chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe diarrhea, abdominal cramps, nausea, headache, low grade fever from 99.6 up to 100.3.  Diarrhea subsided  after taking multiple doses of pepto bismol after 3 weeks.  Headache and nightly low grade fever persisted for another 2 weeks.
3 hrs. after administration of vaccine, pt developed angioedema eyes, mucoid d/c from both eyes, vomiting, SOB, rigors, temp 101 degrees. Pt took OTC BENADRYL & symptoms subsided with 12 hrs.
On 10-3-07 received pneumonia and flu vaccine thru the same injection. Patient observed with slight edema and slight temperature elevation.
Aching, Soarness leading to loss of mobility in right arm. Loss of strength. Constant aching
pt stated rt arm was red around inj site & warm to touch approx 2" in diameter;called daughter-in-law who is lab tech & advised pt to take DPH & apply ice pack @ intervals which did give relief by the next day
Arm swollen up/ It looks like a big lump on the top of his arm; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Arm swollen up/ It looks like a big lump on the top of his arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.  No Medical History information was reported. On 25-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2022, the patient experienced PERIPHERAL SWELLING (Arm swollen up/ It looks like a big lump on the top of his arm). At the time of the report, PERIPHERAL SWELLING (Arm swollen up/ It looks like a big lump on the top of his arm) outcome was unknown. Concomitant medication information was not provided by the reporter. It was reported that patient received booster dose. Treatment information was not provided by the reporter. Reporter did not allow further contact.
she later tested positive for the coronavirus infection; This is a spontaneous report from a contactable consumer via Medical information Team. A female (wife) patient of an unspecified age received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she later tested positive for the coronavirus infection (non-serious) on an unspecified date. Caller would like to know if he should get his second dose of the covid vaccine tomorrow as scheduled since he has been in contact with his family (wife and child) who tested positive for the coronavirus. Will there be an interaction between myself and the vaccine. The caller stated that his wife spoke to somebody already. Caller and his wife both received their 1st dose of the covid vaccine however she later tested positive for the coronavirus infection. Caller was advised to quarantine for 17 days, however since he is quarantining at home with people who have tested positive for coronavirus, can he be in contact with the HCPs for his 2nd dose of the covid vaccine. he patient underwent lab tests and procedures which included coronavirus: positive on an unspecified date. The outcome of event was unknown.  Information on the Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
itching and rash on neck area about 15 minutes after vaccine administration. pt refused diphenhydramine
After receiving the Moderna vaccine I began having frequent headaches.  I figured it was a side effect.  But through the weeks they be came more frequent and more painful.  By April the headaches were lasting longer and my head started wanted to reflex (twitch) to release the pressure of the headaches.  I went to my PCP.  She began treatment but nothing helped.  She referred me to a  Neurologist.  The Neurologist I went to sent me for a MRI and MRA and began treatment.  Medication still not helping.  The results on MRI/MRA showed a lot of pressure (IIH), and swelling of the optic.  During this time headaches are last longer and more painful and I started getting other symptoms: Headache behind the eyes, Ringing  in the ears, ear aches, Blurred vision, Nausea and vomiting, Dizziness, Papilledema (swelling of the optic disc in the eyeball), forgetfulness.   A lumbar puncher was done.  I was diagnosed with Idiopathic Intracranial Hypertension.    I am currently being treated for IIH, but treatment has been hard because I have Chronic Kidney and some treatment  is not recommended with Kidney disease.
09/10/2021 I had itchy skin, hives, and swollen ankles, wrists and hips latest for a week. Now it is just itchiness, and rash if it scratch. I spoke with my doctor on Nov 2nd and advised to taken an otc Loratadine.
Swelling, redness ~3.5x3.5 cm, with small vesicles formed at the site of injection and another bigger vesicle ~6 cm away from that site.
Body aches, nausea  - 12 hours, starting 6 hours after shot Fever 99-101 deg - 18 hours, starting 6 hours after shot  Diarrhea- 2 times
Cold; like hay fever type stuff; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0182), via an unspecified route of administration, administered in arm right on 18Aug2021 (at the age of 55-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Sep2021, the patient experienced cold and on an unknown date in 2021, the patient experienced hay fever type stuff. Caller reported that he doesn't think the cold is related to getting the vaccine, he thinks it was being in a lot of yards, like hay fever type stuff, it only lasted about 24 hours or a couple days, the effects from the weekend over the last couple of days. Caller says he treated the cold with Alka-Seltzer Cold Plus, and he is feeling better, though he is not 100%, since there is still a little bit, it is not all the way gone, but he felt good enough that he went to work today. Therapeutic measures were taken as a result of the event (cold) which included treatment with Alka-Seltzer Cold Plus. The patient received second dose on 08Sep2021. The outcome of the event cold was recovering and event like hay fever type stuff was unknown.  Follow-up attempts are completed. No further information is expected.
