chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt like my body was hit by a truck; felt like my head was exploding; exhausted; arm pain; hardness and swollen in my other arm like a blood clot; brain fog; suicidal thoughts; I got sick for ten days; Migraine; severe body aches; chills; shakes; dehydrated; saw weird lights when I closed my eyes; hard to breathe; earache; This is a spontaneous report from a contactable consumer reporting for himself.    A 47-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Left Arm on Apr2021 (Batch/Lot Number: ER8734; Expiration Date: Apr2021) as single dose for covid-19 immunisation  .  The patient medical history and  concomitant medications were not reported.  The patient experienced suicidal thoughts on 05Apr2021 04:00 with outcome of recovering , i got sick for ten days  on 05Apr2021 04:00 with outcome of recovering , migraine  on 05Apr2021 04:00 with outcome of recovering , severe body aches  on 05Apr2021 04:00 with outcome of recovering , chills  on 05Apr2021 04:00 with outcome of recovering , shakes  on 05Apr2021 04:00 with outcome of recovering , dehydrated  on 05Apr2021 04:00 with outcome of recovering , saw weird lights when i closed my eyes  on 05Apr2021 04:00 with outcome of recovering , hard to breathe on 05Apr2021 04:00 with outcome of recovering , earache  on 05Apr2021 04:00 with outcome of recovering , felt like my body was hit by a truck  on 05Apr2021 04:00 with outcome of recovering , felt like my head was exploding  on 05Apr2021 04:00 with outcome of recovering , exhausted  on 05Apr2021 04:00 with outcome of recovering , arm pain on 05Apr2021 04:00 with outcome of recovering , hardness and swollen in my other arm like a blood clot  on 05Apr2021 04:00 with outcome of recovering , brain fog  on 05Apr2021 04:00 with outcome of recovering.   Suicidal thoughts was considered an Important Medical Event.  The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.  Follow up information has been requested.
Patient report itching and hives to neck area on the right side and spreading , shortness of breath, patient was assessed by EMS, she was placed on non rebreather mask and transported to Emergency Room.
Fever for 2 days (100 F); body ache; Headache; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jan2022 (Lot number: FJ5682) at the age of 13 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (COVID 19, Pfizer, lot number=EW0168, administration date=11Jun2021, dose number=2, vaccine location=Right arm), administration date: 11Jun2021, when the patient was 13 years old, for Covid-19 immunization; Bnt162b2 (COVID 19, Pfizer, lot number=EW0173, administration date=21May2021, dose number=1, vaccine location=Left arm), administration date: 21May2021, when the patient was 13 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 20Jan2022 08:00, outcome "recovered", described as "Fever for 2 days (100 F)"; PAIN (non-serious) with onset 20Jan2022 08:00, outcome "recovered", described as "body ache"; HEADACHE (non-serious) with onset 20Jan2022 08:00, outcome "recovered", described as "Headache"; FATIGUE (non-serious) with onset 20Jan2022 08:00, outcome "recovered", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain, headache, fatigue.  Additional information: Patient had received treatment for events was Tylenol. No covid prior vaccination. No Known allergies.  No follow-up attempts are possible. No further information is expected.
pt recvd vax & several hrs p/dose 3 pt exp nausea;
leg surgery; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB OPERATION (medically significant) with onset 10Mar2021, described as "leg surgery". The patient was taking a pain reliever for her leg surgery after the 1st dose last 10Mar2021 and asked about the vaccination card since she lost it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Light headed, muscle weakness, achy all over. Kidney throbbing pain. Fever 101.6.
Some little bit of dark brown spot little red places on his thigh; red spots in the face; her husband developed a deep cut in the tongue and it was painful./Tongue being painful; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 13Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date as SINGLE for covid-19 immunization. Patient reported her husband developed a deep cut in the tongue and it was painful/tongue being painful on 14Feb2021 and some little bit of dark brown spot little red places on his thigh, red spots in the face on an unspecified date. Reporter also stated "I just have a question we got our second Covid shot (by Pfizer later clarified) on saturday, sunday night my husband started complaining his tongue being painful. I looked in it, it was like cut on the side of the tongue it was red and deep and I notice this morning that he had some little bit of dark brown spot little red places on his thigh and I didn't know if this was a symptom of possibly the shot that he got". "I think he is getting better but I did want to ask about it." The outcome of event tongue pain was recovering and for other events was unknown.  Follow up (17Feb2021): Follow up information received from a contactable consumer.  Information about the Lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Fever, chills, headache, joint pain, injection site soreness, nausea, vomiting, muscle pain and weakness, abdominal pain.  Difficulty getting out of bed and poor oral intake. Took 3000 mg acetaminophen and 500mg naproxen. Lasted 5am-7pm on 01/08/2021 currently severe side effects subsided to minimal side effects.
