chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Highly prurtic rash, worse BLE but has some BUE involvement, no face or neck involvement; sudden onset within last half-hour Scattered red, raised welts that converge in some areas into large plaques BLE and buttocks; dematographism with excoriation noted BLE; minor involvement BUE with patchy redness  Dx: Urticaria; Treated with diphenhydramine hcl 25mg 2 caps po in office and Dexamethasone 8mg IM in office Recheck by phone 2/15/2022 with patient reporting resolution of symptoms.
develops ache; experiencing diarrhea; This is a spontaneous report received from a Pfizer sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Solution for injection; Lot number: UNKNOWN) via an unspecified route of administration on 01Apr2021. On an unknown date, the patient developed ache and diarrhea. The patient took Tylenol for aches and wants to know if she can take over-the-counter medicine like Imodium for the diarrhea. The clinical outcome for the events were captured as Unknown. It was unknown if the reporter a Healthcare Professional. It was unknown if the reporter is the prescribing HCP. It was unknown if the reporter's contact information available to you or a sub-contracted party.  The patient attempted to provide #, caller says that she will just wait on queue.  There was no medical Information: Customer and/or medical inquiry was NOT forwarded or referred.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
One month after my vaccination I was having issues with weight gain/weight loss and not feeling well, doctor check my thyroid every two weeks I had to get blood test because it went over active to under active. I am still dealing with this issues. On July I had hand surgery and the dissolvable stitches was not dissolving. I was having up essives pop up on my  hand and on December is when it the up essive went away. On my blood work it shows I had the antibody immunity.
Developed dizziness about 10 minutes after the vaccine injection. BP 161/81 mmHg and no other associated signs and symptoms. BP fluctuated 136/84 to 150/87 mmHg. Monitored for another 20 minutes without symptoms.
Redness and pain at injection site and it get bigger. Ice pack, Ibuprofen, and antihistamine.
1 blister right hip in diaper area appeared 7/18/01 size of dime and fluid filled.
Pt presented with small scattered papules on back and trunk, arms and face. Diagnosed with chickenpox.
delirious; wheezing; fever up to 102.7; shortness of breath; coughing; slurring; body and face were swollen all over; body and face were swollen all over; new onset of widespread bodily pain; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the right arm on 10Mar2021 at 11:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history included hypersensitivity to iodine contrast, anaphylactic reaction, hypermobile Ehlers-Danlos Syndrome, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) being evaluated for mast cell activation syndrome. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast, estrogens esterified/ methyltestosterone (ESTROGEN/METHYLTES), and other unspecified medication. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 10Mar2021 at 14:00 the patient experienced a fever up to 102.7, extreme shortness of breath on standing, coughing and wheezing, delirious and slurring, body and face were swollen all over. The patient called the doctor on call at her primary care physicians office and treated the symptoms with diphenhydramine (BENADRYL), paracetamol (TYLENOL) and mast cell stabilizers. The patient had a bad flare of ME/CFS symptoms, in Mar2021, for about 7 days. She also experienced a new onset of widespread bodily pain in Mar2021 which didn't go away until the second vaccination. The patient received the second dose of BNT162B2 (Lot: ER8730) in the left arm on 31Mar2021 and had a better experience. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of delirious, wheezing, fever up to 102.7, shortness of breath, coughing, slurring, body and face were swollen all over was resolved with sequel on Mar2021; pain was resolved on 31Mar2021; bad flare of ME/CFS symptoms for about 7 days was unknown.
Patient received dose from vial past the 30-day use by date/vial was initially stored in the refrigerator on 13-Sep-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose from vial past the 30-day use by date/vial was initially stored in the refrigerator on 13-Sep-2021) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from vial past the 30-day use by date/vial was initially stored in the refrigerator on 13-Sep-2021). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received dose from vial past the 30-day use by date/vial was initially stored in the refrigerator on 13-Sep-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Missed second dose of Moderna vaccine due to having had ankle surgery; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose of Moderna vaccine due to having had ankle surgery) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Ankle operation.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of Moderna vaccine due to having had ankle surgery). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose of Moderna vaccine due to having had ankle surgery) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was provided. No treatment  was provided.
