chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of VAQTA (Concentration, dose and route were not reported), lot # M011116, expiration date 17-JUN-2017. Patients' concomitant therapy was not reported. No adverse effect was reported. A product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax;rt eye getting red & tearing,screamed for a while & then alright;rt eye started twitching & went into a daze then lt leg twitching, non responsive for approx 3 min;rt eye watering;T 102.2to MD;felt poss rxn to pertussis;pt fine
Change in menstrual cycle; Heavier periods/ increase in clot sizes; More frequent periods; Breakthrough bleeding with every cycle since vaccine; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 08Feb2021 at 17:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included contrast media allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included phentermine (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN); all from unknown dates for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the left arm on 18Jan2021 at 18:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. On 01Mar2021, the patient experienced change in menstrual cycle. Heavier, more frequent periods, increase in clot sizes, breakthrough bleeding with every cycle since vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 30Mar2021, the patient underwent SARS-CoV-2 SEROLOGY (COVID 19) AB (IGG), IA (Nasal Swab) and the result was Negative. On 20Apr2021, the patient underwent Lumira Dx SARS-CoV-2 Ag Test (Nasal Swab) and the result was Negative. On 25Apr2021, the patient underwent COVID-19 RT-qPCR test (Other) and the result was Negative. On 11May2021, the patient underwent Lumira Dx SARS-CoV-2 Ag Test (Nasal Swab) and the result was Negative. On 03Jun2021, the patient underwent Lumira Dx SARS-CoV-2 Ag Test (Nasal Swab) and the result was Negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events change in menstrual cycle. Heavier periods/ increase in clot sizes, more frequent periods and Breakthrough bleeding with every cycle since vaccine were not recovered at the time of this report.
CHILLS; FEELING COLD; FEELING TIRED; This spontaneous report received from a consumer concerned a 35 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced chills. On 25-JUN-2021, the subject experienced feeling cold. On 25-JUN-2021, the subject experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, feeling tired, and feeling cold. This report was non-serious. This case, from the same reporter is linked to
Tingling/numb feeling on left side of face only. Forehead, cheek, left eye, left side of my lips.
Red rash, both arms, small hive-like bumps in rash.  Treated with OTC antihistamine.
EXTREMELY swollen, itchy and painful baseball sized bump at injection site. Nausea include. Started with itching and overnight it blew up. It?s been 24 hours and it?s still growing.
According to the recipient, there were rash developed on both side of his body, happened in  one ad half weeks after the vaccination. He was not sure either it's the side effect from the vaccine or they are from his Eczema flare up. The rash was getting better in the 3rd week. The recipient reported the rash on the appointment day  of the 2nd dose.
1/10/2022 around 3:14 woke up with fever, muscle aches, chills, headache and pain at injection site. Continued to wake up about every 2 hours with the same symptoms. Throughout the day the fever vaccilitated between 100.6 and 101.3. Continued to feel all the other symptoms along with fatigue and lack of apatite and nausea with certain foods such as banana chocolate chip pancakes. 1/11/2022 developed pain in right shoulder blade during the night. Still had trouble sleeping. My temperature was 98.6 around 11am and 96.8 by 11pm. No muscle aches or chills by the morning. Fatigue was still there. Lessened pain at injection site. Pain continued in right shoulder blade. Appetite was slightly improved. Around 11am developed a sore throat that comes and goes. Around 4pm started to have a strange cough here and there where it feels like I have pressure on my chest and I just want to cough once to dislodge it. 1/12/2022 around 3pm woke up with stiff pain all the way from the base of my skull to my lower back which has not gone away. I was not able to go back to sleep. The strange cough began again around 7am and continues intermittently.
patient was accidentally given  a booster dose 46 days early from her second covid shot. Upon discovery, the patient was contacted and informed and claims to be fine.
