chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left ear hearing loss; unilateral vision loss; Brain fog; Hot; Swelling in her arm that is the size of a baseball; COVID Arm; Itchy; Red circle around injection site; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Left ear hearing loss) and BLINDNESS UNILATERAL (unilateral vision loss) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dairy intolerance. Concomitant products included DOXYCYCLINE from 01-Jan-2020 to an unknown date for Rosacea, DEXLANSOPRAZOLE (DEXILANT) and FAMOTIDINE for Stomach discomfort, ROSUVASTATIN for Stroke, LEVOTHYROXINE for Thyroid disorder NOS, CLOPIDOGREL, CALCIUM, ACETYLSALICYLIC ACID (BABY ASPIRIN), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and MAGNESIUM OXIDE for an unknown indication.   On 29-Jan-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 9:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced FEELING ABNORMAL (Brain fog), VACCINATION SITE WARMTH (Hot), PERIPHERAL SWELLING (Swelling in her arm that is the size of a baseball), VACCINATION SITE REACTION (COVID Arm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red circle around injection site) and FATIGUE (Tired). On an unknown date, the patient experienced DEAFNESS UNILATERAL (Left ear hearing loss) (seriousness criterion medically significant) and BLINDNESS UNILATERAL (unilateral vision loss) (seriousness criterion medically significant). On 13-Feb-2021, VACCINATION SITE REACTION (COVID Arm) had resolved. At the time of the report, DEAFNESS UNILATERAL (Left ear hearing loss), FEELING ABNORMAL (Brain fog), VACCINATION SITE WARMTH (Hot), PERIPHERAL SWELLING (Swelling in her arm that is the size of a baseball), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red circle around injection site) and FATIGUE (Tired) outcome was unknown.            Treatment information not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. 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.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Case upgraded to serious based on event update. Con meds added. Prior event outcome updated. Medical history updated based on information; 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, a causal relationship cannot be excluded.
HEART/CHEST HURT; BACK HURTS; EVERYTHING HURTS; COUGHING UP PHLEGM; CURL UP AND DIE; ARM HURT LIKE HELL; TIRED; SICK TO STOMACH; WEAK; CHILLS; CANNOT BREATH; COUGH; SORE THROAT; RUNNY NOSE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: UNKNOWN) dose was not reported, administered on 13-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 14-JAN-2022, the patient experienced cannot breath, cough, sore throat, runny nose, chills, and weak. On an unspecified date, the patient experienced heart/chest hurt, back hurts, everything hurts, coughing up phlegm, curl up and die, arm hurt like hell, tired, and sick to stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt like hell, had not recovered from cannot breath, chills, weak, cough, sore throat, runny nose, back hurts, heart/chest hurt, everything hurts, tired, coughing up phlegm, and sick to stomach, and the outcome of curl up and die was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
"11 x 10 cm indurated erythematous swelling of Rt. upper arm. Small puncture wound visible-no fluctuance or oozing" (Per provider note).
Couldn't take a full breath. Most intense standing or laying down, lesser when seated/when exercising like I can't take a big enough breathe; Centralized chest pain on sternum.; Felt extremely heavy, not like a regular flu. More like as asthma attack that was waiting to peak; Felt extremely heavy, not like a regular flu. More like as asthma attack that was waiting to peak; Arm soreness; Nauseous all week; loss of appetite; Sore to touch; heavy chested; medical history included Hashimoto's; medical history included Hashimoto's; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318; expiration date not provided), via an unspecified route of administration on 25Jan2021 19:00 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history included Hashimoto's, asthma, and food allergy all from unknown dates and unknown if ongoing. The patient has no COVID prior vaccination. The patient was not COVID tested post vaccination. Patient is not pregnant. Concomitant medications included levothyroxine sodium, liothyronine sodium, progesteron, and sertraline. Adverse events on 26Jan2021 at 07:00 were reported as follows: Centralized chest pain on sternum. Felt extremely heavy, not like a regular flu. More like as asthma attack that was waiting to peak (patient reported that she has asthma). Sore to touch. Couldn't take a full breath, most intense standing or laying down, lesser when seated. Lasted just over 48 hours. Patient also stated, 'Still feel heavy chested when exercising like I can't take a big enough breathe'. Patient also reported arm soreness, nauseous all week, loss of appetite. Also on period. The patient has not received treatment for the events. Outcome of the events was reported as 'Recovered with lasting effects'.
