chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she took her alendronate Sodium (note she skipped her dose on date of vaccination to avoid interaction) within the hour the injection location swelled up into a hard ball with intense itching; she took her alendronate Sodium (note she skipped her dose on date of vaccination to avoid interaction) within the hour the injection location swelled up into a hard ball with intense itching; Pain and swelling for about 3days at injection location.; Pain and swelling for about 3days at injection location.; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 23Feb2021 at 09:00 (at the age of 65-year-old) as a dose 1, single for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis, osteoarthritis, and osteoporosis. The patient was allergic to medications, food, or other products but unspecified. Concomitant medications included alendronate sodium and levothyroxine sodium (SYNTHROID) both taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an 23Feb2021, the patient experienced pain and swelling for about 3 days at injection location. On 01Mar2021, after exactly one week, she took her alendronate Sodium (note she skipped her dose on date of vaccination to avoid interaction), within the hour, the injection location swelled up into a hard ball with intense itching which lasted several days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events pain and swelling for about 3 days at injection location were recovered on 26Feb2021. The clinical outcome of the event injection location swelled up into a hard ball with intense itching were recovered in 2021 on an unknown date. No follow-up attempts are possible. No further information is expected.
Pt called 2/5/11 to report diagnosis of Bell's Palsy onset after vaccination with ZOSTAVAX. Diagnosis by Dr.
Patient developed diffuse arthralgias, esp hips, knees, ankles, tops of both feet, the sternal bone, and per pt, the worst was her neck; NO assoc fever, nausea, vomiting, diarrhea, headache, photophobia, or altered mentation; NO TREATMENT needed; sx started 3 days after the vaccine, peaked 6 days after the vaccine, and at the time of her presentation at my office, sx were nearly resolved.
Fever of 102F-104F, irritability X 5 days, starting 5 hours, post vax. Developed a macular rash, the last 48 hours of fever.
Allergic reaction; Pain; redness; Swelling; Itchy rash; Red dots on the upper arm; Headache; Muscle ache; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced allergic reaction, pain, erythema, swelling, itchy rash, red rash, headache and muscle pain. On an unknown date, the outcome of the allergic reaction, pain, erythema, swelling, itchy rash, red rash, headache and muscle pain were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, pain, erythema, swelling, itchy rash, red rash, headache and muscle pain to be related to Shingrix.  Additional case details were reported as follows: The patient reported an allergic reaction after the Shingrix vaccination.  The patient experienced pain, redness, swelling, muscle aches, headache and an itchy rash with red dots on the upper arm. The symptoms were lasted approximately 5 days to 1 week. The patient was misdirected to medical information and did not understand that the product could not be discussed between her and medical information. The patient did not provide the healthcare professional information when asked.  They did not confirm that a healthcare professional information was consulted when asked if it was reported. The reporter gave permission to follow up.
Tough to sleep; Ringing in ears; This is a spontaneous report from a non-contactable consumer. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 (Batch/Lot Number: En6201) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN]) and losartan, both for unspecified indication. On 16Mar2021 at 16:00, the patient experienced ringing in ears and tough to sleep for a couple days. The patient did not received treatment for the events. The events resulted in disability or permanent damage. The outcome of the event was not recovered. The patient did not had COVID prior to vaccination and was not tested post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Forget to dilute the vaccine before administering it. No adverse reactions were reported by the patient, except for a sore arm
This spontaneous report as received from a pharmacist refers to a 62 year old patient. On 09-OCT-2014, the patient received an expired dose of PNEUMOVAX23 (lot # 09-OCT-2014, the patient received an expired dose of PNEUMOVAX23 (lot #J006921, expiration date: 09-AUG-2014) 0.5 ml, intramuscular. The patient has not demonstrated or reported an adverse experience. Additional information has been requested.
Pt. stated she felt dizzy and lost  consciousness for about 10 seconds.  Pt. woke up and stated she felt much better.  Pt. was moved to gurney.  Vitals were taken and within normal limits.  Pt. drank water and stayed for another 15 minutes for observation before returning home.
