chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fluid in his ears; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Jul2021 08:00 (Batch/Lot Number: FA6780, does not see NDC or expiration date) as DOSE 1, SINGLE (age at vaccination 44 years old) for covid-19 immunisation.  The patient medical history included sinus problem (sinus thing is something that he has had before, he has a sinus problem before the vaccine). There were no concomitant medications.  The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The consumer states he is supposed to go back and take the other one, referring to the Pfizer COVID 19 vaccine. He is sick right now (from unknown date in 2021), there is fluid in his ears, so he is not going to go. He clarifies that he received the first dose of the Pfizer COVID 19 vaccine last month 03Jul2021 at 08:00AM in the left arm. He started to have the fluid in his ears about five days ago (unknown date in 2021) and he went to the doctor and took some medication and he feels by next week he can do it but he is not going to get another vaccination when he is sick. The consumer confirms he thinks he was supposed to get the second dose of the vaccination on 05Aug2021 but he is not going to get it. Sometimes the fluid in his ear goes away fast and sometimes not. He states this has nothing to do with the vaccination, it is caused from his sinuses. He is going to give the medication time to work. The events did not require a visit to the Emergency Room. The events did require a Physician Office visit- was seen at walk in clinic. Relevant tests were none. Therapeutic measures were taken as a result of fluid in his ears and feel sick. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: The event fluid in ears in attributed to an intercurrent or underlying condition, and is considered unrelated to the suspect drug. A potential contributor includes history of sinus disorder. This case will be reassessed upon receipt of additional information.
It was reported post vaccine pt had temp of 103-104F and hives, 10 days later increased rash, legs clustered red papular 1mm-3mm size. Also with otitis.
At the site of injection is a white mark with 2 red dots; Headache; She was nervous; A metallic taste; Fingers were swollen and red; Fingers were swollen and red; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (She was nervous), DYSGEUSIA (A metallic taste), PERIPHERAL SWELLING (Fingers were swollen and red), ERYTHEMA (Fingers were swollen and red) and VACCINATION SITE ERYTHEMA (At the site of injection is a white mark with 2 red dots) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced NERVOUSNESS (She was nervous), DYSGEUSIA (A metallic taste), PERIPHERAL SWELLING (Fingers were swollen and red) and HEADACHE (Headache). 25-Mar-2021, the patient experienced ERYTHEMA (Fingers were swollen and red). On 26-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (At the site of injection is a white mark with 2 red dots). On 25-Mar-2021, NERVOUSNESS (She was nervous) and DYSGEUSIA (A metallic taste) had resolved. On 26-Mar-2021, PERIPHERAL SWELLING (Fingers were swollen and red), ERYTHEMA (Fingers were swollen and red) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (At the site of injection is a white mark with 2 red dots) outcome was unknown.            No relevant concomitant medications provided. No relevant treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Followup was received with NNI
i have a gevee of 101.8 eigjt now earliee it was 100; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (i have a gevee of 101.8 eigjt now earliee it was 100) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021 at 10:10 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced PYREXIA (i have a gevee of 101.8 eigjt now earliee it was 100). At the time of the report, PYREXIA (i have a gevee of 101.8 eigjt now earliee it was 100) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, Body temperature: 100 (High) 100 and 101.8 (High) 101.8.         No relevant concomitant medications were reported. No treatment information was provided.
Back in June I had to get hand surgery, I hadn't worked much since then. Recently in the last 2 months, my right arm has been having more trouble. I couldn't pick anything up without discomfort and pain. Ever since I got the vaccine, I couldn't go to sleep with my arm above my head. I can't do that without discomfort. The pain down the arm has recently started in the last month or so. The pain in my right arm has radiated down to my elbow. You can feel the heat coming from my arm like it's inflamed where the shot was. That's with both arms. Same report from first vaccination, pain has gotten worse in the last few months.