Note 1: Reviewed PDMP, patient not found, NORCO 5/325 #10 2-day supply: 30mg/day, acute initial fill for pain due to vaccinations (PREVNAR 13 and FLUZONE) given 10/5/18, okay to fill, will ask if patient tried other medications prior to visiting physician. Note 2:  patient did not complain about pain following administration of vaccinations, provided appropriate counseling leading up to and following vaccine administrations, daughter dropped off prescription. Note 3: verified patient's identification with the patient's daughter, double checked patient's circumstances with ER staff, per (nurse) - unknown if patient attempted to treat pain prior to ER visit, patient was seen by Dr. around 4 PM (10/5/18) due to pain in arm and was experiencing an adverse reaction due to vaccine administration (PREVNAR and FLUZONE HD), initially given TORADOL injection and diphenhydramine, patient was then given NORCO inpatient and saw improvement and prescription was sent to pharmacy, per Dr. notes patient is to reserve NORCO for severe pain, and to take TYLENOL and/or ibuprofen for pain management for mild/moderate pain, patient did not receive epinephrine injection (did not experience an allergic reaction). Spoke to patient's daughter and her husband about the situation and relayed to them I wanted to understand the full story and circumstances because I administered the vaccinations, both in the same arm, and was concerned for the patient's well-being; explained to them the rationale to give both vaccination in one arm (to maintain full-function in dominant arm for daily activities), both verified understanding and accepted counseling of patient's prescription and would convey the counseling information to the patient.
Patient complained of feeling dizzy within 5 minutes of taking vaccine.  Developed two small itchy hives (1 on neck 1 on face area) within 20 minutes.  No respiratory symptoms - vital signs stable - BP 120/70 P 82 R 16.  Remained in Health Services.  BENADRYL given at 3:30 pm.  Driven home by family.
Information has been received from a physician referring to a male patient of unknown age. The patient had no concomitant medication. The patient had unspecified food allergies and aspirin allergies. In approximately 2012 (reported as about 6 years ago), the patient was vaccinated with a second dose of VARIVAX 1 dosage form (subcutaneous; strength, lot# and expiration date were not reported) for prophylaxis. Suspect therapy also included sterile diluent (lot# and expiration date were not reported). After receiving the VARIVAX, a rash developed on his arms (rash) on an unspecified date a couple days later. The rash spread to his legs (rash) and then to the rest of his body (rash generalised). There was no reaction to the first dose of VARIVAX administered on unspecified date several years ago. The patient's recent titer drawn was negative for varicella antibodies (antibody test negative). Treatment was given for the events. The outcome of the rash and rash generalised was reported as recovered. The outcome of antibody test negative was unknown. The causality between the events and VARIVAX was not reported.
he had the worst diarrhea ever.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 04Mar2021 (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: DIARRHOEA (non-serious) with onset 07Mar2021, outcome "unknown", described as "he had the worst diarrhea ever."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PAIN IN RIGHT ARM; PAIN IN KNEE; CHEST PAIN; TINGLING; NUMBNESS; FEELING LIKE SHE IS GOING TO FAINT; FEVER; FAINTING; This spontaneous report received from a patient concerned a 26 year old White, Non-Hispanic/Latino female. The patient's height, and weight were not reported. The patient's past medical history included birth control stopped 2 months ago, and concurrent conditions included pollen allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with benzoyl peroxide. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-JUL-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 13-JUL-2021, after receiving the vaccine patient reported fainting and fever on the day of injection. On 14-JUL-2021, the day after vaccination patient had chest pain, tingling and numbness and feeling like patient was going to faint. Patient went to the emergency room on the 14-JUL-2021 and patient was told patient was ok. On 16-JUL-2021, patient started feeling pain on the right arm and knee (side of injection). Patient mentioned patient was travelling after few days on a long flight to Germany. Patient mentioned that patient was very healthy. Laboratory data included: Blood test (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, and Urine analysis (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, recovered with sequelae from chest pain, and had not recovered from fainting, tingling, numbness, pain in right arm, pain in knee, and feeling like she is going to faint. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738815-covid-19 vaccine ad26.cov2.s -fainting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Vaccine was given at 1250 pm. Approximately 20 min. after receiving the vaccine patient became general weak accompanied by near syncope, nausea. He was transported to hospital for treatment.
