chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt complained of heart palpitations, sweating, shortness of breath and chest heaviness.  Sx started ~ 1 hour after vaccination.  Relief after about 20-30 minutes with no treatment.  She spoke with the nurse practitioner at her MD office who thought she was having an anxiety attack (no hx of same).  Previous Tdap given at MD office 8/29 per patient (I do not have info regarding this asked for in question 14).
This spontaneous report was received from a registered pharmacist and refers to a 63 year old patient of unknown gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 10-AUG-2017, the patient was vaccinated with an improperly stored ZOSTAVAX, lot number M041087 with expiration date 03-JAN-2018 (dosage schedule, anatomical location and route of administration not provided) for prophylaxis, reconstituted with properly stored diluent (MRK INJ). The administered vaccine was exposed to a temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 1 hour. Previous temperature excursion was reported as 6 degree Fahrenheit to 14 degree Fahrenheit for 45 minutes. The call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010696: US-009507513-1708USA010732: US-009507513-1709USA014569: US-009507513-1709USA014570: US-009507513-1709USA014571: US-009507513-1709USA014572: US-009507513-1709USA014573: US-009507513-1709USA014574: US-009507513-1709USA014575: US-009507513-1709USA014577.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 031L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Jan-2023, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Patient received 3 Moderna COVID-19 vaccine: Shot 1: First Primary monovalent dose on 27-Jan-2021 (Lot# 031L20A & Exp. Date: unknown). Shot 2: 2nd Primary monovalent dose on 24-Feb-21 (Lot# 023M20A & Exp. Date: unknown). Shot 3: First Monovalent Booster dose on 04-Nov-2021 (Lot# 07F21A & Exp. Date unknown). No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live follow up: Added start date of event covid-19 and updated its outcome. Added details of all vaccination of Moderna vaccine. Updated narrative.
Oral thrush symptoms within one week of vaccination, continued through second vaccination on 4/30/21 Moderna lot number 045B21A, finally diagnosed by dentist on 5/19. GI bloating and abdominal distention markedly increased from time of 2nd vaccine on 4/30. Discussed with primary care doctor who referred me to Dr. M. Repeated KUB x-rays show persistent ileus which was not present prior to vaccinations. GI doctor has advised I go to hospital to have nasogastric tube inserted to decompress bowel.
Significant lymph node swelling in armpit of arm that received vaccine. Arm pit so swollen it was no longer a pit. Pain, swelling, difficulty using arm because it felt like tendon and muscles would rip between chest and shoulder Lasted about 4 days Menstrual cycle after vaccine, some spotting and period was much heavier with clots
Initial unsolicited report received from a consumer on 14 May 2018. This case involves a three-year-old female patient who was vaccinated with 0.5 ml intramuscular injection of TYPHIM VI (batch number and expiry date were not reported) on 04 May 2018. The patient's medical history and concomitant medications were not reported. On unspecified date after receiving the vaccine she was tired and generally whiny for a few days she did not have a fever at any point but, she may have had some body aches and she is better now. No Lab data were provided. No corrective measure was reported. On an unspecified date patient's outcome was reported as recovered for all events. List of documents held by sender: none.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It mentioned that the vial was placed in the refrigerator on 22-Sep-2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events. No treatment medications were reported.
This spontaneous report was received from a licensed practical nurse regarding an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030585, expiration date 10-FEB-2017, therapy type RHA). There was no adverse effects reported. Follow up information was received on 05-FEB-2016, stating that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 08-FEB-2016 from the nurse regarding a 4 year old patient of unknown gender. On 10-DEC-2015, the patient was vaccinated with the improperly stored dose of PROQUAD (Merck). This is one of several reports received from the same source. Additional information has been requested. Patient tab, event tab and narrative were updated.
1st dose in 2021, no second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 25th August 2021, the first dose was received).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose in 2021, no second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-MAR-2023 Pharmacist stated that the patient received the 1st dose of Shingrix in 2021. The reporter inquired if the patient supposed to start the series over or could get the 2nd dose now. The reporter consented to follow up via postal. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Muscular (deltoid) pain and swelling beginning 5 days after injection and persisting until at least day 12.