Patient received Pfizer Covid Vaccine Dose 2 (LOT EW0175 EXP 08/2021).  Patient was in post-vaccination observation area sitting in char when she began to feel dizzy and lightheaded.  She fell from chair to floor.  Both HMs assigned to observation area stated they heard impact to the floor and other patient sitting in area witnessed patient hitting head on the floor.  Nurse was notified at 0743 by HM and nurse responded.  When nurse arrived, patient had eyes closed but immediately opened eyes with contact.  Nurse was notified of fall and that she lost consciousness for about 30 seconds upon syncope episode.  Code was called at 0745. Vitals taken (BP 94/65, HR 80, RR 16, 92 BG). Patient continued talk and stated she had nothing to eat this morning and has a known history of syncope/vasovagal with vaccinations and blood work.  Code team arrived at 0747 and Code secured at 0751.  Patient was escorted by code Team to Emergency Department for further evaluation.
found by babysitter to be apneic & startled, vomited & loss consciousness, needed CPR:
SWELLING & REDNESS AT INJECTION SIGHT ON DAY AFTER VACCINE ALSO ON DAY AFTER VACCINE:  FATIGUE, MUSCLE & JOINT PAIN, CHILLS & FEVER      THIS LASTED A DAY & 1/2
Inadvertently gave Moderna bivalent booster when pt already had it 9/26/22.
3/15/21-experienced soreness at vaccination site 3/16/2021- extreme fatigue on waking and difficulty completing morning chores (getting ready, making tea etc.); headache and neckache; difficulty moving vaccinated arm up to shoulder level and experienced pain at trying to lift arm; extremely thirsty and drank daily water quota off by 10:00 am -it is usually a struggle to finish my 64 ounces); still feeling very sleepy and tired; feeling sad and crying for no reason; no appetite except for water.
mom states following DTP pt had several episodes when eyes rolled back & non respondsive until aroused by shaking; day p/vax pt had an episode when crying that became cyanotic & started breathing p/being shaken;
A few minutes after the vaccine, I was talking normally and relaxed and then suddenly had a strange sensation on one side of my face. The right side of my mouth and right eye and cheek felt strange, like a sudden muscle cramp in my face. I was with my daughter and asked her if my face looked funny and tried to smile and she noticed one side (my right side) wasn?t smiling. I got dizzy and nauseous and had to lie down. Clinic staff brought sprite and crackers. After about 30 minutes I was able to sit up and the facial weakness started to subside. However, I continue 5 months later to have occasional facial weakness and eyelid twitching on the right side. It comes and goes. The weakness is gradually improving, but after seeing the story about the J&J vaccine, although I had Pfizer, I thought I should report this.
Left upper arm is fine. Right upper arm has redness, warmth and induration. It is non-tender. Patient has full range of motion. Almost entire right upper arm is affected.
Fever 100.2; chills; headache; swollen lymph neck; muscle and joint ache; muscle and joint ache; Tiredness; injection site pain; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 19Dec2020 at 14:30 at single dose in right arm for covid-19 immunization. Medical history included high blood pressure. Concomitant medication included acetylsalicylic acid (ASPIRIN), amlodipine, benazepril, and multi-vitamin. The patient previously took erythromycin and experienced drug allergy. The patient experienced fever 100.2, chills, headache, swollen lymph neck, muscle and joint ache, tiredness, and injection site pain; all on 20Dec2020 at 14:30. All events were reported as non-serious. The patient didn't receive treatment for  all the events. The outcome of all events was resolved in Dec2020.   Information on the lot/batch number has been requested.
7 PTS WITHIN 2 WEEKS REPORTED JOINT PAIN AND TENDERNESS WHICH RADIATED TO SHOULDER, REDNESS AND SLIGHT SWELLING AT SOI. NO TREATMENT PRESCRIBED. ONE PT IS DUE TO VISIT NEUROLOGIST FOR SHOULDER PAIN
31MAR92 pt recvd 1st dose of Engerix-B vax & 1APR92 devel hive like rash on trunk; an ER or MD office visit was required to treat event;
recipient received first dose of COVID vaccine on 4/24/2021 and was mistakenly given his second dose 2 weeks later on 5/8/2021.
KNOT, BRUISE APPEARING 24 HRS AFTER SUBCUTANEOUS INJECTION  BACK OF RIGHT ARM ALSO RASH WITH SMALL BLISTERS ON WRIST OF SMALL ARM, OCCASIONAL ITCHING.
About a month after receiving my fourth dose of Pfizer, I started to notice that I was dizzy at times. I was at work, where I lift things, and I became very dizzy and had a terrible headache. I was sent home from work for three days until I felt a little better. I saw my doctor and was diagnosed with Vertigo. I contracted COVID-19 in January 2021, and I was diagnosed with diabetes after contracting COVID.