Five minutes after the administration of the vaccines, the patient fainted and lost consciousness. He fell over to his left side onto the table. He then has a brief (five-six) second episode of shaking. After this, he regained consciousness, but was dazed and disoriented. We laid him back on the table and observed him for a few minutes. He appeared stable, but did not immediately recall what happened to him. We then call the paramedics who transported him to the nearest hospital  about a half mile away.
induration, pain & erythema @ inj site;lymphadenopathy axillary area;afeb;sx began 24hr p/vax;tx w/cipro;
it was reported that a 32-year-old female patient received TD Adult vaccination, lot # U0518AA, administered in her right deltoid. She returned to the doctor's office the next day with redness and a very painful right deltoid that looked like cellulitis. Doctor prescribed an antibiotic.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid on 11Jul2022 and stopped on 16Jul2022.  The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
Aching at injection site, 11:30pm beginning. Jaw and face pain- 3:00am day after Hot eyes- 3:00am day after Headache (top of skull)- 3:00am day after  Acetaminophen
Reports worsening shortness of breath associated fever, cough however no chest pain, palpitations, nausea or vomiting.  Denies any changes in urinary or bowel habits  -  ED workup significant for tachycardia, tachypnea, positive COVID-19 swab, abnormal lactic acid initial 2.2, 1.3 on repeat after sepsis fluids. (02/23/2022 21:26 EST CT Chest PE W Contrast) 1. Limited examination but no evidence of a large central pulmonary artery embolus.  2. Findings at both lung bases that may just represent some atelectatic changes however infection cannot be entirely excluded Admitted 2/23/22 - 2/25/22.  Previously vaccinated Pfizer 3/18/21; 4/8/21
Employee called the day after vaccination to report an adverse reaction of:  swollen hives at injection site with nausea and vomiting.
w/in 1 mo of having flu pt starting w/burning gums, nasal, resp congestion; since 30NOV93 lost strength in lt hand; 17JAN94 pain in lt chest, total chest & breast pain moved to rt had problems has seen 4 MD;
Some sinus pressure (started day after receiving dose and lasted approximately 24 hours); Including a minor nosebleed; General feeling of lethargy for about 36 hours after receiving dose; Sore arm at the injection site; This is a spontaneous report from a contactable consumer. A male patient of unknown age received 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. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced some sinus pressure day after receiving dose and lasted approximately 24 hours, minor nosebleed, general feeling of lethargy for about 36 hours after receiving dose and sore arm at the injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. On an unspecified date, the event some sinus pressure was recovered after approximately 24 hours of onset and also general feeling of lethargy was recovered 36 hours after receiving dose in 2021. The outcome of minor nosebleed and sore arm at the injection sit was unknown at the time of this report.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
she had mild injection site soreness for a few days after receiving vaccine, this resolved; then severe pain in left upper arm on 7/16/2021 along with numbness, tingling, and weakness in left arm; also facial numbness
I initially gave the vaccine after giving the VIS sheet. The vaccine was tolerated at the time of the shot. I then left the room. As the family was checking out, the PSS noticed he wasn't feeling too well, so a Medical Assistant and a Nurse Practitioner led the patient back to a room. He reported he was feeling dizzy and light headed and said he had nausea. He was told to lay down, was given apple juice, and a cold pack was placed on his neck . RN monitored him until he started to feel better after about 20 minutes later. No other symptoms were reported.
Chronic cough from mid November 2021 through February 2022 so I made an appointment at a clinic where a throat swab was done result was negative for bacteria culture.
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: patient describes shakiness, anxiety, swelling under and around arm, and pain. Reports taking 600 mg ibuprofen on tues and wed  (600 mg po bid on Tues and Wed) "went away a bit and came back a little bit"
redness; arm pain; headache; mild tremor in hand; This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On 2nd June 2019, 2 days after receiving Shingrix, the patient experienced tremor of hands. On an unknown date, the patient experienced erythema, pain in arm and headache. On an unknown date, the outcome of the erythema, pain in arm, headache and tremor of hands were unknown.   It was unknown if the reporter considered the erythema, pain in arm, headache and tremor of hands to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced headache, sore arm and redness but in the evening of reporting day the patient developed tremor in right hands
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received bnt162b2 (BNT162B2), on 01Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "POTS" (unspecified if ongoing); "obesity" (unspecified if ongoing); "allergy to sulphate" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clyndmycin, reaction(s): "known allergies: Clyndmycin"; Augmentin, reaction(s): "known allergies: augmentin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 04Sep2023 to 09Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Severe pain and swellin in left knee,ankle and leg; Severe pain and swellin in left knee,ankle and leg; Severe pain and swellin in left knee,ankle and leg; Severe pain and swellin in left knee,ankle and leg; Severe pain and swellin in left knee,ankle and leg; Severe pain and swellin in left knee,ankle and leg; Great difficulty walking; This is a spontaneous report from a non-contactable consumer, the patient. A 75-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 24Feb2021 (at the age of 75-year-old), as a single dose for COVID-19 immunisation. Medical history included left knee replacement in 2016. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 03Feb2021, as a single dose for COVID-19 immunisation. On 26Feb2021, the patient experienced severe pain and swelling in left knee, ankle and leg and also experienced great difficulty in walking. Since the vaccination, the patient had not been tested for COVID-19. 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. The clinical outcome of the event severe pain and swelling in left knee, ankle and leg and great difficulty in walking was recovering 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.