Vertigo, nausea, diarrhea, ear pain and fullness, sinus pain and headaches, weakness, exhaustion.
Patient c/o burning as soon as vaccine was administered. Patient called facility 30 minutes later, said injection site was swollen, red, and hot. Nurse advised her to apply cool compress, take MOTRIN, monitor for 24 hours and call back with any worsening changes. Patient called on 11/7/16, said swelling had gone down, reported bruising at injection site.
After 7 days, patient got a covid arm rash, gi issues, low grade fever, headache; They lasted about 1 week.  She still has a small bruise and hurts when lifted high.
Case number PHEH2014US024335, is an initial spontaneous report from a nurse received on 02 Dec 2014 with a follow up information received from the nurse on 19 Jan 2015. This report refers to a 73-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. His vaccination history included administration of previous FLUVIRIN (batch number: not reported) which were previously tolerated. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly in the left deltoid at a dose of 0.5 ml on 03 Nov 2014. The nurse reported that FLUVIRIN prefilled syringe stored at 49 F for 1 hour and 15 minutes was administered to the patient. The reporter confirmed that the patient did not experience any adverse reaction following administration of incorrectly stored vaccine. Follow up information received from the nurse on 19 Jan 2015: Updated gender of the patient, vaccination history, site of vaccination and reporter's comment.
mom reports pt began screaming approx 2 hrs p/vax & was said screaming inconsolably @ 10PM; mom called MD who prescribed APAP;
Breakthrough case admission after three vaccines  Pfizer 2/12/21 Lot# EL9267;  Pfizer 3/5/21 Lot# EN6202;  Pfizer 11/6/21 NO LOT NUMBER AVAILABLE
This is a spontaneous report from a contactable consumer or non-HCP (patient herself). A female patient, of an unspecified age, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on Feb 18, 2021, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. On Feb 18, 2021, patient developed pain in her arm (possibly muscle pain). Reportedly, it has been 8 days since she received her vaccination, but the pain was still there. The pain was not exactly in the site of administration but down the arm. She wanted to know if this was normal. At the time of this report, the outcome of events: not recovered. No follow-up attempts possible. Information about batch/lot number cannot be obtained.
Patient experienced numbness in arm vaccine was given (left arm) and both legs. She could still used all extremities fine. She did state that she had experienced something similar when she contracted the COVID virus previously. The numbness decreased after about 20 minutes and had resolved completely by the next morning.
Pt voiced became lighted while walking and fainted. Patient quickly gained consciousness and responded to commands correctly.
Body aching, pain and swelling where the shot was given, chills, sore joints.
Information has been received from a registered nurse concerning a 15 week old patient who on 05-JAN-2011 was vaccinated with a first dose of ROTATEQ (therapy route and lot # not provided) past the recommended age. No adverse effect reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
I just got up today to get tested and the covid test was positive; I just got up today to get tested and the covid test was positive; This is a spontaneous report from a contactable consumer. This 66-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for Injection) via an unspecified route of administration on 24Feb2021 as a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The next morning, the patient woke work up and it was the worst day ever. On an unknown date, the patient had the flu the before and it was like that. The patient couldn't move, stayed in bed for 24 hours and just got up today to get tested and the COVID test was positive. The patient went to get tested when found out and was told it was too early to be tested. So she went back 8 days later and tested negative. When she saw that they were offering free vaccinations, the patient went on Wednesday to get the vaccine. The patient reported that her husband was positive for COVID 3 weeks ago. The outcome for the events were unknown. Attempted to connect caller for event reporting. Due to prolonged hold time, caller declined to continue holding and agreed to received follow up regarding this event via phone or email. Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Left arm muscle: a large painful bulge formed between Left shoulder and elbow - was sore 5-7 days. Went to my doctor's office to have it checked out. Received a prescription to get ONLY if it didn't get better in a few days. I never got it filled
head, neck, teeth aches; head, neck, teeth aches; dizziness; head, neck, teeth aches; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (head, neck, teeth aches), TOOTHACHE (head, neck, teeth aches), DIZZINESS (dizziness) and HEADACHE (head, neck, teeth aches) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart murmur.    On 02-Dec-2021 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (head, neck, teeth aches), TOOTHACHE (head, neck, teeth aches), DIZZINESS (dizziness) and HEADACHE (head, neck, teeth aches). At the time of the report, NECK PAIN (head, neck, teeth aches), TOOTHACHE (head, neck, teeth aches), DIZZINESS (dizziness) and HEADACHE (head, neck, teeth aches) outcome was unknown.            No concomitant medication was reported.  No treatment medication use was reported   This case was linked to MOD-2021-404357 (Patient Link).   Reporter did not allow further contact
Information has been received from a healthcare worker referring to 49 unspecified patients of unknown age and gender. On unknown dates the patients received doses of improperly stored VARIVAX (Merck) (lot # L041207 with expiration date of 20-OCT_2017; strength, dosage, frequency and route unspecified). No adverse effects were reported. There was no previously temperature excursion. Temperature was 30.6 F  and time frame was 676.9 total cumulative hours. Additional information has been requested.
