subsided by 9pm the next day.
The patient did not have a reaction to this vaccine. I reported this to HD and they stated that this can be counted this 1 time as a tetanus dose.
Information has been received from a health professional concerning a 16 year old female with asthma who on 12-MAR-2008 was vaccinated subcutaneously in the left arm with a second dose of VARIVAX (Merck) (Lot # 659730/1781). There was no illness at the time of vaccination. The date of the first dose was not reported. On 14-MAR-2008 the patient presented with an induration which was approximately 8 cm diameter on her left upper lateral arm, which was warm to the touch, erythema, and tenderness. The patient was treated with Duricef 500 mg PO BID for 10 days for possible cellulitis. The outcome was reported as unknown. No further information is available.
10/18/23 (1 day post vaccine)  Significant swelling, warmth, tenderness to anterior Right thigh associated with limp/difficulty ambulation onset <24hrs after vaccine administration thigh circumference R 1 inch < Left  Patient returned for f/u  10/23/23  6 days post vaccine with complete resolution of symptoms
Cranky and decreased appetite started after he received 5/1 immunizations - developed night sweats, cold symptoms, bruising - hospitalized 5/11/09 - dx leukemia.  7/23/09 Received hospital medical records for 6/9/09. FINAL DX: ALL, T-cell leukemia diagnosed 5/12/09 w/presentation WBC of 614.2 & mediastinal mass. Records reveal patient had experienced irritability, crying,  eye stye & was on oral antibiotics.  This admission for day 29 lumbar puncture, bone marrow aspiration & chemotherapy via mediport. 8/17/09 Received radiation therapy evaluation following chemotherapy. Follow-up: Parents were convinced that his immunizations caused him to develop leukemia. He has T cell ALL and he is currently on maintenance chemotherapy.
Gradual increase of redness and swelling over past three days since vaccines given. Warm to touch and thigh swollen. Dicloxicillin and Benadryl prescribed.
5-10-11: PCV 13 administered (L) thigh. 5-11-11: Mo. called due to swelling at site & limp. 5-12-11: office visit - pt. much improved. No sx nor signs.
Large, baseball sized lump on my arm at the injection site. It started as the size of a marble and over time, a period of three days it grew larger and larger, it was red in color and very sensitive to the touch. after three days it started to "drain" down my arm towards my armpit/underside of my arm and then it was gone.
Sore throat, followed by coughing and fatigue for two weeks. Three weeks after the vaccine, I developed facial pain, arm tingling, and neck pain.
Chronic head pain/ my head had been hurting since April 30th; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Chronic head pain/ my head had been hurting since April 30th) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced HEADACHE (Chronic head pain/ my head had been hurting since April 30th). At the time of the report, HEADACHE (Chronic head pain/ my head had been hurting since April 30th) outcome was unknown.            No Concomitant medication information was reported. No treatment medications were provided.   Reporter did not allow further contact
pt recvd vax; devel fever in few hrs p/ vax; then had convuls;pt taken to hosp where she was adm 8feb95;
TINGLING  ALL OVER HER BODY; BODY TURNED RED AT SOME TIME; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced tingling all over her body, body turned red at some time, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills, and tingling all over her body, and the outcome of body turned red at some time was not reported. This report was non-serious.
Post vax, the patient experienced swelling, redness and pain. The patient was treated with Cephalexin. The patient is still under treatment.
Received Smallpox immunization on 2/26/03. Had noted flu-like symptoms. Developed localized redness, swelling and adenopathy over the past 3 days. Observing.
I received the flu shot and 3 hours after became severely ill. My eye were itching facial and throat swelling. Chills, severe headache,ear ache and massive headache. I almost went emergency room but took BENADRYL and cold cloths to help thru the night. I have the flu shot for 18years never had such a severe reaction.
Chills, fever, aching. Fever measured by me with oral thermometer, 101.  Next day 1/22 better, temp 99.5. All well by 1/23.  Of course, arm hurt, now  5 days later it is just itchy.
Pt. began experiencing SOB and CX pain. EMS performed evaluation including EKG. After speaking with EMS and Dr. on scene, pt. seemed to calm down and symptoms subsided. Pt. signed AMA and family member took her home.
Oct. 17-2014. Decline of neurologic symptoms w/fatigue, ataxia, cognitive changes, neuropathy.
