chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FEELING VERY COLD; ACHES AND PAINS ARE ALMOST LIKE SHE GOT HIT BY A TRAIN; CHILLS; INJECTION SITE BURNING; TIRED; This spontaneous report received from a patient concerned a 64 year old female. 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, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 at around noon on right arm for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the subject experienced feeling very cold. On 25-MAR-2021, the subject experienced aches and pains are almost like she got hit by a train. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced injection site burning. On 25-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 96-97. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site burning on MAR-2021, had not recovered from tired, chills, and aches and pains are almost like she got hit by a train, and the outcome of feeling very cold was not reported. This report was non-serious.
I have headaches every day and memory problems. The headache started about 15 minutes after I received my vaccine and I get headaches every day.
Received Tdap on 04/27, delivered baby via C-section, one day prior to due date. Baby weighed 8lbs.  Few months after delivery my throat was extremely swollen, difficulty swallowing and my neck and shoulder muscles were extremely tight and sore causing extreme discomfort. My energy level was at an all time low and could barely stay awake  in the afternoon / evening time. Waited a few months hoping it would go away on it's own but it became unbearable to hold my head up. Contacted Family Medicine and got blood work and a neck ultrasound completed.
9/30/19 Based on patient's weight (210 lb), a 22 G 1 & 1/2 inch needle was used to administer the vaccine. The patient jumped during administration & moved arm, but the full dose was given to the patient. Immediately after the vaccine, she said it hurt really bad and she felt tingling in her hand. She was asked to sit for observation. She left while giving a thumbs up to my technician. I called to follow up with her at 5:06 pm. She said the tingling subsided, but her arm is very sore down into her forearm, and she's having a hard time moving it. She said she has some range of motion, but she had a hard time putting her dog's leash on. I told her that a sore arm is typical with the vaccine. She was advised to use a cold compress and oral pain reliever if needed. She said she already took an oral pain reliever. She was advised that if any severe symptoms develop, she should seek emergency medical attention. If symptoms persist, she was advised to follow up w/ her doctor. She received her vaccination today, so I will follow up with patient in a few days to see how she is doing.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 01-DEC-2015 at time- 23:38, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.6 and 1.7 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Pt called on 8/30/04 reporting hives starting on 8/26/04 following combined hep A/B #3 (Twinrix). He received Japanese Encephalitis Vaccine #3 on 8/19/04: more like  (JE #1 given 8/5/04 and #2 given on 8/12/04 without problem).  Follow up on 09/08/04 states: "Pruritis 08/27 on ft hives, 08/28. He took Claritin 08/30 and starting improving 08/31.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns an 83-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 24-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid: batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported.
mom reported the pt slept during day & was awake only for feedings; awakened from sleep 2PM w/t102 fever; pt would not open lt eye & body was stiff & curved to rt side; eye opened & staring w/body remained in stiff curved position;dystonic
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided.  No treatment information was provided.   This case was linked to MOD-2021-055451 (E2B Linked Report).; Sender's Comments:  MOD-2021-055451:Second dose case
Vaccine administered was exposed to low temperatures and  is considered an invalid dose. Patient has not reported negative reactions. Revaccination plan is being planned.
Vomiting, red face and some redness in hands and arms, some itching, elevated BP 120/80, heart rate 106. Resolved within 20-30 minutes, always oriented and coherent, alert.
Second dose of Moderna vaccine was administered beyond the appointment due date; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna vaccine was administered beyond the appointment due date) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna vaccine was administered beyond the appointment due date). On 27-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna vaccine was administered beyond the appointment due date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up information received: only email address was added. No newother information was updated.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 07-JUN-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. On 16-JUN-2016 (reported as 9 days after receiving the vaccine), the patient was diagnosed with shingles near frontal area and back of her head. On an unknown date, the patient suffered and was diagnosed with pneumonia requiring hospitalization. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. The patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. ; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, pneumonia was determined to be medically significant. ZOSTAVAX, persistent strain of herpes zoster/shingles and pneumonia  were considered to be disabling. Additional information has been requested.
PATIENT REPORTED A FEVER OF 101.6, MALASE, VERTIGO, NAUSEA, AND RIGHT KNEE PAIN.
