chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VIRUS; This spontaneous report received from a consumer via a media via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (suspension for injection, route of administration not reported, batch number: Unknown, expiry: unknown) dose, dose number in series 01, 01 in total was administered, start therapy date were not reported for prophylactic vaccination. No adverse event was reported following covid-19 vaccine ad26. cov2.s (Dose number in series 01). The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of administration not reported, batch number: Unknown, expiry: unknown) dose, dose number in series 02, 01 in total was administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, following vaccination with covid-19 vaccine ad26. cov2.s, the patient had spent a month in the hospital with virus and still on oxygen months later (Dose number in series 02). Treatment medications (dates unspecified) included: oxygen. Hospitalization date, number of days of hospitalization and discharge date were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of virus was not reported. This report was serious (Hospitalization Caused/Prolonged). The case was associated with product quality complaint (PQC): 90000220698. The suspected product quality complaint has been confirmed that the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20220313639-COVID-19 VACCINE AD26.COV2.S-virus. 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). Therefore, this event(s) is considered unassessable.
This is a spontaneous report from a contactable consumer. A male patient with unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) through an unspecified route of administration and an unknown anatomical site on 15Mar2021 at 14:00 (at an unknown age) as second dose for COVID-19 Immunisation. The patient past drug history included first dose of BNT162B2 on an unspecified date, unspecified route of administration and an unknown anatomical site for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. It was unknown if the patient was diagnosed with COVID-19, prior to vaccination. It was also unknown whether the patient had been tested for COVID-19 since the vaccination. It was unknown whether the patient received any other vaccines within 4 weeks prior to vaccine. On 16Mar2021, the patient experienced high fever and was unwell all the day after vaccination. It was unknown whether the patient received therapeutic measures for the events. The clinical outcome of the events high fever and unwell were recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Looked like seizures and ended up having intussusception. Don't have exact date of administer and hospitalization but right after.
1st vaccination shot of Moderna: Shot was given on left upper arm, the typical swollen itchy sensitive red spot was present at the vaccination area for about 4 days. Approximately 24 hours after the vaccination I began to feel very shaky all over, that lasted for about an hour. This was also the onset of hives on both arms, shoulder to wrist. With my right arm (opposite arm of vaccination) displaying large hives over the entires forearm area, the  large hives looked like a bunch of mosquito bites. I also had a patch of regular hives on my right outside ankle and a very small patch on my left ankle. I had a headache that lasted about 5 days, I typically do not get headaches. I wanted to get the best immune response so I did not take Benadryl or any Acetometaphin or pain medication. The hives were gone sometime overnight (between 2:00-5:00am) after I finally fell asleep. A red rash,  not itchy or bumoy continued on the left forearm for another few days. I contacted my dr a couple days later and was instructed to not get the 2nd shot of Moderna or any mRNA vaccines.
On 12/13 injection site red and got a chickenpox spot on back then got about 10 by 12/16. Between 12/16-12/20 got 10 more. All on torso, neck, 2 on face Older ones scabbing over. Woke up 12/21 with clusters all over both legs. Also on wrist.  Called PCP on 12/16 and they said a few spots normal. Stay away from babies should be gone in about 5 days. Called PCP again 12/21 about new leg breakout. No call back. Used virtual visit and confirmed I had gotten a rare case of the chickenpox from the vaccine. Suggest I report it. Stated it should be ok in about a week when scabbed over.
