chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was initially stored in the refrigerator on 31 Jan 2022 and administered on 09 Mar 2022; Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 31 Jan 2022 and administered on 09 Mar 2022) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination. No Medical History information was reported.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 31 Jan 2022 and administered on 09 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 31 Jan 2022 and administered on 09 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.
This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions or concomitant therapy was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (strength, dose, interval and route of administration were not reported) (lot/batch number reported as K016263, expiration date: 26-JUN-2016). No adverse events or product quality complaints (PQC) were reported. This is one of several reports from the same reporter. Additional information has been requested.
Never had 2nd Dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Never had 2nd Dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never had 2nd Dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Never had 2nd Dose) had resolved.            No Concomitant medications were reported. No Treatment medications were reported.
Pt reports that 8 days after receiving Pfizer number one she developed "numbness" of both feet and her arms. She describes numbness as "a tight feeling like my toes are full of water" she reports she cannot feel the tops of her feet. She states that she does cannot feel her toes on plantar aspect. She reports that this is worse with sitting. Symptoms plateaued around 2 weeks and has noticed an improvement over the last two days. She describes arm problem as "tingling sensation on antecubital fossa radiating distally with movement of arms." only present with movement of arms. Denies weakness. No other neurologic symptoms.  She reports that she has had urge incontinence since giving birth to her two year old son that became worse after receiving vaccine.  Physical exam shows normal appearing female, well developed, in no acute distress. Weight normal.  Neuro: Pt is alert to person, place and time.  CN nerves 1-12 intact. Olfactory tested with alcohol swab. Visual fields tested with confrontation. Fine visual acuity not tested. PERRLA . EOM intact normal. No ptosis and no nystagmus. Trigeminal nerve normal, muscles of mastication normal and sensation in V1, V2, V3 normal. Corneal reflex not tested. Facial nerve normal in both upper and lower motor distributions. Cranial nerve 8 intact, hearing grossly intact. Cranial 9 and 10 normal no uvula deviation, Palatal articulation "KA" normal, Guttural articulation "GO? normal. Accessory nerve normal. Hypoglossal function normal.   Sensation to soft touch is normal in upper extremities bilaterally. Sensation to soft touch is normal in lower extremities bilaterally. this was tested with 10g monofilament and she was able to detect this sensation in hands and feet equally at site of concern.   Strength to large muscle groups of upper extremity is 5/5 bilaterally. Strength to large muscle groups of lower extremity is 5/5 bilaterally. In the extremities Muscle tone is normal, no rigidity, no fasciculation.   Biceps tendon reflex is 1+ bilaterally. Patellar tendon reflex is 2+ bilaterally, achilles tendon reflex 1+ bilaterally.   Coordination- finger to nose normal, pt able to perform rapid alternating movements, heel to shin normal bilaterally, Romberg negative, no pronator drift.  Gait- normal
Patient c/o "numbness and tingling in right lower forearm and right ear feels like it's clogged."  Patient stated the "numbness and tingling started to occur in left lower forearm."  There were no s/s of respiratory distress or swelling noted on or around face or neck or at vaccination site.  Referred patient to Emergency Room.
Swelling and redness to site within 45 minutes.  Treated with 50 mg of Benadryl IV push.
rts body aches, chills, low grade temp 99.5F, throat  dryness. Employee took a sick day 1/20/2021.  Narrative:
Hand and finger tingling; Shoulder pain; Neck pain; This is a spontaneous report from contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 09:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not take any concomitant medications. The patient was not allergic to medications, food, or other products The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 27Mar2021 at 00:00, the patient experienced hand and finger tingling, shoulder and neck pain. No therapeutic treatment was taken for the reported events. The clinical outcome of the events hand and finger tingling, shoulder and neck pain was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received the vaccine and within approximately a minute the patient started stating she did not feel good to her mother.  The patient was on the floor sitting. Got the patient on a chair and elevated her feet. We also got the Nurse Pactitioner, and she check the pt pulse and blood pressure. The symptoms the pt reported was she felt faint, vision issues and pale skin color. The NP stated her pressure was low but after 3 checks the pressure when to normal for her age as she stated. Pt was told to inform her MD.  Pt was also given some water to sip on.  Afterward pt was albe to get and walk out.
Patient became pale and nauseated after receiving injection and vomited.  Patient was observed by EMS at vaccination site and then released to home.