Fever in the 100-102 range persistently for ~24 hours  Significant fatigue lasting more than a day Significant Pain in left arm injection site for 2+ days (no swelling or sign of infection, just bruising and pain) Loss of appetite for >24 hours
the 1st shot made the neck muscle bulge on the left side of my neck, that lasted for 4 months until I received the 2nd shot. After the 2nd shot, the muscle in my neck went away immediately, but then the muscle/nerves in the left shoulder started hurting within minutes of the shot. I still have that pain. I have had a massage, did not help. I went to the chiropractor, that did not help. I went for 2 accupressure treatments, which has helped some, but still not gone.
Day 2- Red, swollen, hot, size of tennis ball. Day 4- same as day 2, with addition of sharp prickly sticks feeling Day arm not as hot, but hot very sensitive to touch. Left ear and throat sore.
Fever; muscle aches; chills; headache & arm hurt.  Took Tylenol to treat; one dose of tylenol took care of most symptoms for the most part but not entirely
Improper dilution of vial resulted in 15 microgram dose.  Mom informed.  Will bring for repeat dose.
I've prior had mild adverse reactions to flu shots where I'd feel slightly ill for a day or so afterwards, but no significant responses to question the initial COVID vaccine. About 3 weeks from receiving the vaccine, I started to develop an intense pain along my left chest/back/and posteriomedial arm which was clinically dx'd as Shingles by my physician. I have physical pictures to detail the areas of effect, but the symptoms remain as significant arm/chest pain with paresthesia along my scapula. Mild nausea and chills are also episodic. Having never exhibited these symptoms and the upcoming date for my second dose (1/27) I'm concerned if this is a trigged immune response which could worsen or prolong with a second dose.
Patient received vaccination at approximately 12:00. Within 10  minutes of receiving vaccination she was faint and neck and chest were turning red. Patient expressed that her heart was racing.  paramedics arrived and transported her to hospital.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWOLLEN TONGUE (Sensation of swollen tongue, nose and throat), PHARYNGEAL SWELLING (Throat swelling), FEELING HOT (body was warm), INJECTED LIMB MOBILITY DECREASED (Could not lift the right arm) and PERIPHERAL COLDNESS (Feet felt frozen for a minute) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced SWOLLEN TONGUE (Sensation of swollen tongue, nose and throat), PHARYNGEAL SWELLING (Throat swelling), FEELING HOT (body was warm), PERIPHERAL COLDNESS (Feet felt frozen for a minute), LIMB DISCOMFORT (Heaviness of arm and neck), TOOTHACHE (Hurting teeth), FEELING ABNORMAL (Heaviness of arm and neck), SENSORY DISTURBANCE (Swish feeling from neck to arm and fingers) and FATIGUE (Fatigue). On 19-Feb-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Could not lift the right arm). On 21-Feb-2021, the patient experienced HEADACHE (Mild headache on and off). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 18-Feb-2021, SENSORY DISTURBANCE (Swish feeling from neck to arm and fingers) had resolved. On 19-Feb-2021, SWOLLEN TONGUE (Sensation of swollen tongue, nose and throat) and PHARYNGEAL SWELLING (Throat swelling) had resolved. On 21-Feb-2021, FEELING HOT (body was warm), INJECTED LIMB MOBILITY DECREASED (Could not lift the right arm), PERIPHERAL COLDNESS (Feet felt frozen for a minute), HEADACHE (Mild headache on and off) and FATIGUE (Fatigue) had resolved. At the time of the report, LIMB DISCOMFORT (Heaviness of arm and neck), TOOTHACHE (Hurting teeth) and FEELING ABNORMAL (Heaviness of arm and neck) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2021: Follow up receive on 04-mar-2021 contains, vaccine route of administration and  anatomical location changed from left arm to right arm, new additional events are added. Treatment medication Ibuprofen added.
