chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HYPOTENSION  4/25/2022 --  RECURRENCE OF SAME SYMPTOMS
This spontaneous report as received from a nurse, and refers to a 5 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 28-AUG-2018, the patient was vaccinated with a improperly stored Oka-Merck PROQUAD recombinant Human Albumin (rHA)(which had a lot # of R006750 and an expiration date of 03-SEP-2018; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccines experienced the following temperature excursion on an unknown date: 11.3 F for 1 hour and 11 minutes. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA013090.
Immediately the vaccine was given, he became aggressive. In the car he said he was going to commit suicide. I started screaming, crying. He had chest pain. Therefore, the emergency room was called, they told us to take him to a mental health hospital. While there, they decided to hospitalize him because he was to restless, scared and nervous. While hospitalized he received medications and therapies. Because of this he lost his college term, he felt tired and dizzy all the time.
a case of shingles; This spontaneous case was reported by a physician and describes the occurrence of HERPES ZOSTER (a case of shingles) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (a case of shingles). At the time of the report, HERPES ZOSTER (a case of shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
it didn't work. I got the shingles/suspected vaccination failure; I got the shingles worse than I ever; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID-19 VACCINE UNKNOWN) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE UNKNOWN. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the shingles vaccine before Covid and it did not work.  The patient got the shingles worse than ever had them. The patient stated that it did not work for everyone. It was unknown if the reporter considered the shingles to be related to Covid vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting. Note: It was not clear from the description that if the patient had received shingles vaccine before Covid pandemic or Covid vaccine, hence it was conservatively captured as Covid vaccine.
having a patient who is about seventeen and one-half years of age receive as their first dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (having a patient who is about seventeen and one-half years of age receive as their first dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical adverse events reported.).    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (having a patient who is about seventeen and one-half years of age receive as their first dose). On 05-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (having a patient who is about seventeen and one-half years of age receive as their first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: 008B21-2A) with no associated AEs.
No other adverse events reported; Caller reports an expired dose of PNEUMOVAX 23 was administered to a patient today.; This spontaneous report has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and previous drug allergies were not provided.   On 29-JUL-2022 (also reported as today), the patient was vaccinated with expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot number T033369 had been verified to be a valid number; expiration date reported and established as: 26-MAY-2022 (dose, route of administration, and anatomical location were not provided). The reporter confirmed dose was properly stored up through time of administration. No other adverse event were reported.
Information has been received from a healthcare worker, office manager who reported that doses of PROQUAD (Merck) (lot # L003221, expired date 30-JUN-2016; lot # L002421, expired date 23-JUL-2016; lot # K025763, expired date 08-JUN-2016; lot # reported as L009206, expired date 17-SEP-2016; lot # L002213, expired date 21-JUL-2016), which were exposed to temperatures outside of the recommended range, were administered to unspecified patients on unspecified dates since 30-JUN-2015 (dose, frequency and route were not provided). No adverse effects were reported. This is one of two reports received from the same source. Lot # L009206 is an invalid lot number for PROQUAD (Merck). Additional information has been requested.
Patient felt heavy tongue, lump in throat, dizziness, weakness, palpitations shortly after receiving her dose. She was immediately taken to the ED for further evaluation.
p/recvd vax pt passed out; attempts were made to revive pt, shake & shout, etc; pt was assisted to the floor unconscious; pt made sz-like activity for 2 sec; then became alert;
Patient says she couldn't see or hear, then felt faint and laid herself to the ground because she felt like she was going to pass out.  I called and checked on her about 45 minutes after the immunization was administered and she said she was feeling good.
On Friday October 8th, 2021, three days after receiving my first dose My left side of my face began to swell and form a rash. As a couple of hours went by the rash spread to the right side of the face. Jaw line and neck as well as hands and arms. I contacted the local clinic to inform them of my symptoms and they suggested to go to the hospital. I went to the hospital and received medication to help the swelling and slow down the spread of the rash.
