chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Moderna dose administered to patients after expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patients after expiration) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patients after expiration). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patients after expiration) 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 (Moderna dose administered to patients after expiration).    No concomitant medication reported. No treatment information was provided.
He got his vaccine, it burned like hell for almost 10 minutes.  Then a couple of weeks later he needed a root canal, an 8 mm kidney stone and then started noticing cramps in his legs, and it felt like also he was being stuck by a needle in all different spots on his body.  It also felt like a parasite trying to scratch out from under his skin in all different locations on his body.  Then those issues continued and in October his left pinky started going numb and it felt like when you fall asleep feeling tingly.  Then it progressed next finger to his pinky, then into his hand, arm, his left foot, left leg, his right toes and then ending up with probably 2 weeks ago from 3/17/2022 moved into his right hand.  He has extreme weakness.  He had a cervical MR about a month ago,  then a nerve induction a week later that showed extreme neuropathy on the left side especially in the motor skills.  That's when his doctors started paying attention in things, and the investigation started in October.  His PCP sent him to a dermatologist, who then sent him to a  neurologist, then after the nerve induction study he had a lumbar MRI, a lumbar puncture for spinal fluid, and about a dozen viles of blood to send to the Clinic.   About 2 1/2 to 3 months ago he had a whole body of about 25 blood tests, was low on B and D vitamins.  He has not gotten the results from the clinic, and the results from the lumbar puncture showed CIDP.   He was then started on IV immunoglobulin therapy.  Back when he first saw the neurologist she gave him a Methylprednisolone Z-PAK, and then started on the IV immunoglobulin therapy on Tuesday 3/10/22, 3/11/22, and 3/14-3/16/22 with the last being yesterday, and has improved but the neuropathy does not seem to be going away.   It got so bad that he could not even open the door to his car.  He fell 7 times in one week as his legs went out from under him. and was not able to turn the ignition over in his car.    He has had flu shots, was in the military and had no reactions to any vaccines, but will never, never get a COVID vaccine.
Patient received Pfizer monovalent as booster instead of Pfizer Bivalent.
Rt arm - large area erythema, warmth. STS medial & mid arm. Tx - apply cold compress 2 -3 x daily 15 min each. Tapered Prednisone.
within 20 minutes she felt a sensation up her nose and down her lungs; Caller stated it was not tightening or wheezing but felt like when she has a mild asthma attack; allergic reaction; Headache; pain at the site; Caller stated she saw a rapid chest rise; breathing is still shallow and is taking effort; could not focus or do anything; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received BNT162b2 (Comirnaty, Formulation: Solution for injection, Batch/Lot number: not provided, expiration date not provided), via an unspecified route of administration, administered on 30Aug2021 as (at the age of 36-year-old) DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medication were not provided. The patient reported, within 20 minutes of vaccination she felt a sensation up her nose and down her lungs which was not tightening or wheezing but felt like when she had a mild asthma attack. The patient thought her asthma was acting up and also thought she had an allergic reaction. The patient's headache was bad previous day from the day of report which was describing as pounding. She also experienced pain at the site. The patient had to use accessory muscles to take deeper breaths. The patient saw a rapid chest rose. The patient could not focus or do anything previous day. Symptoms not severe and she curled up and went to bed previous day. The patient reported that symptoms were more than before she got the shot. On 31Aug2021 her breathing was still shallow and was taking effort. The patient reported she was not normally how she was, but she was better the day of reporting. On 31Aug2021 her headache was mild. The patient thought she was better today as she drunk water previous day. The patient also reported that she was scared to take the second dose noting she did not want to put herself through it. She stated work making her get the vaccine. The patient's hands were tied because she was forced to get it. The patient wanted to guide about getting the second shot. The outcome of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
6:00 pm tired, vomiting-temp of 104 deg at 8:15 pm. Vomited 5 times-taken to ER. received IV fluids.
Information has been received from a female registered nurse with no known drug allergies who was vaccinated with a first and second dose of hep b vaccine recombinant. There was no concomitant medication. Subsequently, approx. one week after the first dose, the pt developed an acne-like rash on her face. Unspecified medical attention was sought. No further details were provided. Additional info has been requested.
