chrisvoncsefalvay/vaers-outcomes huggingface dataset:
AFTER PATIENT WAS VACCINATED WITH JANSSEN VACCINE AND WAITED 15 MINUTES, SHE SAID SHE FELT FINE AND LEFT THE PHARMACY AREA TO SHOP.  A LITTLE WHILE LATER A EMPLOYEE ASKED US TO HELP BECAUSE A LADY WAS GOING TO PASS OUT.  WE WENT OVER AND TALKED WITH THE LADY AND WALKED HER TO THE PHARMACY.  SHE WAS COMPLAINING OF SWEATY, CLAMY, LIGHT HEADED, DIZZY AND FELT LIKE SHE WAS GOING TO FAINT - VASOVAGAL SYNCOPE SYMPTOMS.  WE HAD HER SIT DOWN, GAVE HER A BOTTLE OF WATER AND THEN HAD HER LAY DOWN.  WE ALSO GAVE HER SOME COOKIES BECAUSE SHE WAS HUNGRY.  WE ASKED IF SHE WANTED US TO CALL EMS BUT SHE REFUSED.  AFTER LAYING DOWN FOR ABOUT 35 MINUTES HER HUSBAND CAME AND SHE WAS FEELING BETTER.  HUSBAND TOOK LADY HOME. WE TOOK HER BP (112/67) AND PULSE (74)
A report was received from a health care professional on 12/02/03 concerning a 65 year old male vaccinee who inadvertently received two doses of Fluvirin on unspecified dates, two weeks apart. On unspecified dates a 65 year old male vaccinee inadvertently received two doses of Fluvirin, two weeks apart. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
pain/burning sensation  in right shoulder joint, numbness in elbow, and sometimes into forearm and fingers on right hand
This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN0179), via an unspecified route of administration (at the age of 57-years), administered in arm right on 11Aug2021 at 16:30 as dose 1, single for COVID-19 immunization. Medical history included diabetes mellitus from 2020 to an unknown date additional Information for other conditions: found out last year. There were no concomitant medications. The vaccination was administered at hospital. On an unspecified date in Aug2021, the patient experienced burnt mark on her right arm/dark patch on her right arm, her iron level is high, soreness and muscle spasms. Caller was calling about receiving the first dose of the Pfizer Covid-19 vaccine; her iron level is high per DSU agent. Caller is a 57 year old female who received the first dose of the Pfizer Covid-19 vaccine on 11Aug2021 and states that she is not calling because of her iron level is high. Caller states that after the first dose of the Pfizer Covid-19 vaccine that she had complaints of soreness, muscle spasms, and a burnt mark on her right arm. Caller describes the burnt mark as a dark square that was at her injection site on the right shoulder. Stated that it looks like a suntan; one part is darker than the other. Caller was asking if a burnt mark at the injection site is a side effect that has been re-ported for the Pfizer Covid-19 vaccine? She got her shot, she got something on her arm, a patch, or dark mark on her arm, like it was burnt. Is that normal? Caller mentions she was driving. Adds her next dose on 01Sep2021. Caller reported that she noticed the dark patch on her right arm; she thought it was where the band aid came off; but it looked burnt; a couple of days later after the vaccination she noticed it. It is staying the same. Caller asked can she call back because she has somewhere to go? She does not have time to finish the report right now. Received follow up call from consumer regarding the Pfizer COVID 19 Vaccine. She just spoke with someone at Pfizer Drug Safety and had to run into the store, so she was calling back. She would like to know what was wrong with her iron. It is high after taking the first dose of the Pfizer COVID 19 Vaccine. She did not wish to provide an email or date of birth. There was no product complaint to report. Medical information request: She would like to know what is wrong with her iron. It is high after taking the first dose of the Pfizer COVID 19 Vaccine. The patient underwent lab tests and procedures which included blood iron: high on and unspecified date and her iron level is high. The clinical outcome of the event burnt mark on her right arm/dark patch on her right arm was reported as not recovered while for other events was reported as unknown.
pt recv vax; inconsolable crying x 3-4 hr; low grade fever; pale & listless; v several times; still irritable & lethargic >72 hr p/ vax;
We are reporting a vaccine administration error.  The needle was not fully screwed into the syringe at the time of administration. When the vaccinator began injecting the vaccine, there was leakage at the site.  It appears approximately half the dose leaked out of the syringe. We have contacted Moderna to determine next best steps.