Asthenia; Lethargic; Kidney infection; Swollen ankles; This spontaneous case was reported by a consumer and describes the occurrence of KIDNEY INFECTION (Kidney infection) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis aggravated.    Concurrent medical conditions included Diabetes, Gout and Rheumatoid arthritis (Moderate to Severe).   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In January 2022, the patient experienced KIDNEY INFECTION (Kidney infection) (seriousness criterion medically significant). On an unknown date, the patient experienced JOINT SWELLING (Swollen ankles), ASTHENIA (Asthenia) and LETHARGY (Lethargic). At the time of the report, KIDNEY INFECTION (Kidney infection), ASTHENIA (Asthenia) and LETHARGY (Lethargic) outcome was unknown and JOINT SWELLING (Swollen ankles) had resolved.            The patient had swollen ankles which was lasted about two days. patient felt that it was due to cold weather. Stated that he felt rundown after getting the vaccine. patient was felt weaker, lethargic after getting the vaccine. Stated that he did not feel the same.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medications were reported.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 60-year-old male patient, with relevant medical condition of diabetes, who experienced the unexpected and serious (due to medically significant) event of Kidney infection, which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product included non-company product Upadacitinib for rheumatoid arthritis. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 60-year-old male patient, with relevant medical condition of diabetes, who experienced the unexpected and serious (due to medically significant) event of Kidney infection, which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product included non-company product Upadacitinib for rheumatoid arthritis. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Narrative:  Patient report nose bleed since after taking the covid-19 vaccine on 04/01/21, for about 5-10 minutes 2-4 times a day, started experiencing these nose bleed 3rd day after vaccine administration. History of Allergic rhinitis.
left arm painful; This is a spontaneous report from a contactable nurse (patient). An 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9265), via an unspecified route of administration in the left arm, on 03Feb2021 at 12:05 (at the age of 86-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient had no family history related to the adverse events. The patient had no prior adverse events to vaccinations nor any prior vaccinations within four weeks of vaccination. There were no additional vaccines administered on the same day. The patient experienced left arm painful on 06Feb2021, which was reported with disability. The clinical course was reported as follows: The first 3-4 days (as reported), there were no side effects; however, her arm was painful for days 5- 7, and on day 9, it was still a little sore but better. Therapeutic measures were taken as a result of the event, which included a visit to the chiropractor. The clinical outcome of left arm painful was recovering. The primary reporter (patient) assessed the causality between the event and the suspect product as related.; Sender's Comments: Based on the information available, a causal relationship between event "left arm painful" and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. 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.
Woke up at 11:30 p.m. the same day.  I was dreaming my leg was in a white snow bank and I was shaking from the cold.  My arms and body shook.  I went to take 2 Tylenol and could barely hold the Tylenol bottle or glass with water.  I put a blanket on the bed and heavy pajamas and went back to sleep.  Shaking subsided.  The next day I slept all day and felt like I was run over with a truck, my temp was 99.4.. The next day I felt fine.
Within hours of the vaccine, broke out in bad itchy rash over most of body, including arms, over and under; sides, back, stomach, groin, down both legs to knee area.
bilateral pulmonary embolisms with heart strain, resident complained of shortness of breath, dizziness, and chest pain on 8/16/22 and resident was transferred
Swelling in the joints of both her thumbs; Was very very ill; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Was very very ill) and JOINT SWELLING (Swelling in the joints of both her thumbs) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol. Concomitant products included EZETIMIBE and SIMVASTATIN for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced MALAISE (Was very very ill). On 21-Feb-2021, the patient experienced JOINT SWELLING (Swelling in the joints of both her thumbs). At the time of the report, MALAISE (Was very very ill) outcome was unknown and JOINT SWELLING (Swelling in the joints of both her thumbs) had resolved. Not Provided
No adverse event; on 28-MAY-2019, 1 dose of properly stored VAQTA (expiration date 27-MAY-2019) was administered to a child; This spontaneous report was received from a medical assistant and refers to a child patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions or allergies was not provided.    On 28-MAY-2019, the patient was vaccinated with a properly stored but expired dose of hepatitis a vaccine, inactivated (VAQTA) 1 dosage form, lot # R010954, expiration date 27-MAY-2019 (strength, route and anatomical location were not provided) for prophylaxis. No adverse effects were reported.