Fever,chills,muscle pain,tired,sleepy,arm pain Took Tylenol
Shingles; Information has been received regarding a case in litigation, referring to a female pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 27-JUL-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Approximately in November 2017 (reported as "within four to five months"), the pt suffered severe and debilitating shingles, rashes and severe pain as a result of the zoster vaccine live (ZOSTAVAX) vaccine. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, had and would continued to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, included but not limited to medical losses and costs which included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of herpes zoster was determined as not recovered. The lawyer considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event was determined to be serious due to disability.
Pt recv vax on 4/14/99; on 4/15/99 pt exp lt thigh red & swollen; tx=Duricef, warm compress
I had stomach pains, vomiting, diarrhea twice for 2 days.
Arm was swollen, red and hot to the touch. Swelling started to go away after 4 days.
had occasional diarrhea for about 24 hours, got shot on 12/21/2020 and had diarrhea 4 times on 12/22/2020, also felt tired.
A medical co-ordinator reported the occurrence of adult subjects (gender not specified) who did not respond to a series of hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject's relevant medical histories, concurrent conditions and concurrent medications were not provided.  The subjects received the first injection of the series on 02/06/2001 (Lots: ENG5167A2, ENG3232A4 or ENG3360A4), the second injection was on 03/14/2001 (Lot # ENG3382A4) and the third injection was administered on 08/22/2001.  On 12/13/2002, a titer was drawn.  The reporter stated that "so far, they have seven low-responders ranging from 2 to 9 mIU/mL hep B titers."
We administered the vaccine to the patient and she is only 17 years old.  She will be 18 in 2 months.  She has currently not reported any adverse side effects
This case was reported by a other health professional via call center representative and described the occurrence of fever in a 82-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 18th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced fever, nausea, general body pain, neck pain and pain in arm. The patient was treated with Pain Reliever (Nos). On an unknown date, the outcome of the fever was unchanged and the outcome of the nausea was unknown and the outcome of the general body pain, neck pain and pain in arm were recovering/resolving. The reporter considered the fever, nausea, general body pain, neck pain and pain in arm to be related to SHINGRIX. Additional information was received as follows: This case was reported by a pharmacy intern as the patient reported symptoms to pharmacy. On 18th June 2018, there were no vaccinations other than SHINGRIX was given to the patient. It was unknown if the patient received any other vaccines within 4 weeks prior to the SHINGRIX first dose. The patient received SHINGRIX on the right arm. It was unknown exactly how soon the symptoms started after the vaccine was administered. The patient's doctor told her to take over the counter medications to relieve her pain which was described as being everywhere, specifically in her neck, arms, and legs. The pharmacy had standing order for SHINGRIX. The patient had the physician's office visit because of the symptoms but did not have an emergency room visit due to the symptoms and was not hospitalized for the symptoms. The responsible physician was unknown, but the reporter who was a pharmacist intern granted permission to be contacted at the pharmacy with further related questions.
Covid19 breakthrough.  1st vaccine received on 01/15/2021.  76 y/o PMH BPH, Colon cancer s/p colon resection, Meniere's disease, Hypothyroid, Thalassemia minor  presented with c/o change in gait, falling multiple times and AMS.  Pt found to be Covid +.  Started on low dose steroids.
NO additional AE's; M-M-R II that underwent a temperature excursion and was administered.; This spontaneous report was received from an office manager and refers a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 15-JUN-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # S020162 was confirmed to be valid, expiration date 30-JUN-2021, for prophylaxis (dose, route and site of administration were not reported). The administered dose was exposed to the temperature of 57 degrees Fahrenheit (F) for 1 hour and 53 minutes, 56.3 F for 48 minutes, 47.8 F for 11 minutes and 47.8 F for 5 minutes. The previous temperature excursion was reported as temperature out of range on 03-JUN-2020 for 1 hour and 53 minutes and reached 57 F, 04-JUN-2020 for 48 minutes and reached 56.3 F, 10-SEP-2020 for 11 minutes and reached 47.8 F. The call was because of a digital data logger. No additional adverse event was reported.
gen malaise on 13AUG lt upper arm sore, reddened, hot 14AUG & 15AUG, itchy on 16AUG, used ice to area-duration 4 days;
Patient admitted to hospital on 8/19 positive for COVID after being fully vaccinated. Presented with thrombocytopenia, weakness, and falls.