WILL NOT BE COMPLETING DOSES ONE WEEK PRIOR TO TRAVEL TO HONDURAS; DIFFICULTY IN SWALLOWING THE CAPSULE; CHEWED THE CAPSULE; This spontaneous case report was received from nurse (PVX2019-693) on 21-Mar-2019. It described a 10-year-old female consumer who had "difficulty in swallowing the capsule" and "chewed the capsule". The consumer was receiving Vivotif capsule for an unknown indication. The consumer "will not be completing doses one week prior to travel".  It was reported that the consumer tried to take the first dose of Vivotif on 19-Mar-2019 but she was not able to swallow the capsule. However, she managed to take the dose by chewing it up. It was additionally reported that she had a planned trip within 1.5 weeks.  The action taken with Vivotif with respect to the events "difficulty in swallowing the capsule", "chewed the capsule", and "will not be completing doses one week prior to travel" was not applicable.  The clinical outcome of the events "difficulty in swallowing the capsule", "chewed the capsule", and "will not be completing doses one week prior to travel" was unknown.  Company's Comment: In this case, it was reported that a 10-year-old child female consumer had "difficulty in swallowing the capsule" and "chewed the capsule" of Vivotif. The causality of the both the events is not related with Vivotif vaccine. The causality of the event "will not be completing doses one week prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, it was reported that a 10-year-old child female consumer had "difficulty in swallowing the capsule" and "chewed the capsule" of Vivotif. The causality of the both the events is not related with Vivotif vaccine. The causality of the event "will not be completing doses one week prior to travel" was considered as not applicable.
Patient has been experiencing extreme pain in area of injection (right deltoid) as well as elbow area, presents as stabbing pain when pt tries to use area. Ongoing since injection but gradually lessening.
No signs or symptoms reported; multiple temperature excursion that occurred on 26/OCT/2021. VAQTA was administered to patients after the excursion occurred.; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, or concomitant therapies were not reported.   It was reported a multiple temperature excursion that occurred on 26-OCT-2021. On 28-OCT-2021, the patient was vaccinated with  hepatitis a vaccine, inactivated(VAQTA)  1 dosage form, lot # T031201 and expiration date 14-JUN-2022 (strength, route not provided) for prophylaxis after the excursion occurred. The excursion was at 35.0 °F, 35.1 °F, 35.3 °F, 35.2 °F, and 34.9 °F in a time frame of 53 minutes ( cumulative). There were no previous temperature excursion. No signs or symptoms reported.
chills; facial swelling; headache; pain, soreness; muscle aches; fever; fatigue; This case was reported by a nurse via call center representative and described the occurrence of chills in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number C7B9P, expiry date unknown) for prophylaxis.   On 4th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced chills, facial swelling, headache, pain, muscle pain, fever and fatigue. On an unknown date, the outcome of the chills, headache, pain, muscle pain, fever and fatigue were recovered/resolved and the outcome of the facial swelling was not recovered/not resolved.   It was unknown if the reporter considered the chills, facial swelling, headache, pain, muscle pain, fever and fatigue to be related to Shingrix.  Additional details were provided as follows: The nurse practitioner reported that the patient developed chills, facial swelling, headache, pain, soreness, muscle aches, fever, and fatigue after receiving Shingrix vaccine. These events had resolved except the facial swelling.  The patient had 4 episodes of facial swelling since getting the vaccine. Most of these episodes happened at night. The last episode was a couple of days ago before the day of reporting. The nurse practitioner did not have the expiration date.
she started really itching; red spots one on each finger and each arm; nausea; she can't really sleep; This is a spontaneous report from a contactable consumer (patient). via information team. An 87-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry Date: Unknown), via an unspecified route of administration in the right arm on 28Jan2021 about 15:00 ( at the age of 87-years) as dose 1, single for COVID-19 immunisation. The patient medical history included allergy to penicillin. Patient had no concomitant medications. There was no history of any previous immunization with the Pfizer vaccine considered as suspect nor any prior vaccinations within 4 weeks or additional vaccines administered on same date of the pfizer suspect vaccines. After vaccination, the patient was doing fine until around 13Feb2021 when she started really itching, red spots one on each finger and each arm, nausea, and can't really sleep. The events did not require any emergency room or physician office visit or hospitalization. No relevant tests were done. She was due to receive her second dose of vaccine on 19Feb2021. She asked if this was normal side effect and whether she should receive her 2nd dose of the Pfizer Covid vaccine if she suspects a non-immediate allergic reaction about a week later. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
pt c/o increased temp. 102 & body aches -took Advil and then had sweats-stated had low grade temprature after second Hepatitis b shot.