Got out of bed, took 3-4 steps, got very dizzy or passed out.  Family member stopped by, found me on floor, and called 911.  Paramedics transported me to the hospital where I remained until 4-03-2021.  Many tests, transferred to specialist hospital.
p/vax pt dx w/pneumonia;pt expired on 11/1/99;MD does not feel what occurred is r/t vax;
side effect as a 'beneficial one; Dry nose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NASAL DRYNESS (Dry nose) and THERAPEUTIC RESPONSE UNEXPECTED (side effect as a 'beneficial one) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 20Apr2021) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced NASAL DRYNESS (Dry nose).   On 20-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (side effect as a 'beneficial one). On 20-Apr-2021, THERAPEUTIC RESPONSE UNEXPECTED (side effect as a 'beneficial one) had resolved. At the time of the report, NASAL DRYNESS (Dry nose) had not resolved.      It is reported that patient were experiencing a symptom of 'overly active nose' or a 'very runny nose' for most of their life. After the first dose of the vaccine, the runny nose symptom was replaced with a dry nose between 18-Mar-2021 to 25-Mar-2021. Afterwards the runny nose symptom was still lessened to a certain extent.   Concomitant product use was not provided by the reporter. No treatment information was provided. After the second dose, the dry nose side effect was immediate and has remained persistent. The patient reported this side effect as a beneficial one.
This spontaneous case initially received on 12-Apr-2017 was reported by other non-health professional and concerns a 50 years old female patient. Administration of Company suspect drug: On 12-Apr-2017, the patient was administered with FLUVIRIN  dose: 0.1 ml, batch no: 1618401) via intradermal route. Adverse reactions/events and outcomes: On 12-Apr-2017, the patient was administered with FLUVIRIN 0.1 ml (incorrect dose administered) via intradermal route (inappropriate route of vaccination) with no reaction. Action taken with vaccine was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality between FLUVIRIN and events. This report was not serious.
within two hours of injection, the patient was increasingly weak, and could not go up our stairs to our house. Hecomplained of dizzyness and was running a fever of 101.7 F and very drowsy. the site of the injection was swollen and hot. this continued for the next 48 hours, until the fever slowed and his dizzyness went away.   On the 8th of July, 2019, a red lacy raised rash appeared spontaneously on the anterior thighs and anterior chest/armpit area. I noticed it localized to this area, and called the doctor. The next day the rash had worsened, and continued to spread up his belly and onto the groinal region, and onto the underside of his biceps unilaterally. the Rash now presented as blotchy and speckled with new lacy red welts forming on the posterior thighs and calves and pooled on the anterior thighs. The rash is still present and since the injection, the patient has shown consistent signs of irritability and aggression that would otherwise be abnormal on a day to day.   we are still waiting for the urticaria eruption to go away.
joint pain, chills, nausea, dizziness, HA, chest is heavy, diarrhea X1 episode, spoke to doctor who stated the symptoms are "normal", clarified if she mentioned the dizziness & heaviness to chest, reported she did and her pcp stated it was again "normal". informed her those reported symptoms should be checked in the ED for potential cardiac events. Caller verbalized understanding.
Itchiness in our ear to our bottom of our feet.; terrible fatigue; Nausea; Headache; we are not doing well; my son got up crying this morning; This is a spontaneous report received from a non-contactable reporter (parents). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, "This was not good for Pfizer they should have people who could concentrate because it was hard for us who had the shot. Reporter had kidney failure from the shot, reporter got chronic fatigue, reporter's son has terrible fatigue, they both have nausea, they both have headache, son got up crying this morning and they are not doing well and if reporter die from the shot reporter wanted to document that they are having adverse drug event from the Pfizer shot. Reporter stated, "This shot made us both very devastated, they have itchiness in ear to bottom of feet." The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
malaise/ moderate malaise; fever of 99 to 100.7/low grade fever of 99 to 100.7; headaches/Headache; fatigue; This is a spontaneous report from a contactable physician via medical information team. A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 11Mar2021 (at the age of 50-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took ibuprofen and experienced allergy to Ibuprofen. On unspecified date, the patient experienced malaise or moderate malaise, fever or lowgrade fever or persistent fever of 99 to 100.7, headache and fatigue. The patient underwent lab tests and procedures which included body temperature: 99 to 100.7 on unspecified date. Reporter asking for guidance for a patient with persistent symptoms following their first vaccination. He inquired how long symptoms may last following vaccination from the first dose. Reporter also stated that he had never seen someone complain of symptoms from a vaccine six days later and wants to ask have we seen anyone who symptoms have persisted six days or more. Adds he had the Moderna vaccine and only had symptoms for a day. Clarifies he had flu like symptoms of one day after the second dose and asking what the criteria for a report is advised caller that we document our patient's experience with our product and anything that occurs after the product is administered may be reported. The outcome of the event's moderate malaise, fever, headache was not recovered and for fatigue outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Mild fever, tiredness and loose bowel which cleared up after 12 hours. Vaccine also seemed to provoke an MS-related response with pain in back, leg spasms and difficulty walking. Symptoms began to clear about 24 hours after onset (36 hours after vaccine injection). First vaccine was tolerated well with only mild and normal side effects (mild cough, soreness at injection site, etc.).