Patient notified observing RN of increased "itchy throat" and throat closure s/p vaccination. Hx of anaphylactic reactions. Patient able to ambulate to triage room. Antihistamine provided by pharmacist. Pt able to tolerated water and thins. VSS. 129/84 HR 67, O2 saturation 99%. Patient observed for 30minutes and reported resolved symptoms. Patient ambulated to exit without any issues.
Came down with Covid; Lack of drug effect; Curled tingling feet; Achy; Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Came down with Covid), DRUG INEFFECTIVE (Lack of drug effect), PARAESTHESIA (Curled tingling feet), PAIN (Achy) and FEELING ABNORMAL (Brain fog) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced PARAESTHESIA (Curled tingling feet), PAIN (Achy) and FEELING ABNORMAL (Brain fog). On 21-Aug-2021, the patient experienced COVID-19 (Came down with Covid) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Came down with Covid) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown and PARAESTHESIA (Curled tingling feet), PAIN (Achy) and FEELING ABNORMAL (Brain fog) had resolved.            Concomitant drug was not reported. Treatment medication was not reported. The patient was exposed at school pick up line on the 17-Aug-2021.   This case was linked to MOD-2021-295917 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events Lack of drug effect, Paraesthesia, Pain and Feeling abnormal, a causal relationship cannot be excluded. However, based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination, hence, for the event COVID-19, causality is assessed as not applicable.
PT STARTED SLOUCHING DOWN IN CHAIR, ASSISTED PT TO COT. BP 115/71, HR 81. PT STATES HE FEELS FINE NOW, PROVIDED WATER, SX RESOLVED, NO TRANSPORT.
Information has been received from a registered nurse and a consumer concerning her 15 month old white son with an allergy to cefixime who on 08/17/2001 at 11am was vaccinated with the first dose of MMR II IM in the left leg. Concomitant vaccination that same day included the third dose of Prevnar IM in the right leg. The mother noted that the pt woke on 08/30/2001 at 8am with what looked like hives on his face, neck, ears, upper torso. Previous information received from the registered nurse noted that 12 days post-vaccination, the pt developed a red, flat, blotchy rash and there were no other symptoms noted. The pt had sought unspecified medical attention. The pt was seen by a pediatrician and the pt was started on Atrarax 1/2 teaspoon every six hours. The mother noted that after three doses the hives were continuing to spread down the torso to his upper arms and legs. The mother also noted the next morning the pt was again seen by the pediatrician and it was noted that the "hives" had spread to the pt's hands, feet, flanks and was creeping on the entire back. The mother reported that the Atarax gave no result and that the pt was started on "Oraped" 3/7 teaspoon burst 08/31/2001. The hives disappeared within two doses. It was noted that the pt finished the burst with no further problems. It was also reported by the mother that the rash had slightly raised borders but was not itchy. There was no illness at the time of vaccination. The pt recovered on 09/01/2001. The mother noted that the events were considered to be an other important medical event because there was medical/surgical intervention required to prevent a serious outcome. No further info is available.
This case was reported by a nurse and described the occurrence of an injection site reaction in a 4 yr old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. Medical history included grand mal seizure. Concurrent medications included Carbamazepine (Tegretal). On 29Aug05 the subject received the 5th dose of Infanrix in the left arm (lot AC14A006BA). On 29Aug05 the subject was also vaccinated with measles, mumps, and rubella virus vaccine and inactivated poliomyelitis virus vaccine (Ipol) at unspecified sites of administration. On 30Aug05, 1 day after vaccination with Infanrix, the subject experienced an injection site reaction characterized as redness, swelling, pain and warmth. The injection site reaction resolved on an unspecified date on or after 30Aug05 and on or before 06Sep05. The nurse considered the injection site reaction to possibly be related to vaccination with Infanrix.
