chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received third/ booster dose of BNT162b2; Patient experienced some known/expected side effects (fatigue, chills, pain in arm and fever); Patient experienced some known/expected side effects (fatigue, chills, pain in arm and fever); Patient experienced some known/expected side effects (fatigue, chills, pain in arm and fever); Patient experienced some known/expected side effects (fatigue, chills, pain in arm and fever); some unexpected side effects (nausea, GI distress, vomiting in the middle of the night); some unexpected side effects (nausea, GI distress, vomiting in the middle of the night); some unexpected side effects (nausea, GI distress, vomiting in the middle of the night); This is a spontaneous report from a contactable consumer. An 18-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Nov2021 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patient had no 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 vaccination. The concomitant medication included escitalopram oxalate (LEXAPRO) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as single doses for COVID-19 immunisation. On 07Nov2021, the patient experienced some known/expected side effects fatigue, chills, pain in arm and fever as well as some unexpected side effects; nausea, gastro intestinal (GI) distress and vomiting in the middle of the night. This only happened after the third shot in the night of and day after. No unexpected side effects happened after the second shot. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, chills, pain in arm, fever, nausea, GI distress and vomiting were resolved on an unknown date on Nov2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Developed constant pain originating in right shoulder blade area, wrapping around right under arm to right pectoral on Monday, April 19, 2021.  Diagnosed with shingles on Saturday, April 24, 2021 at after hours clinic and prescribed seven day course of Valtrex to treat shingles.  Still experiencing same pain today, Tuesday, May 4, 2021.
Patient came into pharmacy to report he has a rash or hives that started in the arm he received his Shingrix vaccination in and then proceeded down the arm.  It then spread to the other arm and legs.  Patient treated it by taking over the counter Benadryl.
Itchy and swollen nose/throat. Fever, vomiting, nausea.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 2-year-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). On 14 May 2012 at 11:30 the subject received a 1st dose of PEDIARIX in the left bicep. This dose of PEDIARIX was the subject's 2nd DTaP and hepatitis B and his 1st IPV. On 18 May 2012, 4 days after vaccination with PEDIARIX, the subject experienced swelling injection site and injection site rash. The healthcare professional considered the events were clinically significant (or requiring intervention) as the subject had to return to the physician's office. At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 06 June 2012. The subject received a 0.5 ml dose of PEDIARIX on 14 May 2012. It was reported that the subject experienced a local reaction following administration of PEDIARIX. The subject "did not seem himself" (not being oneself) one day following vaccination, on 15 May 2012. The injection site rash was noted on 20 May 2012, 6 days following PEDIARIX injection. The rash was reported to be the same as of 21 May 2012 and resolved by 23 May 2012. Injection site swelling was noted with onset of 18 May 2012, 4 days following PEDIARIX administration. The outcome of not being oneself and injection site swelling were not known. It was reported that PEDIARIX would not be used for this patient in the future, but alternative products.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with an improperly stored doses of PEDVAXHIB (lot # L006545, exp.date: 16-NOV-2017) (route and dose were not reported). No adverse effects were reported. The outcome of the patient's event was not reported. This is one of several reports from the same source. Additional information has been requested.
Headache. Body aches. Fatigue. Nausea. Chills. Cold sweats. Elevated body temperature. Restless legs, thigh muscle cramps. No energy whatsoever to even go to the bathroom
COVID like symptoms; could not eat; very weak; light headiness; pain from her neck down to her elbow on her left side.n; injection site is yellowish in color about 1 inch round and is black and blue; tried several remedies for the pain but nothing seems to be working; very nauseated; pain from her neck down to her elbow on her left side.n; pain from her neck down to her elbow on her left side.n; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (COVID like symptoms), APPETITE DISORDER (could not eat), ASTHENIA (very weak), DIZZINESS (light headiness) and NECK PAIN (pain from her neck down to her elbow on her left side.n) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included GABAPENTIN for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (COVID like symptoms), APPETITE DISORDER (could not eat), ASTHENIA (very weak), DIZZINESS (light headiness), NECK PAIN (pain from her neck down to her elbow on her left side.n), VACCINATION SITE DISCOLOURATION (injection site is yellowish in color about 1 inch round and is black and blue), PAIN MANAGEMENT (tried several remedies for the pain but nothing seems to be working), NAUSEA (very nauseated), MYALGIA (pain from her neck down to her elbow on her left side.n) and ARTHRALGIA (pain from her neck down to her elbow on her left side.n). At the time of the report, INFLUENZA LIKE ILLNESS (COVID like symptoms), APPETITE DISORDER (could not eat), ASTHENIA (very weak), DIZZINESS (light headiness), NECK PAIN (pain from her neck down to her elbow on her left side.n), VACCINATION SITE DISCOLOURATION (injection site is yellowish in color about 1 inch round and is black and blue), PAIN MANAGEMENT (tried several remedies for the pain but nothing seems to be working), NAUSEA (very nauseated), MYALGIA (pain from her neck down to her elbow on her left side.n) and ARTHRALGIA (pain from her neck down to her elbow on her left side.n) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment tums, Alka-Seltzer, bengay, pain adhesive strips, Motrin, Salonpas pain strips
Fever of 102 f for 3 days , chills, shaking, body pain, head pain, tinnitus, nausea, vomiting for one day , red and painful at injection site , itching for 3 days, lethargic for 3 days, dizzy for 3 days , pain in right ear for 3 days
Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021; dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was infection control manager.  Concomitant medication of the patient was not reported.  There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-491837 (Patient Link).