The evening of my Moderna vaccine I began menstruating.  I am currently taking Lo-Estrin birth control pills and I am in the second week of the pack.  The second night following my Moderna vaccine I was still menstruating.  This indicates to me that the vaccine interferes with the birth control pill.
Headache and pain down right side of neck within 7 hours. Fever 12 hours after for 48 hours. Foggy words not coming out right 2 days after 2nd shot still l at 4 days later
After receiving vaccines: Hepatitis A, MCV4 #2.  Client became very pale, clammy, c/o nausea and dizziness. Time:  12:07 PM  B/P 110/70. Cool pack applied to clients neck, soft drink and foods were given to client to eat.
Since my second Pfizer vaccine for Covid, I have experienced, black floaters, times of slurred speech, veritago. Today I had to call my daughter to meet me because I was having partial blindness in my left eye, severe head pain. I felt blinding pressure behind the left eye and lasted for 2 hours. I now have a severe headache and visual pain.
after the first dose of Shingrix a patient developed shingles; This case was reported by a pharmacist and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the dose a few months ago from date of reporting. The reporter stated that the patient developed Shingles after the dose of Shingrix.  This episode of shingles was not as bad as her previous cases.  No other information was available.
I noticed symptoms with my blood pressure and irregular heart beat in February of 2022. My heart skipped a beat in March and I went to the doctor. I was given a Holter monitor to determine what was going on. At that point it was discovered that I had pre ventricular contractions and 6% of heart beats were those. I was prescribed metoprolol. I have a follow up with a cardiologist and an echogram.
I fainted, I hit my head when I fainted; I fainted, I hit my head when I fainted; Tiredness; Headache; Muscle pain; Chills; Joint pain; Nausea; the arm hurt; This is a spontaneous report from a contactable consumer (patient). A 38-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left on 02Apr2021 at age of 38-year-old (Batch/Lot Number: ER8733) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were none. On an unspecified date in Apr2021, the patient got the tiredness, headache, muscle pain, the chills, the joint pain, the arm hurt, nausea, and then on 06Apr2021 patient fainted, I hit head when the patient fainted. Treatment in response to events was none. The outcome of the events was unknown.
fever first noted approx. 42 hrs after vaccines given.  fever as high as 104.3.  fever lasted 4 days.  fever responded to Ibuprofin, but continued to hover between 100-101 until the fifth day.
Pt developed idiopathic thrombocytopenic purpura. He presented with sudden onset of petechiae.
Diagnosis: Bells Palsy 12/11/09. Right facial drooping noticed on 12/11/09 at 7:00 am. No other symptoms.
Nauseous, weakness, drop in BP. EMS evaluated and cleared when patient was stabilized.
Febrile with 102.5. Severe pain to L arm (at vaccination site). Unable to abduct arm laterally or anteriorly. Fatigue, chills, body aches.
Immediate itching, knot @ injection site on day 2 & beyond area red & warm to touch.
Pt received SHINGRIX on 2/22/18. From 2/24/19 pt started having increasing pain in the arm. It progressed and pt noticed rash on back. Pt was seen in clinic and treated for shingles with VALTREX 1GM one 1d x 7 day. Prednisone 40 mg x 5 days. Calamine lotion 4-5 x daily for itchiness. Ibuprofen for pain.
(1) Hives occurring approx 25 hours after vaccine administration (MMRV, DTaP, IPV)-treated with Benadryl and resolved (2) local swelling (L) arm at site of DTaPs IPV over deltoid extending to within 1 inch of elbow
fatigue; nausea; no taste; headache; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (Comirnaty, Formulation: solution for injection, Lot/Batch not provided, expiry date not provided), via an unknown route of administration, administered on 24Aug2021, as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received his first dose on 24Aug2021, Since then consumer confirms that since vaccination he has experienced fatigue, nausea, no taste and a headache. He was still experiencing these symptoms to date and he confirms he would like to know if this is normal. The patient also enquired whether should he got tested for the actual virus. The outcome of events was not recovered.   That information on the Lot/batch number has been requested
Local allergic reaction, patient was evaluated at ER dept. (R) arm vaccine site redness and fever. Redness increased in size 24hr. after immunization given.
