chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chloride level 110 mmol/L; Bili total 1.1 mg/dl; Cholesterol 212 mg/dl; Respiratory rate (12 br/min); sick with respiratory virus; 142 mmHG; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "mild asthma", start date: 2016 (ongoing); "overweight" (unspecified if ongoing); "Allergies", start date: 2016 (ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE] oral taken for asthma, hypersensitivity, start date: 2016 (ongoing). Vaccination history included: bnt162b2 (Dose 1, Single, Intramuscular, Arm), administration date: 01Jan2021, for COVID-19 Immunisation; bnt162b2 (Dose 2, Single, Intramuscular, Arm), administration date: 02Feb2021, for COVID-19 Immunisation; bnt162b2 (Dose 3 (Booster), Single, Intramuscular, Arm), administration date: 09Sep2021, for COVID-19 Immunisation; bnt162b2 (Dose 4 (Booster), Single, Intramuscular, Arm, Time: 18:15), administration date: 03Mar2022, for COVID-19 Immunisation. The following information was reported: BLOOD PRESSURE SYSTOLIC INCREASED (non-serious) with onset 25Apr2023, outcome "unknown", described as "142 mmHG"; RESPIRATORY TRACT INFECTION VIRAL (non-serious) with onset 25Apr2023, outcome "unknown", described as "sick with respiratory virus"; RESPIRATORY RATE DECREASED (non-serious) with onset 22Sep2023, outcome "unknown", described as "Respiratory rate (12 br/min)"; BLOOD BILIRUBIN INCREASED (non-serious) with onset 26Sep2023, outcome "unknown", described as "Bili total 1.1 mg/dl"; BLOOD CHLORIDE INCREASED (non-serious) with onset 26Sep2023, outcome "unknown", described as "Chloride level 110 mmol/L"; BLOOD CHOLESTEROL INCREASED (non-serious) with onset 26Sep2023, outcome "unknown", described as "Cholesterol 212 mg/dl". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Mother and sisters all took BP meds.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335763 Same patient/ product, different dose/event;
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and advised vaccine maintained activity necessary to protect against covid 19 on date vaccine was administrated. Also patient did not call in to advise of adverse event.  This is administrative error without adverse event.
Urticaria on face, limbs, arms, and legs. Recommend benadryl q 4hr, Zyrtec prn, refer to allergist for evaluation.
pain and swelling on vaccination site pain radiates arm to shoulder to under arm down side; muscle ache around site pain down to wrist + fingers
started w/nausea & vomiting 28DEC92 afternoon cont intermittently into next day 29DEC92; 7-UP helped settle stomach; seen by MD no tx 11JAN93 devel rash;
Noticed early this morning a large swollen area above  my left clavicle. This was about 36 hours after my vaccination.
Site: Bruising at Injection Site-Mild, Additional Details: Patient presented green bruise with slight capillary rupture under the skin. Claims started 8 days ago on day of vaccination
The patient received a flu vaccine around 1:30 - 2 pm. At 4-5 pm, they noticed ringing in their right side ear. They noticed it becoming more prominent when they went to sleep on a pillow. The next day, the ringing became more prominently in their left side. the ringing also began to worsen. It was recommended the patient follow-up with their primary care provider.
arm was really painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 06Feb2021 (Lot number: EN6202) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm was really painful". No follow-up attempts are possible. No further information is expected.
Loss of use of upper body Severe Menstrual clots and changes Pain in Jaw and ear (these sysmptoms occurred in 2002 when I took a flue shot... lasted approx 7 months and the terms guillain barr was thrown around by my doctor but I was not diagnosed I was only told to never get a flu shot again) aslo when I went to pharmacy to get the J&J shot they denied for this reason so i wauted until the Pfizer was approved for ages 12 and up and went to medical center and explained to them this extact info... they  proceeded to give me shot with no concerns at all.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported 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 reporter stated that, another pharmacist gave the patient a dose of SHINGRIX, subcutaneously instead of intramuscular route which led to incorrect route of vaccine administration. The reporter did not provide any other details. He stated he called to ask if the patient needed to be re-vaccinated before he would contact the patient.
