chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At time of vaccination I was 11 weeks and 5 days pregnant. Estimate delivery date 10/10/2021.
Patient was administered the Pfizer Bivalent 12+ vaccine instead of the Pediatric Pfizer Bivalent 5-11Y vaccine. Mother was informed. Patient was monitored for 15 minutes post vaccination. No signs and symptoms of any side effects or adverse reactions observed. Mother was provided education on signs and symptoms to monitor for. Mother verbalized understanding.
Child cried out 10-20 minutes after injection. Complaint with abdomen pain and hold abdomen. Felt warm temp 97.6 P 80-20. Diaphoretic, pale. Room air O2 97-98. Exam by medical doctor. Prescribe Benadryl 20mg PO given and return to clinic next day.
Body ache, chest congestion, chills, cough, fever, headache, nasal congestion.
Hives within 45 minutes of getting immunizations, referral to allergist, Benadryl PO 12.5mg PRN itching given. P90, RR 20, BP 88/54.
Fever of 102.2 lasted for about 4 hours on 8/9/2020. Patient rested and the fever went away. Patient also felt fatigue.
Patient received the second dose of vaccine on 17Mar2021; Have not had a period since receiving the vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 03Mar2021 at 09:00 (at the age of 44-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 17Mar2021 at 09:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included escitalopram oxalate (LEXAPRO) for unknown indication from an unknown date and unknown if ongoing. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had received the second dose outside the range of 19-42 days after the first dose and hence there was a medication error (inappropriate scheduling of vaccine administered). On 03Mar2021 at 09:00, the patient has not had a period since receiving the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event not had a period since receiving the vaccine was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
severe left sided testicular pain, lasting approx 3 hours.   Pt unable to stand or walk for several minutes after waking up.  After using the restroom later, pt felt some pain diminish, but is still tender.   Scheduled visit with Dr to evaluate on 6/22/2021.  Suspected Testicular Appendage Torsion.   Today (6/23/21)  small blue "bruise type" spot on upper left testicle.
Pt reports tension in upper back and neck with a mild headache beginning the day after vaccination administration. No treatment used.
LEFT UPPER ARM / DELTOID AREA - RED, WARM, SWOLLEN, SLIGHTLY FIRM. ABLE TO MOVE ARM WITH MINIMAL DIFFICULTY.
The patient reports receiving her moderna booster on 12/4/2021. About a week ago she began to experience hives on different parts of her body including her hairline, chest, abdomen, hands, feet, and neck. The rashes do not appear all at once and last for about an hour. She reports improvement in her symptoms after taking OTC antihistamines and topical steroids. She also reports that the frequency of the rashes has been improving.
This is a spontaneous report from a contactable physician (physician). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 09Jun2021 09:30 (at the age of 56-year-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hyperlipidaemia, prediabetes, no prior history of respiratory disease, non-smoker. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX); duloxetine; pantoprazole; and liothyronine. Historical vaccine included BNT162B2 dose 1 on 09May2021 at 09:30 AM (at the age of 56 years old) in the left arm for COVID-19 immunization. The patient was not pregnant. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. She had no known allergies. It was reported that on 09Jun2021 09:30, the patient had immediate pain, soreness injection site. On 09Jun2021 21:30, 12 hours post injection the patient had chills, body aches, headache and nausea. On 11Jun2021, 48 hours post injection, she had ipsilateral auxiliary and supraclavicular adenopathy. In Jun2021, 4-5 days post injection, she had substernal chest discomfort radiating to back, continued nausea/chills/headache. In Jun2021, 18 days post injection with continued symptoms seen in ER and diagnosed with RLL pneumonia/pneumonitis. She was treated with antibiotics. 2 weeks later (2021) still same symptoms but now episodic coughing and more shortness of breath. Diagnosed with viral syndrome and placed on albuterol inhaler and prednisone. No resolution to date. No prior history of respiratory disease, no smoker. She had been tested for COVID-19 since the vaccination which included PCR (nasal swab) test with negative result on 12Jul2021. The events resulted to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events including antibiotics, prednisone, and albuterol inhaler. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
Intradermal flu vaccine, administered to 17 year old, approved age range: 18-64 yrs.