Patient was given the adult dose of PNEUMOVAX 23, instead of PREVNAR 13, on 12/11/12. Family reports no reaction.
epidural hematoma/abscess- developed fevers, severe back pain, required OR evacuation of hematoma and spinal surgery, will require 6-8 weeks IV abx
I immediately started having menstrual cycle changes after my fianc received the vaccine; This lasted 5-6 months of excruciating cramps, bleeding 50% of the each month with heavy flow; This lasted 5-6 months of excruciating cramps, bleeding 50% of the each month with heavy flow; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Feb2021 (at the age of 28-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 to medications, food or other products. 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. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 12Feb2021, the patient immediately started having menstrual cycle changes after her fiance received the vaccine. Or there after anytime she was around a group of vaccinated and she would get her period 24- 48 hours after. The periods lasted 5-6 months of excruciating cramps, bleeding 50% of each month with heavy flow. Prior to this, the patient had a light period once a month 3-4 days, no cramping. The events resulted in doctor or other healthcare professional office/clinic visit. 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 she immediately started having menstrual cycle changes after her fiance received the vaccine and this lasted 5-6 months of excruciating cramps, bleeding 50% of the each month with heavy flow was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Around 4/29/21 healthy male pt developed a rash on right thigh and the right side of chest.  Pt spoke to medical professionals that he works with and was told it was a case of the Shingles.  The rash was getting worse so he started taking Valtrex.  He has only been taking this medication a couple of days so it has not had time to improve his symptoms yet but he feels like the rash is pretty contained at this point.
Tiredness; Soreness mainly at injection site, but mildly through out my body; Soreness mainly at injection site, but mildly through out my body; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 18Aug2021 at 17:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19Aug2021 at 07:00, the patient experienced tiredness, soreness mainly at injection site, but mildly throughout the body. 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 the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tiredness, soreness mainly at injection site, but mildly throughout the body was resolved on an unknown date in Aug2021.   No follow-up attempts are possible. No further information is expected.
BLURRED VISION; This spontaneous report received from a consumer concerned multiple patients. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On an unspecified date, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blurred vision was not reported. This report was non-serious.
Pt received 2 doses of COVID Pfizer vaccines  - contracted COVID-19 mild symptoms on 8/3/21  Immunizations          COVID-19 Vaccine, PFIZER, External administration 4/27/2021, 4/4/2021       Dose Site Route Manufacturer Lot # Product    4/27/2021 Given 0.3 mL    EW0171  Delete History  4/4/2021 Given 0.3 mL    ER8732
This spontaneous report was received from a physician, referring to a patient of unknown age and gender. Concomitant therapy included sterile diluent. No information was provided regarding the patient's medical history and concurrent conditions. On 28-MAR-2019, the patient was vaccinated with an expired dose of M-M-R II lot # N009172 (expiration date: 20-MAR-2019), for prophylaxis (strength, dose, frequency and route of administration were not reported). No adverse effect was reported.
Pt received 1st Hep-B on 4/9/02. On 4/11/02, pt started vomiting and was afebrile. On 4/12/02, continued vomiting and afebrile. On 4/13/02, had onset of fever (101F) with vomiting. On 4/14/02, fever was 103F with continued vomiting and seen in ER and given Phenergan. PMD felt she had a virus. Since 4/15/02, saw MD and "no gastroenteritis; probable viral; no evidence of abdominal problems; fever 103F.
Patient was waiting 15 minutes after receiving the vaccine and before the 15 minutes were up, he stood up to ask a question to the staff. While walking to the counter patient fainted hitting neck on a stand as well as head on ground.  Staff members came out to approach patient at which time he was conscious. He was able to identify his name/age and speak normally but reported dizziness. Emergency services were contacted and while waiting for them to arrive patient had requested to sit up and was moved slowly to chair. Emergency services evaluated patient and determined he was ok and didn't need to go to hospital and was ok to leave when comfortable.
Patient's mom referred patient started with rash on the evening of 07/29/08.  The rash is present on the neck, face and buttocks area.  Patient was feeling tired and mom referred he felt warm like having a fever (she did not measure his temperature).
Immune response in my thyroid.  Inflammation thru out my body.  Caused also allergies and asthma to activate.
This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated/Small Flair Up) and VACCINATION SITE PAIN (Vaccination site pain/Achy after the Moderna shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Rheumatoid arthritis. Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Second dose, lot number and expiration date unknown) and COVID-19 Vaccine (First dose lot number and expiration date unknown). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine and COVID-19 Vaccine. Concurrent medical conditions included Psoriatic arthritis and Rheumatoid arthritis. On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain/Achy after the moderna shot). On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated/Small Flair Up). At the time of the report, CONDITION AGGRAVATED (Condition aggravated/Small Flair Up) had not resolved and VACCINATION SITE PAIN (Vaccination site pain/Achy after the moderna shot) outcome was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medication information was provided. The reporter's causality for the event(s) of ACHY AFTER THE MODERNA SHOT with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of FLARE UP with HUMIRA(ADALIMUMAB) was a reasonable possibility. No treatment medication information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Live follow up, Medical history was updated. Reporter causality was updated. i-narrative supplement was updated.