Left deltoid area, redness and swelling, can move his arm - per doctor's note dated 08/22/2005.
got really very very hyper; brain zaps which is a serotonin reaction in the brain; depression got worse; anxious; achy; immediately got a headache; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOMOTOR HYPERACTIVITY (got really very very hyper), CEREBRAL DISORDER (brain zaps which is a serotonin reaction in the brain), DEPRESSION (depression got worse), ANXIETY (anxious) and PAIN (achy) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LORAZEPAM and BUSPIRONE HYDROCHLORIDE (BUSPAR) for Anxiety, NIACIN for Cholesterol, BUPROPION HYDROCHLORIDE (WELLBUTRIN) and DESVENLAFAXINE SUCCINATE (PRISTIQ) for Depression, AMLODIPINE BESILATE (NORVASC) for Hypertension.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, 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 experienced PSYCHOMOTOR HYPERACTIVITY (got really very very hyper), CEREBRAL DISORDER (brain zaps which is a serotonin reaction in the brain), DEPRESSION (depression got worse), ANXIETY (anxious), PAIN (achy) and HEADACHE (immediately got a headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Headache, at an unspecified dose and frequency. At the time of the report, PSYCHOMOTOR HYPERACTIVITY (got really very very hyper), CEREBRAL DISORDER (brain zaps which is a serotonin reaction in the brain), DEPRESSION (depression got worse), ANXIETY (anxious), PAIN (achy) and HEADACHE (immediately got a headache) outcome was unknown.            Action taken with mRNA-1273 in response to the event/s was not applicable  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: follow up received on 4-may-2021 contain no new information; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
This prospective pregnancy report was received from a 33 year old female patient. On 26-JUN-2016, the patient was vaccinated with VARIVAX for prevention of varicella. The patient took TYLENOL once in a while. The patient received a confirmation she was pregnant on 17-JUL-2016. The patient sought medical attention via phone cell to physician. At the time of this report the patient was 4 weeks pregnant with LMP of 24-JUN-2016 and EDD of 31-MAR-2017. The pregnancy outcome was pending. Additional information has been requested.
2/10 vaccinator went to give vaccine and some amount leaked out onto clothing; unknown amount administered to patient. Upon inspection, it appear Vanishpoint syringe from OWS was cracked and vaccine must have leaked through crack rather than being injected  Infection Control connected with Department of Health who advised second attempt as first dose  2/11 first dose administered (as stated in item 17)  2/12 employee felt unwell and called out sick from work
Pt. rcv'd 1st Infanrix; also rcv'd Hib-Titer at same time. On 4/30/99, pt went to ER w/fever of 104.7 & was hospitalized. Pt. tested pos. for Haemophilus Influenzae; Lumbar puncture revealed frank pus & was pos. for H. Influenzae. Child was
Extreme arm soreness, unable to lift or touch arm without severe pain. Dizzy spells accompanied with ?brain zaps?. Nausea. Fatigue.
administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 51-year-old male patient who received HAB (Twinrix) (batch number dk23d, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th February 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 15th February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Twinrix in left deltoid. The patient was inadvertently administered an expired dose of Twinrix, which led to expired vaccine used. Expiration date was from Company. The reporter did not consent to follow up.
Per patient her arm bleed at time of injection (it has now subsided). Site of reaction is now hurting and in pain.
This spontaneous report as received from a registered nurse refers to an 12 month old male patient with no known drug reaction/allergies and no other pertinent medical history. On 12-JUL-2013 the patient was vaccinated with his one and only M-M-R II, subcutaneous (dose and lot number not provided). There was no concomitant medication. The nurse noted on 20-JUL-2013 that the patient developed a fever, was lethargic, and slept all day. Subsequently, on 22-JUL-2013 at 7AM the patient developed a rash. The rash worsened by 23-JUL-2013 and the patient was seen in the office for medical attention that same day; measles was diagnosed during that office visit. No treatment was given for the adverse event. No lab diagnostic test were performed. The outcome of the event was reported as not recovered/not resolved. The causal relationship was not reported. Additional information has been requested.