chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I tested positive for COVID-19 on 05/20/2022 positive. I received my 4th dose on the 04/15/2022. My COVID-19 symptoms on 05//20/2022 at night around 8:00PM with a slight cough. 05/23/2022 nurse did a quick test at a clinic then she send the results to my doctor and she also called and told me that I was positive. I called my doctor on the same day  for an appointment for 05/24/2022 visual appointment with my doctor. My doctor gave me codeine for cough; azithromycin 200miligram tablets 6 pack for 5 days. I was also on prednisone 10miligram; yeast infection fluconazole 150 milligram.
p/vax pt devel h/a, arm felt heavy & didn't feel good;then went to sleep;woke up was fine;
Heart palpitations started 2 days after vaccination and continued for 12 days. I had so many palpitations that I felt tired, light headed and chest pain. I was put on a 24 hour holter monitor and nothing substantial found. Palpitations stopped 12 days later. The palpitations  return periodically for a day or a few hours.
Area is warm to touch; Got a red circle of 5 cm on 04-Oct-2018/05-Oct-2018 the circle has gone from 5 cm to 6 cm; This spontaneous case, initially received on 05-Oct-2018, reported by other healthcare professional (nurse), concerns a female patient of unspecified age.  On 03-Oct-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 00344611A (reported as 03144611A) and expiry date: 30-Jun-2019] for active immunization against influenza.  On 04-Oct-2018, 1 day after vaccination, the patient developed a red circle of 5 cm. On 05-Oct-2018, 2 days after vaccination, the red circle was enlarged from 5 cm to 6 cm, which was warm to touch.  It was reported that, the patient was not hospitalized.   At the time of this report, the patient had not yet recovered from the events.  The reporter assessed this case as non-serious.  This case was cross-linked to case 201804327 due to the same reporter.; Reporter's Comments: A female patient of unspecified age developed erythema, 1 day after vaccination and skin warm 2 days after vaccination with Afluria Quadrivalent. The company assessed the causality of the events as related due to plausible temporal relationship between the events and suspect vaccine.
Paxlovid has made my husband and I both feel better after the first 2 doses; Paxlovid has made my husband and I both feel better after the first 2 doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid has made my husband and I both feel better after the first 2 doses". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Result Unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19. Caller states "my husband and I both had 4 Pfizer Covid19 shots." "Paxlovid had made my husband and I both feel better after the first 2 doses."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On 02-FEB-2016 the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot # K009105 with expiration date of 21-JAN-2016, dose, strength and route unknown). The nurse stated the PNEUMOVAX 23 did not have any temperature excursions. No adverse symptoms reported. Additional information has been requested.
Case number PHEH2016US029019, is an initial spontaneous report received from a consumer on 03 Nov 2016. This report refers to a 30 years old male patient. Past medical history and concomitant medication were not reported. She was vaccinated with a single dose of expired FLUVIRIN (batch number: 15733P, Expiry: May 2016) 0.5 ml intramuscularly on an unknown date in mid Jun 2016. No adverse event was reported following this maladministration. The case was considered as lost to follow up as consent to contact the reporter was not provided.
Information has been received from a physician concerning his 8 year old son who in 1997, 7 years ago, was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. In March 2004, the patient experienced chicken pox. It was reported that there were about 50 lesions on the throat and chest area. There was no fever. The rash lasted about 5 days. Unspecified medical attention was sought, but no treatment was given. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a medical assistant, refers to two unspecified patients of unknown age and gender. The patients' pertinent medical history, their concomitant medications, and information about their drug reactions or allergies history were not provided. The medical assistant reported that, on an unspecified date, the two unspecified patients were administered one dose of ROTATEQ, orally, for prophylaxis (lot numbers and expiration dates were unknown by the medical assistant). The medical assistant reported that, the doses were administered to the two patients after she had difficulty opening the two separate ROTATEQ vials (product use complaint, circumstance or information capable of leading to medication error). No adverse effects were reported. It was reported that, vaccination with ROTATEQ was continued. Upon receipt of follow-up information, this case is now valid as patient demographics were received. Follow-up information was received from medical assistant through a telephone call on 22-OCT-2018. This report refers to two infants under 9 months. The reporter stated that they were able to open the vials of ROTATEQ after initial difficulty and administered the doses to two unspecified infant patients. No adverse effects occurred following the vaccine administration.
received the first dose of Twinrix back in Feb 2021.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in February 2021).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Twinrix which led to incomplete course of vaccination. The reporter asked if the patient could get the 2nd dose now or did he/she need to restart, and how to proceed with the 3rd dose. The healthcare professional declined to provide patient information. Reporter consented to follow-up by email.