Caller states she wound up with a lighter spot than her complexion; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-healthcare professional) from medical information team. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: Unknown) for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, She never had a problem with her first and second shots.) for Covid-19 immunisation, Bnt162b2 (DOSE 1, SINGLE, She never had a problem with her first and second shots.) for Covid-19 Immunisation. The following information was reported: SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "Caller states she wound up with a lighter spot than her complexion".  Additional information: Caller would like to know the difference between two of the Pfizer covid vaccines (Purple and Grey top). She says that when she asked the nurse who was administering it to her she gave her a vague and uninformative response about the way it is diluted. Transmitting possible duplicate AE as caller stated they already reported AE to previous agent. Caller refused to provide further demographics as she states she already gave this information. I normally take the PFIZER with the purple cap. they gave me an injection with a grey top. Caller stated she wound up with a lighter spot than her complexion (she is Ethnicity withheld). She never had a problem with her first and second shots. Caller states a lady was telling her she was transferring her to someone that would answer her question . However, nobody ever came back. She just left me on hold. So she hung up and called us back. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
sudden felt paralyzed; no strength in legs; weakness in legs; Saturday woke up very tired; queasy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 18:30 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 14Oct2023, outcome "recovered with sequelae" (15Oct2023), described as "Saturday woke up very tired"; ASTHENIA (non-serious) with onset 14Oct2023, outcome "recovered with sequelae" (15Oct2023), described as "no strength in legs"; NAUSEA (non-serious) with onset 14Oct2023, outcome "recovered with sequelae" (15Oct2023), described as "queasy "; PARALYSIS (medically significant) with onset 14Oct2023, outcome "recovered with sequelae" (15Oct2023), described as "sudden felt paralyzed"; MUSCULAR WEAKNESS (non-serious) with onset 14Oct2023, outcome "not recovered", described as "weakness in legs". Clinical course was reported as follows: Had the vaccine at 6:30 on 13Oct2023 evening, next day he woke up very tired, was queasy, ran errands at the mall and all of a sudden felt paralyzed, went down very quickly. Had no strength in legs whatsoever, was holding onto a rail and could not stand up, caller couldn't use legs at all, no strength at all in legs. Recovered with lasting effects, still has a little weakness in legs, walks a little and feels tired very quickly in legs. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Information has been received from a physician concerning a patient who on 13-JUN-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot#: 672675/0068AE, exp. date 03-APR-2012) after being stored at room temperature for 12 to 24 hours. It was unknown if the patient sought medical attention. No adverse symptoms noted. Follow-up information was received from a physician who stated that the 64 year old female patient on 13-JUN-2012, was vaccinated SQ in the right arm with a dose of ZOSTAVAX (lot# 672675/0068AE). The physician stated that the patient did not have any adverse event. The patient received a dose of ZOSTAVAX that had not been properly frozen due to a building BLDG power failure. The patient did not sought medical attention. No further information is available.
Client was given a Dtap/Polio IM injection in the left deltoid on Wednesday 6/24/2009. Client and mother returned to clinic at 9:00AM on Friday 6/26/2009. Client's mother was concerned because client's arm was red, slightly swollen and warm. Client's mother was instructed to follow-up with family physician.
Information has been received from a physician via a center (case #2006023-2357329) concerning a 72 year old female who on 16-NOV-2006 was vaccinated with Pneumovax 23 (lot #651406/0620F), 0.5 ml in the deltoid.  Concomitant medication was not reported.  On 16-NOV-2006, later the same day, the patient developed pain and swelling at injection site, fever of 100.4 and an area of redness was 14 cm in size at the injection site.  The outcome of the events was unknown.  Additional information is not expected.
Left arm is still sore after approximately 6 weeks from receiving injection. He reported this 1-11-12.
Generalized itching- small bumps on arms and chest advised pt to take Benadryl sx appeared at 8:45pm.
Developed fever to 103 x 2 days, then severe bilateral leg cramping x 2 days, dizziness and syncope 3rd and 4th day following shot. 4 days following shot developed nausea and abdominal cramping.  Abdominal symptoms continued 2 weeks with subsequent constipation and abdominal pains.
fatigue; VACCINATION SITE PAIN; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE PAIN (VACCINATION SITE PAIN) and FATIGUE (fatigue) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    Concurrent medical conditions included Drug allergy (sulfa antibiotics allergy), Latex allergy and Allergy. Concomitant products included GABAPENTIN, NORETHINDRONE ACETATE, IRON, LEVONORGESTREL, ESCITALOPRAM OXALATE (LEXAPRO), LEFLUNOMIDE and IBUPROFEN for an unknown indication.   In March 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 09-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PAIN (VACCINATION SITE PAIN). In April 2021, the patient experienced FATIGUE (fatigue). At the time of the report, VACCINATION SITE PAIN (VACCINATION SITE PAIN) and FATIGUE (fatigue) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable
pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (pounding headache) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced HEADACHE (pounding headache). At the time of the report, HEADACHE (pounding headache) outcome was unknown.        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.
COURSE SORE THORAT, MUCUS CONGESTED CHEST, SLIGHT FEVER, RUNNING NOSE, SLIGHT HEADACHE.