Fever, vomiting, coughing, crying fits, general change in behavior, fatigue, loss of appetite.
Initially HA, tired, nausea, sore site. Took Tylenol.  Itchy around 1600, hives and lump in throat, took Benadryl. Went home. Took more Benadryl. Had lip swelling and hives in throat. Went to UC on 9/21/23. Per UC prescribed oral Prednisone, continue with Benadryl as needed and Pepcid as needed.  Currently, all hives gone (as of Sunday, 9/24/23). Continues on meds. Advised to follow up with PCP.
Tiredness; Fever with head ache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), PYREXIA (Fever) and HEADACHE (Fever with head ache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032m20a and 012m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (Fever). On 08-Mar-2021, the patient experienced FATIGUE (Tiredness) and HEADACHE (Fever with head ache). On 06-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, FATIGUE (Tiredness) and HEADACHE (Fever with head ache) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
I first felt tingling on my left side...then it became pain.  It has not let up in my arm, back, and neck.   This is 3 weeks after shot!  I do not want to have the second shot in my right arm because then I will perhaps feel pain (back is bad on both sides-nerves and muscle easily irritated).    Want to know where else I can receive the shot, not in the same place, but same arm or somewhere on left side.
Child received flu vaccine on 11/9/04 in AM and was sent home from preschool in afternoon because child had swollen face and low grade temp. Child had swollen face through 11/18/04 accompanied by loss of appetite and diarrhea. No medical treatment sought.
diagnosed with Covid-19; Testing positive for Covid-19 after first dose of the purple cap Pfizer Covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 12 year-old male patient received bnt162b2 (COMIRNATY), administration date 30Sep2021 (Batch/Lot number: unknown) as dose 1, 0.3 ml single 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) with onset 15Nov2021, outcome "unknown", described as "diagnosed with Covid-19"; COVID-19 (medically significant) with onset 15Nov2021, outcome "unknown", described as "Testing positive for Covid-19 after first dose of the purple cap Pfizer Covid-19 vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Nov2021) positive, notes: diagnosed with Covid-19 on 15NOV2021 via a PCR test. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
Pt got shot at 11:25AM. At 11:30AM came to me stumbling, lightheaded, sweating, pale. Stumbled into wall. Called 911. They came and check BP, was 95/70. Pt refused care. Sat and drank juice and started to feel better so left. Applied ice pack to neck.
No adverse effect reported; A patient was inadvertently administered a expired dose of VAQTA; This spontaneous report was received from a medical assistant, concerning a18 year old patient. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 25-JUL-2019, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis, lot #R013858 and expiration date 12-JUN-2019 (strength, dose, frequency and route of administration were not reported). No adverse effects were reported.
pt recv vax & exp metallic taste in mouth 15min p/vax which persisted for 3hr;
Shortness of breath, sensation of a lump in the back of throat. Symptoms improved with Benadryl 50 mg orally and Zantac 150 mg.
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage than recommended. Patient presented fever,  pain at injection site and generalized pain and tiredness that lasted  48 hours.
mom returned to clinic 23APR93 for next appt; informed by mom pt had reaction to last vax 19FEB93; devel fever the same evening t105; adm to hosp the next day; all lab work neg;
Erythema from left shoulder to elbow - outside of arm only - tenderness noted to touch.
Vaccine received 5/18/21 in AM  Symptoms started 5/19/21 at 1400 to include body aches, nausea, rash on chest, fatigue, and headache 5/20/21- Symptoms continue and get worse 5/21/21- Symptoms continue, rash has spread to face
Pt was feeling itchiness near site of injection. Pt was given BENADRYL and water. Paramedics were called and they checked the pt and she had no sign of adverse effects.