Information has been received from a physician concerning a female who was vaccinated with a dose of Gardasil. Immediately after the vaccination, the patient experienced dizziness. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested. Initial and follow-up information has been received from a physician and a health professional concerning a 16 year old female with no pertinent medical history who on 31-MAY-2007, at 13:30, was vaccinated, into the left arm, with a first dose of GARDASIL (lot # 657736/0389U). On 31-MAY-2007, at 13:15,  the patient experienced dizziness, sweaty, pale and was nauseous. Blood pressure measurement was 90/60, total heartbeat was 64 and pulse oximetry oxygen saturation measurement was 99 percent. The patient was laid down on the exam table and given water. Her color improved and she felt better. On 31-MAY-2007, the patient recovered from dizzines, sweaty, pale and nauseaus. No further information is available.
Patient received the vaccine. About a minute later, she left the immunization room, feeling dizzy. She fell and hit her head on the shelving. There was a small bump afterwards. It took a few minutes for her vision to come back. Patient given water and an ice pack. After about 30 minutes of evaluation and filing reports with store management, she felt fine and left with her guardian.
The day after IZ, broke out with red rash only on left side of body (same side as IZ was given). There were blotches and itching with lasted 48 hours. Started on meds and Topicort cream; Aristocort at immunization. Rash lasted 48 hours, after starting to use the creams.
From initial information received from a health care professional on 18Aug04 regarding an adverse event occurring it was reported that a 29 year old male pt received his second dose of Menomune A/C/Y/W-135 vaccine, lot number UE301AA, administered SC in the left upper arm at 6:00PM on 16Aug04. The next day on 17Aug04 at 12:45AM, the pt experienced pain and swelling under his left armpit and his neck glands were sore and felt swollen. He also experienced nausea, vomiting, diarrhea, chills and felt like he had a fever. Reportedly, the pt recovered from these events. From additional information received on 18Nov04 from the initial reporter, it was reported that this case was reviewed and there is no additional information at this time. No further information is anticipated, this case is considered closed.
This case was reported by a pharmacist and described the occurrence of inappropriate age at vaccination in a 1-year-old patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced inappropriate age at vaccination. On an unknown date, the outcome of the inappropriate age at vaccination was unknown. It was unknown if the reporter considered the inappropriate age at vaccination to be related to BOOSTRIX. Additional information: A BOOSTRIX dose was inadvertently given to a 1 year old patient. BOOSTRIX was recommended for children of 10 years and more.
Tachycardia with any exertion up to 153 beats per minute and sensation of rapid heart beat limiting the amount of exercise able to be performed. Prior to vaccination with similar exertion level max heart rate was 131.
Chest pain; Joint pain/ joints around his heart, rib cage, were being affected; 14-year-old; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), ARTHRALGIA (Joint pain/ joints around his heart, rib cage, were being affected) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14-year-old) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain), ARTHRALGIA (Joint pain/ joints around his heart, rib cage, were being affected) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14-year-old). At the time of the report, CHEST PAIN (Chest pain), ARTHRALGIA (Joint pain/ joints around his heart, rib cage, were being affected) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14-year-old) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient stated that coworker took 14-year-old son to the ER because of having chest pain.  The patient did not know which vaccine patient received and ER doctor said they are finding that more people were complaining of joint pain, not just 24 hours after the shot. It's like long term now and said that the joints around heart, rib cage, were being affected.  The patient heard this from coworker and would like more information regarding joint pain.
Client reported immediate reaction to vaccine: chills, malaise, tongue & throat went numb but denied swelling. Client took 2 benadryl about an hour apart and symptoms resolved somewhat. Client then contacted office where she received vaccine and was informed to immediately discontinue vaccine and to follow up with PCP. From conversation between client & writer today, she was was placed on prednisone by PCP but "still doesn't feel better". Client advised to continue to follow up with PCP and if cause of allergic reaction is determined to contact writer back.
