chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 05/09/2021- the day after the vaccine my period started full force. I usually have cramps prior to my period. On 06/04/2021- with the previous period I had strong cramping and heavy flow. With this period, I had severe, stabbing pain on the left side. The pain was so intense I went to the ER. I was diagnosed, with my IUD had gotten misplaced and it caused uterine pain. In the ER they did remove the IUD that was misplaced. They found a 4 cm enlarged cyst. They diagnosed it as a hemorrhagic cyst. No treatment they just referred me to follow up with my PCP. Doctor had me do an ultrasound-they found no rupturing or bleeding. My pain had improved significantly, so she did not provide any treatments or medications or anything. Right when my period was starting, just sudden pain, right where the spot where my ovary is. I was having the same stabbing pain. I had a 2nd visit to the ER in November 2021, were I had a fallopian tube removed. I had surgery the last week of November and I had no further problems. The surgery was performed in clinic by doctor.
The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.; No Adverse Event; Patient received vaccine after 30-day Use by Date.; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use by Date.), PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.) and NO ADVERSE EVENT (No Adverse Event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination. No Medical History information was reported. On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use by Date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use by Date.), PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use by Date.) and PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.). Concomitant drugs were not reported. Number of doses or vials around 50 doses from 5 vials. The vials were initially refrigerated on 08 Jul 2022. The vial did not undergo any temperature excursions. Treatment details were not given.
BOOSTRIX given in RM. without incident.  On leaving office had syncope episode.  Mom stated he hit back of head during fall.  Ice pack applied to back of head, no open areas noted.  Pt. awake & alert.  C/o nausea.  Skin color pale.  Speech clear.  AROM.  After 20 mins. no change.  Able to walk.  Instructed mom with concussion protocol.  Call if needed.  Skin color pink.  Dr. eval. pt.  Will follow up with call in  AM.
This is a spontaneous report from a non-contactable consumer (patient). A 37-years-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date in Apr2021 (at the age of 37 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the patient received no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced PCR Covid Positive and related symptoms of disease (medically significant) on unspecified date in Aug2021. The patient received treatment of Advil in response to event. The patient been tested for COVID-19 since the vaccination. the patient underwent lab test included PCR/Nasal Swab with positive result on unspecified date in Aug2021. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Patient noticed reddish rash around injection site appearing the day of vaccination. Area tingled some & felt a little itchy".
Headache, Myalgia, Fever, arm pain, redness and swelling. chills, fatigue Narrative:
LUMP; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced lump. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lump was not reported. This report was non-serious.
Pt states she started feeling pain at the site of injection 3 to 4 days after the shot and is still there 6 weeks later.
Pt recv vax on 10/8/98; on 10/9/98 pt exp pain at vax site w/ decreased movement, funny feeling, stiff neck, difficulty sleeping
Left deltoid, visible red puncture site with spreading area sl redness extending inferior to injection site. Redness is blotchy/lacy and blanching. 10cm x 11cm. Area is indurated and warm. Slightly swollen.
pt recvd DTP vax & 7 hrs later mom described seizure activity; reports stiffened arms, legs, sl tremor of limbs, breathing ceased & pt turned blue; resp 40, t101;
Disoriented, tired, shoulder hurts, headache, can barely stand, sweating Later on, able to stand up,  chills.
Red lump to anterior left thigh where Varicella injection given 2 weeks prior-area firm to touch, red and warm to touch, tender to touch, measures approximately 3cm by 3cm redness with 2 cm firmness.
Pt received vaccine on 10/25/11 approximately at noon then developed an itchy rash & minor swelling of face & lips on 10/26/11 in the evening. Required a visit to doctor where she received a steroid injection.
Report 2001027635-1 describes bradycardia in a 32-year-old male who received hepatitis B vaccine recombinant (Engerix-B). Medical history, concurrent medications and concurrent conditions were not specified. On 10/01/2001, the pt received his 1st injection of Engerix-B. Two to 3 hours post-immunization, he experienced bradycardia and broke out into a cold sweat. He recovered, without treatment. On 11/01/2001, the pt received his 2nd injection of Engerix-B. Approx 5 minutes post-immunization, he broke out into a cold sweat. Additionally, he experienced bradycardia. Medical attention was required at the occupational health clinic. His heart rate rose gradually from 48 to 51 to 61 beats/minute. As of 11/20/2001, the events had resolved.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 11-DEC-2017, the patient was vaccinated with VAQTA lot # N019924 with expiration date on 02-SEP-2018 (strength, dose, route of administration were unspecified) for prophylaxis. The suspected vaccine was improperly stored in temperature between 9 Celsius degrees and 25 Celsius degrees for 1 hour and 6 minutes. No adverse effects was reported. The digital data logger was involved. No previous temperature excursions were reported. This is one of two case reports received from the same reporter. Sender's Comments: US-009507513-1712USA005657.
child started w/low grade fever on 12OCT98 & fussiness;mom noticed approx 20 bumps on tummy, back, arms & legs on 13OCT98;child dx by phone w/mild chickenpox on 24OCT;
Previous two Covid vaccinations did not produce any pain or side effects. Previous two Covid vaccinations were received at Pharmacy Jan. 27 & Feb.  24, 2021. Due to being immunocompromised, this was a FULL third dose of Moderna; NOT a half dose booster. Significant pain at injection site radiating down arm to elbow. Progressive red, itchy rash from injection site down to elbow, approximately 4 inches across. All symptoms resolved by Nov. 10, 2021.  Did not contact doctor. Searched Covid vaccine side effects and used hydrocortisone cream as suggested online through Nov. 10.  Cream MINIMALLY reduced itching.