My arm started hurting at 3pm the day of the vaccination  The pain  increased imand went to my shoulder. I was unable to move arms above head without extreme pain.  I couldn't sleep because of pain.  I am still having pain and going to a PT
Nausea, Diarrhea, Extreme muscle soreness, fatigue, muscle aches, etc.  Symptoms were worse on 10/18/11 and are improving, although still not resolved on 10/19/11.
Flat red rash with bumps started on back day after vaccine.  About one week later shoulder and neck pain.  A few days after that chills and fatigue and increased neck pain requiring emergency room visit.  Had fever, elevated BP and decreased  oxygen level with extreme neck pain.  Treated and released with medication.  Negative CT of head and neck.  Next day had extremely swollen uvula and sore throat requiring sleeping elevated to breath.    Throat was not examined in ER night before.  Unable to get up by himself and slept for 27 hrs except for occasional trip to bathroom.  He is recovering now.
Inconsolable crying infant DC DX Abdominal colic Occult trauma excluded Admitting DX vaccination reaction versus occult trauma verus rule out sepsis. HX: Inconsolable cry, status post vaccination on 8/14/06, mom denies fever or any other symptoms, little bit of cough prior to vaccination, no diarrhea, no vomiting, no irritability prior. Did have reduced po intake day before. PE: Irritable, crying, appeared mildly dehydrated. Hospital course: remained afebrile during stay. RX with IV fluids. During stay mom indicated that baby's siblings might have caused some trauma in the baby.
pt recv vax 6FEB98 & had itching, mood swings & irritability beginning on 7FEB98;pt did not see a MD for s/s;itching resolved & mood swings/irritability were resolving;
This case was reported by a nurse via call center representative and described the occurrence of hives in a 2-month-old female patient who received PEDIARIX for prophylaxis. Co-suspect products included ROTATEQ for prophylaxis, PREVNAR 13 for prophylaxis and ACTHIB for prophylaxis. In July 2018, the patient received the 1st dose of PEDIARIX (intramuscular), ROTATEQ, PREVNAR 13 and ACTHIB. In July 2018, less than an hour after receiving PEDIARIX, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to PEDIARIX. Additional details reported as follows: The reporter called from the allergy and asthma consultant office. The patient received vaccination at primary care physician. In mid of July 2018, the patient received the PEDIARIX along with the ROTATEQ, PREVNAR 13 and ACTHIB. The batch number and expiry date were not reported. After vaccination, within 10 minutes the patient broke out in hives. The patient kept at the clinic for a couple of hours and monitored afterwards. The origin of the hives was unknown because several vaccines were given on the same day. The patient's family wanted the patient to undergo skin allergy testing and try to figure out which vaccine the patient was reacted to, before the patient received her 4 month vaccines. It was reported that, the insurance company would not pay so, the reporter called for allergy physician or allergy and asthma consultant office and tried to get samples or a small batch of PEDIARIX for a skin test.
Rash on face that looked like she broke out in pimples; Rash on face that looked like she broke out in pimples; This is a spontaneous report from a contactable nurse (patient).   A 49-year-old non pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EH9899) in the left arm, on 22Dec2020 at 09:00, at single dose, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included hypothyroidism. No known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID) and bupropion hydrochloride (WELLBUTRIN). On 24Dec2020, the patient experienced rash on face that looked like she broke out in pimples. No treatment was received. The patient recovered from the adverse event on an unspecified date. The patient had not experienced Covid-19 prior vaccination. Post the vaccination, the patient has not been tested for COVID-19.