On March 15, 2021 around 9:00 a.m., I started to have severe COVID-19 symptoms. The most severe symptoms were, in the following order, fatigue, shortness of breath, dry cough, and nausea. I also had a moderate chills and a headache. All of these symptoms remained severe or moderate until approximately 2:00 p.m. The symptoms have now all lowered to mild after about 3:00 p.m.
This spontaneous report as received from a pharmacist refers to a 63 years old female patient with no known allergies. The patient was vaccinated subcutaneous into upper left deltoid with 0.65 ml ZOSTAVAX (lot # 672563/1649AA, expiration date 21-JAN-2013) on 16-APR-2012. No other co-suspects were reported. Concomitant medications included acyclovir, acetaminophen, PERCOCET, clonazepam, lovastatin and amlodipine. Pharmacist stated she read the local paper and found out that client was found dead at her home residence on 18-APR-2012, due to natural causes. Pharmacist stated the patient did have health conditions, unspecified, but she wanted to make sure that no problem existed with this ZOSTAVAX lot number. Lot check was requested by the reporter. Event was considered to be disabling and life-threatening. This is one of the two reports from the same reporter. Additional information has been requested.
I did get the arm soreness like I get from the Flu shot for about 48 hours in the left arm where I was injected.  I'm not sure if this because of the shot, but about 5 days after I discovered a blister or boil on my back right shoulder and then another on my left shoulder.  7 days after the shot there was another blister in my mouth bottom lip and 9 days after I found another blister on my inside right little toe.
Swelling, redness (4.0 x 5.0 cm), fatigue, mild hypotension which started the day after the vaccination.
Immediately after the vaccination, my left arm was tingling for approximately 45 minutes.  On 4/16/21, the tingling in my left arm returned. I am not sure if the tingling on 4/16 is related to the vaccination. At the time of this report, my left arm is still tingling.
Pt. with no adverse symptoms or reaction. Pt. received adult dose 1 ml of Hep A instead of pediatric dose 5 ml of Hep A. Telephone cell made to mother to advise signs and sxs advised. Mother to call if concerns arise.
9:30 - patient reports having a headache, itching at injection site, on neck, chin. Area about 2 cm x 0.5 cm on right side of neck, smaller area on back of neck - localized. A small area redness on right side of neck near shoulder. Denies throat itching or swelling. Noted redness on left arm and around neck. Transported to private observation via w/c.  Ice given for comfort. States the ice is relieving the itching. EMT on site in attendance. BP 110/80: HR 106 per radial pulse. Has dark nail polish on fingers and pulse ox not picking up sats  9:44 States that she is feeling better on arm with ice pack.  9:48 - Has husband with her and he drove. She states she has skin reaction to many things due to her lupus. State benadryl always relieves it. States she usually takes 50 mg of benadryl.  BBS CTA, no stridor noted per auscultation done by IK, RN.  Not driving and agreed to Benadryl. Gave two 25 mg tablet by mouth with water. Swallowing without difficulty. Gave additional ice packs for neck area. 9:54 Patient reports that she is improving. BP 124/90; radial pulse 100. Continues to apply ice to neck and left arm. Redness subsiding.  9:57 Patient states she feels much better, itching subsided. No additional red areas developed. Patient able to ambulate. Gait steady. Accompanied by husband to personal vehicle. Will be driven home by husband. Recommended to seek medical care if symptoms return or worsen.
Received 3 immunizations on 4/4/07 around 4:30 PM.  DTaP and IPV in left leg/MMR in right. Reaction started 4/5/07.  Patient was seen on 4/6/07 with a 20cm x 20cm on upper left thigh.  Erthema was present and site was warm to touch.  Parent told to give Benadryl as needed and to call back if site enlarged from markings placed during office visit.   No call back from parent
Vomit x 1 24 hours vaccination. Temp measured 99.1. Axillary 24 hours after vaccination. Denied continued nausea and vomiting, diarrhea or temperature after this episode.
