chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Since getting the vaccine I've been dealing with headaches; and pressure that moves around my head and eyes; and pressure that moves around my head and eyes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Jan2023 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (Dose: 3, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 16Jan2023, outcome "not recovered", described as "Since getting the vaccine I've been dealing with headaches"; HEAD DISCOMFORT (non-serious), OCULAR DISCOMFORT (non-serious) all with onset 16Jan2023, outcome "not recovered" and all described as "and pressure that moves around my head and eyes". The events "since getting the vaccine i've been dealing with headaches" and "and pressure that moves around my head and eyes" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, head discomfort, ocular discomfort.  Additional Information: There was no other vaccine in four weeks and no other medications in two weeks. Since getting the vaccine I've been dealing with headaches and pressure that moves around my head and eyes on 16Jan2023. The events received treatment of Magnesium. It was reported that no covid prior vaccination and covid tested post vaccination.   The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Mouth Itching. Increasing Spasmodic Coughing. Immediately took Benadryl. Symptoms subsided.
Severe weakness/paralysis of arms/legs starting a few days after first dose.  Worsening tremors and memory loss/confusion/disorientation also.  Symptoms worsened for next 2-3 weeks until was checked into the hospital with severe neck pain and continued weakness/partial paralysis of arms/legs.  After little recovery was transferred to a rehab facility for 4 weeks of treatment with some strength returning but still unable to walk unassisted.  Currently at a care facility with L3 care with no ability to walk or care for oneself without 24hr care.
Patient rec'd her second dose of the covid vaccine on 4/15 . The next day she experienced fever/chills/fatigue. It progressed to a whole body raised rash and a swollen discolored tongue.  The rash worsened and she saw her PCP on 4/20. The PCP recommended a course of prednisone but the patient declined and is managing symptoms with OTC topical products.  Rash is slowly resolving but her tongue is still irritated and discolored.  She still has significant fatigue.  No unusual reaction after the first dose
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BACK PAIN, NECK PAIN, PAIN IN EXTREMITY, and VACCINATION SITE REACTION (right arm, but all my symptoms are in left side of body) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  .  Concomitant products included MONTELUKAST for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 06-Mar-2021, the patient experienced BACK PAIN, NECK PAIN, and PAIN IN EXTREMITY. On an unknown date, the patient experienced VACCINATION SITE REACTION, JOINT SWELLING, MUSCLE SPASMS, PAIN, PAIN IN EXTREMITY, SWELLING, and INDURATION. The patient was treated with TYLENOL at an unspecified dose and frequency and ALEVE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), BACK PAIN, NECK PAIN, PAIN IN EXTREMITY, VACCINATION SITE REACTION, JOINT SWELLING, MUSCLE SPASMS, PAIN, PAIN IN EXTREMITY, SWELLING, and INDURATION outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that that it is happening for so long and went to her doctor regarding these concerns. Other concomitant medications included Vitamins.
On 10/01 my urine was discolored it was a very intense yellow color that was very grainy, and I had the constant need to urinate. I was very lethargic and by end of day was running a low grade fever of 99.6. That evening I was also experiencing mild chest pains. Over the course of the next week I was having mild right flank pain, but on 10/07 the pain had intensified. I became very weak. I went to Urgent care who sent me to the ER. My blood tests had some elevated levels in my lymphocytes and white blood cell count. My urinalysis came back with minimal blood. I was started on antibiotics, doctors could not provide me with an answer to my pain, although UTI was suspected, there wasnt bacteria in my urine. On October 10th the pain was so intense in my back I went back to the ER, same tests were performed, same outcome, new antibiotic was prescribed. Still being very sick, I made appt with Regular Doctor and my blood pressure was very low. It had been low in the ER too, but I thought that was a misread. It is now October 17th, I still have the right flank pain, and still lethargic, and running a mild fever off and on. I am not on Cipro, the third antibiotic and have another urinalysis and blood test scheduled next week. The chest pain has not been addressed, but also still present.
family members having covid right now; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (family members having covid right now) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced COVID-19 (family members having covid right now). At the time of the report, COVID-19 (family members having covid right now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.  The reporter reported that lot of family members having covid right now, on 2021 November 7,8,9,10. There are 4 family members- 2 males and 2 females. All patients are vaccinated but caller don't know the manufacturer of vaccine.  This case concerns a male patient of unknown age with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. The event occurred on an unknown date after mRNA-1273 vaccine, dose number not provided. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of unknown age with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. The event occurred on an unknown date after mRNA-1273 vaccine, dose number not provided. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
pt recv vax & was shaking, convulsing; to ER;  t 104; pt given apap & t dec;
sharp pain in left shoulder 2 weeks after second dose, followed by numbness in left  hand, loss of feeling and strength, loss of all muscle mass in left hand , diagnoses of Brachial Plexus injury by neurologist.   Have been treating with physical therapy and steroid injections.   At seven months since vaccine injection the condition has worsened and not improved.