Pain, mild heat and significant swelling at injection site.  Wheal ~2" in diameter and swelling in the upper arm/deltoid with visible difference from my other arm.
DAD AND 2 CHILDREN CAME INTO THE ROOM FOR COVID-19..A LOT OF NOICE WITH THE KIDS AND TALKING WITH DAD ..SO I LOOK AT THE BIRTH DATE OF SISTER AND NOT THE PATIENT  ..SHOW 12 YEAR OLD AND GAVE THE ADULT DOSE..AFTER GOING BACK TO THE PHARMACY NOTICE THAT THAT THE BIRTHDATE I LOOK AT WAS THE SISTER AND  NOT THE PATIENT..CALL MOM AND DISCUSS THE PROBLEM..MOM WAS VERY UNDERSTANDING AND THANKUS FOR CALLING HER,,SHE REPEATED THAT SHE WAS SORRY ..TOO BUSY AND THE KIDS WERE ONLY BEING KIDS..
Pt recv vax on 10/27/98; on same day pt exp swollen, tender, warm LA, fever, chills, sweat; tx=Prednisone & ice pack to area
Moderna COVID-19 Vaccine EUA Symptoms:  100.2 fever, chills, total body aches, extreme fatigue, mild nausea (no vomiting), lack of appetite.  Could not sleep on left side due to pain, swelling at the injection site.  Treatment:  Dr. recommended Tylenol or Advil.  I took one  High strength Tylenol at 11:00 AM and an Advil at 8:30 PM when I went to bed.  Duration:  Symptoms began at 2:00 AM (14 hours after injection) but subsided that night.  I felt great the next morning.
first dose on Feb. 23, 2022, second dose on March 25, 2022; This case was reported by a nurse via sales rep and described the occurrence of drug dose administration interval too short in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 25th March 2022, the patient received the 2nd dose of Shingrix. On 25th March 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 28-MAR-2022 Reporter's Comment: The patient was approximately 66 years old. The patient received second dose of Shingrix less than 2 months after first dose. The patient got her second dose at a pharmacy, but her first dose from reporter address. The patient denied having any problems or reactions with the second dose, she wanted GlaxoSmithKline to knew she had gotten both doses. The reporter did not consent to follow-up. Connected with medical information via to address nurse question. Additional supportive information: The patient received 2nd dose of Shingrix earlier than the recommended interval, which led to drug dose administration interval too short.
small red welts on outside of arm pits, on breast bone and inside of elbows and very itchy on scrotum
I started with chills a shore arm and a headache and then my pulse kept getting higher to 103 then I counted and it was 120 or something at night. and in the morning I still had it, I was concerned about the clotting issue but the racing heart was making  I should  get checked out. So I went to the ER. It's been 12 hours of my heart going that fast.  they gave me a liter of fluid.
Woke up to visible swelling along my collar bone, it felt like lumps under the skin. The area was also tender to the touch. Went to urgent care and was told my lymph nodes were very swollen there. Now experiencing swollen lymph nodes on my left arm and possibly leg. Trying to get in to see my primary care doctor, but I have not seen her yet.
This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received first dose of BNT162B2 (solution for injection) via an unspecified route of administration, in left arm on 09Feb2021 (Batch/Lot Number: EN5318; Expiration Date: 31May2021) at single dose for covid-19 immunization. Medical history included diabetes mellitus from 2004. There were no concomitant medications. The patient said yesterday morning he had whelps on his left and right legs with some swelling, also whelps to upper left arm and left elbow. He clarified that he had slight swelling to his legs, with little whelps or hives to his legs and calves. He had done no treatment, though last night before bed he put alcohol, clarified to being Swans 70% rubbing alcohol with a swab where it was itching, it seems to be getting better, it doesn't itch as much. Swans 70% rubbing alcohol LOT: 0501407, EXP Sep2023, UPC: Number. Outcome of itching was recovering, and outcome of other events was unknown.
Muscle aches, chills, fatigue, malaise, anorexia. All started about 14 hours after injection, lessened within 24 hours after injection, fully recovered 36 hours after injection.