chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have had two Pfizer shots and the booster.   1. Two weeks after my second shot, my period returned even though I was still regularly nursing a baby.   2. Every time I have my period, I get a headache the day before. Prior to the vaccine, I had never had a menstruation-induced headache. I rarely had headaches at all, in fact. Now I get them every month right before my period.
Refused a dose of Rotateq for a patient and the patient missed the dose; No further adverse event reported, no further information; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were not reported.   On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) Lot# 1742434, expiration date : 16-MAR-2023 (exact dose, frequency, anatomical site were not reported) as prophylaxis. The parent of patient refused a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for a patient (product dose omission issue). No additional adverse event reported, no further information provided
Left arm sore improved after first shot as well as after second shot; He had 101.1 degree fever; Exhaustion and extremely tired; His stomach was hurting a lot; lungs felt like someone reach inside inside and punched him in the lungs; Achiness in joint in any place he had problems in the past in his body; nauseated; came right up on Pulmonary oil micro embolism or POEM; This is a spontaneous report from a contactable consumer, reporting for himself.   A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular, administered in the left arm on 15Apr2021 at 12:00 (Batch/Lot Number: EN6204) as 2ND DOSE, SINGLE (at the age of 48 years old) for covid-19 immunisation; and testosterone cipionate (Perrigio manufacturer), via an unspecified route of administration from 2018 (Batch/Lot Number: 2005126.1; Expiration Date: Jul2023), at 200mg/ml. 100mg injected weekly for secondary hypogonadism .  Medical history included hypogonadism from 2018, diagnosed allergies from an unknown date, compromised immune status from an unknown date, respiratory illness from an unknown date, genetic /chromosomal abnormalities from an unknown date, endocrine abnormalities from an unknown date, diabetes from an unknown date, and obesity from an unknown date.  The patient's concomitant medications were not reported. Historical vaccine included flu vaccine over a year ago, and the first dose of BNT162B2 on 24Mar2021 at 12:30 injected intramuscularly in left arm for which he had a mild sore left arm. The patient experienced came right up on pulmonary oil micro embolism or poem  on 16Apr2021 with outcome of unknown, left arm sore improved after first shot as well as after second shot on 16Apr2021 at 13:30 with outcome of unknown, exhaustion and extremely tired on 16Apr2021 at 00:30 with outcome of recovering, his stomach was hurting a lot on 16Apr2021 with outcome of recovering, lungs felt like someone reach inside inside and punched him in the lungs on 16Apr2021 with outcome of recovering, he had 101.1 degree fever on 16Apr2021 at 01:00 with outcome of recovering, achiness in joint in any place he had problems in the past in his body on 16Apr2021 with outcome of recovering, and nauseated on 16Apr2021 with outcome of recovered on 18Apr2021.  Details were reported as follows: 16Apr2021 at 8-9 am he gave himself the testosterone injection and he felt that tickling, rough feeling in his wind pipe like he just had to cough hard. Caller states, "yesterday, 22Apr21, I  gave myself the testosterone injection like I have always done, my wind pipe started feeling like I had to cough, it tickled and felt just like it did on 16Apr21 following the 2nd vaccine dose. I looked my symptoms up on line and found  pome-(pulmonary oil micro embolism)."  The patient underwent lab tests and procedures which included pyrexia: 101.1 fahrenheit on 16Apr2021.  The action taken in response to the event(s) for bnt162b2 was not applicable, and for testosterone cipionate was unknown.
Patient arrived in observation area. Patient began complaining of throat tightening stating "It feels like someone is squeezing my throat." The observation team immediately notified the site lead of the reaction and initiated anaphylaxis protocol. I called 911. One dose of epinephrine was given at 11:53. EMS arrived on site at 12:02. EMS assessed the child and advised the child go to the emergency room to be examined. Mom agreed, but requested she take her by POV. The child was taken to facility for further monitoring.
Fever 100.2 at 3:00 am, Fever 100.5 at 3:30pm Tylenol was taken and warm bath was taken. Repeated body ache and chills throughout course of day beginning at 12:00pm to present time.
This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 06Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient received the vaccine on 06Jan2021. A week after, she started getting itchy on may Wednesday or Thursday. She went outside at night, and maybe got bitten by mosquito bites, but she itched. Saturday night, her back was really itching and she put alcohol on it, and it stopped the itching. On Sunday, it was really getting itchy, and her doctor said to get Benadryl. She got Benadryl by pharmacy. She got vaccine in left arm and her left shoulder got red. She thought it was hives but never seen before and it went away within 5 minutes. When she took the Benadryl, the itching went away after half an hour. Now it's almost 12 hours later, and she's starting to get a little itchy, but not as bad. Her doctor said she needed one more dose of Benadryl. She had also had a very, very slight headache on the right side and she felt her glands were swollen in her neck. All event started on Jan2021. She was due for her next dose on 27Jan2021. Outcome of event itchy was recovering. Outcome of other events was unknown. Information on the lot/ batch number has been requested. Follow-up (18Jan2021): New information reported from a contactable consumer (patient) includes: reaction data (add hives). Information on the lot/ batch number has been requested.