Mom brought child to clinic and requested the covid vaccine for her child.  Mom reported child's dob.  During the visit, staff asked mom 3 times to confirm child's dob. Each time she reported the same dob.  Staff asked mom the age of the child, mom stated "he is 5 almost 6".  Pediatric Pfizer 5-11 years was then administered to child.  After administering the vaccine, the child's dob was verified in System differently.  After administering the vaccine, the child's dob was verified in Medical Records.  Child was 4 yrs old and 9.5 months at the time the vaccine was administered.
Breakthrough case admission after 3 vaccines ; Pfizer 2/18/21 lot# EN6200;  Pfizer 3/11/21 lot# EN6207;  Pfizer 9/1/21 loT# FC3183;
103 temp second and third day,  very achey all over, feels like I have the flu, headache, cough that hurts, thick flem when I cough, slight smell change(hard to describe)  Been taking Tylenol and ibuprofen, Vit C, Vit D3, drinking more water and juice
This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On unspecified dates, patients were vaccinated with improperly-stored doses of PNEUMOVAX23 injection, (strength and dose were not reported) (lot # M036728, expiration date 20-MAY-2018, 23 vials/ lot # reported as "N005597", expiration date 19-OCT-2018, 23 syringes) for prophylaxis. According to the reporter, PNEUMOVAX23 doses were exposed to the following temperature excursions: 51 hours between 32 degrees Fahrenheit (F) and 35F, and for 14 hours and 15 minutes between 47F and 77F (60F). No adverse effects were reported. A digital data logger was involved. This is one of several reports from the same reporter. Additional information is not expected as the reporter refused additional contact.; Sender's Comments: US-009507513-1705USA000386: US-009507513-1705USA000387:
This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis on upper arms) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis. Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis). Concomitant products included BETAMETHASONE for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) UNK dosage form. On an unknown date, the patient experienced PSORIASIS (Psoriasis on upper arms). At the time of the report, PSORIASIS (Psoriasis on upper arms) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No treatment medications were reported.
Systemic: Rash (other than injection site)-Medium, Systemic: Other- HIVES
He reported that after receiving vaccine he has rash on his ankle; This spontaneous case was reported by a consumer and describes the occurrence of RASH (He reported that after receiving vaccine he has rash on his ankle) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported. No concomitant medication reported.     On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced RASH (He reported that after receiving vaccine he has rash on his ankle). At the time of the report, RASH (He reported that after receiving vaccine he has rash on his ankle) outcome was unknown. Not Provided
Arm pain; Severe dizziness next day that lasted 3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 11:30 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: ZOLOF. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Mar2021 13:00, outcome "not recovered", described as "Arm pain"; DIZZINESS (non-serious) with onset 10Mar2021 13:00, outcome "recovered" (13Mar2021), described as "Severe dizziness next day that lasted 3 days". Therapeutic measures were not taken as a result of pain in extremity, dizziness.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Zolof 200 mg. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown age and gender. Medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX 1 vial or 1, almost 0.6 ml, lot number, expiration date and route were not reported. Concomitant therapy was reported. The pharmacist informed that on an unknown date, she reconstituted ZOSTAVAX with sterile water diluent and ZOSTAVAX vial which resulted in an under filled vial of almost 0.6 instead of the required 0.65. The vaccination was still given to the patient. No adverse symptoms were reported. The patient did not seek medical attention. A PQC was filled. This is one of several reports from the same source. Additional information has been requested.
testicles swelled extremely large, extremely painful; testicles swelled extremely large, extremely painful; Testicle cysts; testicles, they're smoked, they're not coming back in their former glory; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (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: TESTICULAR SWELLING (non-serious), TESTICULAR PAIN (non-serious), outcome "unknown" and all described as "testicles swelled extremely large, extremely painful"; TESTICULAR CYST (non-serious), outcome "unknown", described as "Testicle cysts"; TESTICULAR DISORDER (non-serious), outcome "unknown", described as "testicles, they're smoked, they're not coming back in their former glory". The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Patient is a nurse by trade and she stated that she felt the shot was given too high on her shoulder.  She believes that the needle "hit a nerve and triggered a panic state in her body."  She felt an aching in her arm.
