chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other adverse event; temperature excursion; This spontaneous report was received from a health business professional (HBP), referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.  On 07-JUN-2021, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (single dose, lot # T000883, expiration date: 28-MAY-2022, strength and route were not provided) for prophylaxis.  The administered dose of vaccine experienced the temperature excursion of 32.7 degrees Fahrenheit for 13 hours (product storage error) recorded by data logger. No previous temperature excursion was reported. No other adverse event or product quality complaints reported.
About 24 hrs. post vaccine administration - increased sleeping; one 15 minute episode of becoming limp after mother picked up from play with eyes rolling back & not as responsive -> wanted to sleep - "back to normal after 45 minutes" reported by mother; no jerking; CMP, calcium and EEG; all WNL.
Flu-like symptoms, chills, body aches 24 hours after dose; severe muscle pains in areas of body where prior injuries occurred 48-72 hours later; menstrual cycle started within 48 hours after dose received- 15 days earlier than scheduled; severe fatigue and continued joint and muscle pains 2 weeks after dose.
I had a fever and chills after the vaccine for a day. I started feeling symptoms on 05/28/22 and tested positive for COVID-19 on 05/29/22. I had a fever, sweating, tired and disoriented. I spoke to a specialist at my local hospital. At first the doctor did not prescribe anything and advised to wait. I felt worse and then they prescribed molnupiravir. I felt better but it gave me severe diarrhea so I was only able to take it for 2 1/2 days.
developed pneumonia twice; developed pneumonia twice; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 84-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pneumococcal polysaccharide vaccine, 23-valent (PNEUMOCOCCAL POLYSACCHARIDE VACCINE, 23-VALENT), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Colitis" (unspecified if ongoing), notes: It is not related (She does have a history of Colitis, but that is not related). The patient's concomitant medications were not reported. She has no history of these vaccines. She has never had pneumonia before.  The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "developed pneumonia twice". The patient underwent the following laboratory tests and procedures: Chest X-ray: Pneumonia.  Clinical course: The patient received both Prevnar-13 and PPPSV23 in 2015 and 2016. She developed pneumonia twice this year. She wanted to know if it would be recommended that she get the PCV-20 and also questioned if it would it be harmful to receive Prevnar-20 after having the PCV-13 and the PPSV23. She had no history of these vaccines. She has never had pneumonia before. She can't remember if she got Pneumonia the first time in Jan or Feb2022 or in Nov2021, but then a few months after she got it again. She got it twice in a few months. She went to urgent care, and they did an x-ray to find out.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
GOUT FLARE UP IN RIGHT ANKLE. EXTREME PAIN, WALKING DIFFICULTY. COLCHICINE TAKEN TO REDUCE FLARE UP, CLEAR OUT JOINT. BLOOD TEST DONE AT QUEST LABS. URIC ACID LEVEL NORMAL. I TAKE ALLOPURINOL REGULARLY AND DO NOT GET GOUT FLARE UPS. WITH URID ACID LEVELS NORMAL I SHOULD NOT BE HAVING AN ATTACK. THE ATTACK OCCURED SHORTLY AFTER GETTING THE VACCINE.
Presented with n/v; fever; muscle aches; non-productive cough; +Covid 6 days PTA; no PNA; treated with steroids, zinc, minimal supplemental O2; discharged home on room air
1. Raised red, warm bump about 5 inches in diameter (as of 3/16/21) 2. Increased size to about half of upper left arm 3. Hives spread to inner thighs (as of 3/22/21) 5. Hives spread to front thighs and behind knee *First course of treatment - Ibuprofen, Claritin - no reduction *Second course of treatment - began 3/25/21 - Claritin, Benadryl, Triamcinolone Acetonide Cream  As of 3/28/21 - slight reduction (no further spread)
Lower body ache, low fever, physical weakness and tiredness, large warm red patch at injection site.  On 10/05/2013 had fever of 103.2, body aches, red patch on arm about 5X4", red and hot.  Went to Immediate Care, Dxd cellulitis at injection site and UTE, started Keflex. On 10/08/2013 (time of reporting) symptoms are improved, inflammation site smaller; less red, less hot.
11/25/2021 red itch at site  and still  itch and red now
Noticed a rash on both thighs on 3/24/21 around 6:00am. Didn?t feel well during the day- very tired. Around 5:30pm noticed rash was spreading over body, burning rash in left armpit/arm and neck. Took 50 mg Benadryl around 5:45pm. Within a few minutes throat was irritated, voice became hoarse, then throat started to close. Called 911 when throat started to feel like it was closing. Paramedics gave another 50 mg Benadryl and Zofran for nausea during ambulance ride to ER. Was monitored in ER and given steroid. D/C?d to home after rash and throat improved. Took Benadryl  q6hrs and prednisone daily x 5 days. Given rx for epi pen.