Myalgia, Fever, NauseaVomiting & HYPERtension
JOINT PAIN; FATIGUE; NEGATIVE SIDE AFFECTS; JOINT PAIN, FATIGUE AND HEADACHE WENT AWAY (UNEXPECTED BENEFICIAL EFFECTS); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: joint pain, headache, and fatigue. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAR-2021, the patient experienced negative side affects for less than 24 hours but felt great after that. On an unspecified date in MAR-2021, after receiving vaccine, the patient's joint pain, fatigue and headache went away (coded as Unexpected beneficial therapeutic response). On an unspecified date in NOV-2021, the patient joint pain, and fatigue came back (all events dose number in series 1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from negative side affects. The events joint pain, and fatigue, and the outcome of joint pain, fatigue and headache went away (unexpected beneficial effects) was not reported. This report was non-serious. This case, involving the same patient is linked to 20211226128.
she had pain at the injection site and so did her entire family; This is a spontaneous report from a contactable consumer, the mother of the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, administered in Arm on 01Jun2021, as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was stated that, on an unknown date in Jun2021, the patient experienced pain at the injection site and so did her entire family but had that pain for 2 days and then it went away. The mother also reported that, if they could educate her daughter at home, she would not have taken the shot, but they decided to take it as a family. She also told she did not do well with vaccines but she could not stomach giving her daughter a vaccine that she would not take. She said, She did not want daughter to get it, completely blind and had to go to school to be educated, not comfort. The outcome of the event was recovered on an unspecified date in Jun2021.   Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021785013 same reporter/drug, different patient.
This spontaneous report as received from a nurse and an office manager (also reported as clerk) regarding a 21-year-old male patient. It was reported that there was no illness at the time of vaccination and patient was without pre-existing physician-diagnosed allergies, birth defects and medical conditions. No information was provided regarding the patient's pertinent medical history. On 04-JAN-2018, the patient was vaccinated with first dose of improperly stored GARDASIL 9 (exact dose, dose number, lot # M034780 with the expiration date of 15-APR-2019) intramuscularly for prophylaxis. The patient's concomitant medication included meningococcal vaccine (unspecified), hepatitis a virus vaccine inactivated, and influenza virus vaccine inactivated (unspecified). The patient was vaccinated in a public health clinic/hospital. The patient did not have prior vaccination within 4 weeks prior to 04-JAN-2018. This event was not previously reported. The administered dose of GARDASIL 9 underwent a temperature excursion at or above 32 Fahrenheit degrees (F) up to 35 F (35.4 F) for 7 hours and 15 minutes. Previous temperature excursions were at or above 32 F up to 35 F (35.1 F) for 2 days, 1 hour and 37 minutes, and at or above 32 F up to 35 F (35.4 F) for 7 hours and 15 minutes. Digital data logger was involved to capture the temperature excursions. No adverse effects were reported. This vaccine was stored at the clinic where the temperature excursion (also reported as for a few moments). It was reported that the office manager made contact with all manufacturers who stated vaccine did not need to be pulled from inventory and the office manager received follow up stating GARDASIL 9 given to the patient was supported through expiry.
started with muscle pain around the vaccination site, pain spread through arm and shoulder gradually developed fever 100.1F chills muscle pain fatigue
Patient presented to Observation check in area (@ 4:20 PM) appearing shaky, diaphoretic and was complaining of being lightheaded. Patient was assisted to sit in a wheel chair and wheeled back to treatment area where he was assisted again onto the cot to lay down. Patient history was obtained while he was inside treatment area. Pt denied Medication and Food Allergies as well as any Past Medical History. Patient was given water to drink and stated he felt normal again, wanted to and was ready to leave 5 minutes later at 4:25 PM.
heavy sleeping for 5-6 hrs 1 hr p/shots hard to wake up; dazey, eyes not focussing; very slow to awaken; denied fever, crying, fussiness;
tinnitus.  started a few days after my first shot of pfizer.  hissing sound in the ears all the time.  like the day after you go to a loud concert.  it's been getting on to three weeks and is still present.  distracting but not debilitating.  hope it goes.