Day after vaccine, family reported that patient dizzy and frequently falling.  They were monitoring blood pressure and temperature which were within normal range.   Admitted to hospital on 1/2/22. Died 1/23/22
I had very sore upper right arm below the shoulder and above the elbow. It seems like I had a lump there. I saw a doctor and I have not had any tests done yet.  I have a sonogram scheduled for next Monday. I am seeing an orthopedist tomorrow. I have taken Aleve a couple of times. It is a constant pain. I am also going to physical therapy for that pain. We are also looking to see if it is a tumor.
facial swelling; redness; hot red rash at injection site spreading around top part of arm; headache; nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (facial swelling), ERYTHEMA (redness), VACCINATION SITE RASH (hot red rash at injection site spreading around top part of arm), HEADACHE (headache) and NAUSEA (nausea) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (facial swelling), ERYTHEMA (redness), VACCINATION SITE RASH (hot red rash at injection site spreading around top part of arm), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, SWELLING FACE (facial swelling), ERYTHEMA (redness), VACCINATION SITE RASH (hot red rash at injection site spreading around top part of arm), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided.
Swollen Lymph Nodes on Right side of neck.  Stiffiness to neck and tenderness to touch on Right side of scalp and neck as well as inside of Right elbow.  Moderate to Sever Headache mostly on Right side of head and back of Right eye, low grade fever from 99 to 101.7,  Doctor stated to take Ibuprophin 3 times a day, this has provided mild relief of the pain.  The tenderness on the neck makes it difficult to sleep.  I have been using an icepack to help relieve the pain on the neck and head with some relief on pain.
Patient with rash/erythema/swelling at injection site - erythema appeared approximately 12 hours after administration. No treatment given. Reaction to MENACTRA injection.
Abdominal pain and nausea, onset 2 days after receiving vaccines at check-up. Symptoms resolved the following day with supportive care.
Pt received 2 vaccines to left shoulder and one to right shoulder on 5/21. Returns on 5/24 with macular erythema to right and left shoulder. Tender and itchy.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 15th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. The patient reported that her arm was painful for up to 4 days.
This is an administration error. Parents lied about patient's age to obtain the vaccine for their son. The patient has 15 yrs at the time of vaccine administration (04/12/21). No adverse events reported so far. The administration error was reported to the Immunization System. Parents were instructed to wait until their son turns 16 yrs to obtain the second dose. They were also instructed about the importance of telling the truth when filling any application for vaccine administration or any other health service.
patient's care giver said approximately week after 1st dose patient was ttested positive and later admitted to hospital with pneumonia complications. patient  was discharged after treatment
Patient fainted 5 minutes after receiving Influenza vaccine. Pt had slurred speech, felt tired and nauseated. Call 911 after 45 minutes pass and patient not recovering from symptoms.
cut on his leg; had the site got really red and thick, the thickness was 8th of inch and hot and red; Initial information received on 07-Jun-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 12 years old male patient who experienced cut on his leg and had the site got really red and thick, the thickness was 8th of inch and hot and red, while he received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, following the vaccination the patient experienced wound and inflammation localized (inflammation).  (Other relevant tests included no lab data.)  Final diagnosis was wound and inflammation localized (inflammation).  It was not reported if the patient received a corrective treatment.  The outcome of the events was reported as unknown at the time of reporting.  Information on the batch number was requested.  List of documents held by sender: none.
Patient is eligible for full additional 3rd dose due to being immunocompromised and patient received a half dose as a booster. Patient came back and received a second half dose from the same vial with the same lot to make a full "additional" dose.
presented to the vaccination site on 11/19/2021 at 1055 requesting dose 2 of the Pfizer COVID vaccine. The client notified that she received a single dose of Janssen COVID vaccine on 3/10/2021 and dose 1 of Pfizer COVID vaccine on 10/28/2021. Patient reported medical conditions include asthma, reactive airway disease, and GERD. Allergies include amoxicillin, Rocephin, ibuprofen, NSAIDs, shellfish, Septra. Medications include azelastine, flucatisone, Protonix, Pulmicort, Singulair, Spiriva, Symbicort, and frequent use of up to 60mg of Prednisone, last use 1 month ago. Patient showed a medical note from provider recommending the patient receive the full Pfizer series. Patient reported feeling lightheaded with mild dysphagia after receiving the Janssen dose, no side effects to the 1st dose of Pfizer. submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Pfizer. Approval to proceed with COVID vaccine Pfizer dose 2 was obtained from medical consult team via text message from RN, Vaccine Operations Lead. Client received COVID vaccine Pfizer LotFF8841 on 11/19/2021. The client did not report any symptoms during the 30 minute observation period. RN educated client on possible adverse reactions and when to seek medical care. The client left the vaccination site at 1205 walking with steady gait.