Pt recvd 1 sot dose of Recomb 18JAN91 & later in the day exp nausea & rt sided abdominal pain;
A report was received from a health care professional on 12/03/03 concerning eight vaccinees of unspecified sex and under 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date, eight vaccinees under 4 years of age inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality. Update 1/20/04: Follow up information received from a health care professional indicated that a 3.5 year old female vaccinee inadvertently received Fluvirin on 11/18/03. No follow up pending.
This was the 2nd shot (no reaction to first shot). Facial swelling & nausea. Lot #ER8727. Booster shot: November 2021 - Tongue swelled double in size, couldn't talk. Facial & gland swelling for several days. I have continued to this date having random facial & tongue swelling.
Mom called to say that the baby was crying inconsolably and his leg was red from the injection. OTC pain reliever recommended.
Patient presented 1 hour post vaccination with Rash - puff lips...Treated 25mg diphenhydramine every 2 hours x 24 hour next developed angioedema and needed to present to ED.
Patient went home after immunization in afternoon developed headache, nausea, felt cold. Woke up next morning, fever 100.2 degrees, felt very cold, had difficulty breathing. Seen in office, received albuterol aerosol treatment. Felt better. Had chest discomfort, used albuterol x 2 same day. Improved next day.
This spontaneous report as received from a physician refers to a 66 year old female patient. The patient had a history of anaphylactic reaction to unspecified tetanus toxoid vaccine on an unspecified date. The patient did not have any other pertinent medical history. On 16-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (strength, lot# and expiry date were not reported) in the arm (reported as further down the arm where someone might get an allergy shot). Concomitant therapies included ZYRTEC, pramipexole, CRESTOR, PREMARIN, ESTRACE, vitamin D, AMITIZA, AUGMENTIN, guaifenesin, albuterol, sertraline hydrochloride, NORCO, NUVIGIL, DALIRESP, liothyronine sodium, clonazepam, ziprasidone, NEXIUM, potassium chloride and simethicone. On 16-DEC-2015, the patient developed 6x4 centimeter red, raised area around the injection site that was warm to touch following the administration of ZOSTAVAX. The patient received treatment with ice and BENADRYL. At the time of this report, the patient had not recovered from the event. The patient sought medical attention via calling the office. The causality assessment between adverse events and the ZOSTAVAX was not provided. Additional information has been requested.
Coughing; Pain in arm; Flu-like symptoms; Lost weight; Rheumatoid arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4493973-00 (AbbVie).  A 54-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 22Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1162590), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 23Apr2022, outcome "unknown", described as "Rheumatoid arthritis flare up"; COUGH (non-serious), outcome "unknown", described as "Coughing"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in arm"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu-like symptoms"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Lost weight". The patient underwent the following laboratory tests and procedures: Weight: Lost. The action taken for adalimumab was unknown.  The reporter considered "rheumatoid arthritis flare up", "coughing", "pain in arm", "flu-like symptoms" and "lost weight" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, the event rheumatoid arthritis flare up is related to the natural course of RA, possibly associated with MODERNA COVID-19 VACCINE based on close temporal relationship (event onset 1 day after booster dose), and is assessed as unrelated to BNT162b2. The causal relationship between BNT162b2 and the events cough, pain in extremity, influenza like illness and weight decreased cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
I had missive pulmonary embolism. I went to the emergency room. I could not work without getting out of breath and felt that I was going to pass out. Then I went to the hospital. I don't know how long it lasted.