Vaccinated pt admitted to inpatient facility with covid infection. No information on date, type, location, etc.
EXPIRED VACCINE ADMINISTERED UNINTENTIONALLY; This spontaneous report received from a pharmacist concerned a 55 years old male patient of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no Illness at the time of vaccination, no history of similar event, no adverse event after any previous vaccination, no history of allergy to vaccine, drug, or food, no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days with cause, no family history of any disease (relevant to vaccination) or allergy. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: Unknown) dose was not reported, dose number in series 1, 01 total, administered on left arm on 09-JUN-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, dose number in series 2, 01 total, administered on right arm on 23-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-DEC-2021, expired vaccine was administered unintentionally (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered unintentionally was not reported. This report was non-serious. This case, from the same reporter is linked to 20220210382, 20220260967, 20220261042, 20220261063, 20220261011, 20220261024, 20220261048, 20220261092 and 20220261014. .
4/10 vaccination 4/11 1AM, I started to feel generally sluggish and tired, chills. 230 AM the chills came full blown. Extreme chills, shaking, elevated 115-120 BPM, SOB that lasted 2 hours. I called to the advise line with medical facility. They told me to take some Tylenol. I made sure it was ok to take my anxiety medication with the Tylenol. 2 hours later, the chills had stopped.
30 minutes after 3rd dose felt chest constriction lasting 4 hours, "Like an elephant on chest when you have COVID; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (30 minutes after 3rd dose felt chest constriction lasting 4 hours, "Like an elephant on chest when you have COVID) and VACCINATION SITE PAIN (soreness at injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Anxiety, CYCLOBENZAPRINE for Muscle relaxant, LEVOTHYROXINE and MIRABEGRON (MYRBETRIQ) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 03-Nov-2021, the patient experienced CHEST PAIN (30 minutes after 3rd dose felt chest constriction lasting 4 hours, "Like an elephant on chest when you have COVID) and VACCINATION SITE PAIN (soreness at injection site). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. On 03-Nov-2021, CHEST PAIN (30 minutes after 3rd dose felt chest constriction lasting 4 hours, "Like an elephant on chest when you have COVID) had resolved. At the time of the report, VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.            This case was linked to MOD-2021-374850 (Patient Link).
Within 5 minutes of vaccine administration, patient appeared shaky and reported tightness in throat. Pharmacy staff suspected anxiety/panic attack as symptoms appeared to be triggered by pharmacist stating that patient must remain on site for a 15 minute observation period in case of an immediate and serious reaction. Out of an abundance of caution, EMS was called and reported to the pharmacy. EMS stated airway was clear, and patient did not appear to be in anaphylaxis. Because patient was wheezing, epinephrine was administered, and patient was taken to local hospital. Patient was discharged around 10:00pm (approximately 5 hours after the incident).