5/1/23: Patient received their first COVID vaccine, but received the 0.2 mL/10 ug from dark pink cap/yellow label boarder instead of the 0.25 mL/25 ug from blue cap/gray label border. 6/14/23: Patient received their first COVID vaccine, but received the 0.2 mL/10 ug from dark pink cap/yellow label boarder instead of the 0.25 mL/25 ug from blue cap/gray label border. On 7/3/23 we noticed "Inadvertent Vaccine - Inadvertent Administration" in his database so we reached out to agency to find out what that meant and were told he received the wrong vaccine. Patient's mother was notified by email and phone call.
Patient received covid vaccine and went to observation room for 15 minutes. While sitting in observation room patient began c/o of dizziness. Staff RN in observation room  elevated patient's feet on a second chair. Patient had normal pulse ox, HR and RR. After another 10-15 minutes, patient began c/o of chest pain and EMS was called. Ambulance took patient to ED.
This case was reported by a physician via call center representative and described the occurrence of shingles in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 18th September 2018, the patient received the 1st dose of SHINGRIX. On 3rd October 2018, 15 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The reporter did not have lot number or expiry date of the vaccine.
Mom noted soon after vaccine there was redness on child's ears and neck on arriving home mom noted hives on stomach, back and legs. Mom gave Benadryl 12.5mg which helped. Mom calls me about 2:30pm hives resolved but now brownish spots on mouth and cheek and where he got the shot. Mom called Dr. and he told her to call me. Told mom to continue with Benadryl every 6-8 hours till hives/rash resolve. Will call on Monday. Told to seek emergency help if trouble breathing, wheezing.
Rash several minutes after vaccination. Rash was blanching small macular lesions. BENADRYL 12.5 mg/5 ml. 2 ml x 1 dose given by mother at clinic.
I had the PNEUMOVAX 23 shot on January 20th 2016 at around 10L50 -11ish am. On that same day, by 2:00 pm, I could not move my arm, it felt very heavy, and with severe pain. The pain was worse the next day, and continued until Feb 1st 2016 I still have muscle pain, but I will cope with this pain.
Itchy; Sore like it burns; Raised (bumped); Red; Ache; Swelled lymph node in the armpit; Arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm was hurting), PRURITUS (Itchy), BURNING SENSATION (Sore like it burns), INJECTION SITE BRUISING (Raised (bumped)) and INJECTION SITE ERYTHEMA (Red) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm was hurting). On 15-Jan-2021, the patient experienced PRURITUS (Itchy), BURNING SENSATION (Sore like it burns), INJECTION SITE BRUISING (Raised (bumped)), INJECTION SITE ERYTHEMA (Red), PAIN (Ache) and LYMPHADENOPATHY (Swelled lymph node in the armpit). On 08-Jan-2021, LIMB DISCOMFORT (Arm was hurting) outcome was unknown. At the time of the report, PRURITUS (Itchy), BURNING SENSATION (Sore like it burns), INJECTION SITE BRUISING (Raised (bumped)), INJECTION SITE ERYTHEMA (Red), PAIN (Ache) and LYMPHADENOPATHY (Swelled lymph node in the armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant product details was not provided by the reporter Treatment Benadryl and "Sertac"   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Email address updated
Infant inadvertently given Pediarix and IPV vaccines on same visit, 2 weeks after HepB vaccine had been given at the MD's office.  Parent reports that child had pain in both legs, with fever up to 101 degrees the night that the vaccines were given.  Slept poorly.  Parent had used Acetaminophen and warm baths.  Did not seek medical treatment.
Patient presented at the pharmacy on 10/12/2020 and had a several inch wide, rectangular-shaped red area on her arm. The area was several inches below and to the side of the injection site. She stated it had gotten larger throughout the day. She said it did not itch and was not hot to the touch.
lump under his armpit; Fever; Chills; This is a spontaneous report from a contactable consumer or other non hcp.    A 19-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection,Batch/Lot Number: EW0157), dose 2 via an unspecified route of administration, administered in Arm Right on 21Apr2021 10:30 as single dose for covid-19 immunisation; ibuprofen (IBUPROFEN), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at for an unspecified indication.History: She says he took ibuprofen and that they all started to have fever and chills.He took ibuprofen. She things the dose was 300mg or 400mg and he took a total of 3 doses .Prior Vaccinations within 4 weeks (List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s)): no. The patient medical history, concomitant medications were not reported. On 21Apr2021 The patient experienced fever, chills, and on 23APr2021 lump under his armpit. The outcome of events was recovered ,On 23Apr2021 and lump under his armpit (axillary mass) was not recovered.  Follow-up (23Apr2021): No follow-up attempts are needed. No further information is expected.
