chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 08-AUG-2015, the patients were vaccinated with improperly stored VAQTA lot # K019560, expiration date 02-JUN-2017. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 3/12/21 and 4/13/21. Presented to the ER on 1/26/22 with c/o SOB and cough, Covid+. At home her oxygen saturation was 82%. Admitted for acute hypoxemic resp failure 2/2 Covid PNA c/b COPD exacerbation.  Placed on non-rebreather mask. On 02/02/2022-respiratory status worsened left side, placed on BiPAP.  CXR showed worsening bilateral infiltrates. Throughout admission continued to decompensate, placed on comfort care/DNAR. Tx'd with rocephin, azithromycin,steroids, vitamin c, zinc and remdesivir. Expired on 2/09/22.
neuropathy in my hands; pain; numbness in my hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy in my hands"; PAIN (non-serious), outcome "unknown", described as "pain"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness in my hands".  Patient got bitten by a scorpion last week and had her booster on tomorrow for covid-19 and getting Pfizer. Patient spoke to the pharmacist at the placed. They said that patient did not have any information but patient was not sure would be a problem then patient directed to withheld, they also did not have anything about this, and they kind a thought maybe it would be ok to. Caller also stated that they recommend her to call the manufacturer and see if they have any information regarding to that. Upon clarification, caller clarified, She had no adverse effect to the Pfizer other than just 36 hours of pain. Patient had numbness in her hands and neuropathy in her hands but patient would not consider that to be a severe reaction, that was a, because they attacked her nerves. Patient did not have like anaphylactic, and any flooting issue, or tongue swelling or throat swelling, none of them typical reactions to a bite or sting. Caller also said, the pharmacist she did not think that it would necessary be a problem otherwise then that there are people who are getting the flu along with the covid and there not had issues. But patient was felt like at her age should have it. Patient could wait longer, because the only alternative for her was to wait for 28 days you know for her to complete her system. Caller wanted to know if they did have any information regarding all that and if she should wait another or should she get it for tomorrow. Upon checking the official PI they did not find any potential interaction or INT study for administration with patients who got bitten by a scorpion a week ago, this may not have been studied. Referred to HCP for further guidance.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was supposed to receive Spikevax and Fluad, but the pharmacy accidentally dispensed Spikevax and Arexvy (RSV). Patient received Arexvy a few weeks ago.
Consistent headaches for 20 days, nausea, dizziness, chest tightness, heart palpitations.
no symptoms or side effects reported/No additional AE/No PQC; a PNEUMOVAX 23 prefilled syringe was administered after expiration to a patient today, 25-OCT-2023; This spontaneous report has been received from a medical assistant and refers to a 59-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.  On 25-OCT-2023, the patient was vaccinated with an expired second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection 0.5 milliliter intramuscularly (IM) as prophylaxis (anatomical location of vaccination was not provided; lot number W007035 has been verified to be valid, expiration date 20-OCT-2023) (conflicting information, lot number also reported as UT8076JA) (expired product administered). No symptoms or side effects were reported. There were no previous temperature excursions on the vaccine.
Patient described feeling nervous, anxious the next morning (Wednesday) after the vaccine. He later fell in the bathroom after using the restroom, his legs gave out (his words) and consequently was on the ground for 23 hours before being transported to the hospital. That was Thursday afternoon. He was diagnosed with COVID-19 on Saturday night and died the following Friday morning.
Hives over whole body and not eating well. The hive come and go and on day 3 are still ocurring.
Information was received on 14-JUN-2017 from a pharmacy intern regarding an unspecified number of patients. Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the unspecified patients may have received improperly stored dose of M-M-R II (lot # M035388, exp 02-AUG-2018), (dose not specified); PEDVAX HIB (lot # N00327, exp 25-OCT-2019 (dose not specified) or PNEUMOVAX 23 (lot # M047519, exp 04-AUG-2018) (dose not specified). Lot and expiration date of STERILE DILUENT for M-M-R II are unknown (it is unclear if diluent was improperly stored). No adverse effects were reported. The action taken was not applicable and the outcome of improper storage was unknown.  Temperature excursion details: Temperature: 78 degrees Fahrenheit or warmer (95 degrees Fahrenheit) Time frame: 10 days Previous temperature excursion? No Was call because of a "data logger"? no. No further details provided. Additional information has been requested.