pt received 1st dose moderna and experienced nausea, vision changes.  He became hot, sweaty and shaky.  Pt was administered first aid and 911 was called.  Pt reported numbness in arms, hands and legs.  Emergency staff arrived and ambulance and took patient to local er
Pharmacy mailed Shingrix, No refrigeration used; This case was reported by a nurse via sales rep and described the occurrence of intercepted product storage error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 22-Sep-2022 Reporter's comment: The nurse reported that 4 patients that had an prescription which was sent to pharmacy, the pharmacy mailed the Shingrix to their home for the patient to bring in office to be administered.  These were patients.  No refrigeration was used by pharmacy.  In one case the Shingrix vials were put in a pill bottle and mailed.  All doses were spoiled, and patients sent back to pharmacy.  The nurse was checking with patients to see if the patient had got the vaccination after that. The reporter agrees to follow up from GlaxoSmithKline. Additional Supportive Information: All doses were spoiled, and patient had not received the doses, which led to Intercepted product storage error. This case was 1 of 4 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR136866:Same reporter- Patient 4 US-GSK-US2022AMR136885:Same reporter- Patient 3 US-GSK-US2022AMR136883:Same reporter- Patient 1
On 1/19/2023, I developed flu-like symptoms, such as head congestion, a minor cough, sore throat, and general malaise. I also developed a fever, but it never reached beyond 99 or 100 degrees. On 1/21/2023, I took a home antigen test and got a positive result. On 1/23/2023, I called the doctor's office and was prescribed Paxlovid, which I began taking that night. I completed taking it, and I continued testing positive until about 2/3/2023. On 2/3/2023, I got a negative result on a home antigen test. The symptoms lasted until around 2/3/2023. Ever since then, I have had an intermittent headache pretty much every day. It's not a severe headache, but it is present. I've taken an Extra Strength Excedrin to treat my headaches every now and then, and it does help alleviate the pain. I don't like to take it every day, but I do sometimes take it. Aside from the headache, I don't really have any residual issues from the COVID-19.
This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient received a 0.25ml Pediatric Dose instead of a 0.5ml Adult dose) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jan-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (The patient received a 0.25ml Pediatric Dose instead of a 0.5ml Adult dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The patient received a 0.25ml Pediatric Dose instead of a 0.5ml Adult dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (The patient received a 0.25ml Pediatric Dose instead of a 0.5ml Adult dose).    No concomitant medications were reported.  No treatment medications were reported.
4/3/98 deployed to Africa; 4/17/98-back pain; 8/26/98-hand pain; 11/13/98 rheumatologist noted penile lesions & mult episodes of NSU may represent mild Reiters synd; 2yr hx of hand pain which is worse since starting Anthrax series;
This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. On 17-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot # K011562, expiration date 08-APR-2017) (strength, dose and route were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Patient passed out after getting their vaccination for flu, Covid and Gardasil 9 and followed Company policy for CODE WHITE AND CALL 911. Medic arrived and took her to the hospital. Store is filling out store  Incidence report and I am filling out SCRT and VAERS. Pateint passed out for couple of minutes and helped her to lay down on the floor until Ambulance arrived at the store.
Joint pain, aching muscles, muscle weakness, confusion, generally feeling unwell, seizure, bad headaches, some rashes. Patient after getting a series of three HPV vaccinations, the last of the HPV shots was given on 8/15/13. Patient then started having joint pain, aching muscles, muscle weakness, generally not feeling well. Patient has had some unexplained rashes. In 8/15 he started having seizures, bad headache, confusion. Patient has not been able to finish his senior year of high school. Patient has been seen by three or four different Dr.'s this last nine months. Patient is now very discouraged.
Patient complained  of feeling dizzy getting worse with time. Paramedics on site, assisted and assessed patient.  Patient felt better and walked out with significant other.
No adverse event. Patient stated he felt fine. Advised patient of common side effects. Patient was advised to contact the clinic if symptoms worsen or new symptoms show.
Seizure; This spontaneous serious safety report with reference number 2022SA063571 was received by a partner on 23-FEB-2022 and forwarded to Agency on 24-FEB-2022 from a health care professional.  A 9 month and 24 days old patient, with unknown medical history of seizures, had been vaccinated with the 3rd dose of Vaxelis on unknown date for prophylaxis.  The following concomitant vaccinations were reported: Pneumococcal 13 valent vaccine  On the same date as Vaxelis vaccination, within 4 hours after vaccination the patient developed seizures.  At time of this report, the outcome of the event was unknown.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of seizure.  Further information is expected.  For reference purposes only case is linked to MCM-003180 (same reporter).   Company comment:  Seizure is assessed as serious due to the event being medically significant.   Seizure is listed for Vaxelis as per the Reference Safety Information (CCDS).    Considering the event appeared 4 hours following Vaxelis vaccination, and despite the concomitant vaccine as a confounding factor, the causal relationship between Vaxelis and Seizure cannot be excluded and is assessed as related.   This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.; Sender's Comments: Seizure is assessed as serious due to the event being medically significant.   Seizure is listed for Vaxelis as per the Reference Safety Information (CCDS).    Considering the event appeared 4 hours following Vaxelis vaccination, and despite the concomitant vaccine as a confounding factor, the causal relationship between Vaxelis and Seizure cannot be excluded and is assessed as related.   This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.
Pt appt for covid (Bivalent) vaccine. Pt in on 2/2/23 for Moderna Bivalent. Card was given to scheduler which showed patient had his first (2) Moderna vaccines in another state and third in this state. First 2 werent in the web so I did not check with scheduler about his vaccine card and I gave a prymary Moderna not Bivalent. So I inadvertly gave prymary Moderna vaccine #4 which should have been a Bivalent Moderna due to not looking at his covid card he had and not rechecking with scheduler here at clinic patient had gotten first 2 Moderna vaccines in another state wich werent in this states web just on patients card.
Nothing and normal the first two days. From day three and continuing today, I have severe fatigue, severe numbness, severe ear ringing.