8:48 AM- Patient complains of dizziness/chest tightness and SOB after second dose of moderna covid vaccine. States she experiences SOB sometimes but this time feels different. States she takes BP medication and has a hx of high bp. Denies throat swelling, assessed and all appeared normal. Vital signs at 8:51 AM- 118/88, 98%, 60. Assisted patient and husband to private room and assessed stomach, back and arm for rash and/or hives; none apparent. Patient states she is feeling better and not having difficulty breathing. Vital signs at 9:00 AM- 108/82, 96%, 58. Assessed throat for swelling, none apparent. Vital signs at 0905- 118/79, 98%, 60. Patient states she is feeling completely better and sob and chest tightness went away. Also had patient walk in hallway and states she is no longer dizzy. Advised patient and husband that all vital signs are normal and no other apparent signs of anaphylaxis, however if she still felt dizzy or any other symptoms she could stay as long as needed. Patient denies having any remaining symptoms and states she is ready to go home. Advised patient that if she experienced any other symptoms after leaving clinic such as sob, chest pain, rash/hives to contact emergency services. Patient and husband verbalize understanding. RN
Patient experienced fever, severe myalgia, severe fatigue, and tachycardia that began the night of 10/28/2021.  Tachycardia (as well as other symptoms) continued on 10/29/2021.  Patient had Atrial Fibrillation Ablation/SVT Ablation on 9/7/2021 and had tapered Sotalol dose from 160 mg BID to 40 mg BID with a goal of discontinuing Sotalol on 11/16/2021.  Patient went back into Atrial Fibrillation around 9:00 AM on 10/31/2021.  He contacted Electrophysiologist, who had performed his ablation to report the tachycardia (that began on 10/28/2021) and atrial fibrillation (that began on 10/31/2021).  She said that it was probably myocarditis.  Doctor advised patient to increase his Sotalol to 160 mg BID to treat the Atrial Fibrillation.  Patient converted to Normal Sinus Rhythm after 2 doses of Sotalol 160 mg.  He was then instructed to decrease Sotalol to 80 mg BID.  Patient is still having to continue the Sotalol 80 mg BID for now and will continue this dose until his follow-up appointment with Dr. in January 2022.
RECEIVED 1ST DOSE OF MODERNA VACCINE 11/3/2021. AFTER ADMINISTRATION BEGAN WITH PAIN TO HER LEFT ARM THAT RADIATES TO HER HEAD. ALSO C/O LUMPS UNDER HER LEFT AXILLA AND NEAR HER LEFT CLAVICLE. REPORTS SHE NOW ALSO HAS A GLOBUS SENSATION THAT IS MILD TO THE LEFT SIDE OF HER THROAT WHEN SWALLOWING AND TINGLING TO THE LEFT SIDE OF HER BODY. REPORTS SOME MUFFLED HEARING TO LEFT SIDE AS WELL. DENIES RASH, SOB, CHEST PAIN, TACHYCARDIA, PALPITATIONS, OR OTHER ASSOCIATED SYMPTOMS. HAS BEEN TAKING ADVIL 600MG PO WHICH ALLEVIATES PAIN FOR 6-8 HOURS, THEN PAIN RETURNS  SPOKE WITH PATIENT AT LENGTH - STRONGLY ENCOURAGED SHE PRESENT TO URGENT CARE/ER FOR FURTHER EVALUATION  -AT THE VERY MINIMUM PATIENT CAN TAKE OTC BENADRYL AND IBUPROFEN 800MG Q 8 HOURS - IF ANY INCREASE IN SYMPTOMS OR IF THE DO NOT RESOLVE MUST PRESENT TO ER/URGENT CARE
Before administering the vaccine, I asked the patient to provide their date of birth and age so I could write it on their form. She gave date of birth (which ended up being different than the DOB I got from insurance). I asked her how old she was, and she said she was 66. I wrote both down on her consent form and prepared the Fluzone high dose because she said she was 65+. I administered the vaccine and the error was identified when billing insurance today, 10/31/2022.