received adacel a couple of weeks after the vaccine expired with no reported adverse event; Initial information received on 28-Jul-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 53 years old male patient who experienced received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] a couple of weeks after the vaccine expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Jul-2023, the patient received 0.5 ml of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: C5882AA, Expiry date: 10-May-2023) (Strength: Standard, Frequency: Once) via unknown route in unknown administration site for immunization.  On 07-Jul-2023, the patient received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] a couple of weeks after the vaccine expired with no reported adverse event (expired product administered) (Latency: same day).  It was reported, Physician states that a patient received ADACEL a couple of weeks after the vaccine expired. The vaccine was given on 07Jul2023, and the expiration date of the vaccine was on 10May2023. Physician mentioned that the patient is good fine and does not have any adverse event. Physician did not want to provide information about the patient due to HIPAA. Physician mentioned that he will be seeing the patient on Saturday (28Jul2023) and will talk to patient about redoing the ADACEL vaccine. The physician mentioned that he will make a clinical decision about if the consumer should be taking the ADACEL again or not and mentioned that the patient will be traveling. Physician. This situation is reported as a medication error due to expired vaccine administered.  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Soreness, swelling lymph nodes left  armpit  and a bit of fatigue with second dose.  A bit of fatigue with first dose.
Pt received covid vaccine. Medic reports as soon as she was stuck she started shaking. Pt with husband reports she has anxiety and is on meds. Pt able to talk continues to shake face red. Pt reports she  takes Zoloft  daily . After 15 minute wait pt was talking and laughing Face no longer red of shaking Pt reports she feels fine BP 126/78 HR 78 pt states she will report to MD
Vomiting, nausea, dizziness, double vision, low blood pressure, inability to stand up. Examined by Hospital team, nurses, Drs and including Neurologist
Nausea and chills 1 hour after injection. Vomit x1 6 hours after injection. Fever x2 days (to 101.5 F). 6x6cm raised rash surrounding injection site (8/1/07). Headache on 8/1/07.
Patient was given a 0.1 ml dose of the COVID vaccine rather that the 0.5 mL dose. this was caught by the clinical staff and the patient was revaccinated with a full o.5 mL dose in the opposite arm.
Ct received injections 100pm around 5:30 pm c/o "throat tightening with progression of hives to chest, tunnel vision. Ct used personal epi-pen in route to med facility , then to ER. Given IV fluids and BENADRYL. No further treatment.
Patient's DOB in system did not match patient's DOB on ID. 11-year-old patient vaccinated with Pfizer vaccine. Patient monitored for 30 minutes with EMTs. No adverse reactions. Patient advised to follow up with PCP.
Got light headed around 5. Went in the house and sat down. My vision was blurry for about 45 minutes. And the next day my vision got blurry around 10:00 am for about a half an hour. Then all was good.
Cold; Sore throat; left arm soreness; This case was reported by a consumer via call center representative and described the occurrence of cold in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of pain.   On 18th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th June 2019, 2 hrs after receiving Shingrix, the patient experienced pain in arm. On 21st June 2019, the patient experienced sore throat. On 22nd June 2019, the patient experienced cold. On an unknown date, the outcome of the cold, sore throat and pain in arm were recovered/resolved.   It was unknown if the reporter considered the cold, sore throat and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. The patient had some left arm soreness or achiness, which started about 2 hours after the injection and lasted about 2 to 3 days. The patient stated the soreness or achiness was like when you had a flu vaccine but she did not mention any name of the Flu vaccine she was referring.  3 days after receiving vaccination, the caller also stated that she developed a sore throat and then that weekend ( 4 days after) developed a cold which lasted about 10 days. The caller stated she did not know if the sore throat or cold was related to the vaccine but that her husband was also sick around the same time and when he was sick previously she got his cold as well. The reporter gave consent to follow up.
Pain at injection site. Inflammation, pain in joints, loss of mobility, muscle wasting, weakness, extreme tiredness.
Post vax, the pt experienced an injection site reaction described as "a quarter-sized, red, peeling, itchy and non-raised area." The pt sought unspecified medical treatment. The reporter noted "no reaction with the first dose." Follow-up from a physician indicated that the pt "scratched the vaccination site and it became irritated at the site." On an unspecified date, the pt recovered. No further information is available.