Paraesthesias, pins and needles , began in both feet about 8 hrs after vaccination. One day later, both legs and fingertips, in addition to feet have pins and needles.
Overnight on the 6th - muscle aches, chills, fever, headache, weakness. Starting on Sunday morning the 7th - bad nausea all day with vomiting for 12 hours. Barely able to have an ice chip.
PATIENT WAS GIVEN EXPIRED FLUAD 2021-2022; NO ADVERSE EVENTS REPORTED
- Profuse diaphoresis for 6 hours - Cerebral crawling headache for 2-3 days - Difficulty breathing - Confusion and inability to hold thought for about 3 days
Information has been received from a physician concerning a 16 year old female with a history of seasonal allergies who on 15-AUG-2007 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) IM (Lot #658556/1060U).  Within 10 minutes the patient experienced a tight cough and fainted.  Subsequently, the patient recovered from the tight cough and fainting.  The patient sought medical attention in the office.  Additional information has been requested.
Lady returned saying she had a red area (rash), tender around shot site with a dry skin appearance. Pt said she had had reactions before. Pt had slight fever 100 degrees. Pt said she had blisters (like for 3 weeks).
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Initially vial was stored in the refrigerator on 21-Jan-2022, expired on 13-May-2022 and administered on 26-May-2022.) and NO ADVERSE EVENT (no adverse event) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 031L20A, 025A21A and 051F21A) for COVID-19 prophylaxis. Acute illnesses at the time of vaccination and up to one month before were unknown. Chronic or long-standing health conditions were unknown. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 8:11 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 8:11 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initially vial was stored in the refrigerator on 21-Jan-2022, expired on 13-May-2022 and administered on 26-May-2022.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Initially vial was stored in the refrigerator on 21-Jan-2022, expired on 13-May-2022 and administered on 26-May-2022.) and NO ADVERSE EVENT (no adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (Initially vial was stored in the refrigerator on 21-Jan-2022, expired on 13-May-2022 and administered on 26-May-2022). No concomitant medications was reported. Dose administered after 30-day use by date or after manufacturer date of expiry. The vial did not undergo any temperature excursions. The reporter thought that Moderna had an extension like Pfizer, and it would expire on the 13-Jul-2022 but it was expired on the 13-May-2022, they realize this on the 08-Jun-2022. Number of doses/vials was 5 vials. The used vial was placed in in the refrigerator on the same day of administration (26-May-2022). The event did not cause the patient to seek medical care. It was unknown if there was any other potential causes. It was unknown if the patient experienced a similar event in the past. No treatment medications were provided.
Inflammation and burning sensation in shoulder and along back that also runs down arm accompanied by numbness -still experiencing.
Patient was given a syringe of pfizer on 9/7. Vaccine had been drawn into syringe on 9/3 and was in the fridge until time of administration. Stability once drawn up is 6 hours.
Pain in joints - especially spine/neck; fatigue; indigestion started 11/14/15.
This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-NOV-2016, the patient was vaccinated with an expired dose of VARIVAX, lot # reported as K018944, expiration date: 15-OCT-2016, (dose number, route and anatomical location of administration were unknown). No adverse effect was reported. Additional information has been requested.
Pt received Pneumovax on 05/17/04. She called our office on 05/19/04 c/o arm immediately painful after injection given and continues to be sore. Also broke out with welts, redness at injection area on 5/18/04. States hurts to even move arm on 5/19/04. Saw nurse practitioner on 5/19/04, presented Prednisone 30mg taper Benadryl x 2 days for erythema at site with raised wheals entire upper arm. Follow up appt. 5/25/04 with Dr. Reaction resolved.