pt got the vaccine , was waitng on the designated area felt dizzy, felt passing out , called 911 , comforted patient,  responsive, no breathing issue , EMT came , they thought pt is doing ok and were leaving but pt sweating ,  passing out , so they took him to hospital to check it out
Pfizer-BioNTech COVID-19 Vaccine EUA: two days after receiving COVID-19 vaccine dose #3 patient hospitalized for legionella pneumonia. Administered antibiotics and discharged to home medically stable.
Patient received immunizations and was discharged home, as she walked down the hall with her parents, per father he stated she leaned on the wall and slid to the floor. Dad picked her up and nurse assisted her to a bench were she showed signs of vasovagal syncope, nurse and NP used alcohol wipe to awaken patient. She did not completely lose consciousness. It took a few minutes before we were able to obtain a blood pressure which was 100/54 Patient observed for 30 to 40 minutes, when she left she was stable, walking down the hall unassisted and playing on her phone.
Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Numbness of left arm(vaccination arm)
It may have started with the shortness of breath and I called 911. My wife was positive for COVID-19 at that time. They took me to the ER and did tests to determine it was not the heart. When I got home I had symptoms of shortness of breath and fatigue for 10 days. I had a cough. But not headaches or temperature. Oxygen was 95% or higher. I was given pills from the hospital that starts with an R and I took 4 pills a day for 5 day.
3/12/2021:  Fever 100.1F; lasting from 2:30pm through 3:30pm; elevated temp of 99.2-99.6 until 3/15/2021 3/12/2021:  Chills  ~8pm until ~2am on 3/13/2021 nasal congestion 3/13/2021 7:30am-11:00am elevated pulse ~115bpm sporadically from 3/13/2021-3/15/2021 swollen neck glands/throat tightness 3/14/2021 8pm-11pm numb lips & tongue 3/15/2021 2pm-3pm
Exactly 24 hours after injection, patients right jaw swelled. Exactly 24 hours after the swelling began, the swelling disappeared. No other symptoms were noted. His doctor at the time- she no longer works for Clinic and has moved out of state. I did call her office on 2/26/18 to report the reaction and spoke with a phone nurse. I explained the reaction and asked that she make a note in his file. I recently pulled his records - no note was made. For his 18 month visit, we had moved towns and I took him to the doctor he currently sees - I also told her then of his reaction at 15 months. From what I can tell from those records, no note was made.
Information has been received from a female medical technologist with penicillin allergy and ulcerative colitis who on an unspecified date was vaccinated with one dose of RECOMBIVAX HB (manufacturer unknown) (route, dose and lot number not reported). Concomitant therapy included tuberculin purified protein derivative ("PPD") and "medication for ulcerative colitis". The patient reported that she received RECOMBIVAX HB and tuberculin purified protein derivative ("PPD") that made her ill with fever and chills. No laboratory tests were performed. At the time of the report the outcome of the patient was recovered (date unspecified). The patient did not seek medical attention. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of death nos in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced death nos (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the death nos was fatal. The reported cause of death was unknown cause of death. The reporter considered the death nos to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that, one of his patient told him that she did not want to get the 2nd shot of SHINGRIX because of what the patient overheard beauty parlor talk that someone was admitted to the hospital and died from the SHINGRIX vaccine. The physician did not have any additional information regarding the patient who died from the SHINGRIX.; Reported Cause(s) of Death: Unknown cause of death.
12/18  0815 receive vaccine 2100 slight cough and very tired 2200 chills and chattering teeth; no fever 98.9F 2230 feeling very cold; went to sleep  12/19 0430 wake up with fever of 102.6F and headache 0845 still exhausted; fever 101.1F Stayed in bed most of the day 1730 get out of bed; temp 99.9F; notice slight rash on face across nose and cheeks ; slight redness and pain at injection site