chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant refers to a patient of unknown age and unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 05-JUN-2014 the patient was vaccinated wiht an expired dose of PNEUMOVAX 23, batch# H022062, Lot# 0506AE, expire date 28-FEB-2014, 0.5 ml, intramuscular. No adverse effecs were reported. Additional information has been requested.
COPD flare with severe dyspnea, improvement with decadron and DUOneb
Received only the liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA747A, expiry date 1st October 2023) for prophylaxis.   In January 2023, the patient received Menveo. In January 2023, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate preparation of medication was unknown.   Additional Information: GSK Receipt Date: 01-FEB-2023 Reporter's Comment: The nurse called to report that last week before reporting, the patient received Menveo liquid portion without the powder.  A few days later according with Disease Control recommendations, the patient received a full dose of Menveo vaccine. The permission to create an account on sales force declined.  The reporter did not consent to follow up. Additional Supportive Information: The patients received Menveo vaccines without the powder portion which led to inappropriate preparation of medication.
Shingles; This is a spontaneous report from a contactable consumer. A 36-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8734) via an unspecified route of administration on 30Mar2021 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6199) via an unspecified route of administration on 08Mar2021(at the age of 36-year-old) as a single dose for COVID-19 immunisation. On an unknown date in Apr2021, the patient experienced shingles. Therapeutic measures were taken as a result of the reported event which was not specified. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event shingles was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
on the same arm and lymph node, under my arm pit, there is a swelling the size of a lemon; This is a spontaneous report from a contactable healthcare professional (patient) via medical information team. A female patient of an unspecified age (reported as 59, no unit) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, on the arm, on 03Feb2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation on an unspecified date. The patient received the second dose of the Pfizer vaccine last 03Feb2021 and reported that "today (07Feb2021) on the same arm and lymph node, under my arm pit, there is a swelling the size of a lemon." The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Two months after vaccine developed a blood clot on finger inside the inside of palm; Went to Urgent Care, they sent me to the ER; Blood sugar was tested; Doctor only visually examined my finger; Was told to keep watch on it and it did go away on its own like Doctor said it should; Was in Menopause for 2 years, then suddenly got a very heavy period;
PATIENT FELT CHEST TIGHTNESS AND PAIN IN CHEST. USE COLD PACK AND WAITED ADDITIONAL 15 MINUTES. HE IMPROVED AND WAS ABLE TO LEAVE ON HIS OWN
HCP called to report a temperature excursion on VAQTA, GARDASIL 9, MMR II, PNEUMOVAX 23 AND ROTATEQ. Caller states, the VAQTA was administered one time and the ROTATEQ was administered two times; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 13-OCT-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S040483, expiration date not reported, but upon internal validation established as 19-JUN-2021 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to an unspecified temperature excursion.  This is one of several reports received from the same reporter.
At about 115pm this afternoon I administered an 18 year old male a trumemba vaccine. He came in with his mother and a script from the physician. The selection tool was completed and the patient was eligible for the vaccine. No adverse reactions to any vaccinespreviously were reported. After administration of the vaccine, the patient and his mother waited a minute or two then began to walk towards the photo department to walk out of the store. When he got to the photo department he began to feel dizzy and said he was just going to lie down. The upfront manager got me from the pharmacy and I went up to the patient. He was completely coherent and speaking without any hesitation. I asked him if he had anything to eat today and he said no. I asked if they wanted us to call an ambulance they replied No. I felt his pulse (it was weak), and he was very sweaty. I kept speaking to him and he was given cold apple juice that he quickly drank. He stayed sitting down for a few minutes. After a few minutes passed he felt fine and walked out of the store with his mom. I called the pharmacy liability intake and reported the incident.
The morning of May 7th, I started noticing a pressure in the center of chest - just below my sternum. The pain and pressure increased. Felt like a big cat sitting on me. I started to feel a pain sensation going up to my left jaw and under my ear. My husband took me to Hospital ER and they did a cardiac workup and all sorts of things. They decided to admit me for observation overnight after ruling out a heart attack. They admitted me because they did not cause the heart pressure and pain which was relieved by two doses of nitroglycerin. However, I had pain through the night and then it eased up the following morning. I was discharged the following morning. I had fluids and during the night I was given Oxygen because my saturation level was down to 85. No treatment other then lifestyle changes regarding diet and instructions to follow up for a echo-cardiogram and a stress test and a sleep study. I had sleep study done through Health Care - no results yet. Echo-cardiogram and stress test were done at Memorial and I also wore a heart monitor for two weeks and that was through the Memorial as well. All tests were negative. Just a follow up to review result and still waiting for sleep study result which is on October 6th.