Pt. received 2 month vaccines in office, returned home with mother and then cried continuously for >4 hours, with mother unable to soothe baby
pretty bad high fever; chills; really not well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization, reaction(s): "was semi-okay". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "pretty bad high fever"; CHILLS (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "really not well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated, that "Okay, well it's not me, it's concerning my girlfriend. Yesterday, we got the Omicron, my girlfriend and I got the Omicron shot, here it says shot at 9am. She woke up having serious reactions right now. Right now her fever only about 100 but she is shivering and freezing and it has been since last few hours and vomiting too." When paraphrased the concern reporter stated, "Okay, she has had 4 of your shots, the first one she was semi-okay with it but the other three shot she got pretty bad high fever, chills, really not well." When probed to clarify the concern with Pfizer COVID-19 Vaccine, reporter stated, "This is her 5th shot, with Pfizer, it's Pfizer, it was the Pfizer, yes with the Omicron variant (Hence, suspect product name captured as COVID-19 Vaccine)." When probed to clarify the concern, reporter stated, "No, but I want to know what the best thing for me to do but I can't get anything for her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201252978 same product, patient, different AEs, different dose;
Painful hot purple red arm; Painful hot purple red arm from injection site to just above elbow and 50% of width of arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Painful hot purple red arm ) and VACCINATION SITE PAIN (Painful hot purple red arm from injection site to just above elbow and 50% of width of arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Painful hot purple red arm ) and VACCINATION SITE PAIN (Painful hot purple red arm from injection site to just above elbow and 50% of width of arm). At the time of the report, RASH ERYTHEMATOUS (Painful hot purple red arm ) and VACCINATION SITE PAIN (Painful hot purple red arm from injection site to just above elbow and 50% of width of arm) had resolved.            No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-114185 (Patient Link).
No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 08-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Bell's Palsy - L facial droop; This is a spontaneous report from a contactable physician.  A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK4176), intramuscularly on 22Jan2021 at 08:00 am on the left arm at single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM 2), hypertension (HTN), hypersensitivity lung disease (HLD), and hepatitis C (Hep C) s/p treatment, all from an unknown date. Patient had no known allergies. Concomitant medication included acetylsalicylic acid (ASA), gabapentin, lisinopril, and an unspecified statin from unknown dates and indication. No other vaccines were received in four weeks. On 27Jan2021, it was reported that the patent experienced Bell's palsy - L facial droop which resulted in emergency room visit and required treatment of "Pred". The patient had no COVID prior to vaccination and was tested post vaccination on 27Jan2021 via nasal swab which had a negative result. The patient received the vaccine in a hospital. The outcome of the event was reported as recovering.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of event Bell's palsy cannot be excluded, due to temporal relationship.  The case will be reassessed should additional information become 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.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 09-APR-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
I took the Johnson vaccine on 4/11 at 6 pm PST at the drive through. At about midnight, I started having severe chills, fever of 38.4, extreme weakness and nausea. I had a Tylenol 500mg  on 4/12 at 00:30 am.    I am extremely fatigued and can't even get out of the bed.  My whole body has been hurting.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 3/27/2023 Discharge Date: Mar 31, 2023  PRESENTING PROBLEM: Hypoxia  Acute on chronic respiratory failure with hypoxia (HCC)  COVID-19    HOSPITAL COURSE: 75 year old female presented with hypoxia and shortness of breath. She was found to have covid infection and COPD exacerbation. She was started on prednisone. Her symptoms improved. She had CT angio and CT abdomen due to history of breast cancer, questionable weight loss and persistent shortness of breath. It showed small nodule on liver and was recommended outpatient MRI. She was evaluated by respiratory therapist and was sent home on home oxygen. Care was discussed with daughter.
chills; This case was reported by a physician via sales rep and described the occurrence of chills in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was unknown.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional details were provided as follows: The physician shared that some of his patients experienced chills with the 1st dose of Shingrix which had resulted in them refusing the 2nd dose.  The physician did not agree to be followed up.
Moderna COVID-19 Vaccine EUA 4 degree higher than normal fever, chills, headache and body aches lasting approximately 32 hours Took Tylenol and drank large amount of water to stay hydrated. Stayed in bed because I couldn't hardly move.
On 11/08/2003 noticed right knee felt heavy and difficulty bending.  "Felt tight" Within 12 hours both knee involved both knees swollen.  Decreased flexibility.  Has applied heat, cold and take ibuprofen.  Right knee is more involved than left knee.
Pt developed an inject site rxn. Aea was erthematous, hard & warm to touch several days /p immunization, treated  w/ Benadryl.
Intermittent, but pretty consistent Sore arm, tingles in nerve. Been approximately 3 weeks. Heat and/or Cold packs don't seem to help.