Jan 24,2022  I started having chills they tested me for covid I had it  so was off work for 2 weeks
feeling tired; Name: Comirnaty; Route: Subcutaneously; Name: Comirnaty; Route: Subcutaneously; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; NOVOLOG; PROLIA. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset Feb2021, outcome "unknown" and all described as "Name: Comirnaty; Route: Subcutaneously"; FATIGUE (non-serious) with onset Feb2021, 2 days after the suspect product(s) administration, outcome "recovered" (Feb2021), described as "feeling tired".  Additional Information: Consumer reported feeling tired on day 2 following Covid vaccine, fully resolved by day three.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received the wrong Manufacturer of Covid vaccine .  Wanted to get Jansen but was given Pfizer.  After discussions with patient was ok with the Pfizer due to it having a higher  effectiveness
Arm feels tight on the side; It had gotten much worse; Arm was red; Arm was warm; A spontaneous report was received from a nurse,  a 48-year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  a red arm, arm was warm, and arm feels tight on side.  The patient's medical history was not provided. Concomitant medications reported included ascorbic acid and cholecalciferol.   On 22 Dec 2020, approximately 2 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 ([LOT# 025520-2A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 24 Dec 2020, the patient noticed her arm was red and warm. By 31 Dec 2020, it had gotten worse as her arm was redder and warmer, and it felt tight on the side. She was concerned about how long the reaction lasted and reports never having a reaction like this to previous vaccines. She has rotated warm and cold compresses on the arm but has not taken treatment yet, though her primary care provider advised her to take Claritin. Treatment for the event included warm and cold compresses.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, arm was red, arm was warm, and arm feels tight on side, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information relayed second hand from vaccine clinic director.  Recipient c/o muscle pain immediately after the Moderna injection on 12/29/2020 and congestion and body aches 3 days after the injection. Now yesterday, 8 days after the injection she has a circular red area below the injection site that is slightly warm to touch, itchy and swollen. She is taking Benadryl.
PT WEAK, DIZZY, AND FAINT FEELING; RECORDED PATIENT BP AND HR (BOTH LOW), BG NORMAL; PT REMAINED ALERT AND RESPONSIVE IN UPRIGHT SEATED POSITION UNTIL EMS ARRIVED.
4 blood clots in left leg.  Perfect health. No risk factors for blood clots.  Perfect blood work.  Hospital "baffled" at a person with no risk factors getting one blood clot, and shocked  my husband had FOUR.
Information has been received from a licensed practical nurse concerning a 6 year old white male with a history of cardiac murmur, who on 18 March 2003 at 14:30 PM, was vaccinated in the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot # 643540/0604M). There was no illness at the time of vaccination. On 05 January 2006, the patient had less than 50 lesions visible for three days. No treatment was necessary and the patient had "no effects" The patient was recovered on 09 January 2006.
pt recv vax & turned white, pt was standing against the wall & fell to the floor (sliding down the wall) eyes rolled back in head;apparently blacked out for 8 sec according to step-mom;was assisted to recline on exam table;drank juice,
Felt like hot liquid. Increased blood sugars. Diarrhea. Shaky feeling, like caffeine high.
POUNDING WHOLE BODY ACHES, SHOOTING IN HER LEGS AND BODY, STABBING PAINS; BONES HURT (KNEES, ARMS); UPPER ARM PAIN; This spontaneous report received from a patient concerned a 93 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced bones hurt (knees, arms). On APR-2021, the subject experienced upper arm pain. On 13-APR-2021, the subject experienced pounding whole body aches, shooting in her legs and body, stabbing pains. Treatment medications included: paracetamol. On 18-APR-2021, treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upper arm pain on APR-2021, and had not recovered from pounding whole body aches, shooting in her legs and body, stabbing pains, and bones hurt (knees, arms). This report was non-serious. This case, from the same reporter is linked to 20210436303.