pt recv vax & devel a rash & swelling & redness @ inj site & radially outward;
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details provided were as follows; The case was reported by patient's wife. Age at vaccination was not reported. The patient received Shingles vaccine and a week later experienced shingles. Follow-up would not be possible as no contact details available.
Baby was sitting in bouncy chair when she became red around the eyes/teary-eyes rolled back in head- stopped breathing. Dad began CPR and called 911. By the time EMS responded baby was breathing. Normal exam in Emergency Room. Admitted to hospital for apneic episode which did not repeat during hospitalization. 12/03/09 Discharge summary, ER  and hospital records received for DOS 07/03/02-07/05/02. Pt. presented with episode of apnea at home, eyes teared, face reddened, eyes rolled back,  became limp. Episode lasted about 1-2 minutes and began breathing again after parent administered CPR. Admitted for observation. No recurrence while in hospital. Discharged home, stable, with apnea monitor. DC DX: apnea episode
Hospitalization for COVID-19 pneumonia, hyponatremia, hypertension, T2 Diabetes, hypothyroidism on dates 10/2/2023- 10/7/2023.  Treated with dexamethasone, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
shortness of breath; chest pain; right jaw pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), CHEST PAIN (chest pain) and PAIN IN JAW (right jaw pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (medical history not provided).    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Jan-2021, the patient experienced DYSPNOEA (shortness of breath), CHEST PAIN (chest pain) and PAIN IN JAW (right jaw pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), CHEST PAIN (chest pain) and PAIN IN JAW (right jaw pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.; 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, a causal relationship cannot be excluded.
Fever, tired, body aches, after 24 hours arm redness is spreading, arm is painful and has fever in it.
After vaccine around 6 pm, felt weakness, all over  body aches, severe chills and high fevers, delirious, headache and all symptoms was non stop for two days. Arm site very sore n swollen, tender to touch.  Took Tylenol and Ibuprophen and Benadryl for tow days.
Wrong product administered; Administered Vaxelis, Hep B, and PCV; Product use in unapproved population; No adverse event; This case was retrieved on 12-JAN-2022 with the following reference number: 1801803. The original narrative from the sender is as below:  Patient came in for a well child check today and the provider ordered the administration of Vaxelis, PCV-13, and Rotavirus vaccine. While I was taking these out of the fridge, I got distracted and pulled out Hep B by mistake instead of rotavirus. I administered Vaxelis, Hep B, and PCV. Within one minute of administration, I realized that I gave Hep B by mistake and forgot to administer the rotavirus vaccine. I immediately informed the provider, and she spoke with the patient's mother. Patient did not experience any symptoms or signs while in the office, and the provider advised mother to monitor for any concerning signs or symptoms.  The case was considered off-label use, since product was administer in unapproved population (patient 1 month old).