Woke up with one eye red; HCP diagnosed as allergy/conjunctivitis; HCP diagnosed as allergy/conjunctivitis; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EN6200) via an unspecified route of administration, on an 21Feb2021 at around 11:30 (age at the time of vaccination was 68-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not have prior vaccinations within 4 weeks or any AE(s) following prior vaccinations. In 2021, the patient experienced, HCP diagnosed as allergy/conjunctivitis. On 23Feb2021, the patient experienced Woke up with one eye red. Caller reported that she has had two doses of the pfizer covid 19 vaccine. Caller reported she had the first dose on 21Feb2021 and later woke up with one eye red. HCP diagnosed as allergy/conjunctivitis. Caller stated she had the second dose on Sunday and woke up this morning, 16Mar2021 with redness in the same eye. Caller stated she got the vaccine in the left arm and the redness is in the left eye. Caller wanted to know if this is a reported side effect. Treatment: Caller stated had not taken anything for treatment. Caller then stated she has over the counter dry eye drops and the eye doctor said she could use that. Outcome of Woke up with one eye red was recovered on 26Feb2021, while the outcome of HCP diagnosed as allergy/conjunctivitis was unknown.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age who in October 2012 was vaccinated intramuscularly with a 0.5 ml dose of both AFLURIA and PNEUMOVAX23 in the same arm (in an unspecified arm) during the same visit. No concomitant medications were reported. The patient developed injection site pain and shoulder pain (October 2012). The patient recovered two weeks later. The patient sought medical attention (she called the pharmacist). The relatedness for the events and PNEUMOVAX23 and AFLURIA was unknown. Additional information has been requested.
Fever, exhaustion, diarrhea, loss of appetite lasting 60 hours. Intermittent elevated temperature, bronchial cough with significant phlegm persistent after eleven days despite antibiotics and OTC treatment.
Ache/pain/fatigue, beginning day after shot, resolved within 2 days   Approx 2" red inflamed area on arm at injection sight. Itchy, painful to touch, and warm to touch. Began 9 days after receiving vaccine, not yet resolved but improving
Employee states redness, swelling, pain and left  arm site was warm to touch, Reports a fever of  101.0 oral. Employee states ice packs to site, Tylenol  and Benadryl helped to relieve symptoms. Reports to  employee health on 7/17/2020 symptoms resolved.
On day eight post vaccination, patient developed a quarter size raised, red,itchy area.  Medicated with Benadryl and Tylenol, and ice therapy at the direction of physican's office. On  day 10 post vaccination site is now approximately the size of a half dollar but is not longer raised.
she said that with the first 2 shots she got "fever and chills, not a real dea; she said that with the first 2 shots she got "fever and chills, not a real deal; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (she said that with the first 2 shots she got "fever and chills, not a real dea) and CHILLS (she said that with the first 2 shots she got "fever and chills, not a real deal) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included ESTRADIOL for an unknown indication.   In September 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (she said that with the first 2 shots she got "fever and chills, not a real dea) and CHILLS (she said that with the first 2 shots she got "fever and chills, not a real deal). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (she said that with the first 2 shots she got "fever and chills, not a real dea) and CHILLS (she said that with the first 2 shots she got "fever and chills, not a real deal) outcome was unknown.            Some supplements as regular medications was reported The booster shot on the 03 Dec 2021   This case was linked to MOD-2021-404326, MOD-2021-404472 (Patient Link).
around 20OCT97 pt devel 1 x 1 1/4 lesion red & blistered has had for 3wk w/o problems;MD feels like immun rxn;
01/26/2022 I had vaccination. 06/28/2022 I started to experience what I thought was a sinus infection to include pressure in sinuses, headache and sore throat. I did not have a fever at this time. 06/30/2022 I did have a fever of 100.5. The symptoms had continued. The 3rd day I did a COVID-19 test. The test was positive. I sent a message to doctor through online application. They did not prescribe any medication. I still have pressure in sinuses with gunk. It is getting better. My doctor advised me not to have the 4th vaccination on 06/13/2022 as she deemed it unnecessary due to not being immunocompromised any more.
The patient called and reported that several days after receiving the first dose of SHINGRIX he had pain/tingling and weakness in his extremities. This weakness was extreme on exertion. The patient also reported pain in his arm and bruising at the injection site. I advised the patient to seek medical attention because he had been feeling these side effects longer than 1 week. He received a steroid shot from his PCP and visited the pharmacy stating he was feeling better. I noticed the bruise on his arm was not on the deltoid but towards the back of his arm.