PT WITH ITCHY RASH/HIVES TO HANDS AND LEGS >24 HOURS AFTER VACCINATION
Significant arm swelling and pain that began one week after the vaccine. Both the swelling and pain are 2-3 times worse compared to the first 24 hours post vaccination.
all the medication did not go into the patient, no AE; While administering Menactra the medication was leaking out between the needle and the syringe because it was not tight enough or connected correctly, no AE; Initial information received on 12-Oct-2021 regarding an unsolicited valid non-serious case from a nurse practitioner and consumer non health care professional via Media Information (under reference number 00808548).  This case involves a 16 years old female patient who was administered with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and while administering the medication was leaking out between the needle and the syringe because it was not tight enough or connected correctly (syringe issue), and because of which all the medication did not go into the patient (underdose).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medication was given to the patient.  On 12-Oct-2021, the patient received 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (injection, lot U7191AA and expiration date: 18-Jan-2023)via unknown route in an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to vaccine underdose and also a case of syringe leak (same day latency).  It was reported "The nurse practitioner is reporting that the syringe leaked while she was administering Menactra to a patient and she would like to know if the patient should receive another dose and is that safe and if so when should they receive it and do they have to wait a specific amount of time. The nurse practitioner states that she never had this happen before and she just attempted to administer Menactra to a patient and she noticed that the medication was leaking out between the needle and the syringe because it wasn't tight enough or connected correctly. She states that all the medication didn't go into the patient. She states that she pulled up the medication from the vial without any issues."  No laboratory data reported.  The nurse will revaccinate the patient.  At time of reporting, no adverse event was reported and the outcome was unknown for the reported events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recvd vax & had headache; pain in head; joints painful; chills; no appetite; weakness; redness; heat & soreness at inject site; shooting sharp pains;
Severe short term memory loss since vaccination. Brain fog. Not able to pay bills, drive, remember medications etc.  Received dose Pfizer 2/2/21 and 2/26/21   I can not locate the vaccination card!
Bright starbursts/auras around lights at night.  Pretty significant at night while driving.
rash on R arm of injection 3 to 4 inches wide and spreading from outside to inside of R arm; Chills; little fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (little fever) and RASH (rash on R arm of injection 3 to 4 inches wide and spreading from outside to inside of R arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 621B217) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN, VITAMIN D NOS and MULTIVITAMIN & MINERAL for an unknown indication.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 06-Apr-2021, the patient experienced CHILLS (Chills) and PYREXIA (little fever). On 07-Apr-2021, the patient experienced RASH (rash on R arm of injection 3 to 4 inches wide and spreading from outside to inside of R arm). At the time of the report, CHILLS (Chills), PYREXIA (little fever) and RASH (rash on R arm of injection 3 to 4 inches wide and spreading from outside to inside of R arm) outcome was unknown. Not Provided          Treatment- Advil, Tylenol and Benadryl   This case was linked to MOD-2021-072787 (E2B Linked Report).; Sender's Comments:  MOD-2021-072787:1st dose of vaccine
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information about the patient's relevant medical history, drug history and concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 lot # reported as 36301, expiration date December 2017 (dose and route of administration not reported) that underwent a temperature excursion and had been exposed to a temperature of 32.1 degrees Fahrenheit for 7 hours. The patient did not experience any adverse events. It was unknown if any relevant tests were done. This is one of several reports received from the same source. Additional information has been requested.
Difficulty breathing and swallowing, was informed this was a normal reaction. I was given a Benadryl and sent home.   Missed period, hair loss, hormonal, insomnia , and exercise asthma attacks. Checked for pregnancy and blood tests and nothing different or shown up as wrong except for diabetes. Was told to wait again and follow up with obgyn to see if my period would begin. It has still not begun and have scheduled a follow up. I am still losing hair in clumps and hormonal. I wa a given an inhaler for the asthma attacks.
Hives; fatigue; achiness; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of hives in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of urticaria (received 1st dose on 21st May 2021 and experienced hives began on their feet, then spread to arms, legs, and stomach, refer case US2021161368).   On 25th July 2021, the patient received the 2nd dose of Shingrix. In July 2021, 2 days after receiving Shingrix, the patient experienced hives, fatigue, pain and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the hives was not recovered/not resolved and the outcome of the fatigue, pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the hives, fatigue, pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient had received second dose of Shingrix and experienced hives, fatigue, achiness, and flu-like symptoms. All symptoms were began approximately 2 days after receiving second dose. The patient reported that the fatigue, achiness, and flu-like symptoms were resolved within approximately 24 hours. The patient reported that the hives were ongoing. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021161368:same patient/reporter (1st dose)
This spontaneous report was received from a nurse and refers to an unknown number of unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates in 2017, the patients were vaccinated with improperly stored doses of VARIVAX, subcutaneous, lot# L027288 with an expiration date 21-JUL-2017 for prophylaxis (dose was not reported). No adverse event was reported. Administered doses of VARIVAX experienced the temperature excursion of -13.3 degrees Celsius for 30 minutes on 30-JAN-2017, -14 degrees Celsius for 30 minutes on 31-JAN-2017, -13.1 degrees Celsius for 45 minutes on 01-FEB-2017, -13.8 degrees Celsius for 30 minutes on 02-FEB-2017, -13.3 degrees Celsius for 60 minutes on 03-FEB-2017, -13.1 degrees Celsius for 75 minutes on 04-FEB-2017, -13.8 degrees Celsius for 30 minutes on 05-FEB-2017, -13.6 degrees Celsius for 30 minutes on 05-FEB-2017, -13.6 degrees Celsius for 30 minutes on 06-FEB-2017,-13.3 degrees Celsius for 75 minutes on 10-FEB-2017, -14.9 degrees Celsius for 15 minutes on 10-FEB-2017, -13.3 degrees Celsius for 60 minutes on 10-FEB-2017, -13.2 degrees Celsius for 75 minutes on 11-FEB-2017, -13.2 degrees Celsius for 45 minutes on 12-FEB-2017, -13.2 degrees Celsius for 75 minutes on 11-FEB-2017, -14.9 degrees Celsius for 15 minutes on 11-FEB-2017, -13.2 degrees Celsius for 45 minutes on 12-FEB-2017. There was no previous temperature excursions. Data logger was involved. Product quality complaint (PQC) was not reported. This is one of two reports received from the same reporter. Additional information is not expected because no consent to contact with the reporter was provided. Sender's Comments: US-009507513-1703USA000327.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 11-OCT-2010 the patient was vaccinated with first dose of GARDASIL (dose, lot number unspecified). The patient received second dose of GARDASIL late on 03-APR-2013. The patient was not experienced any known symptoms. The outcome of the patient was unknown. It was unknown if the patient had sought medical attention. Additional information has been requested.
