chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Received vaccine 1 day after manufacturer expiration date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine 1 day after manufacturer expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine 1 day after manufacturer expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine 1 day after manufacturer expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received vaccine 1 day after manufacturer expiration date).    No concomitant medication was reported. No treatment medication was reported. In the facility, the patient was injected a vaccine 1 days after manufacturer expiration date. The information was unknown whether the vial was stored in the refrigerator.   Reporter did not allow further contact
She received her Covid vaccine on 12/24/2020  denies any s/s of illness on day of the injection. On 12/25/2020 she reports after 1200 pm noting feeling of fatigue, sl. cough with SOB noted, and fever of 100.4. On 12/26/2020 she reports having sorethroat, fevers around the 100 range, but denies cough. On 12/28/2020 she got tested for Covid due to having s/s mentioned above. She was found to be Covid  positive on 12/28/2020. She was seen in the ER with s/s of some loose stools, mild pleuritic cough, mild fever and pulse oximetry in the 80 range. She was placed on an Albuterol inhaler and 6 days of Dexamethasone 6 mg with instructions to not to return to work at least until 01/11/2021. Our local Health Department felt a VAERS form should be completed since she became Covid positive and required medical treatment even though she could have had the exposure prior to receiving the vaccine.
This is a spontaneous report from a contactable physician received via a sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced heart failure on an unspecified date due to vaccine according to preliminary investigations of symptoms. Event took place after use of product. The outcome of event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on the information currently available, a causal association between the reported event heart failure and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
Numbness of lips on 1/28/2021 and then developed numbness of tongue and eye would not close.  Saw physician who treated her with steroids, anti-virals and OTC eye drops for lubrication of eye.
Information has been received regarding a case in litigation which was reported in Litigation Report concerning a 48 year old female who in November 1992, was vaccinated with the first dose of RECOMBIVAX HB and received the second dose on 16-DEC-1992. Concomitant medication was not reported. In approximately December 1992, after the second vaccination with RECOMBIVAX HB, the patient sought medical attention for left body and leg numbness. The reporter concluded that "the RECOMBIVAX HB caused the patient's multiple sclerosis." The outcome of the event was not reported. Upon internal review, multiple sclerosis was considered to be an other important medical event. No further information is available.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing), notes: other medical history: GERD; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin; "known allergies: Gluten" (unspecified if ongoing), notes: known allergies: Gluten; "known allergies: Lactose" (unspecified if ongoing), notes: known allergies: Lactose; "known allergies: Fructan" (unspecified if ongoing), notes: known allergies: Fructan. Concomitant medication(s) included: PEPCID AC; TYLENOL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Patient received Paxlovid as treatment of COVID-19 from 04Jul2022 to 08Jul2022. COVID rebound on day 4 (on 11Jul2022 at 04:00 PM) after Paxlovid treatment completed. COVID symptoms (nasal congestion, headaches, diarrhea, cough, fatigue, foggy thinking) came back with a vengeance and have been growing stronger 6 days since they restarted.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient had experienced a previous reaction to Pfizer Vaccine #1 (ADR - reported separately).  Plan was to give J&J vaccine for second dose, but Pfizer vaccine given in error.  No ADR following #2 Pfizer Vaccine
7/28/21 11:00 AM approx. pt received 2nd dose of Gardasil-9 to RA deltoid muscle, 2 inch down from acromium process. She stated pain at entry so needle depth adjusted to 3/4 inch. 7/29/21, patient complained of should/arm pain & stiffness and she could not go to work. Advised to take OTC ibuprofen 3x/day x5 days which patient reported later did not take as directed 8/3/21, patient reported went to urgent care but nothing significant was fould. Her pain then has spreaded to the neck area. Urgent care medical staff advised to take Motrin 600mg TID for a few days. Patient said she would not take because she heard it might hurt her kidneys. Pharmacy delivered to her house 8/4 alternative OTC Naproxen and ARnica cream. 08/11/21 - Pt reported seeing MD for corticosteroidal inj. due to shoulder joint inflammation
Localized site reaction.  Arm red and painful surrounding injection site.  Started approximately 3-4 hours after injection
I experienced an intensified ringing in my left ear (which is my "good" ear--not the ear that I've had lifelong issues with). Also experiencing a sense of tightness and sensitivity in left ear. Slightly blurry vision in left eye.