Mother states 4 days after dose of ROTATEQ baby became fussy, drawing up legs, cry seemed hoarse. This lasted from 8/13/13 until 8/19/13. No fever-Had diarrhea 9 times on day 4 and 5 after vaccine. Day 6 and 7 some loose stools - day 8 normal.
Pt recvd vax 15NOV91 & immed tingling sensation of lt arm; resolved w/in 3 hrs w/o tx;
Redness, swelling, itching & pain from axial to proximal right forearm.
I received my first dose of the Pfizer vaccine through employee vaccination for medical center at about 6:45 pm on 12/16/2020. The same evening, I had no side effects to report. The next morning, on 12/17/2020, I woke up with a sore arm (know this is a common complaint). As the day progressed on 12/17/2020, I became fatigued and developed joint aches. Took a normal dose of Tylenol, took a bath, and went to bed. Went to work at the hospital the following day, on Friday, 12/18/2020. Was fatigued for my twelve hour shift on 12/18/2020. Following my shift on 12/18/2020, I came home, ate a little supper, showered, and went to bed. I did not have much of an appetite at this time. The following morning, I woke up with vertigo, dizziness, slight nausea, and felt a little shaky. I informed my workplace that I did not feel well and my charge nurse instructed me to "see how it goes.' I proceeded to go into work at 0630 that morning on 12/19/2020. Upon arrival at work, I stated that I did not feel well or normal and I was instructed to call the employee health hotline to report my symptoms. I did and spoke with a woman, over the phone. She instructed me to go get a COVID test to confirm I did not have COVID. I told her that I really felt like it had to be from my vaccination, but she insisted I get tested for COVID. She scheduled me an appointment at a walk-in across from our hospital and I went and was tested. I went home to wait for my results and ended up missing the rest of my twelve hour day shift. My test came back negative later that day. the following days, until 12/26/2020, I had nausea when I would wake up. I still had some vertigo and dizziness and fatigue. Today, 12/27/2020, I have felt better. I am a little scared to get my second dose and wanted to report what I experienced.
bilateral palms, bilateral soles of feet, erythematous/swollen; bilateral palms, bilateral soles of feet, erythematous/swollen; Pfizer Bivalent Dose Number: 1; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 33-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Jan2023 at 15:00 as dose 1, single (Lot number: GL0446) at the age of 33 years intramuscular, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "hyperlipidemia" (unspecified if ongoing), notes: Other medical history: hyperlipidemia; "prediabetes" (unspecified if ongoing), notes: Other medical history: prediabetes; "obesity" (unspecified if ongoing), notes: Other medical history: obesity. Concomitant medication(s) included: METFORMIN; SIMVASTATIN. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 04Jan2023 at 15:00, outcome "unknown", described as "Pfizer Bivalent Dose Number: 1"; ERYTHEMA (medically significant) with onset 06Jan2023, outcome "unknown", PERIPHERAL SWELLING (medically significant) with onset 06Jan2023, outcome "unknown" and all described as "bilateral palms, bilateral soles of feet, erythematous/swollen". The event "bilateral palms, bilateral soles of feet, erythematous/swollen" required physician office visit. Therapeutic measures were taken as a result of erythema, peripheral swelling.  Clinical course: AE treatment: Depomedrol 40mg and dexamethasone 4mg, prednisone, hydroxyzine, Clobetasol. It was unknown if other vaccine in four weeks. It was unknown if covid Prior vaccination. No, covid tested post vaccination. Known allergies: KNA.  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 known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2. Based on known drug safety profile, there is reasonable possibility of causal association between the event and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
HE WAS ADMINISTERED MODERNA THAT TEMPERATURE  EXCURSION.  MODERNA ASSURED THAT AT TIME OF VACCINATION THE VACCINE WAS FULLY ACTIVE.
Patient is 60 years old and received a Fluzone Quad High Dose vaccine. According to CDC: Fluzone High-Dose Quadrivalent vaccine is approved only for people 65 years and older. Fluzone High-Dose Quadrivalent is not approved for people younger than 65 years or for people of any age with a history of severe allergic reaction to any influenza vaccine or to vaccine components other than eggs. I
25 min after injection client complains of feeling throat swelling (on inspection throat was swollen) - difficulty swallowing.  Lungs clear by auscultation - no respiratory distress at that time.  Benadryl 50mg PO given - monitored - pt. recovered.
pt devel episode of crying, tighening up 28hr p/vax;pt recv first 2 doses of vax w/no problems x/some crying for a short period p/vax; w/u in progress;possible infantile spasms;
After my second dose my next period did not start. I took pregnancy test every day for 10 days starting 2 days prior to period as my husband and I are trying. I am not pregnant and have yet to start a period. It is now 9 days late. I spoke to my OBGYN and after a series of questions she concluded its probably a side effect from vaccine.