52-year-old male presenting with right arm pain that began 2 days ago. Patient is concerned because he received his COVID vaccine in his right arm 4 days ago. Denies headache, fever, nausea, emesis. He states that he has history of stroke in August of 2019. His previous symptoms felt with his stroke are not similar to his current symptoms. pt had stroke on 08/2019 with mild right side weakness pt states this feels different. no focal deficits noted in triage.
Crease in arm started feeling hot (not injection site but same arm) then numbness in left arm and left leg, stood up and noticed heartbeat increasing to pounding and not stopping. Checked myself into hospital for testing.
Developed Hives about 30 minutes after getting the COVID vaccine. Was given vaccine at 815 am, arms had a burning feeling and hives started to develop. Was also feeling very anxious and hyperventilating. I had no swelling or shortness of breath. Went back to vaccine clinic immediately and there they administered EPINEPHRINE at 846 am. Started to calm down around at 849 am. Burning feeling in arms started to go away and hives started to disappear. Was then taken to the ED department to be monitored. Because I have had an recurrent hives after EPINEPHRINE, I was given Benedry IV, Solu-Medrol IV, and Pepcid IV.  I was also sent home with a prescription for Prednisone as well as an Epi-pen. I am feeling much better now. Hives have not come back, yet. Fingers crossed they don't!
Started with extremely sore area some 2? away from injection site, which changed areas in the next 3 days until the painful area had traveled all around my arm. Also have bad headaches, nausea, general feeling of malaise.  This is the first time I?ve ever had a reaction to a vaccine and I?ve had many of those through the years.
Employee received flu shot in L arm on Sept 26 2023 and having reactive lymph node enlargement R axilla every time she gets flu vaccine; + tenderness and swelling occurs 2-10 days after vaccination. It started after she received her 2nd COVID-19 vaccine Jan 26 2021 and every time she gets the flu and  allergy vaccination;  tenderness and lymph node enlargement lasting up to 3 months.  Initially saw PCP in 2021.
Patient was given mistakenly given her second Moderna 0.5ml COVID vaccine 11 days before her due date to get the repeat dose. She is a young woman with no allergies, recent illnesses, or health problems. She stayed for approximately 20 minutes after and had no immediate side effects. She was directed to contact a clinic if she had any adverse reactions. Once the error was realized the next morning, this RN called her abd the number has been disconnected. Our supervisor emailed her in her native language to contact the clinic as soon as she received the message. Our staff at the clinic made some clerical errors and will streamline administrative processes to ensure the safety of our patients moving forward.
Product storage error; Patient given a dose of expired Moderna COVID 19 vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given a dose of expired Moderna COVID 19 vaccine) and PRODUCT STORAGE ERROR (Product storage error) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given a dose of expired Moderna COVID 19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given a dose of expired Moderna COVID 19 vaccine) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Vial was initially stored in the refrigerator on 20-April-2022. Vial did not undergo any temperature excursions.  No treatment information was provided.
Beginning on 3/17/21, two days after receiving the second vaccine dose, I began to experience a painful cluster headache. The cluster headaches continued for the next 52 days, ending on 5/8/21. The headaches occurred nearly every day, sometimes as often as three times per day, until 5/8. I have a history of cluster headaches, but never as severe or as long lasting as this cluster. I asked my neurologist if this cluster could have been triggered by the vaccine.  She said it's possible, but the treatment would be the same either way.  So we proceeded with sumatriptan injections, steroids, oxygen, and other standard treatments.
GAVE VACCINATION WITH EXPIRATION OF 11/01/2023 ON 11/17/2023. CALLED MERCK (REF#02510114) AND WAS INFORMED IN HOUSE DAT SHOWS EFFICACY/POTENCY IS INTACT AND VACCINE IS VALID. ANY SIDE EFFECTS WOULD BE SIMILAR TO THAT OF SIMILAR VALID VACCINE. SPOKE TO PATIENT AND LET HER KNOW.