swelling; pain; redness; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, pain in arm and erythema. The patient was treated with prednisone. On an unknown date, the outcome of the extensive swelling of vaccinated limb, pain in arm and erythema were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, pain in arm and erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had swelling, redness, and pain on the injected arm from elbow to shoulder. The patient was started on prednisone. No additional information was available. The reporter did not consent to follow up. This case has been linked with case US2019230503 and US2019230505, reported by the same reporter.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium
This spontaneous report was received from a registered nurse via a company representative concerning a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, the patient developed shingles two weeks after vaccination. The shingles were described as contained to one dermatome on the torso (front and back), painful, red with many papules. The patient sought medical attention (contacted nurse). The patient was undergoing pain management at the time of reporting. It was unspecified if any lab tests were performed. The outcome of the event was reported as not resolved. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Patient was mistakenly given a third dose of Pfizer COVID-19 vaccine at a clinic conducted by pharmacy at Care Center.
after 2  months, patient still has sore arm and limit movement of the left arm, possible shoulder muscle injury
Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Mild
Patient received 1ml instead of .5ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received 1ml instead of .5ml) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 17-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient received 1ml instead of .5ml). On 17-Aug-2021, ACCIDENTAL OVERDOSE (Patient received 1ml instead of .5ml) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
POSSIBLE BLOOD CLOT ISSUE; ELEVATED HEART RATE (OVER 100 AT REST); KIDNEY PAIN; NO APPETITE; FLU LIKE SYMPTOMS; SWOLLEN GLANDS IN NECK; SERIOUS BRAIN FOG; DIARRHEA; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to contrast dye.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: unknown) dose was not reported, 1 total, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021 after getting vaccination, the patient experienced elevated heart rate of over 100 at rest for four days. On an unspecified date in JUN-2021 after vaccination, the patient also experienced shortness of breath, headache, kidney pain, diarrhea, no appetite, flu-like symptoms, swollen glands in neck, aches and pains and had severe fatigue. On 14-JUN-2021, after four days of vaccination, the patient heart rate decreased to a healthier range but shortness of breath, headache, swollen glands, extreme fatigue and diarrhea continued. The patient also had serious brain fog. On 21-JUN-2021, after 11 days of vaccination, the patient had a severe shortness of breath and the patient's PCP (primary care physician) directed patient to visit an emergency room in a hospital. The patient took blood test and showed an elevated d-dimer indicating possible blood clot issue. The patient could not perform lung CT (computed tomography) or angiography due to a severe allergy to contrast dye. The patient also had an MRI (magnetic resonance imaging) of brain and ultra sound of the legs and the results were normal. The patient was on day 16 post vaccination at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated heart rate (over 100 at rest) on 14-JUN-2021, had not recovered from flu like symptoms, swollen glands in neck, possible blood clot issue, serious brain fog, and diarrhea, and the outcome of shortness of breath, kidney pain and no appetite was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210660381-Covid 19 Vaccine ad26.cov2.s-Possible blood Clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient received flu shot and two days later developed Guillain-Barré syndrome that confirmed by CSF analysis and EMG/NCS .
Headache, Fever, Diarrhea, chills, body aches, fatigue Narrative:
Injection Site Swelling, Injection site erythema, Injection site pain, Injection site warmth - Information has been received from a nurse practitioner concerning a 5-year-old hispanic female patient  with a history of measles monovalent vaccination in Mexico who on 01-May-2000 was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) reubella virus vaccine live (second generation ) lot #630631/05453) sc in the left deltoid.  Concomitant vaccinations that same day included a first dose of hepatitis B vaccine incombinant (yeast) (MSD) (lot #634144/17413) IM in the right deltoid, a first dose of varicella virus vaccine live (MDS) (lot #633304/07273) SC in the right arm and a fifth dose of diphthoria toxoid (+) pertussis vaccine (+) tetanus toxoid (lot number:  0006r) Im in the left deltoid.  On 03-MAY-2000, the patient experienced a swollen, red, warm, tender area 2.5 inches in diameter near injection site of the left deltoid.  The patient was afebrille.   The patient sought unsepifed medical attention.  Follow-up information from a nurse practitioner indicated that the reacton occurred at the site of the measles virus vaccine live (-) mumps virus vaccine live (+) rubella virus vaccine live (second generation) injection.  The affected area was approximately the size of a baseball and there was no fever or other systemic signs.  Additional information has been requested.
Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006n20a) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and TIMOLOL for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. On 11-Feb-2021, PAIN IN EXTREMITY (Soreness of arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included supplements and timolol in form of eye drops for unknown indication.  On 10 Mar 2021, the patient their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. Action taken was not applicable as the patient received both scheduled doses of vaccine.   This case was linked to MOD-2021-049367 (Patient Link).
patient received the expired vaccine in for their Primary Series.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the expired vaccine in for their Primary Series.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the expired vaccine in for their Primary Series.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the expired vaccine in for their Primary Series.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient received the expired vaccine in for their Primary Series.).    No concomitant medications was reported.  A Female patient received a dose of the Moderna Covid-19 vaccine last week in a clinic. The Pharmacist does not know which dose the patient received the expired vaccine in for their Primary Series.  No treatment medications was reported.