Initial and follow up information has been received from a healthcare professional, concerning a 22 year old caucasian female patient, with allergies to penicillin, amoxicillin and cefaclor (CECLOR) and a recent unspecified infection with azithromycin (Z-PAK) completed just prior to vaccination, who on 11-JAN-2008 was vaccinated IM, with the first dose, 0.5 ml, of GARDASIL (lot #659055/1522U). Concomitant therapy included YASMIN. After the vaccination, the patient experienced dizziness and lightheadedness. She was placed in a reclined position and observed for 30 minutes, and was then able to leave. However, later in the day, she called to report that she was still dizzy, lightheaded, nausea, and she had a low grade fever (temperature not taken with thermometer). On 14-JAN-2008, the patient felt better and had recovered. Additional information is not expected.
sore arm; slight headache.; This is a spontaneous report from a contactable consumer (Patient). A 38-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration on 22Mar2021 11:00 at single dose for Covid-19 immunization. Medical history included before the vaccine, he was exposed to poison ivy and developed a slight poison ivy rash that got worse. The patient's concomitant medications were not reported. In the past patient took when he had this in his hands and face he usually takes a steroid pill like prednisone or cortisol. The patient experienced sore arm, slight headache. The outcome of events were unknown.  Information about batch/lot number has been requested.
EXTREME Dizziness, Fatigue, Joint Pain, Nausea and sounds in left and right ears during moments of dizziness.
Pain in arm, neck near vaccine area.  Has continued, patient has been seen by her primary care physician who is perscribing pain medication.  Called 10/15/2013 to state pain is still in arm, now having problem with fingers.
Within  20 hours aches all over, arm red and sore. Within 24 hours fever of 101. Took advil, went to bed, fever broke during the night and achy-ness began to resolve.  Even 72 hours later arm red, sore and knot.
2-22-07 pt reported feeling dizzy and tired, nauseous, and arm just stopped hurting yesterday, symptoms started day after injection, no lump, no bump at site
15Jul96 Pt recv 1 dose vax. 20Jan98 Pt devel "very mild" outbreak of varicella,less than 50 lesions. Mainly on lower extremities. No fever
My mom, age 84, is currently hospitalized for a thoracic surgery to drain fluid from her right lung. This is related to having a chronic heart condition, including a mechanical mitral valve, but she is still active at her age.  She does live on her own in her own home and does the bookkeeping/ bill-paying so she is still living an active life.  She admitted to the hospital last week on Wednesday Sept 16, 2020. Her surgery took place on Sept. 17.  The night before, on the 16th, she was given a flu shot which I was told was made by  Glaxo Smith Kline "Fluzone Quad" lot B7473  MDC 58160-885-41  exp 6/30/21.  I believe this may be a stronger quad vaccine, using recombinent DNA, with three or four times more hemagglutinin antigen versus standard dose quad activated vaccine, with more reports of adverse reactions in the elderly than normal.  One of my mom?s nurses said her own mother was sick for a day and half after getting her flu shot recently. My mom?s reaction has been severely swollen and black and blue arm including her hand. She complained of pain with the arm during the night before her surgery.  Immediately after her thoracic surgery, her first complaint was the pain in her ?flu shot arm.? She complained she never slept the night of her flu shot due to pain. She complained of headache, back ache, fatigue and weakness. The surgery outcome was bad and she required it to be redone which occurred on 9/24/2020.  I became very concerned when I showed pictures of my mom?s arm to a co-worker (also a nurse) who said her dad?s arm looked just like that after he got a flu shot.  He then started to have fever, weakness, change in level of consciousness and was dead in 2 weeks. Allergy to flu shot was listed as cause of death on his death certificate.  He was doing well before that.  My mom is on chronic blood thinners (coumadin at home and heparin now in the hospital) which the hospital is citing as the reason for the bruising to her arm-- but that does not explain the swelling, pain and other symptoms. The bruising is excessive and not something ever experienced before when she did NOT have a flu shot while on heparin.  She has never had a reaction like this to the flu shot before. I feel her immune response may very well have affected the surgical outcome in which she was left with a full liter of gelatin like blood in the region of the lungs, requiring a second surgery.  My mother only took the shot because it was suggested by the hospital.  I feel this product should NOT be recommended for use immediately prior to surgery.  My mother was seen by a vascular surgeon as a result of the large, hard hematoma to the vaccination injection site. The arm was needed for lab work and IVs (other arm is post mastectomy from many years ago)  but ultimately the flu shot arm could not be used due to compromised condition. It remains darkly bruised from shoulder to finger tips, wrapped with a pressure dressing, swollen and painful. My mother's hemoglobin fell dramatically, at least partially related to this arm, and her ultimate outcome is still uncertain.