Flue like symtoms; body ache; headache; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flue like symtoms), PAIN (body ache), HEADACHE (headache), CHILLS (Chills) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flue like symtoms), PAIN (body ache), HEADACHE (headache), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, INFLUENZA LIKE ILLNESS (Flue like symtoms), PAIN (body ache), HEADACHE (headache), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient said that she got same symptoms after 3 weeks. No concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-015298 (Patient Link).
Patient placed in room with younger sister who was set to receive Hep B dose, pt was set to receive TDAP. Vaccines switched accidentally and patient given Hep B when not due. Immediately informed provider and patient's guardian. Pt is not at risk of harm from 4th Hep B dose. Given TDAP as ordered in right deltoid. Addressed with patient safety to eliminate room for error in future.
During my case, I felt exhausted and wiped out, my nose was running with sinus congestion, deep cough, and diarrhea. I felt I had the flu and had been hit by a truck. I took an at-home COVID 19 on 09/26/2022 which confirmed my positive assumption. Through an urgent care doctor, I was able to get a prescription for Paxlovid. I didn't even have the energy to drive to the pharmacy to receive my prescription. It took about two weeks after receiving my prescription to finally test negative. I got a follow-up call from the doctor on 09/29/2022, but I didn't have enough energy to talk. I spoke to the endocrinologist the next day but not for long. Since then, I still have breathing issues, brain fog, and floating headaches since then so I'm assuming their long-COVID symptoms. I've also had gastrointestinal issues since then, but I'm not sure if it's correlated to my long-COVID issue.
Another pharmacist used that vial to administer a single dose of the vaccine at 3pm.; The vial was left out at room temperature Sunday night into Monday (16Aug2021); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (The vial was left out at room temperature Sunday night into Monday (16Aug2021)) and EXPIRED PRODUCT ADMINISTERED (Another pharmacist used that vial to administer a single dose of the vaccine at 3pm.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (The vial was left out at room temperature Sunday night into Monday (16Aug2021)). On 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Another pharmacist used that vial to administer a single dose of the vaccine at 3pm.). At the time of the report, PRODUCT STORAGE ERROR (The vial was left out at room temperature Sunday night into Monday (16Aug2021)) and EXPIRED PRODUCT ADMINISTERED (Another pharmacist used that vial to administer a single dose of the vaccine at 3pm.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.  Suspect details included: Manufacture date: 21Apr2021  Original refrigeration date: 14Aug2021 (In freezer/frozen prior to that)  Temperature stored in fridge: 38°F  Stored at room temperature at 2:30p on 15Aug2021.  1st puncture: 15Aug2021 at 2:54pm.  At room temp prior to her getting off work  Left out at room temperature from 2:30pm 15Aug2021 through 3:00pm on Mon 16Aug2021.
"Pfizer-BioNTech COVID-19 Vaccine EUA" Numbing/Tingling sensation on left side of body (i.e., left side of face to corner of mouth, down arm to fingertips and left leg)
Client reports 2-3 hours after receiving Moderna Booster via Left Deltoid that a raised red, swollen "hot to touch" area developed. Symptoms continued and area expanded to include left upper arm deltoid area  to 3 inches above antecubital space. Client reports she is taking Benadryl 25-50mg prn as directed on OTC bottle and applying ice to area several times a day. Client states worst day was Saturday 4/9/22, and symptoms are slowly resolving. Client denies fever, chills, body aches.
Information has been received from a physician concerning a 19 year old female who about two years ago, in approximately 2007 was vaccinated with all three doses of GARDASIL. On an unspecified date, Papanicolaou (PAP) test was performed. Recently, in last two months, approximately November 2009, the patient was diagnosed with "Lsil". At the time of the report, the outcome was reported as not improved. The patient sought unspecified medical attention. Additional information is not expected.
This spontaneous report was received from a pharmacist, via a company representative, concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The pharmacist reported to the company representative that an unspecified patient has been administered ZOSTAVAX three times in the last three years. The pharmacist stated that two of the ZOSTAVAX administrations look place on unspecified dates in recent months. No adverse effects reported.  Additional information has been requested.