--fever begin approximately 24 hours after vaccination and continued intermittently for five days, controlled by Tylenol, just longer than expected 24-48 hours; accompanied by standard symptoms of body aches, etc. for only 24-48 hours  --period started three days early, which is practically unheard of for me; I should have started on Wednesday 2/10, but started on Sunday 2/7; this is similar to my first dose (given on 1/6) after which I started my period two days early on Monday 1/11 instead of the expected Wednesday 1/13; since I'm reporting this so late, I'll also share that my most recent period would have been expected on Wednesday 3/10, but started on Monday 3/8
Dizziness, chills, sweating, feeling faint, and abdominal pain with in 30 minutes of injection.
Skin rash; Fatigue; Body aches; This is a spontaneous report from a contactable healthcare provider reported that a 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, via an unspecified route of administration on 26Jun2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation; and palbociclib (IBRANCE), via an unspecified route of administration from 01May2021 (Batch/Lot number was not reported), at 125 mg for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced skin rash, feeling fatigued and body aches on an unspecified date with outcome of unknown. The action taken in response to the events for bnt162b2 was not applicable, for palbociclib was unknown.  Information about batch/Lot number has been requested.
swollen lip; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen lip) 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 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced LIP SWELLING (swollen lip). At the time of the report, LIP SWELLING (swollen lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Was vaccinated and still got shingles twice/Suspected vaccination failure; Shingles twice; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and and still got shingles twice. The patient stated that no thanks to vaccines. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Diagnosed as erythema multiforme; Developed an all over body rash 9 days after vaccine; Other vaccine same date product: Flucelvax Quadrivalent Serqirus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 20:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 12 years, in right arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT), on 10Oct2022 as dose 1, single (Batch/Lot number: unknown), in right deltoid for immunisation. The patient's relevant medical history included: "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Patient did not have any known allergies. Concomitant medication(s) included: AMOXICILLIN. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0153, Location of injection: Arm Right), administration date: 18Jun2021, when the patient was 11-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0187, Location of injection: Arm Right), administration date: 28May2021, when the patient was 11-year-old, for COVID-19 immunization Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 10Oct2022, outcome "unknown", described as "Other vaccine same date product: Flucelvax Quadrivalent Serqirus"; RASH (medically significant) with onset 19Oct2022 at 06:00, outcome "not recovered", described as "Developed an all over body rash 9 days after vaccine"; ERYTHEMA MULTIFORME (medically significant) with onset 19Oct2022 at 06:00, outcome "not recovered", described as "Diagnosed as erythema multiforme". The events "diagnosed as erythema multiforme" and "developed an all over body rash 9 days after vaccine" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Oct2022) Negative, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of erythema multiforme, rash with Medrol dose pack- d/c after day 1 and Benadryl.  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.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium
Shingles - started with extreme pain in left neck, shoulder, arm, wrist, hand; skin painful to touch; rash developed within 5 days - relatively minor with dry skin, blisters on left shoulder, forearm, and hand/fingers.  Extreme fatigue.  Symptoms lasted so far for 3.5 weeks.
Swelling of left axillary nodules. Acetaminophen for treatment. Time Course once or twice a day prn.
This spontaneous report as received from a registered nurse refers to unknown patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB 2.5/0.5 (Lot# reported as M010611, expiration date 02-JUN-2018; M022077, expiration date 10-MAR-2019; M023718, expiration date 09-MAY-2018) (Dose and route were not provided). Concomitant medications were not reported. The temperature excursion details were 9 degree C for 1 hour 24 minutes, with an additional excursion of 10 degree C for 2 hours for RECOMBIVAX HB lot# M010611, expiration date 02-JUN-2018; M022077, expiration date 10-MAR-2016. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Situation: There was an Adverse reaction to the patient couple of minutes after her Pfizer Vaccine at 9:55 AM PST. The patient advised she felt nauseous and dizzy but she advised that she was pregnant also. At 10:20 AM HR 75, Oxygen 98%, Temp: 98.6, 102/70. At 10:35 AM HR 80, Oxygen 99%, Temp 98.9. At 10:40 AM HR 67, Oxygen 99%, Temp 98.9, 116/78 BP. She sat down since she was shaking and shivering and called her significant other since she was advised not to drive home. The patient indicated she had a Stomach infection that was not treated since she did not want to harm the baby. 10:45 AM She was released with her significant other and 911 was not called.  Patient declined to have EMS activated and was informed by RN to seek medical attention upon discharge.  Patient agreed to seek medical care.