1645 pt vaccinated with 1st dose of Pfizer  1701 pt expressed itchiness around throat, upper chest, and upper arms.  redness visible on chest and arms, small hives appearing under chin/on upper neck.   1704 more small hives appearing under chin/upper neck, redness expanded laterally across entire upper neck/under chin.  HR 76 RR 18 O2: 94 BP 140/90.  pt complained of legs itching.  50mg Diphenhydramine (Benedryl) oral tablets given.   1726 pt hives and redness decreased.  no longer complained of itching.  skin color returned under chin, although small bumps remained.  HR 76 O2 94 BP 132/80 1730 pt asked to leave, we explained risks of having Benedryl and driving.  She said she has taken Benedryl before and no fatigue side effects.    1735 pt left clinic
Pt recv vax on 10/6/98; within 1 hr pt exp coughing; swelling of lips & eyes; tx=Benadryl; pt referred to allergist.
I have felt completely normal until 2-1/2 days after the flu shot.  I am having mild to moderate dizziness.
About 10 minutes after receiving the vaccine the patient came back to the pharmacy complaining of nerve pain, numbness, and tingling down his right forearm and a nerve pain and warm feeling in his thigh and lower back.  When checking with the patient several hours later around 6 pm, he reported most of these symptoms were gone other than some numbness persisting in his right hand.  He also reported having a temporary rash on his forearm that had since faded.
Rash onset 8/13/03. Rash began around hips and progressed up to neck during subsequent days. 8/17/03 fever of 37.1 degrees C. No medications taken. Going to visit PMD today (8/20/03).
Information has been received from a physician concerning a 16 year old male with no pertinent medical history who was vaccinated with a dose of RECOMBIVAX HB. The physician reported that the patient had a reaction to the RECOMBIVAX HB. The patient also had an adverse reaction after vaccination with VARIVAX (WAES# 0811USA00949). No further information is available.
Hives starting within 2 hours of vaccination initially near vaccination site followed by generalized spread.
This spontaneous report was received from a respiratory therapist refers to a one amount 23 unspecified patients, age and gender were unknown. Medical history was not reported. The respiratory therapist informed that between 01-FEB-2014 through 31-MAY-2014 the patient was vaccinated with PNEUMOVAX 23, lot number, T013345 expiration date 11-JAN-2015 (route, strength and dosage were not reported) which was improperly stored. Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) filed. The action taken was assessed as not applicable. The causality was assessed as not related to the suspect therapy. This is one of several reports received from the same reporter. Follow up information has been received. Lot number T013345 is an invalid lot numbers for PNEUMOVAX 23. Additional information has been requested.
No known adverse effects.; On 09/17/2020, a patient received a dose of PROQUAD that was reconstituted with an expired diluent.; On 09/17/2020, a patient received a dose of PROQUAD that was reconstituted with an expired diluent.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patients' pertinent medical history, current conditions, previous drug reactions, or allergies and concomitant medications were not reported.   On 17-SEP-2020, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) injection (strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T013537, which has been verified to be valid, expiration date reported and validated as 17-OCT-2021) as prophylaxis, however; it was reconstituted (medication dilution) with an expired sterile diluent(MERCK STERILE DILUENT) (formulation, strength, dose, frequency and route of administration were not reported; lot number N029881, which has been verified to be valid, expiration date reported and validated as 24-MAY-2020) (expired product administered and product preparation issue). It was not known any adverse effect.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2009USA007780:
Diarrhea; Chills; Fatigue; Slight fever; Sever vomiting; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, diarrhea, fatigue (very tired), pyrexia(slight fever) and vomiting( severe vomiting).  On 20 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 17 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 21 Feb 2021, 6 days after vaccination, the patient experienced  sever vomiting, chills, slight fever, diarrhea and she was feeling very tired.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
I developed severe lightheadedness and equilibrium problems approximately 14 days after my second vaccine dose.  The symptoms have not ceased.  I continue to be extremely lightheaded and off balance.  I can no longer drive.  I have seen multiple doctors/specialists, have had several hospital stays, and numerous tests/procedures.  No cause has been identified for my symptoms.  The only explanation left for my symptoms is the vaccine.
sore arm; felt tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EN6201) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing), notes: She can be susceptible to seasonal allergies. First 10 years in (withheld) had weekly allergy shot; "sinus problems" (unspecified if ongoing), notes: She had sinus problems; "pituitary cyst" (unspecified if ongoing), notes: Cyst found accidentally and discovered contrast dye to do contrast dye MRI is bad on her kidney. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "felt tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had 4 years of underwent MRI and no need to do it anymore. That is her decision because she needs her kidneys. That drug was under investigation for kidney problems. She has not done MRI since Dec2020. All previous were Pfizer COVID vaccines. Did all at the same site as well. 1st dose of Pfizer COVID vaccine 13Feb2021, Lot EN6201. She thinks it was right arm because she is left-handed.
The patient started to have a rash and fever at home on 11/1/17, patient was brought in on 11/2/17 where Dr. determined that pt has a measles rash from the Vaccine, patient also has a fever in clinic of 101.6.
Shingles diagnosed on 1/8/2021 in PCP office--may be unrelated to vaccine?
102 fever, chills, headache, body aches, nausea,  fatigue, and hallucinations. Fever stayed between 99.8 and 102 and lasted  32 hours. Ibuprofen and Tylenol was given every 4-6 hours.