Dull headache; Extra tired; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL8982) via an unspecified route of administration in the left arm on 17Feb2021 at 10:45 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. Medical history included ministroke two and a half years ago and blood cholesterol abnormal. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and ubidecarenone (COQ10); all for an unknown indication on an unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231) via an unspecified route of administration in the left arm on 27Jan2021 at 10:45 (at the age of 68-year-old) as a single dose for COVID-19 immunisation and no bad adverse events were noticeable after the dose. The patient also received unspecified cholesterol medication to lower the cholesterol. On 18Feb2021 at 20:30 the patient experienced only dull headache and extra tired, the evening of the second day after the second dose. The reported events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dull headache and extra tired were resolved on an unknown date in Feb2021.  No follow-up attempts are needed. No further information is expected.
Patient came into the pharmacy 4/29 and stated the Moderna booster shot caused her severe pelvic pain to the point that she can't stand up. She says the vaccine altered her menstrual cycle and also caused her throat to close in the evening - I clarified that she did not experience her throat closing immediately following administration of the vaccine (not an anaphylactic reaction) but says that from evening until 8 am her throat felt like it was closed. I encouraged her to speak with her physician.
diagnosed with ear infection in both ears; both ears starting bothering her; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (diagnosed with ear infection in both ears) and EAR DISCOMFORT (both ears starting bothering her) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Sulfonamide allergy (allergic to sulfa.).   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced EAR DISCOMFORT (both ears starting bothering her). On 22-Feb-2021, the patient experienced EAR INFECTION (diagnosed with ear infection in both ears). At the time of the report, EAR INFECTION (diagnosed with ear infection in both ears) and EAR DISCOMFORT (both ears starting bothering her) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment medications included unknown antibiotics.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
ill; Initial information was received on 18-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient) via social media.  This case involves a patient (demographics unknown) who was ill (illness), when received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was ill (illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE. The patient got ill every time after receiving vaccine.  After stopping the vaccine, patient rarely got ill. The patient will not take the vaccine.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
persistent R sided back pain beginning 2 weeks ago. Pt states she has had R sided "lung pain" most notable to her back. Pain is exacerbated with deep inspiration. She endorses persistent joint pain s/p receiving her second dose of COVID vaccine 2 months ago. Denies associated fever, recent travel, or hormone therapy.
The Rabavert was administered intramuscularly to a patient in the thigh instead of the deltoid; Case reference number US-BN-2022-001983 is a spontaneous case report initially received on 19-Aug-2022 from other health care professional (reference number: USBAV22-1098) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the Rabavert vaccine (Rabies Virus (Inactivated, Strain Flury LEP); batch number: unknown), intramuscularly in the thigh instead of the deltoid, for post-exposure to rabies (explicitly coded as 'vaccine administered at inappropriate site').  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received on 22-Aug-2022 from Bavarian Nordic included local case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with the Rabavert vaccine intramuscularly in the thigh instead of the deltoid, for post-exposure to rabies, which is considered as vaccine administered at inappropriate site. No associated adverse events were reported. Vaccine administered at inappropriate site is listed per company convention. The patient's medical history and concomitant medication details were not provided. Vaccine administered at inappropriate site is not related to Rabavert, but to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the Rabavert vaccine intramuscularly in the thigh instead of the deltoid, for post-exposure to rabies, which is considered as vaccine administered at inappropriate site. No associated adverse events were reported. Vaccine administered at inappropriate site is listed per company convention. The patient's medical history and concomitant medication details were not provided. Vaccine administered at inappropriate site is not related to Rabavert, but to a human factor. The case is non-serious.
ON 1/22/21 DEVELOPED RED, RAISED RASH AT INJECTION SITE.
received first dose in 11March2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received first dose in 11March2021) 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received first dose in 11March2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received first dose in 11March2021) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.