?Moderna COVID 19 Vaccine EUA? : 3 of 4 vials used to administer booster doses were punctured 21 times, instead of the max limit of 20. Vaccine storage, handling and draw were all performed with integrity. Vaccine was stored between 2 degree C and 8 degrees C until time of draw. Each vial was drawn with sequential punctures, and batched for administration. Syringes and vials were inspected prior to moving to administration table. No defect identified. Each of 3 vials where 21st dose was extracted, has all 21 doses extracted within 15-20 min.  It is not known if any patient received any of the 3 "21st' doses". 29 Patients were identified as receiving a booster dose from one of the 3 vials, where a 21st dose was drawn. However, we are not able to verify if any of these 3 "21st" doses were in fact administered.
shortness of breath on Aug 6, shortness of breath and hives on feet and ankles and onset of bleeding all at same time on Aug 7... bleeding was the heaviest of my life and was at the wrong time of the month (not part of my regular monthly cycle)... I experienced none of my usual symptoms with menstrual bleeding (no cramps, no knee swelling/pain, no irritability, no abdominal bloating)... bleeding stopped Aug 14... shortness of breath and heart palpitations, fluttering, irregular heartbeat, fatigue/light-headedness on Aug 12-21
Information has been received from a pharmacist referring to a 54 years old female patient. The patient had no concomitant medication or pertinent medical history. On 28-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (route and dose unknown, lot # M027552, expiration date unknown). On 28-SEP-2016, the patient experienced fever and extreme soreness in the arm where she received the injection within a few hours of vaccination. The patient emailed the pharmacist to seek medical attention. Treatment had been given for the events. No lab was performed. The patient was recovering from the events. The causal relationship between the events and PNEUMOVAX 23 was unknown. This is one of two reports received from the same reporter. Additional information has been requested.
4-16-21:  9:30am began nausea only to continue to worsen, arm swollen, painful, burning sensation, was pretty lethargic most of that day after 11am, slept mostly only awake perhaps a total of 5 hours that day.  4-17-21:   still very groggy, slept most of the day away, took a hot shower hoping to soothe body aches and swollen arm, red, hardness, itchy, awake maybe 7 hours total that day. 4-18-21:  woke for the day at 10:30am. Body aches persist, but feeling more awake and getting back to normal,  painful, burning arm, red, swollen, itchy, hardness at injection site about softball size 4-19-21:  Feeling ok, body aches, arm same as yesterday I have taken benedryl and rotate tylenol and ibuprofren  prn.
Patient received Pfizer COVID vaccine on 3/10/21 (lot # EN6208), 4/7/21 (lot # ER8729), and 12/16/21 (lot # FD7218). On 5/29/22, patient was admitted to our inpatient facility (med/surg unit) with lethargy and failure to thrive secondary to COVID-19 pneumonia and possibly bacterial pneumonia. As of today (7/2), patient is still admitted in the med/surg unit.
first dose on Oct 2019, second had not been given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2019 with batch number 7RK7A and expiry date 26th November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 04-May-2022 Reporter's comment: Pharmacist would like some guidance if a patient received first dose of Shingrix and on the date of reporting, they were planning to give a second dose however, the second shot had not been given at the moment of the call. Consented to follow up by email. Additional Supportive Information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
On 3/2/01, parent reports that pt had approx. 1" hard knot with redness and "felt hot" where shot was given. Occurred on 3/1/01 at approx. 14:30. No temperature taken. 1 chewable Tylenol given to pt. At approx. 20:00, pt had SOB and was lethargic; so was given albuterol. Called PMD on 3/2/01 at 08:45 and got an appt. for 14:30. Child was much improved at this time, 09:00.
16:40-Pt received 1st dose covid vaccine. At 16:45 pt started to exhibit s/s  pale, cold, clammy, sweaty, HR 48, quickly increased to 70, BP 116/71, SaO2 100%, EMS assessed. Pt stabilized within 10 mins and drive home
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 08-OCT-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # K001700 and expiry date: 08-MAY-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Mother stated patient skin color changed within seconds after vaccination was given.  This nurse observed patient laying in mother's lap face pale with jerky head movement.
When we got her up in the morning to change her diaper we noticed some red splotches on her chest & belly. The rash spread all over her body by 7/31/14, I contacted the doctor's office several times with the receptionist being very rude, they finally got back with me at close to tell me it was most likely a virus. I am a stay at home mom, my baby did/does not go out in public often how could it be a virus? I felt they weren't concerned with my childs reaction at all. The rash took a whole week to completely disappear. She also had horrible watery/foamy bowel movements that lasted for at LEAST a month .They were so bad it was burning her baby skin. I did not change anything in my diet or change any products used on her skin, she's breastfed & completely healthy so I know in my momma's instincts that it was all related to the shots.
Pt presents to the clinic c/o itchy, red rash located on arms, back, chest, head since approx. 0500 this morning.