ACUTE RESPIRATORY FAILURE 7/12/2022 ESSENTIAL HTN  ACUTE RESPIRATORY FAILURE 7/12/2022 ANOXIC ENCEPHALOPATHY  ACUTE RESPIRATORY FAILURE 7/12/2022 OBSTRUCTIVE HYDROCEPHALUS  ACUTE RESPIRATORY FAILURE 7/12/2022 ESSENTIAL HTN
pt devel high pitched, irritable, unconsolable crying 29 hrs p/vax; PE was neg x/high pitched crying treated homeopathically w/Chamomilla 1m x 2 in office over 1 hr period w/good results;
Information has been received from a female consumer of unknown age referring to herself. The patient's concurrent conditions included high blood (unspecified), diabetes and cholesterol. The patient had no concomitant medication or drug reactions/allergies. In 2013, the patient was vaccinated with ZOSTAVAX (1 time vaccination, dose, lot #, expiration date and route not reported) in arm to prevent shingles. On 24-NOV-2016 (reported as "Thanksgiving 2016"), the patient started feeling tenderness on the skin on her back, back pain and abdominal pain. The patient was taken to the emergency room (ER) (24-NOV-2016 reported as "Thanksgiving Day") and the doctor advised her that she had symptoms of shingles, but there was no rash. Unspecified treatment was given for the event. No laboratory test was performed. The outcome of the event was unknown. The causality between ZOSTAVAX and the event was not provided. Additional information is not expected as there was no consent to contact the physician.
8/12/21 @1407, Clients exhibited anxiety, face numb, and nausea, vomiting,  wheezing, right cheek numbness. Pt. is diabetic.  Vital signed taken x4. @1407, HR130, SpO2 97%, BP 161/108; @1409, HR 130, SpO2 97%; @1411, HR 126, SpO2 97%, BP 145/014; @1425, HR 114, SpO2 97%, BP 146/91; @1439, HR 110, SpO2 97%, BP 152/105. On site EMS called EMT at 1431, assessed client, and put client to a seated position and fluid is offered. Pt. stated that she hadn't eaten today. Pt. was given a sandwich, 911 called, fire department arrived to assess patient, advised to transfer to hospital, Pt. refused and signed AMA at 1452. NP educated patient about proper preparation for second dose, i.e. eat the meal, and hydration. Pt.  verbalized understanding, and left at 1511.
Flu shot 10-2-14 between 12 -1 pm. By 10/3 5:30 AM developed full body itching and rash. Treated with OTC ZYRTEC during day then BENADRYL OTC that night. Denies pain or any loss of function.
Involuntary muscular twitching in finger and face. Started two days post injection without warning. No previous issue with involuntary twitching.
Patient given pediatric dose (10ug) for her first dose of Pfizer. Given adult dose (30ug) for 2nd dose.
weird dreams; upper respiratory cough; extremely tired; covid-19; slight tenderness at injection site; slight redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19), ABNORMAL DREAMS (weird dreams), COUGH (upper respiratory cough), VACCINATION SITE PAIN (slight tenderness at injection site) and VACCINATION SITE ERYTHEMA (slight redness at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (slight tenderness at injection site) and VACCINATION SITE ERYTHEMA (slight redness at injection site). On 13-Mar-2021, the patient experienced COVID-19 (covid-19). On 14-Mar-2021, the patient experienced ABNORMAL DREAMS (weird dreams), COUGH (upper respiratory cough) and FATIGUE (extremely tired). On 18-Mar-2021, COVID-19 (covid-19), ABNORMAL DREAMS (weird dreams), COUGH (upper respiratory cough) and FATIGUE (extremely tired) had resolved. At the time of the report, VACCINATION SITE PAIN (slight tenderness at injection site) and VACCINATION SITE ERYTHEMA (slight redness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included antibodies. Concomitant medication not provided.   This case was linked to MOD-2021-067546 (E2B Linked Report).; Sender's Comments:  MOD-2021-067546:Husband case
Swelling, redness and warmth right arm measuring 10cm x 7 1/2cm. Mom states it started 11/3/16. 11/7/16-phone call to mother, states arm is back to normal.
Information has been received from a physician's employee concerning her 8 year old son who about seven years ago (in approximately 1998) was vaccinated with a dose of varicella virus vaccine live. Within the last month, in August 2005, the patient experienced serious breakthrough chickenpox. Unspecified medical attention was sought. It was reported that the patient recovered. No product quality complaint was involved. Additional information has been requested.
PATIENT REPORTED THE FOLLOWING SYMPTOMS SORE THROAT, FEVER, BODYACHES, COUGH AND FATIGUE.
One week of elevated erythema, warmth, 10x13cm of induration. Rx with Keflex and local Rx.
Came in today for second set of immunizations.  States that following last immunizations he ran a fever the next day between 101 and 102 degrees.  He used Aleve and his fever broke later in the day.  Since then he has been having muscle pain in his shoulders and having difficulty lifting his arms.  He is also complaining of pain in his knees.  He is still taking Aleve on a daily basis.