Around dinnertime day of vaccination, patient started feeling pain in her arm around site of vaccination sensitive to temp. and touch. Next day pain increased, and pt became nauseous and experienced unbearable myalgia. No treatment necessary, patient recovered in 1-2 days.
THIRSTY; SORE ARM; TIRED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced thirsty, sore arm, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thirsty, tired and sore arm was not reported. This report was non-serious.
Patient while sitting in the post-vaccination area for 15 minutes, started experiencing lightheaded and faint when he got up. I instructed the patient to sit back down and he complied. I went to grab the patient water and calm him because he seemed a little anxious and then he started shaking, so we immediately called 911. I tapped him to see if he was okay, and he said yes was okay but really faint and the patient was sweating. I asked if he was having trouble breathing, but he denied. He drank the water and had chocolate and I kept conversing with him to assess for any physical/mental status changes, and during the conversation the patient said he usually feels faint and anxious when he gets blood drawn but did not mention it during the screening because he never has when receiving vaccinations. The patient was appearing to improve, less anxiousness, less sweating, and getting more color back to his face. When the EMS arrived within 5-10 mins, they assessed his vitals which were all normal and the patient requested not to be taken to the hospital. The EMT personnel felt the patient was doing okay and left. I had the patient stay for another 30 minutes to make sure he was remaining okay before he left.
Information has been received from a physician concerning a 6 month old male who "the week of " 02-APR-2007 was vaccinated with a PO third dose of Rotateq. Concomitant vaccination included a dose of Prevnar and dose of DTaP. "The week of" 02-APR-2007 the patient developed vomiting, diarrhea and blood in stool and was hospitalized. All tests that were performed "came up negative". A stool culture was done. It was reported that the physician was "unsure of what caused the patient's symptoms". The patient present status was "fully" recovered. It was reported that the patient was at home. The date of discharge from the hospital was not reported. There was no product quality complaint involved. Additional information has been requested.
Mom states swelling did not happen on 6/7/17 or 6/8/17 states noted 6/9/17. Also reports tender to touch and redness.
On 04/25/2022 ,I went to sleep with a headache, I woke up with heart arrhythmia. I went to the ER on the 04/26/2022, as I was in tachycardia, I developed a heart block. My medications have been changed from Aspirin 81mg once a day to Eliquis 5mg twice a day. I have had to get a pace maker put in. The doctors feel the immune response to the fourth dose of the vaccine caused the arrhythmia. The doctors say my medications may change as they monitor my heart through the pace maker.
Nausea, horrible headache, throbbing in head, body aches, chills, fatigue
About 5-6 hours after the shot I started to experience nausea. It is night time so I attempted to sleep. I just woke up with the urge to vomit. Have been vomiting now for more or less 10minutes (all of what I ate during dinner).   Other symptoms include slight headache, feeling slightly warm although I have not checked my temperature and also at the same time slightly cold, and pain in the right arm.   On the previous dose the only symptom I had was pain in my left arm (I switched sides this time around although don?t think that is relevant)
Headache Chills,fatigue, eye twitching Narrative:  Missed 1/2 day of work
Expired Havrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received HAV (Havrix) (batch number T57F3, expiry date 16-FEB-2023) for prophylaxis.   On 08-MAR-2023, the patient received Havrix. On 08-MAR-2023, an unknown time after receiving Havrix, [the patient experienced expired vaccine used (Verbatim: Expired Havrix administered).The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:08-MAR-2023  Reporter's comment: The nurse reported that she/he gave expired vaccine of Havrix to patient. The adverse event contained all information provided. The reporter consented to follow up. Additional supportive information: The patient was administered with expired vaccine of Havrix which led to Expired vaccine used.
Bad chills and started shaking for 10 minutes along with a fever 101 and very tired with headache. I'm still tired on day 2.
Area of injection grew red, hot, very hard. Kept getting larger, fever present, flu like symptoms. Was prescribed KEFLEX 500 mg and BENADRYL - after 2 day appearance of site improved and continues to improve.