PATIENT WAS ADMIN VACCINE AFTER 20 MINUTES PATIENT VASOVAGAL IN LOBBY OF CLINIC.
Nausea, extreme pain in arm, felt like hot flashes, felt like someone hit me in the arm really really really really really really really hard, made my whole body feel like sludge.
headache; Brain fog; fatigue; This non-serious case was reported by a physician via sales rep and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, 2 weeks after receiving Shingrix, the patient experienced headache (Verbatim: headache), brain fog (Verbatim: Brain fog) and fatigue (Verbatim: fatigue).  The outcome of the headache, brain fog and fatigue were unknown.   It was unknown if the reporter considered the headache, brain fog and fatigue to be related to Shingrix.     It was unknown if the company considered the headache, brain fog and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-SEP-2023 The doctor asked about the possible side effects of shingrix which might occured 2 weeks after receiving shingrix vaccination. The patient stated that she had headache, fatigue and brain fog after 2 weeks of Shingrix administration. This case is linked with US2023AMR135282, same suspect, same reporter and different patient. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR135282:same suspect, same reporter US-GSK-US2023AMR135282:wife case
This spontaneous report was received from a pharmacist  and refers to a male patient of an unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. Approximately in 2017 (reported as "over 1 year ago") when he was 16 years old the patient was vaccinated with his first dose of GARDASIL 9 (dose, route, lot # and vaccination site were not provided), for prophylaxis. Now, the patient would like to receive the second dose. No adverse symptoms reported. No product quality complaint was reported.
slight case of shingles; couple bumps; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   In December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles and papular rash. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the papular rash was unknown.   It was unknown if the reporter considered the shingles and papular rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced a very slight case of shingles. The patient stated It was just a couple bumps and he/she had shingles twice before so recognized it right away. The patient asked could he/she get his/her 2nd dose of Shingrix while he/she had this slight outbreak and what were the side effects if he/she get 2nd Shingrix shot. The patient stated he/she had read the side effects but could not find anything on if you get the shot while having an outbreak.
I'll had terrible after effects. Got these shots at local pharmacy on 10/24 about three o'clock..sore left arm and shoulder expected. Went to sleep about 1:00 am, woke up at 3:00am shivering ( couldn't stop ). watched as my temperature went from 101.5 to 104.3. Thought of the ER. Did that once, temp was 103 ended up the Flu. But this time, I figured  it was the shots and would go away. Well it did in the morning ,but it's sort of creeping up again. Should I go to the ER if it goes high ??     I plan on reporting the after effects somewhere. Thank you
She got her vaccine, no reaction for the first time ever, no reaction, felt fine all day on the 20th, even her arm was fine.  She woke up on 6/21/23 was fine, but by midday her lips were swollen, her eyes were swollen and itchy.  She had not taken any NSAIDS and had not had any mangos.  She had the classic symptoms she gets.  She took a Claritin that night and by the next morning the symptoms were gone.  She did not feel well on 6/22/23 and had an odd neurological reaction, had an altered state of consciousness, not a stroke or a TIA, did not loose consciousness, but it was odd.  She felt like she was in two realities at the same time that lasted about 7 minutes.  She was continuing to talk and acted normally.  She did mention it to her neurologist, and it was like an aura.  She did not feel well for the entire month, incredibly drowsy where she just wanted to sleep all the time.  Her IBS symptoms were worse, which was normal give the circumstances.  This makes her nervous about getting another one, but probably will.
High fevers; chills; sweating; Extreme knee joint and calf muscle pain; Extreme knee joint and calf muscle pain; Extreme knee joint and calf muscle pain; This is a spontaneous report from a contactable other hcp (patient).    A 42-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) on 09Jan2021 08:00b for Covid-19 immunisation, administered at hospital.   Medical history included Crohn's disease, allergies to sulfa drugs. The patient had not experienced Covid-19 prior vaccination. Patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 19Dec2020 14:30 for Covid-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine.  The patient experienced high fevers, chills, sweating and extreme knee joint and calf muscle pain on 09Jan2021 20:30. No treatment received. Post vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering.  Information about Lot/Batch number is requested.
Patient's main symptom is constant, severe chest pain. He also suffers from dizziness, fatigue, lack of appetite, and intermittent pain in his stomach, side, and back. He has been sick since Monday, Feb 26th 2018. At office, he has seen 4 different doctors (two PCPs, 1 pediatrician, 1 pediatric GI specialist). He is yet undiagnosed.
Got the 2 shots and still got shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the 2 shots and still got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via  interactive digital media. The patient reported that he or she received two doses of Shingles vaccine and still experienced shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.