Insomnia and fever in middle of the night along with racing pounding heart. Extreme heartburn began the next day following vaccination lasting approximately 6-8 hours. Heartburn meds, such as antacid and famotadine, did nothing to help. Was ready to go to ER due to severity of pain but it spontaneously resolved at approx 8pm. I didn't report because it resolved on it's own so completely but now wonder if it was an inflammatory response. I do have a trivial heart murmur which I forgot to mention in the previous section. Thanks for reading this.
Rigors, body aches, extreme fatigue, started abruptly about 10 hours after injection,  (slept for 18 hours), treated with hot baths, ibuprofen, Tylenol, still very fatigued, extreme body pain.
After 7 days after my 2nd dose I started to have arithma and papulations.  I did not think anything of it for the first few days.   I waited a few days and it happened again. I contacted my physician and they gave my a monitor to wear, they diagnosed it as atrial fibrillation.  The doctor wanted to monitor it long term.   I currently have a loop recorder in which  they download the data everyday.  I have not have any atrial fibrillation since there.  I did not have any shortness of breath or I did not faint.  They are going to repeat my EKG in a few months to make sure it doesn't show anything else.
Pt had 3 vessel CABG on 1/14/21 after presenting to ED with chest pain on 1/9/21.  Pt is critically ill following OR after cardiogenic shock, bleeding.  Requiring inotropes and Impella.
Pain at the injection site (right arm), pain in right pectoral chest muscle, fatigue, joints ache various, both knees and overall body. 12-24 hours.
Pt recvd 3 doses of Engerix-B 27OCT89, 1DEC89, & 3APR90 & titer was checked 17JUL91 & found neg for antibodies; immunity status is non-immune; pt will recve booster dose;
chills; fever; diarrhea; nausea; sore shoulder; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient indicated receipt of first dose on Tuesday. Starting Wednesday night, the patient experienced chills, fever, diarrhoea, nausea and sore shoulder. Outcome of all the events were unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received and experience adverse event refer linked case US2018GSK141983). On 11th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported for the reporter's brother. The age at vaccination was not reported. On Wednesday, 11th July 2018, the patient received 2nd dose of SHINGRIX shot. The patient experienced arm soreness. Arm soreness was still a little sore but not as sore as after the first Shingles shot but still worse than any other shot (example Tetanus). The patient noticed it most at night as he can not sleep on the shoulder that received the shot.
This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In approximately March 2016, the patients were orally vaccinated with improperly stored (reported as improperly exposed to 32.9 degrees Fahrenheit (F) for 1 hour on 24-MAR-2016) doses of oral ROTATEQ (lot # L013188, expiration date 02-NOV-2016, dose was not provided). No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
he got a foot infection will be in hospital, he is diabetic and has ulcers for months; This is a spontaneous report from a contactable consumer (patient wife). A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in Feb2021 (at the age of 76-years-old) as single dose for COVID-19 immunisation. Medical history included diabetic and had ulcers for months. The patient's concomitant medications were not reported. It was reported that the patient got the covid vaccine 3 weeks ago (Feb2021) and tomorrow he would get another dose, but he got a foot infection and would be in hospital, he was diabetic and had ulcers for months and now they had to go to hospital to get it cleaned. They wanted to know how long they could wait to get the second dose. Outcome of the event was unknown.  No follow up attempts are possible. Information about lot/batch number cannot been obtained.