Patient due to extenuating circumstance, received intermixing of vaccines. First vaccine product was Moderna, and second vaccine product was Pfizer. Patient was given the option of receiving Moderna at another clinic, but due to mobility constraints, patient requested we give him Pfizer.  Vaccine was administered 28 days post 1st vaccination.
At 1:10 pm on Feb. 11, 2021 received vaccine in upper left arm.  Felt fine, very little arm soreness, no other reaction.  Around 8:30 pm that evening started getting terrible stomach cramps and then terrible diarrhea started.  Continued with awful stomach pains and diarrhea for about 2 hours.    Had somewhat of a headache and chills.  Next morning felt better but still had slight stomach cramps and slight diarrhea., felt cold.   Better 3rd day.
Fever of 103, Chills, Body convulsions, shaking,vomiting, chest pain on left side, stiffness on left side of body, weakness of the body, unable to stand long period of times, on going night sweats, migraine.
Inflammation, erythema no induration, tenderness at injection site 24 hours after administration treated as cellulitis with 10 day course antibiotics.
Case number PHEH2013US023210 is an initial spontaneous report received from a pharmacist on 04-NOV-2013. This case refers to a 15-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 006011A and expiry date: JUN 2014) at dose of 0.5 ml intramuscularly on 01 NOV 2013. No adverse event was reported following this administration error.
48 hours post vaccine - patient developed hives on neck, arms, hands, trunk, legs, feet that were red, blistery, itchy.  Symptoms reoccurred for 8 days.  No symptoms on 9th day post vaccine.
Pt developed Rt Inguinal lymphadenopathy seen by MD on 06/26/02.
Dizziness, nausea, fainting, chills, soreness at injection site, fatigue
This case was reported by a nurse via sales rep and described the occurrence of swollen joints in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swollen joints and itchy rash. On an unknown date, the outcome of the swollen joints and itchy rash were unknown. It was unknown if the reporter considered the swollen joints and itchy rash to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient was vaccinated with the 1st dose of and developed a unilateral incredibly itchy rash on torso, elbow and knee. The patient's joints also blew up.
giving two IPOL doses with no adverse event; Initial information received on 22-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female patient who received two ipol doses (IPV (vero) [Ipol] and diphtheria-15/tetanus/5 HYBRID AC pertussis/IPV (MRC5) vaccine[Quadracel]) with no adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On 22-Mar-2023, the patient received 0.5 ml (dose 4) of suspect IPV (VERO) (frequency- once, strength- standard, lot number and expiry date - not reported) via intramuscular route in the left gluteus medius and 0.5 ml of (dose 5) of suspect diphtheria-15/tetanus/5 HYBRID AC pertussis/IPV (MRC5) vaccine (frequency - once, strength - standard, lot C5970AA via intramuscular route in the left deltoid for prophylactic vaccination (immunization).  On 22-Mar-2023 the patient received two ipol doses with no adverse event (extra dose administered) (latency: same day)  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA093619:linked report
Patient received this vaccine on 7/3/18 and denied any pain, discomfort, or rash until 7/6/18. On 7/6/18 she noticed a rash near the site of the injection, measuring about 3" by 3".  It was warm to the touch. It was not raised or infected in appearance.
Menstrual cycle disrupted for 4 months after vaccination; This is a spontaneous report from a contactable consumer. A female patient of unspecified age 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 and also the patient previously received the second 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. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient had received any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced menstrual cycle disrupted for 4 months after vaccination. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event menstrual cycle disrupted for 4 months after vaccination was unknown 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.
I had swelling, itching, and raised bumps on my left arm that lasted 8 days. It started 8 days after the shot and it was about 4 inches and it was huge an uncomfortable. I went to the emergency room. They gave me Cortisone pills and antibiotic. They said it was covid arm.
Pt received flu vaccine on 12/1/00 in left deltoid. On 12/14/00, pt complained of some pain at site and returned to clinic on 1/25/01 with severe pain, needle-like feeling in the area and swelling. MD noted some irregularity in area. Comfort measures employed, NSAIDS and pt referred to physical therapy.