14 hours after vaccination I began a fever of 101.5 that lasted 28 hours along with body aches and headaches.  I sweated through several t-shirts during the night, during the day not so bad.  I was taking 600 mgs of acetaminophen every 6 hours during this time.
2 days of terrible chest pain  I didn?t go to the dr because we were in the mountains when the pain started. The people I was with thought it was possibly dehydration or affects to altitude.  It lasted 2 days and began to lessen on the 3rd day.
tenderness at the injections site; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included testosterone injection. Concurrent medical conditions included hiv infection.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness was recovered/resolved.   It was unknown if the reporter considered the injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for himself. The patient received 1st dose on left arm. The patient experienced tenderness at the injections site on his left arm which was hardly noticeable and it was a little sore for a while and then resolved. The patient did blood work every 3 months for 20 years. On 21st December 2020, the patient had hand surgery for dupuytrens. The reporter consented to follow-up. For tolerance of 2nd dose, refer case US2021AMR035399.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR035399:same patient, Same reporter
Developed increasing right shoulder pain with decreasing mobility in late April. By EOM May, I'd lost a large degree of mobility in my right shoulder and was pursuing phsyical therapy. Eventually went for imaging and was diagnosed with frozen shoulder
This case was received from a health care professional on 01 May 2009. It was reported as one of a cluster of three patients; the other two patients' events are captured in case numbers 2009-01931 and 2009-01933. A five-year-old female patient received the following vaccinations on 28 April 2009: a left arm fifth dose of DAPTACEL (lot number C3084AA), and a left arm fourth dose of IPOL (lot number B0475-2). On either 29 or 30 April 2009, the patient's parent reported a red, swollen left arm. The area was treated with cool compresses. Outcome was not reported. Follow-up information was received from the health care professional on 22 May 2009. The patient recovered.
Patient was administered vaccine that was outside of recommended storage parameters. Vaccine was left at room temperature for 23 hours after first puncture at room temperature. Recommended storage is up to 12 hours at room temperature. Patient currently has not reported any adverse effects.
Began with rash on 6/4/10. Has about 30 papules on legs, arms, neck and scalp. Given ATARAX for itching.
Info has been received from an RN concerning a 4 year old healthy female with no medical history or allergies who on 3/4/02 was vaccinated with a dose of varicella virus vaccine live (lot 637957/1882K). The RN reported that on 11/3/05, the pt developed a fever of 101F. On 11/4/05, the pt developed 40 pox. By 11/6/05, the pt's pox were noted to be drying. On 11/8/05, the pt's pox resolved. Additional info is not expected.
Nausea, vomiting, facial hives (2) in evening after vaccine, states too Benadryl and improved next AM. Pt states she gets hives frequently: always carries Benadryl.
Pt complained of pain in arm the day of vaccination. Pt also complained of swollen arm. The swelling ceased and the arm quit hurting. On 3/31/00, the arm became swollen again and started hurting with touch. Pt experienced induration, bruising and redness.
Hives on day 11 post vaccination, taking antihistamine; not yet resolved 54 hours later.
Pt. states that around 1600 pm on 2/3/21 she started having difficulty swallowing along with feeling her heart beat fast.  Pt. states that she went to ER where she was given an epi pen and steroids and observed for a few hours before being discharged from the er to follow up with her pcp. Pt. states that today she is feeling much better and is able to swallow.
Case number PHEH2013US026603 is an initial spontaneous report received from a nurse on 26 Dec 2013. This report refers to a doctor of unknown age and gender. On 26 Dec 2013, when the doctor pulled out MENVEO (batch number: M13051, expiry date: 31 May 2015) from the box, the vial containing the powder broke off and the powder spilled out all over the box and on to the fingers of the doctor. No dose was injected to the patient. No adverse event was reported.