Before administration patient  was given handout regarding Moderna information and read through handout patient denied any previous adverse reactions to vaccines and consent was signed. Patient received vaccine at 1407. Around 5 minutes after administration the nurse was notified that patient was "not ok". RN quickly assessed patient and called for help. At first assessment, patient was having involuntary movements and delayed verbal response to questions.  Shortly after he began labored breathing and became unresponsive. He continued having involuntary movements in bilateral upper extremities. He did not respond to sternal rub. At that time EMS was called. BP was 50/32 in right arm with HR of 52 and O2 saturation of 93% on room air.  EMS arrived to the clinic approximately 5-6 min after patient began having adverse reaction. EMS  took over care at that time. He was then transferred to ED by ambulance for further evaluation.
Pain at injection pain,  head ache muscle pain in arm, should, neck and back, and lymph node inflammation - all within 4-5 hours of injection of the second vaccination.  The following day, approximately 15 hours after injection, the pain in the areas mentioned above got worse, and I  also became light headed, had ringing in my ears and was very tired.    Later in the day, approximately 24 hours after injection I developed a very low grade fever and got the chills as well as having all of the symptoms mentioned above.  1 1/2 days after the injection, I am experiencing all of the signs, but they are better and I have no fever.
This spontaneous report was received on 07-OCT-2016 from a other health professional referring to a patient of unknown age and gender. Medical history and concomitant medications were not reported. On 05-OCT-2016 the patient was vaccinated with PNEUMOVAX 23 lot # K010465 expiration date 23-MAR-2016, which was expired. No adverse effects were reported. No further information was reported. Additional information has been requested.
In one week, developed Tinnitus in both ears. Confirm with Dr. who referred me to ear, nose and throat Dr. Confirmed on June 18th
Woozy/heavy feeling, racing heart, right arm cold/numb that traveled down to my finger tips. Arm changed color(blue/purple). High BP, Right sided lower facial swelling, droopy right eye, traveling head, eye and jaw pain.  Right eye went Ice cold with pain like brain freeze.  lips went numb.  Lymph nodes on right side swollen.  Next day had head ache, tinnitus, fever 101.1, chills, exhaustion. Low grade fevers on and off for almost two weeks.  Had continued facial/lower jaw swelling for more than 3 weeks, continued transient  right sided head pain continues on and off.  Right eye is HYPER sensitive to air and burns and twitches.  Still fighting constant exhaustion.
a patient was administered a 1 ml dose of IPOL vaccine/ No AE; Initial information received on 17-Sep-2021 regarding an unsolicited valid non-serious case received from an other health care professional via physician via consumer via phone via Medical Information number: 00775118.    This case was linked to cases 2021SA312255, 2021SA312326, 2021SA314182 and 2021SA314197 (same reporter).  This case involves a 14-years-old female patient who received a 1 ml dose of IPV (VERO) [IPOL] (overdose).  The patient medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.     On an unknown date, the patient received a 1 ml total dose of suspect IPV (VERO) lot number: U1A452M, expiry date: 20-Feb-2023, frequency: once, strength: standard via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of overdose (latency: same day).   It was reported " Caller/ Medical Assistant reports that IPOL was administered to 5 patients, caller states that she does not know if patients received a 1 mL dose or a 0.5 mL dose, caller requests information on possible adverse effects from a 1 mL dose of IPOL. Caller states she does not have time to look through all patient charts for adverse event information, she will call back at a less busy time."  At time of reporting, no adverse event was reported.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
Providers feel pt was experiencing an URI/panic attack. In the ED she was given KENALOG, BENADRYL, and ZOFRAN. She experienced hyperventilation (most likely 2/2 panic disorder) and kept overnight for observation. Rash and dyspnea, injection site pain, nasal discharge, swelling, water eyes. Triamcinolone, diphenhydramine, ondansetron.
Received TC from mom, child broke out with chicken pox after receiving varicella 1 mm on 4/25/2005. Seem by PCP on 4/27/2005 who ordered Benadryl Syrup, use calamine lotion on body. Mom c/o pt still itching. Reported to MD, she ordered Aveeno bath PRN, to call if any problem.