Sore elbow/ pain on wrist; Joint mild inflammation; Pain on forearm muscle; Sore arm when picking heavy objects with hand; Numbness while sleeping; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 20Apr2021 at 12:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. 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 COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 30Mar2021 at 12:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 12:00, the patient experienced sore elbow, joint mild inflammation, pain on forearm muscle and wrist, sore arm when picking heavy objects with hand and numbness while sleeping. On 06May2021, the patient underwent for nasal swab COVID-19 test and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. The clinical outcome of the events sore elbow/ pain on wrist, joint mild inflammation, pain on forearm muscle, sore arm when picking heavy objects with hand and numbness while sleeping was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Difficult and painful urination, frequent urination,  excessive burping, very painful body aches, chills, slight fever, inability to sleep from the body aches and pain, constipation
Pt developed rash from injection site down to her elbow that encircled her arm. Stated she had a very difficult time moving her right arm.
Hospital acquired Covid. Tested negative x 2 early in the admission, tested positive on 1/20/22. Also on 1/20/22, patient went from requiring 3L O2 to 7L O2 with increased SOB, headache, started intermittently requiring hi flow oxygen,cough,
PATIENT PROFUSELY SWEATED, UNABLE TO STAND, PALE, UNABLE TO ANSWER QUESTIONS
BODY ACHES; SORE THROAT; EXTREME FATIGUE; FEVER; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient does not have any known allergies. 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 31-MAR-2021 10:00 on right deltoid 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 31-MAR-2021, the subject experienced body aches. On 31-MAR-2021, the subject experienced sore throat. On 31-MAR-2021, the subject experienced extreme fatigue. On 31-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme fatigue, body aches, fever, and sore throat. This report was non-serious.
Case number PHEH2011US02508 is an initial spontaneous report received from a pharmacist on 22 Aug 2011: This report refers to an 18-year-old female patient. She was vaccinated with a dose of MENVEO (batch number: unknown) intramuscularly on an undetermined date. She had already been given the vaccine (MENVEO or MENACTRA) three months earlier in May 2011 also. No other adverse reaction was reported.
Fever; body ache; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL0142, unknown expiration), intramuscular in right arm on 13Jan2021 at 07:15 AM at a single dose for COVID-19 immunization in a hospital.  Medical history included diabetes and high cholesterol.  The patient's concomitant medication included unspecified vitamins. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, unknown expiration) via intramuscular in left arm on 23Dec2020 at 07:15 AM in a hospital. The patient also had known allergies to codeine. The patient experienced fever and body aches on 13Jan2021 at 13:00. The patient did not receive other vaccines in four weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not received treatment for the events. The patient had not yet recovered from the events.
Warm, spreading rash on (R) arm, starting the day following administration. Pt c/o increasing pain and tenderness in area.
12 y.o. boy first time vaccinee given smallpox vaccine as post-exposure prophylaxis for monkeypox.  He was exposed to a prairie dog, and also to father who is confirmed monkeypox case.  On post day 6 had pustular rash on back; by post day 7: 15-20 rash lesions mainly on trunk, in different stages of development papules, vesicles, pustules, each 1-2 mm.  Otherwise asymptomatic and not acutely ill.  Rash is pruritic.  Specimens have been sent.
Woke up with fever and vomiting beginning at 11:30pm.  Fever rose through the night and at 06:30am peaked at 100.2. Was able to get fever down at home, vomiting subsided as well, and was fatigued for remainder of the day at home.
This spontaneous report was received from a physician regarding a 19 weeks old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 14-MAR-2019, the patient was vaccinated with the first dose of ROTATEQ orally for prophylaxis (lot # R034700, expiration date: 16-JUN-2020) (dose was not reported). No adverse effect was reported.
Endometriosis; Period going on for 2 weeks now; Severe period cramping; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 34- year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 (Lot number: FH8030) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Severe asthma" (unspecified if ongoing), notes: Severe asthma. Concomitant medication(s) included: APRI taken for contraception. Vaccination history included: Bnt162b2 (1st dose, lot number: EN6201, administered in left arm.), administration date: 14Feb2021, when the patient was 33 years old, for COVID-19 immunisation; Bnt162b2 (2nd dose, lot number EN6206, and was given in her left arm., Her second vaccine it happened, but she was due for her period at that time. She was on a different birth control then, and still had periods.), administration date: 07Mar2021, when the patient was 34 years old, for COVID-19 immunisation, reaction(s): "Still had periods". The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021, outcome "unknown", described as "Booster"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 11Dec2021, outcome "not recovered", described as "Period going on for 2 weeks now"; DYSMENORRHOEA (non-serious) with onset 11Dec2021, outcome "not recovered", described as "Severe period cramping"; ENDOMETRIOSIS (non-serious), outcome "not recovered", described as "Endometriosis". The event "period going on for 2 weeks now" was evaluated at the physician office visit.  Additional information: patient had concomitant therapy. Patient didn't receive other vaccines within 4 weeks prior to vaccination. After the COVID booster, she got a period, and she has had it for 2 weeks now. It occurred the day after the booster. Actually, she doesn't get a period because of her birth control so this is concerning to her. She has had severe period cramping. She has had this period for 2 weeks now. She has actually gotten all 3 vaccines from Pfizer. Her second vaccine it happened, but she was due for her period at that time. She was on a different birth control then, and still had periods.    No follow-up attempts are possible. No further information is expected.