No adverse effects reported; the Patient received improperly stored VARIVAX (lot R023513 & expiration date 8/16/2020). The VARIVAX was reconstituted with properly stored STERILE DILUENT; This spontaneous report was received from a Medical Assistant and refers to a 15 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 13-AUG-2019, the patient received an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023513 with expiration date of 16-AUG-2020, for prophylaxis (route and frequency were not reported), that was reconstituted with a properly stored sterile diluent (STERILE DILUENT MRK) lot# S000130 with expiration date of 23-AUG-2021. No adverse effects were reported.    It was stated that the vaccine underwent a temperature excursion of -14°C (degrees Celsius) to -10°c (-13.2 C) for 46 minutes No previous temperature excursion was done. The call was because of a "data logger".  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1909USA007312: US-009507513-1909USA007177: US-009507513-1909USA007118: US-009507513-1909USA006939:
Immediately after vaccine baby became cyanotic, stiff, arched back and eyes rolled back. Immediately got Dr and O2 sat monitor. O2 sat in 80's while cryying. Go O2 mask which brough sat up to high 80's low 90's. When calm increased too 95%. Called EMS. Baby brought to ER. 2/11/09-records received for DOS 12/15-12/26/08-DC DX:TAPVR with surgical repair on 12/22/08. C/O turning blue after receiving vaccines. Cyanotic spell. Cardiology referral revealed TAPVR. Follow-up: Pt admitted to hospital. And was found to have an underlying condition -Total Anomalous Pulmonary Venous Return, which had not been identified previously.
Patient developed pale pink erythema and swelling below vaccination site.  Given Keflex and prednisone
Moderate tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6207) via unspecified route of administration in the left arm on 21Mar2021 at 10:00 AM (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6202) via unspecified route of administration in the right arm on 28Feb2021 at 10:00 AM (at the age of 41-years-old) as a single dose for Covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 22Mar2021, the patient experienced moderate tinnitus. The patient did not receive treatment for the reported event. The clinical outcome of moderate tinnitus was unknown.   No follow-up attempts are needed. No further information is expected.
pt recv vax 3JUL96 & 4JUL96 pt devel fever, sore throat, aches & pains & presented to ER;pt was not admitted;throat cult was negative;
It's been 5 days since the vaccine. I felt symptoms at around 4 almost 5am. Diarrhea, vomiting, chills, heart racing.
Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 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, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-Apr-2022 Reporter's comments: This case was reported by the patient's husband. The patient had injection site pain after her first dose of Shingrix. The reporter did not consent to follow-up. The reporter did not know lot number or expiration date. The patient was not available to give consent for follow up. Additional Supportive Information: For tolerance of 2nd dose, refer case US2022AMR067953.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR067953:Same Reporter
Pain in arm; This is a spontaneous report from a non-contactable consumer, the patient. A 24-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 09Apr2021 at 18:45 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 12Mar2021 at 18:45 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 16:15, (also reported as 2 weeks later), the patient experienced pain in arm. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination the patient had not been tested for COVID-19.  Therapeutic measures were not taken as a result of the event. The clinical outcome of the event pain in arm was unknown at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Since Sunday 2/14 , pain that comes and goes in both legs. Mostly thighs. Weakness in thighs. Pain feels mostly like tight muscle, but also had nerve like pain in upper outer right thigh for about 1.5 days. Not sure if related to the vaccine. Felt fine from 2/2-2/14.
Injection site very sore but no redness or swelling.   Redness and swelling below injection site with warmth to touch.  Arm is very sore.
This was the patient's first flu shot.  Within 2 minutes of receiving the vaccine she started to complain of loss of vision, feeling very hot and had labored breathing.  911 was immediately contacted.  The patient remained responsive and started to complain of numbness and tingling in extremities.  I gave the patient 50mg diphenhydramine by mouth.  When the paramedics arrived they took her vitals and determined she was having a vagal response.  At this point the patient was feeling better and breathing and eye sight were back to normal.  She refused additional medical treatment from the paramedics and after 30 minutes returned to work by escort.  She remained under close supervision of a co-worker for the rest of the work day.
Severe fatigue, low grade fever, extreme muscle pain, swollen lymph nodes, bruising, constant headache, brain fog
This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 15:00 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunisation. Medical history included type 2 diabetes, thyroid cancer, ovarian cancer from an unknown date and unknown if ongoing. Concomitant medications included metformin, glipizide, levothyroxine, omeprazole. Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Feb2021 15:15 (Batch/Lot Number: EL9265) as SINGLE DOSE for COVID-19 immunization. On 29Jan2021 22:30, The patient experienced severe fatigue, nausea, vertigo, muscle aches, lack of appetite, diarrhea, vomiting and soreness at injection site. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.