COVID-19 symptoms started 28Jun2022-29Jun2022/Tested positive for COVID on 30Jun2022; COVID-19 symptoms started 28Jun2022-29Jun2022/Tested positive for COVID on 30Jun2022; This is a spontaneous report received from contactable reporter (Physician). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 18Dec2020 as dose 1, single (Lot number: Eh9899), in left arm, on 15Jan2021 as dose 2, single (Lot number: El1284), in left arm and on 19Aug2021 as dose 3 (booster), single (Lot number: Fd8448) at the age of 30 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Persistent asthma" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Infertility" (unspecified if ongoing); "Rosacea" (unspecified if ongoing). No known allergies. Concomitant medications included: ADDERALL; METFORMIN; AZELAIC ACID; IBUPROFEN; ALKA-SELTZER PLUS COLD & FLU MEDICINE; OMEPRAZOLE; FLOVENT; ALBUTEROL [SALBUTAMOL]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Patient received vaccine in four weeks and other medications in two weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Jun2022, outcome "unknown" and all described as "COVID-19 symptoms started 28Jun2022-29Jun2022/Tested positive for COVID on 30Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with Paxlovid. Clinical course: COVID-19 symptoms started 28Jun2022-29Jun2022. Tested positive for COVID on 30Jun2022. Started Paxlovid on 01Jul2022. Within a few hours of starting Paxlovid noted a terrible taste in the mouth and stinging sensation on anterior 1/3 of the tongue. Neither had been present before and worsened with each dose. When taking the fourth dose she noted the anterior 1/3 of her tongue was red and blistered. She was unsure if this had been present since the taste/stinging started as she had not looked in the mirror before the 4th dose.; Sender's Comments: The company cannot completely exclude the possible causality between the reported COVID-19, which is considered as failure of vaccine BNT162B2, and the administration of BNT162B2, as the efficacy of a vaccine varies individually and may be affected by different factors including drug potency.
Broke out with a rash on my face starting the 20th mainly with bites under my chin. By Sunday a rash was under my chin and on left side of my face and chest. Intense itching, no pain.
Day 4 s/p vaccinations developed T 103, GI bleeding, muscle pain, nausea, headache, hospitalized x 5 days at Med. Ctr. Was given IV steroids, antibiotics, acidophillus. Symptoms have now resolved.
Half of my face was red and itchy, especially under my chin area. It only lasted for that day and I woke up better the next morning. This is now happening often but the worst has been on 12/4/09 when my entire face was red and itchy.
Large, swollen red circle that covers entire arm.  Nothing is making it go away at this point.
The first two days I had fever, chills and muscle weakness then the pain concentrated on my back. I have been taking Tylenol and Advil to manage the pain but it's been 10 days and it hasn't subsided.
Pain and soreness at injection site.  Lightheaded for few hours following injection.  Mild Fatigue several hours after injection.  Occasional itching at injection site a few days after injection.
Booster; in the pool of blood; passed out; eyes rolled back to head; because in the fall; feeling a bit light headed/ Dizzy; badly bruised; diarrhea; felt very nauseous; very sick; not able to eat; hit her head; hit jaw so badly; This is a spontaneous report from a contactable consumer (patient). This 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Oct2021 at age of 66-year-old (Batch/lot number FF2590) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Concomitant therapy was none. None other Vaccine (Prior to 4 weeks of COVID Vaccine). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 66-year-old for covid-19 immunisation and experienced sore arm. The patient previously received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 66-year-old for covid-19 immunisation and experienced low grade fever, tired, sore arm. The patient had booster shot last Tuesday and woke up on Wednesday, when woke up on Wednesday morning on Oct2021, she was feeling a bit light headed and dizzy and the next thing she knew she was on the bathroom floor in the pool of blood and then she got herself up and she did not, When she was on the floor she did not know how she got there, when she got herself up, she passed out again, she had never passed out in life. Obviously she am badly bruised and whatever from the fall but she just, she don't know if other people have reported this but she think it is just important because this is the new vaccine and people have made aware of, you know what can happen. She got self on, she was not actually the good thing is she take care of her mother who was 94 and care giver ran upstairs, she heard the patient go down and helped but care giver was very nervous, care giver said the patient eyes rolled back to head, she then because she need to get to the bathroom where she could see, then had diarrhea felt very nauseous and very sick from this from this and the first two vaccine the patient was, you know other than sore arm except second shot she had very, very low grade fever and was just tired you know she thought was not big deal she thought she can take that and this booster shot though absolutely, she actually just  wasn't killed, she know this sounds like she have added but you know she hit her head and whatever. Few days after the patient just took some Advil because the not able to open, not able to eat because in the fall the patient hit jaw so badly, so the only thing the patient had been taking was some Advil, the patient took absolutely before vaccine and took nothing for two or three days after vaccine. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101465991 Same patient and drug, different events separated in time;US-PFIZER INC-202101465992 Same patient and drug, different events separated in time