Patient called pharmacy and wanted to let us know her arm was red and itchy. She was going to call MD as well.
Information has been received from a physician assistant concerning a 5 year old male who on 15-AUG-2003 was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). Additional suspect therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) given in the other arm. "Ten days after vaccination" on 25-AUG-2003 the patient developed about 20 lesions all over the body. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested. The patient's twin brother had the same experience after vaccination with varicella virus vaccine live (Oka/Merck) and measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) WAES#0708USA01289.
Hot Red rash, itchiness,  dull throbbing pain with swelling on redden area at injection sites of moderna covid vaccine. Itchiness on and off at injection site throughout the week. Noticed early morning on 3/11/21 that area was red, hot and swollen along woth itch and dull pain.
a patient got an extra dose of Rotarix; inappropriate age at vaccine administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number yl9yn, expiry date 20-APR-2025) for prophylaxis.   Previously administered products included Rotarix (received 1st dose on 20th December 2022 by oral route, batch number 5279E, expiry date 25th February 2024). Concomitant products included LIVE ATTENUATED HUMAN ROTAVIRUS G1 STRAIN (ROTARIX).   On 21-APR-2023, the patient received the 3rd dose of Rotarix lyophilized formulation (oral). On 21-APR-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: a patient got an extra dose of Rotarix) and inappropriate age at vaccine administration (Verbatim: inappropriate age at vaccine administration). The outcome of the extra dose administered and inappropriate age at vaccine administration were 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: 09-MAY-2023 The reporter was a practice administrator stating that a patient got an extra dose of Rotarix.  They received their first 2 vaccines in the appropriate time frame and then got a 3rd dose of Rotarix.  The reporter was consented to follow up. The patient received 3rd dose of Rotarix, which led to Extra dose administered. The patient received 3rd dose of Rotarix at 6 month of age, which led to Inappropriate age at vaccine administration. This case was identified as duplicate of case US2023066939. All future correspondence would be added in case US2023066941, which stands as case of record for this patient and the case US2023066939 would be deleted.
Mother witnessed 2 episodes of patient's arms and legs "contracting" and her "eyes rolling back" last night.  Episodes lasted about a minute with vomiting noted in between.  Rectal temperature after event was 104.  Last prior temperature taken at 8:15pm and it was 97.5 rectally.  Event occurred around 9 pm and patient taken by parents to emergency room.  No treatment. Diagnosed with febrile seizures in the ED.
Fever, swelling and redness at injection site 2 days with complaint of constant muscle tightness to upper lt back and neck with decreased range of motion in neck
redness and swelling around injection site, shortness of breath, rapid heart rate (112 bpm), tingling lips, chest pain
Prolonged soreness of left shoulder with movement 4 days after getting her injection on 10.22.20. Pain was rated 6/10 and unresponsive to Ibuprofen.
When entering the vaccine that was administered on 3/1/2021 into the system, user was notified that the patient completed his dosing of the vaccine.  When investigating it was found that the patient was vaccinated on 2/20/2021 with the pfizer vaccine.
Pt complained within seconds of receiving flu shot of not feeling well. Pt states that he felt tightness around nose and flushed but denies shortness of breath. Vitals are 122/70, pulse 63, O2 94% and temp 99.0.
Red, swollen, warm to touch area over inj site area stated approx baseball to softball size inflammation. Pt did not seek Tx used cold packs, poss Tylenol/Advil/.
"Given Tdap, patient developed cellulitis at the site of the injection." Upon furhter review, cellulitis very rarely associated with Tdap vaccine but injection site reaction (swelling, redness, tenderness) are very common. Entry into hospital's adverse drug reaction reporting system contains inadequate information to differentiate the presentation and does not include if antibiotics were given to treat as a presumed bacterial cellulitis.
Pt right away after getting MMR #2 and Varivax got a rash around both injection sites 5x5cm. Pt was given 37.5mg of Benadryl. Pt waited 20 min. Then had a hard time breathing. He was also given 0.3ml of epinephrine 1:10000 subq in L arm. Pt started feeling better also given Orapred 15mg 15cc 40 min later at 11:40am. Pt feeling better but sleepy. Released home with Rx Prednisone 20mg tabs bid x 3-5 days.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 20-OCT-2012 11:25, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.