Lump on my breast parallel to the arm pit and it is not on the side where I was injected, it is on the oppesite side; This is a spontaneous report from a contactable consumer (patient).  A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL926 and expiry date: not reported), via an unspecified route of administration on 03Feb2021 as dose 2, single (Age at vaccination: 76-year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL3247 and expiry date: May2021) via an unspecified route of administration on 13Jan2021 as dose 1, single (Age at vaccination: 76-year-old) for COVID-19 immunization. On 10Feb2021 (After receiving her 2nd dose of the COVID-19 vaccine), the patient has developed a lump in her breast parallel to the arm pit and it was not on the side where she was injected, it was on the opposite side. The patient believes it was a direct result of receiving the vaccine. The lump hasn't gone away, and it hasn't gone down terribly much but she thinks it's going down, but she can't tell (Patient was not sure). The patient did not receive any treatment for the event. Outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
multiple PE and DVT, admitted 3/5/21 on heparin and then eliquis
52-year-old female presents to the emergency department with complaints of left arm tingling sensation which is radiating up her neck to her jaw.  She had just received the second dose of her Materna COVID-19 vaccine.  She was resting in the 15-minute waiting area and only had a few minutes to go when she suddenly developed the symptoms.  She then felt lightheaded and as if she was going to pass out.  They did check her vital signs there and then decided to bring her to the emergency department for evaluation.  On arrival here she states that the arm seems to get more tingling sensation into her fingertips now and she has some tingling on the left side of her face including the left side of her tongue.  She denies any chest pain or shortness of breath.  No cough fever or chills.  No swelling of the lower extremities or calf pain. Patient received Diphenhydramine 25mg IV x1, Famotidine 20mg IV x1, Ondansetron 4mg IV x1, Acetaminophen 1000mg po x1,  1000 ml Normal Saline Bolus x 2 boluses Pt discharged from ER at 1800 1/29/21 MD note on discharge =MD went to the patient's room and discussed her work-up with her.  MD discussed the finding on the CT scan.  They also discussed the findings of the CTA head and neck.  MD reexamined the patient, and she notes that she continues to have some numbness in her right upper extremity and in her mouth, but notes that the numbness in her tongue is improving.  MD offered this patient observation admission, as well as evaluation by neurology with an MRI of the head, however the patient declined this, noting that she would prefer to be discharged home.  Patient lives at home with her husband and child, she is a nurse by occupation, and overall is healthy.  Given that she has understanding into the nature of her pathology, will have somebody at home to help her if she needs it, and will be reliable for follow-up, I am comfortable discharging the patient at her request.  MD extensively discussed return precautions with her, and she verbalized understanding and agreement with the plan
Pt reports back of tongue and throat feel swollen. Pt with no IV access. Pt given Diphenhydramine 25 mg po x 1. Symptoms relieved by 12 NOON.
Client "fell asleep" within few minutes after the shot (unwitnessed by staff); when woke up approximately 40 minutes after the shot he was confused, disoriented, didn't remember having received the flu shot.  He was aware something was wrong - kept saying "this is weird" and "why am I here?".  No obvious neurological deficits other than mild confusion and short term memory loss.   BP 168/100 initially, 190/110 after 15 minutes.  Referred to ER but client left on own with family to go to another ER where he was told he "had a reaction to his flu shot".  Referred to a doctor the next day, who felt he probably had a TIA.  Had brain CAT scan on 12/21/04 (results unknown at this time), scheduled to have an unltrasound on 1/17/05.  Per phone call follow-up on 12/21, client states he felt fine the next morning when he woke up, but was aware of episode from the previous evening.  He and his family state he has never had any similar episodes in the past.
Immediately after receiving the HPV 9 and flu vaccines, the pt. began to feel dizzy. The pt. lay down for ten min., drank some juice and ate a protein bar. Pt.'s vital signs were checked. Once the pt. was feeling better, he left with his mother.
Dose 1 - itchy throat 45 minutes post vaccine.   Sore throat about 3 hours post vaccine. Mild fever,  fatigue, flu like symptoms began 22 hours post vaccine and lasted about  24 hours.  ***** Day 8 developed  "Covid arm". Hive like swelling at injection site. Mildly swollen for about 18 hours, then flattered and began to shrink in size. No trace after 4 days.   Vaccine 2 has been reported to V-safe, so follow up will continue there.
Raging High Blood Pressures - Hospitalized and placed on Heart & blood Pressures 2nd Hospitalization 3/3/21 High Blood Pressure and Mini Stroke It has been 2 months and still have fluctating blood pressures
Received 2nd dose of Shingrix vaccine 7/2/2019 9:30am (1st dose 3/25/19).  No adverse side effects on 1st dose.  Had side effects on 2nd dose: Took 800 mg ibuprofen when I got home to reduce right arm pain at injection site. Woke up approximately 1-2am with painful stiffening and cramping in both hands and shivering because I was cold.  Took another 800 mg iibuprofen.  Injection site still sore. Woke up 7am ? no hand pain or shivering.  Injection site mildly sore.
sick to stomach; fever... threw up several times... very chilled... lasted most of the night...