This is a spontaneous report from a contactable consumer (patient) reporting for herself received from a Pfizer sponsored program support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Mar2021 at the age of 76-years-old as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that she got the first, everything was fine a week ago on an unspecified date in Apr2021, she fell in the street. States she was to receive second dose today and did not feel "one hundred percent". She was asking, what was the most time in between doses as well as recommendations on those who do not feel well. It was reported that she was scheduled to get the 2nd dose the next day, 18th April and 1st dose was on 28Mar, however on an unspecified date in Apr2021, she fell on the street and she doesn't feel good enough with her pain on the shoulders and knees. she would like to postpone her 2nd dose and does not know what to do, she was asking for an advice and rescheduling. She asked if she is to return to the same vaccination site. The outcome of events was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
itchy; Red; Rash; Swollen; Sore/Tender; Warm to touch; Hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Hard), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (Rash) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Hard), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE RASH (Rash), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Sore/Tender). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Hard), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE RASH (Rash), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Sore/Tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
This spontaneous report has been received from a pharmacist, concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 lot # M027552 and expiration date 04-FEB-2018 (dose, frequency and route of administration were not provided) for prophylaxis. At the next date of administration, the patient requested the lot number and expiration date in order to report an unspecified adverse event. The outcome of the unspecified event and causality were not reported. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1707USA005155:
Information has been received from a licensed practical nurse concerning a 17 year old female with a history of insect bite allergy who on 18-JUL-2007 was vaccinated with a first dose of Gardasil (lot # unknown) IM.  On 18-JUL-2007 the same night as the vaccination the patient developed a fever.  On 20-JUL-2007 "about 2 days after vaccination", the patient went swimming and broke out into a "rash with hives".  Medical attention was sought.  The patient went to her physician where they believed the event was related to ant bites and treated the patient with steroids (therapy unspecified).  After the treatment was completed there was a reoccurrence of hives.  The outcome of the fever was not reported and patient's rash with hives persisted.  No further information is available.
No additional AE details provided; Improperly stored administered VARIVAX 9.6 C for 80 mins; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 12-AUG-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot #S032356, expiration date 14-OCT-2021 (formulation, strength, exact dose, anatomical location, and route of administration were not reported) for prophylaxis (product storage error). The temperature excursion was reported as 9.6 degrees Celsius for 80 minutes. There was no previous temperature excursion reported. It was unknown if a data logger was used to capture the temperature. No additional adverse event details provided no adverse event. The outcome of the event was unknown.  This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-108USA006155.
Swelling, Redness, Itching.  OTC HYDROCORTISONE CRM 1% 3 TIMES A DAY FOR 5 DAYS.
Information has been received from a Certified Nurse Practitioner referring to a patient of unknown age and gender. There was no pertinent medical history or drug reaction/allergies reported. The patient was vaccinated with the first dose of GARDASIL (0.5 ml, lot# and expired date not provided) intramuscularly on 28-JUN-2013. The patient received the second and third dose on 08-JAN-2015 and 13-MAR-2015, respectively (inappropriate schedule of drug administration). No adverse effect was reported. Lot number H020801 (expired date 05-JUL-2015) of the third dose is an invalid lot number for GARDASIL. Additional information has been requested.
Patient went to the ER two days after the vaccine administration (10/29/2017) due to redness and pain in the left arm. Patient states that she was diagnosed with cellulitis and subsequently filled cephalexin 250mg (take 500mg four times daily for 10 days). Diagnosis on the prescription states erysipelas (diagnosis code A46).
Initial information was received from a consumer concerning her daughter, an approximately 20 months old female patient without pertinent medical history or drug reaction / allergies, who on 09-NOV-2012, was vaccinated with a dose of VARIVAX (merck) and need if for school (dose, route and lot number were not reported). No other co-suspects were reported. Concomitant medications included: amoxicillin. It was reported that after receiving the injection, she began to experienced adverse reactions. On 10-NOV-2012, she had fever and a rash that started on her legs. It was reported that the patient looked like a "bug bite" on her left knee cap. The patient was taken to healthcare care professional where she was given amoxicillin (manufacturer unknown). The patient also had a double ear infection. The health care professional informed that the rash would go away in about one week. It was reported that at the time of report, the rash has spread and was all over her body. No treatment was given for the events. No laboratory test was performed. It was reported that the patient sought medical attention by contacting the office on 12-NOV-2012. At the time of report, the patient had not recovered from the events. Additional information has been requested.