Arms felt like pins and needle; cant sleep; my arm felt heavy; lump below left armpit,5 inches,like golf ball; Swelling of lymph node under arm she received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Arms felt like pins and needle), INSOMNIA (cant sleep), LIMB DISCOMFORT (my arm felt heavy), MASS (lump below left armpit,5 inches,like golf ball) and VACCINATION SITE LYMPHADENOPATHY (Swelling of lymph node under arm she received the vaccine) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 10202) for COVID-19 vaccination.     Concomitant products included AMLODIPINE BESILATE (NORVASC), ATORVASTATIN CALCIUM (LIPITOR), METOPROLOL SUCCINATE (TOPROL) and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swelling of lymph node under arm she received the vaccine). On an unknown date, the patient experienced PARAESTHESIA (Arms felt like pins and needle), INSOMNIA (cant sleep), LIMB DISCOMFORT (my arm felt heavy) and MASS (lump below left armpit,5 inches,like golf ball). At the time of the report, PARAESTHESIA (Arms felt like pins and needle), INSOMNIA (cant sleep), LIMB DISCOMFORT (my arm felt heavy), MASS (lump below left armpit,5 inches,like golf ball) and VACCINATION SITE LYMPHADENOPATHY (Swelling of lymph node under arm she received the vaccine) outcome was unknown.            No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow up SD received on 02-JUn-2021 in which concomitant medications and events are updated
6/8/18-right arm "extremely sore," felt tired and low fever; 6/9/18-nauseous, but did not throw up; 6/10/18-nausea resolved, arm still sore; 6/11/18-right arm red around injection site, some itching, spread towards elbow area also developed fever blister; 6/15/18-both left and right elbows itching with little red blisters, painful to touch 6/23/18--all symptoms resolved.
I have received flu shots for years and never had the severe reaction as of 9/10/09. That night I awoke to chills and severe shaking, body soreness and flu like symptoms.  The shaking lasted for 1/2 hour.  No energy the following day and body soreness.
Started having shortness of breath; Went to Cardiologist, after exam was referred to a Pulmonologist; Ran tests and  gave me a breathing treatment machine with CROMOLYN; Waiting for follow up exam.
Rt upper arm red, warm to touch and slightly swollen.  Treatment: warm compresses and TYLENOL flu with E.R. worse.
Immediate burning. Said it was too high in shoulder. Went to doctor had x-rays x 3 and cortisone shot. If not better may get
One week post vax, localized erythema, induration, and pruritis, extending distally and into axilla on left (where IZ site is).
Vaccine #1: extreme fatigue, genital herpes outbreak and mental sensation of euphoria or unnatural high. These symptoms lasted for 2 days.  Vaccine #2: high fever, nausea, vomiting, severe headache, dizziness. In bed for 2 days with symptoms . Remained fatigued, dizzy and nauseous for about a week. Second week experienced high mental anxiety and a internal sensation of my body vibrating uncontrollably. Third week I experienced burning, aching sensations on my face. My face was bright red with a burning raised rash all over my face but especially on my left cheek. Had a herpes outbreak inside my left cheek a few days after the burning started on my face. Herpes lasted about 7 days. My face still burns and I still have a rash on my left cheek.
Patient reported redness, swelling and burning sensation on site of injection, swelling described as "bigger than golf ball" and painful. No itching or shortness of breath. Patient took benadryl but did not help. Per patient, she can take tylenol or motrin with no problem, not pregnant or diabetic, to help with pain and swelling. Also advised patient to see a doctor, if needed.
On 04/07/2021,excruciating bone pain in sternum, clavicles, ribcageShortness of breath due to pain, Raynaud syndrome inall extremities with temperature change, chills.On04/09/2021,same symptoms plus hypotension BP:100/65. Normally,130/85.
pt having a serious rxn to immun can barely move are;Friday Saturday couldn't move arm at all;rash to rt arm;pus pocket size of a dime;had fever x 2 days;referred MD;
Information has been received from a physician concerning a 21 yr old female with no past medical history and no drug allergies who in 1989 and in 1997 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no concomitant medication. In 2005 a titer was negative for measles. Unspecified medical attention was sought. The pt was reported to be not recovered. No product quality complaint involved. There were also reported to be no lab diagnostic tests performed. Additional information has been requested.