Rash that lookedand felt like chicken pox on left upper part of my body; In addition another rash broke out on all other parts of my body that is still present; it is itchy; swelling; allergic to ingredients in the Shingrix vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of varicella-like rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced varicella-like rash, generalized rash, itchy rash, swelling and allergy to vaccine. On an unknown date, the outcome of the varicella-like rash and allergy to vaccine were unknown and the outcome of the generalized rash, itchy rash and swelling were not recovered/not resolved.   It was unknown if the reporter considered the varicella-like rash, generalized rash, itchy rash, swelling and allergy to vaccine to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient received a dose of Shingrix and a day or two days after receiving the Shingrix vaccination, the patient was broken out with a rash that looked and felt like chicken pox on the left upper part of my body. In addition, another rash broke out on all other parts of his/her body that was still present. The patient stated that rash was itchy, and some swelling was present. The patient never had these types of breakouts but apparently allergic to ingredients in the Shingrix vaccine.  The patient asked that what were the ingredients.
"an awful side effect"; a severe racing heart palpitations; not receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL ("an awful side effect"), PALPITATIONS (a severe racing heart palpitations) and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL ("an awful side effect"), PALPITATIONS (a severe racing heart palpitations) and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose). At the time of the report, FEELING ABNORMAL ("an awful side effect") and PALPITATIONS (a severe racing heart palpitations) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient in Feb experienced "an awful side effect" 12 hours after vaccination patient experienced a severe racing heart palpitations and went to the ER .The symptoms are not ongoing. Patient wanted to receive the 2nd dose anyway. Patient stated that it was told her not to receive the 2nd shot   No concomitant medication was reported. The treatment information was unknown.
Began feeling nauseous and light-headed, almost like motion sickness by the evening of vaccination. Still feeling this way ten days later.
Right deltoid injection uneventful. Awoke from sleep at 02:00, the following day, with a moderately severe headache that has persisted for several hours. Also has body aches and leg cramp. No fever, nausea or vomiting. Injection site normal.
Pt states she couldn't breathe and was completely out of whack. Was taken to health center and then transferred to hospital in Wichita, KS. States they diagnosed her with pneumonia.
11/12 1350 resident received influenza vaccine on 11/11 to R deltoidthis shift, area where injection given pink, hard and warm  11/12 2015 resident c/o R arm pain upon inspection found a 9 cm x 6cm red raised area that is warm to touch on R upper armresident received influenza vaccine to R deltoid on R  Benadryl 25mh 1 cap q 6 hours x 4 dosesplace influenza VAC on chart as allergy
Patient received vaccine at 3:45pm on 08/20/21. 5 min after vaccine patient stated to feel flush. Vitals were taken. BP 120/80 hr89 pulse 98%.  Patient reported that he was wheezing.  within the 15 min window patient felt cold and dizzy. Provider went outside and patient sitting with back against the wall  BP 160/100 hr. 110 res 36 pulse 98%. 911 was called. Third set of vitals at 5:02pm BP 120/80 pulse 110 res 32 pulse 99%. patient became irradiated complained of chest pain. EMT arrived. When patient was stable patient declined going to ER. Patient was a medical assistant at the pop up site. patient was sent home for the Day.
temperature excursion product administered to patient with no reported adverse event; Initial information was received on 07-Aug-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 1 years old and unknown gender patient who experienced temperature excursion product administered to patient with no reported adverse event after receiving IPV (VERO) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect IPV (VERO) (Suspension for injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for prophylactic vaccination  (Immunization). The information on the batch number was requested.  On an unknown date, the patient had temperature excursion product administered to patient with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly, Temperature the product reached: 47.6 Fahrenheit = 8.67 Celsius Duration: less than 30 minutes Data Logger is present, but only tracks temperature every 30 minutes, by the next 30 minutes temperature is already back down, so the nurse was not able to say how long the temperature excursion was. It was not alerted or anything, since she said she was just inserting vaccines inside the refrigerator since they just got a delivery that day, she said she is assuming that it was the reason why the products had temperature excursion.  Action taken: applicable.  At time of reporting, the outcome was Unknown for the event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Allergic reaction; Swelling of tongue, roof of mouth; Swelling of tongue, roof of mouth; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 59-year-old (age at vaccination) non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Oct2021 13:00 (Batch/Lot Number: FE3590) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included known allergies: Shellfish, Iodine. Concomitant medications included losartan and atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported. On 23Oct2021 13:30, the patient experienced allergic reaction-swelling of tongue, roof of mouth and shortness of breath. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 27Oct2021 Nasal Swab. Therapeutic measures were taken as a result of the events which included treatment with EPIPEN. The patient did not recover from the events. Follow-up attempts are completed. No further information is expected.
Pt received vaccine on 3/27/00, on 3/28, pt developed 4cm x 4cm red indurated lesion on right upper arm and deltoid. Pt was also experienced a fever of 100.4. Pt returned on 3/29 with a 6in x 3in area of redness on distal deltoid to distal right arm. Pt experienced a 4cm x 4cm bruise in center of lesion where shot was initially given.