I started itching that day on the left side. The nurse told me to wait an additional 30 minutes. Since then, sometimes I just itch and it?s uncomfortable. I haven?t changed soaps, perfumes or lotions.
Received at Hospital stayed 10 mins, Nasal FM given, within 20min-reports sore throat, facial swelling, fever 101, muscle aches, headache. Reported by 11/23 fever gone + headache. She also felt after shot her pulse was fast. By 11/24 - facial swelling gone continues as of 11/25 has sore throat + muscle aches. Did not go for MD follow up. No prior hx of a flu shot. No medications, no health problems, 4 children - 2FM-2-IM did fine. Referred for MD advice on further H1N1 vaccine or flu.
Immediately after receiving the vaccine, patient noticed that she had a metallic taste in her mouth. Approximately 4 minutes later she called the attention of a staff member to alert them that her tongue felt tingly. The RN was called to come observe patient, blood pressure taken at this time, reading was 118/82. Patient began complaining that mouth and tongue both felt numb and it was becoming hard to swallow.  EMS was called at this time along with MD. MD directed nurses to continue to monitor patient, while on the phone with MD, patient stated that her chest felt heavy. MD ordered patient to receive 0.5 ml of Epinephrine. Patient received dose of epinephrine. BP taken again at 1:18, 3 minutes after Epi injection, reading was 124/86. Patient began complaining of a "heaviness feeling" in legs at approximately 1:19. Ambulance and EMS staff arrived at 1:21. Ambulance left with patient at 1:26. Spoke with patient at 4:45 pm, patient has made a full recovery and is at work.
aching; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 20 hrs after receiving Shingrix, the patient experienced influenza-like symptoms and pain. On an unknown date, the outcome of the influenza-like symptoms and pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 60 or 61 years. The patient received Shingrix on right arm. The patient experienced flu like symptoms and aching. The symptoms started approximately 20 hours after receiving Shingrix and lasted for 24 hours. The reporter consented to follow up. For tolerance of 2nd dose of Shingrix, refer case US2019AMR184078.
This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 30th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced generalized rash, generalized erythema, blister, generalized pruritus and nerve pain. In August 2018, the outcome of the generalized rash, generalized erythema, blister, generalized pruritus and nerve pain were recovered/resolved. It was unknown if the reporter considered the generalized rash, generalized erythema, blister, generalized pruritus and nerve pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient experienced rash, nerve itching, nerve pain, redness and blisters on the left side of her body. The rash was described as approximately 2 inches long. The caller was unsure of when the symptoms were started, however, the symptoms lasted for approximately 2 weeks before going away.
Received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT PREPARATION ISSUE (Received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT PREPARATION ISSUE (Received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds). At the time of the report, PRODUCT PREPARATION ISSUE (Received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.  The patient received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds and the reporter said it feels it was more than a gentle swirl.
Information has been received from a medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. In July 2015 (also reported as unspecified dates since 01-JUL-2015) the patients were administered an unspecified number of improperly stored doses of ROTATEQ (oral, lot#, strength and dose were unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers to a female patient. The patient received a first dose of RECOMBIVAX HB (Lot #, dose and route not reported) "one year ago" and would receive a second dose today. No adverse effects were reported. It was not known if the patient sought medical attention. Additional information has been requested.
This spontaneous report as received from a healthcare professional refers to a 4 year old patient. On 23-MAY-2014 the patient ws vaccinated with (Oka/Merck) VARIVAX (lot # J012377, expiration date 13-OCT-2014, dose and route not reported which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Rash Tightness of chest next day.  Benadryl + steroids.
10/05/2021 around 2-3PM. I started feeling difficulty breathing and I passed out. Dose 1- I felt normal the first days. The 2nd day I felt fatigue and low fever. March 22/2021 dose 2- extremely tired, fatigue, low fever only. March 27/2021 I had difficult breathing, my body was shaking, I felt my heart palpation was rapid. My heart beat was 220 per minutes. It was very very bad. I called my doctor and he checked my records  that my heart was very fast  than normal. I was admitted in the hospital for a day and had a heart surgery ( where they burn your heart). My heart still goes up and down. It gets high and sometimes low.
16MAY92 temp elevation 104.8; to ER 930PM dx & treated for bilateral ear infection;