I developed a case of COVID which I do NOT attribute to the vaccine - it was a breakthrough case. Since Monday evening April 25 I have had symptoms, starting with throat irritation and sinus congestion. I had a positive rapid test at home on April 26 and went for a PCR that day. April 27 I had fever (100.4 F.), aches, nasal congestion, bad headache, vomiting for about an hour, and severe runny nose for several more days. Coughing developed on April 29 and has gotten slightly better today. The fever has reduced (without medication) to 99.4 through today. I had  NO breathing problems and have been recovering at home.
SWELLING OF TONGUE, LIPS, LYMP NODES UNDER ARM UP TO 6 DAYS AFTER.  INJECTION SITE EXTREMELY SWOLLEN ,   SEVER BODY ITCHING FOR A WEEK., FATIGUE AND LOSS OF APPETITE
I was on a cruise when I noticed the symptoms. I had a runny, big cough, sore throat, headache and fatigue. I tested for COVID-19 twice and Strep and both tests were negative. He prescribed a cough suppressant and diagnosed me with a cold and advised me to rest. I am finally starting to feel better. Today was the first day I felt better. I have not completely recovered. I am close but not yet recovered.
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (Arm pain), FATIGUE (Fatigue) and MYALGIA (Muscle aches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. No relevant medical history was provided. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm pain), FATIGUE (Fatigue) and MYALGIA (Muscle aches). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (Arm pain), FATIGUE (Fatigue) and MYALGIA (Muscle aches) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication reported. No treatment information provided by the reporter. This case was linked to MOD-2021-133027. Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received updated patient initials and email address. On 12-Jul-2021: Non-Significant follow up appended.
Pt. admitted on 05/11/2021 for "failed non operative treatment consisting of at least 6 weeks of physical therapy and medical treatment"; discharged to HCF on 5/17/2021  after having lumbar procedure.
10 x 11 cm local react in lt arm; treated w/Atarax & lodine & modified work x 10 days;
Itching at the area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the area of the injection) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the area of the injection). The patient was treated with CORTISONE at an unspecified dose and frequency. On 03-Mar-2021, VACCINATION SITE PRURITUS (Itching at the area of the injection) had resolved.            Concomitant product used was not provided by the reporter.  Treatment included cortisone cream on the injection site.
about 1 hour after vaccine-weakness "couldn't stand up"-dizzy/nauseous, "chest felt heavy", throat felt swollen, choking on spit states she fell asleep and was "out cold" her daughter had a hard time waking her up. She states she didn't feel anything during her half hour wait at clinic and then at the end of her drive home started feeling sick and had to have her daughter help her out of the car.
Employee stated she felt she was beginning to get chills, felt shaky and was complexion became flushed and blotchy.
Chest discomfort (4/10), headache, neck pain. Denies dizziness, sob, difficulty breathing, abd pain. Tylenol 650 mg po x 1 given for headache. BP 200s. HR 70. O2sat 98. Reports she has had similar chest discomfort in the past. Pt taken to ER.
mom states pt became lifeless, blue, unresponsive 1 hr later went to ER MD attended & adm to hosp; MD recommends DT only in future;
Sore arm the first day. Second day was tired, fever (over 100) aches, head aches, sore throat. Symptoms were much like my Covid systems in June. I ended up taking Ibeprofin (sp) and sleeping. The next day felt much better, still tired and arm is still sore. I had not heard of anyone else experiencing side effects from the shot. For me, to relive the same side effects was scary. I am hoping the second shot is not as bad! Hopefully everyday will get better.
Patient received a DTAP #4 and a Hepatitis A #1 on 4/13/11. The mother is calling today 4/22/11 stating that within a minute of receiving vaccines his cheeks & side of his neck broke out in a rash. That lasted 3-4 minutes. The nurse was aware at that time. While in the car on their way home he was grinding his teeth & crunching his muscles. Mother reported this reaction to us on 4/22/11. Medical assistant reported to me that she did not see a rash on 4/13/11.
On day 7 my arm was hard and itchy at the injection site -like a rash.
4 wks after receiving HPV injection hair began falling out this was her 2nd dose. Mother felt this should be documented.