A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning an 86 year old female vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.
Patient received injection on 11/18/22, as a non-smoking, healthy individual.  WAS FOUND DECEASED IN BED on 11/21/2022, 48 hours later.  EMTs and sheriff called. Patient's body sent to Medical Examiner's office
Lips turned blue and gasping for air immediately vaccines were administer by the pediatric resident. Patient were administer epinephrine, given O2 and PO prednisolone. Patient was sent home after recovering with PO BENADRYL.
Dizziness, Headache, HYPERtension, INCREASED HEART RATE, CHILLS employee states: immediately following vaccination,he experienced tenderness at the injection site and then a few hours later chills. beginning on Friday he had dizziness and headache which increased during the day. By Saturday he also had increased heart rate. His BP began increasing as well. His readings were: BP 186/94 and HR 124. He left work and went to the ER at which time 9about 45 min later) his BP was 210/128. Was given saline bolus. at discharge his BP was still 178/108. He has continued to monitor his BP and it has remained higher than normal. States he has no history of high blood pressure. Sees his PC regularly, last seen 1/29/2021. He is still experiencing dizziness and is now on BP medication and f/up with PC.
Patient felt lightheaded upon standing when her observation period was over.   She also may have stood up too quickly, per pt.  She reports a low BP in general.  A bottle of water was given to patient; after drinking, she felt better. Her BP was 112/90.  Her HR was 68.  Patient reassured and felt better.  She was given another bottle of water and walked around a bit with no symptoms.  Patient left stable.
Arm soreness at injection after each 3 doses/She then stated that her arms stay sore and still are. This occurred after she got the vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received BNT162b2 (BNT162B2), on 18Feb2022 as dose 1, single (Lot number: FK9729) at the age of 83 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "eye problems" (unspecified if ongoing), notes: She had eye problems since she was 14 years old; "Crippling Arthritis in leg" (unspecified if ongoing), notes: Crippling Arthritis in leg, She has had it since 15; "blood pressure be high" (unspecified if ongoing), notes: blood pressure be high , She has had that since she was 18.; "nervous" (unspecified if ongoing), notes: She has had that since she was 18. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Arm soreness at injection after each 3 doses/She then stated that her arms stay sore and still are. This occurred after she got the vaccine.". Therapeutic measures were taken as a result of vaccination site pain.  Additional Context: Patient already got 3 does of the Pfizer COVID 19 vaccine and saying she had scheduled for booster shot, which was first dose of the vaccine. The HCP who was supposed to give the vaccine did not come to her place, so she was calling to get the 4th dose. She missed her 4th dose. Caller stated she just turned 85 on her birthday. She then stated that her arms stay sore and still are. This occurred after she got the vaccine. She said she was tall and provided her height as between 5'8"-5'9". 18Feb2022, 1st one in Right arm Lot FK9729. She later came back and said that it could be RK9729. 16Mar2022, 2nd one in Left arm Lot FK9894, and later said it could be RK9894. She then thought the card said she got two shots on the same day. She started providing 26th of a month and unable to confirm which month. She was not sure about that number and then gave number of RK9729 again when asked when the 3rd dose was given and what that lot number was. She did not remember if she had two on one day and was unable to read the card to see what was given. It is confusing her. Caller stated her eyes are so bad. She could not hardy read. She had eye problems since she was 14 years old. She has got one of her eyes she could hardly see out of. She was frustrated because she cannot make out the numbers on the vaccine card and decided to disconnect.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200941012 Same patient/drug and different dose/AEs.;
edema in the injected arm from elbow to shoulder,extending into the anterior part of the chest devel 2 days p/inj;treated w/ATB
Pt. called and reported that the skin on his back and shoulders were burning and it was very painful. No fever/chills. No rash. No difficulty breathing. Pt. was advised to see his medical provider for further evaluation. During follow up call, pt. indicated he visited the ER and received an anti inflammatory medication.