I'm having chills. Woke up at 130am in the morning shaking; I'm having chills. Woke up at 130am in the morning shaking; Brand: booster/ is bivalent: true/ dose number: 1; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 08:30 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 30Sep2022 at 08:30, outcome "unknown", described as "Brand: booster/ is bivalent: true/ dose number: 1"; CHILLS (non-serious), TREMOR (non-serious) all with onset 01Oct2022 at 01:30, outcome "recovering" and all described as "I'm having chills. Woke up at 130am in the morning shaking". Therapeutic measures were not taken as a result of chills, tremor.  Additional information: Adverse event reported as having chills. Woke up at 1:30 am in the morning shaking. Hospitalization prolonged reported as no. No other vaccine received in four weeks. COVID tested post vaccination reported as no. The patient was not diagnosed with COVID-19 in Prior to vaccination. The patient had not been tested for COVID-19, since vaccination.  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.
Severe headache, started about four hours after vaccination and continued for 72 hours. Including sensitivity to light and sound (with no history of migraines or head injury) Flu-like symptoms with body aches and extreme fatigue for 72 hours after vaccination. Currently scheduled for an abdominal ultrasound after recent blood work in April 2021 showed elevated renal values (no history of renal problems)
Nausea and dizziness started around 11:00 AM and ran for 4-6 hours.  Mild fever and coughing started around 3:00 PM got up to 99.8 and ran till bed at 8:00 PM. Took Acetaminophen PM at bed time and was over majority of symptoms by morning, 5:00. Felt like prelude to when I got Covid in April of 2020.  Have heard 2nd shot is usual side affects and worse so not looking forward to second shot. (but will be getting on 5-28-2021)
Information has been received from a nurse practitioner concerning an approximately 19 year old female who was vaccinated IM with a first dose of Gardasil. Subsequently, the patient was diagnosed with Guillain-barre syndrome and was hospitalized. The patient's Guillain-Barre syndrome persisted. No product quality complaint was involved. Guillain-barre syndrome was considered to be disabling and immediately life-threatening. Additional information has been requested. Additional information is not expected.
Received following vaccines: Dtap, MMR, IPV- immediately after given vaccines, tiny pimple rash appeared. Yesterday AM she complained of redness, heat and swelling, left arm only. Tx with cold cloth. 07/19/04 Follow up call, mother says she's fine.
Felt very hot, shivering, difficulty breathing later on.  When we had a chance to use a thermometer his temp was 106.6 at about 10pm.  Went straight to ER at that point and they gave Motrin and treated it like a UTI, but when results came back 3 days later, it was not a UTI.
Patient states arm hurting significantly and has potential damage to nerve. Patient states they have missed work and has been going to physical therapy. Patient states potential damage to rotary cuff.
Edema, erythema and warmth 10.5cm x 10.5cm around injection site
17 x 9 cm indurated, red area at (Lt) upper thigh (injection site). Pt on Ab for Dx impetigo - to finish course. Monitor leg & watch for increased s/s &/or refusal to walk.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 77-year-old female patient who received SHINGRIX (batch number NR4Z4, expiry date 11th October 2020). On 15th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 16th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, headache, fatigue and injection site swelling. On an unknown date, the outcome of the injection site erythema, headache, fatigue and injection site swelling were unchanged. The reporter considered the injection site erythema, headache and fatigue to be related to SHINGRIX. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. At 9:30 AM, the patient received SHINGRIX on the left arm. At the time reporting, the patient's side effects remain unchanged.
she broke out in a rash on the left side of her face; This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old female patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Unknown, Lot Number: ER8731, Expiry date: 31Jul2021), via an unspecified route of administration on left arm, on 17Apr2021 at 9.30 as a 0.3 mL, single dose for COVID-19 immunization. Medical history and concomitant medications of the patient were not reported. On 18Apr2021 she broke out in a rash on the left side of her face. The patient stated on 17 APR 2021 at 09:30 received vaccine then 24 hours later, which was Sunday, she would say mid afternoon, she broke out in a rash on the left side of her face and she was placed on antibiotics to clear it up doxycycline, and she's going to take that for a couple more days, it seems like its helping. The outcome of the event was Unknown.   No follow-up attempts are needed. No further information is expected.