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 15-Apr-2022; Vaccine was expired on 01-Apr-2022 administered on 15-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 15-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 15-Apr-2022) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 15-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 15-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 15-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 15-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that pharmacist thought that the vaccine was expired in Jun-2022, however it was expired on 01-Apr-2022.  No treatment information was reported
Dermatomyositis: which includes rash, that is attacking her mother's body. Caller states that her mother's muscles in her arms and thighs have lost muscle mass; lost weight; her mother cannot walk; got weaker; This is a spontaneous report from a contactable consumer. An 83-year-old female patient (reporter's mother) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via unspecified route on unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Since patient got the vaccine, she has been diagnosed with dermatomyositis. It was reported she was diagnosed when she was checked out of the hospital and states the date of 07May2021. This condition gave her a rash that is attacking her body. Patient's hands and feet still function, but her muscles in her arms and thighs have lost muscle mass and she has lost weight. Because of this, she cannot walk. Reporter stated that her mother (patient) was bowling, cutting grass, and was totally vital until she got the vaccine. Patient was in the hospital for a week and then they sent her home. She followed up with a rheumatologist and her doctor. The doctor gave patient steroids and they did not work. The doctor also gave patient intravenous steroids and she showed no improvement. She got worse with the intravenous steroids and got weaker. She took intravenous steroids for 3 days. Reporter stated that she is not sure if her mother is just getting weaker from the condition or it is the medicine. Patient has prednisone 10 mg tablets by mouth and was instructed to take 30mg by mouth twice a day, unless she is getting intravenous steroids. The intravenous medication was specified as Methyl Prednisolone Sodium Succinate, 1000 mg in normal saline 250 ml, in an intravenous bag. The outcome of the events was not recovered.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
In the night of 08/11/2022 I tested positive for  COVID-19. On  08/12/2022 I started  experiencing  chills; eyes were watery;  sore throat.  I felt like I had a severe cold.  I did a tele health with my doctor  she advised  me to take Nyquil Cough, Cold  &  Flu Medicine and  Tylenol . I took  it approximately for  8 days. I started feeling better afterwards.
Red, painful, warm to the touch area, approximate size of a tennis ball on the upper right arm.  Advised the parent to use cool, moist compresses and Tylenol/Motrin.
rash on the side going to her lower back; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 09Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. On Mar2021, the patient experienced rash on the side going to lower back. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
stuffed up nose; sore throat; fatigue/more exhausted and tired; sore muscles and legs; sore muscles and legs; stomach is hurting; she woke up with a really bad cramp on her side.; headache/headaches had been pretty bad; felt a little sick; This is a spontaneous report from a contactable consumer (patient herself). A 25-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, lot number: EL1284), via an unspecified route of administration on 26Dec2020 at single dose for COVID-19 immunization. Medical history reported none. There were no concomitant medications. After vaccination, the patient felt sick, the patient experienced headache on 26Dec2020; fatigue on 27Dec2020; sore muscles and legs (really sore) in night on 27Dec2020; stomach is hurting on 27Dec2020; she woke up with a really bad cramp on her side on 27Dec2020, it was unbearable to the point where she had to sit down, she woke up really bad; woke up with a stuffed up nose on 28Dec2020; sore throat on 28Dec2020 (really started this morning). She was more exhausted and tired. Her headaches had been pretty bad. The patient underwent lab tests and procedures which included COVID test with unknown results on 28Dec2020. She was taking medicine for the headaches on 28Dec2020. The outcome of events was not recovered.
arm soreness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number Z4359, expiry date unknown) for prophylaxis.   On 5th July 2019, the patient received Shingrix (intramuscular) .5 ml. In July 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the one of his patients received the Shingrix vaccine. The patient started having arm soreness after the injection and had the soreness, even though it has been 3 weeks.
Initial unsolicited report received from a pharmacist on 07 June 2016. This case involves a female patient (age not reported) who received a dose of Flu Vaccine (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced "anaphylactic" reaction to the flu vaccine. Laboratory data was not reported. Corrective treatment was not reported. Outcome of the events was reported as unknown. Upon internal review, the company decided to consider the event serious because of important medical event anaphylactic reaction to a flu vaccine. List of documents held by sender: none. Sender's Comments: This is a poorly documented case of anaphylactic reaction after INFLUENZA VACCINE. Further information regarding dates of vaccine administration and the reported events, investigation results and etiological work up are needed for the complete assessment of the case. Based on the data provided, the role of vaccine cannot be assessed.
A non-serious, spontaneous report of 61 Year Old was inadvertently administered novel H1N1 was received from a nurse regarding a 61-year-old female patient following H1N1, Intranasal. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.
Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. List of concomitant medication were not given.