I developed small red bumps on my waist and upper legs about March 20, 2021.  The bumps developed into blisters filled with blood and/or white fluid during the summer.  Dermatologist, diagnosis was bullous pemphigold.   on Sept 8, 2021 He gave me a steriod shot.  the blisters and itching were worse and I received a second steroid shot on 10/4/21. with a prescription to take 500 MG of Mycophenolate twice a day which I contiune to take. .
within 10 minutes of receiving vaccine pt complained of itchiness on and around injection site, no swelling or redness so we gave Benadryl 25mg and pt was fine afterwards. monitored after for 30 minutes with no issues
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (lot # L004297 with expired date 17-AUG-2016, lot # L009209 with expired date 17-SEP-2016, lot# L009207 with expired date 17-SEP-2016, lot # L023113 with expired date 24-DEC-2016, dose and route were unknown). No concomitant medication was reported. The reporter could not tell how many of each lot number of the vaccine had been administered. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected since the reporter refused to be contacted.
Became nauseated and diaphoretic with one episode of emesis. After emesis, patient improved quickly. He was able to tolerate PO and ambulate before leaving clinic.
Symptoms - Arm tenderness, chills, increased heart rate (110), low grade temperature (100.2), chest heaviness; treatment Tylenol as needed
Needlestick injury occurred to provider after administering a flu shot on 11/10/20 5:40pm
COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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) all with onset 2023, outcome "unknown" and all described as "COVID". Clinical details: the patient had 4 Pfizer vaccination/boosters and no ill effects. Patient also recently had COVID.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Started briefly with a drip that led to a cough at about one hour. That went away but then headache kicked in at about 3 hours. With the headache was dizziness and fatigue. That lasted from Saturday around noon until Tuesday morning.
Within 5 minutes of administration patient become dizzy and reported a darkening of vision.  The patient was given water and a granola bar and helped to the ground with feet elevated.  The patient never lost consciousness, but remained in an adverse state for about 10 minutes.  The patients blood pressure and pulse were taken once the student was helped to the floor and were 116/82 mm Hg and 56 bpm respectively.  The patient reported that his pulse is normally in the low 60s.  After about 10 minutes on the floor with the patient reporting that he was okay, he was helped to a chair and remained observed for about 15 minutes, and as the patient reported no further reaction he subsequently left the pharmacy.
Rash localized in my arm pits.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash localized in my arm pits.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history information.  Concomitant products included SERTRALINE, ATORVASTATIN and PANTOPRAZOLE for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced RASH (Rash localized in my arm pits.). On 05-Feb-2021, RASH (Rash localized in my arm pits.) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable. No treatment information provided.
Pt was admitted to the hospital with chest pains, had heart cath (-), c/o headache, had CT, MRA, MRI that were normal.
started with shortness of breath then bloodpressure went out of control . I couldnt get it down --ended up going to the emergency room
Right away next morning pain and soreness moving from one area to another, within 6 days it was so bad I could barely walk. This went on for next 2-3 weeks with 3 trips to urgent care and emergency. After many test RA #s very high. I have been on prednisone, methotrexate and pain meds for over month. I absolutely believe this was all triggered from shot. I was healthy when I went in to begin. Why in Gods name is this shot recommended for otherwise seniors who have been healthy with no prior lung issues? Now I will deal with this for the rest of my life and only.
DTaP - Hib combo given before 15 months of age. No side effects reported
2/10/2021 4:15 Vaccination  4:30 strange sensation in my tongue, which moved to my throat; scratchy. I had taken the Benadryl and Tylenol an hour before 2nd vaccine per PCM.  Sat for extra 30 min after to be monitored with 1/2 dose Benadryl.  No SOB.  Dr. gave prescription Hydroxyzine HCL 10 mg before bed.   2/11/2021 I took Benadryl every 4-6 hours. Arm was a little sore. Slight fever, achy body and chills. Symptoms lasted for 24 hours.  2/12/2021 low energy. Still had scratchy throat.
Large rash on left arm - began 2 days after the vaccine, became larger and itchy on day 8 post-vaccine, has been growing larger (now day 9 post-vaccine). Mildly tender to touch. Rash post-vaccine day 9 now covers entire shoulder. I would like to know if it is safe to take dose 2 or not...should I take any precautions prior to the second dose? Please follow-up.
stomach upset; congestion; HA; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 30 year-old male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Lot number: EL3247) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Previous dose details , Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose lot number: EL3247, Prev dose lot unknown: False, Prev dose administration date: 23Feb2021 , Prev dose dose number: 1), administration date: 23Feb2021, when the patient was 30 years old, for covid 19 immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "recovering", described as "stomach upset"; HYPERAEMIA (non-serious), outcome "recovering", described as "congestion"; HEADACHE (non-serious), outcome "recovering", described as "HA". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of abdominal discomfort, hyperaemia, headache.  No follow-up attempts are possible. No further information is expected.
reconstituted with sterile diluent 0.7ml; reconstituted with sterile diluent 0.7ml; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 9-month-old male patient who received Hib (Hiberix) (batch number 4R924, expiry date 15-MAY-2024) for prophylaxis.   On 18-AUG-2023, the patient received Hiberix. On 18-AUG-2023, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with sterile diluent 0.7ml) and inappropriate dose of vaccine administered (Verbatim: reconstituted with sterile diluent 0.7ml).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 21 August 2023 The nurse reported that the patient received Hiberix reconstituted with sterile diluent 0.7ml from Merck company which led wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up via email.
RN stated the client stood up quickly after receiving the vaccine and was standing next to his mother while his sister was receiving the COVID vaccine. Client reported feeling nauseous to his mother and the client's mother alerted RN. RN provided a chair for the client. The client removed his mask and RN noted sweat on the client's face. The client was offered water and took a small sip. RN and Ancillary were fanning the client. RN  entered the vaccination room, noted RN fanning the client, and responded. RN offered the client juice and the client took a few sips. The client reported nausea to RN . Vitals were obtained with a pulse oximeter at 2:20PM and were as follows: HR 77, O2 99. The client began vomiting into an emesis bag at 2:21PM. After emesis, the client stated he felt better. RN began obtaining a blood pressure reading around 2:24PM, the reading was difficult for RN to hear but was approximately 82/60. EMT responded. RN noted new onset of pallor of the client's lips and face. The client was provided a cotton ball with peppermint oil on it to smell. The client stood up with assistance and transferred into an antigravity chair. The chair was reclined to a semi-fowler's position. The client denied any persistent nausea. At 2:28PM vitals obtained with the pulse oximeter were as follows: HR 78, O2 99%. BP obtained at 2:31PM was 86/60. The client's mother stated the client did not have any current medications, chronic conditions, or known allergies. The client ate at a fast food chain prior to coming to the vaccination site. The client's mother denied any history of syncope or nausea with vaccinations. The client reported a history of nausea when riding in the car. RN noted return of reddish color to the client's lips and face. Respirations were 24 per minute at 2:33PM. At 2:36PM the client stated he felt normal. Vitals obtained at 2:36PM were as follows: BP 98/72, HR 92, O2 99%, RR 18. RN provided education to the client and his mother regarding s/s of anaphylaxis and when to seek EMS. RN recommended the client's mother follow up with the client's primary care provider within 24 hours regarding the client's symptoms. The client and the client's mother voiced understanding of this education. The anti-gravity chair was adjusted to a high folwer's position. Vitals obtained at 2:46PM were as follows: O2 99%, HR 90, BP 98/68. The client stated he felt normal. The client's mother confirmed that the current state was normal for the client. The client stood up unassisted from the anti-gravity chair. At 2:50 PM the client ambulated from the vaccination room to the observation area with a steady gait while holding his mom's hand. The client ambulated unassisted with a steady gait out of the vaccination site at 3:04PM.
PATIENT FELT SICK AFTER RECEIVED VACCINE. HE TOOK A DAY OFF WORK.
I have a lot of allergies so when I awoke on June 12, 2022with a headache and sinus drainage I thought it was just my allergies. Later that day I called my doctor and had a telehealth visit after having taken a home COVID-19 test once my symptoms had progressed to fatigue, cough with a fever. He prescribed Paxlovid that I started taking the next day for five days. I have been feeling much better.
Pt complained of puffiness and redness underneath both eyes a day post vax. She also complained of chills, minimal cough and watery stool on the night of teh day of vax. Given cold compress, Tylenol PRN, and Benadryl.
Itching, swollen, blistered and peeling skin on both hands (on the fingers).
Area hot - swollen - 4"X 1 1/2" raised area - very  lethargic after receiving vaccine. Red and very hot area of vaccine " 4" X 1 1/2" ".  Arm bruised - swelling lasted 1 week.