chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 15 minutes after injection, patient developed a severe headache, dizziness and swelling of the face with red rash across cheeks and nose.  Profound fatigue - needed to lay down rather than sit up.  Was admitted to the Emergency Room for observation and benadryl IV was administered. Patient experienced the profound fatigue for seven days after the vaccine.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Reporter stated that when the lot number of Moderna Covid-19 vaccine of 010A21A is entered into the expiration date lot number look up finder on Modernatx.com the expiration date was 14-Aug-2021.  Reporter also had a screenshot of the above lot number 010A21A entered into the lot number expiration date look up program on Modernatx.com that shows the expiration date as 14-Oct-2022.The vial did not undergo any temperature excursions.  No treatment information was provided.
I have a poison oak like rash on legs arms back and stomach; This is a spontaneous report from a contactable consumer, the patient. A 64-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 26Apr2021 at 11:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to absolute vodka. The patient did not take any concomitant medication. 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 vaccination. On 26Apr2021, the patient had a poison oak like rash on legs arms back and stomach. She was not sure whether it was from the vaccination or was truly poison oak. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event had a poison oak like rash on legs arms back and stomach was unknown at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Severe pain radiating from left shoulder to left elbow, swelling, fever, difficulty moving left arm, left arm usable again after 24 hrs, afebrile at 48 hrs, 1" dia cold spot at injection site on Left Arm for 6 hrs after onset.  No reaction from vaccine administered to right arm.
gum condition; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient (patient's age: 72; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GINGIVAL DISORDER (non-serious), outcome "unknown", described as "gum condition". Additional information: The patient asked if he could take antibiotics after receiving both BNT162B2 doses, said he has gum condition after dentist appointment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
shingles; other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the pt was treated by healthcare providers for shingles and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue 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, including but not limited to medical losses and costs 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. The outcome of the events shingles and other zoster-related conditions was not recovered. The causality assessment was considered as related by the lawyer.
The next morning after I woke up with a low grade fever, body aches, fatigued and beginned getting chills about 6hrs after I woke up and about 6pm that evening the fever broke and all symptoms subsided
Reports general malaise 101 degree F. temp & numbness and tingling from inj site to jaw. On left side.
Husband reported. Warmth, redness, swelling developed on left arm. Patient did go to work, no other problems.
Severe/ Debilitating Backache; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 17Mar2021 at 14:15 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. No relevant medical history was reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. Concomitant medications included levothyroxine 100 (MANUFACTURER UNKNOWN), simvastatin 20mg (MANUFACTURER UNKNOWN), allopurinol (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unspecified date in Mar2021 at 15:30, the patient experienced severe / debilitating backache. The patient received ibuprofen as a treatment for the adverse event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe / debilitating backache was resolving at the time of this report.   Information about lot number cannot be obtained. No further information is expected.
Headache; This is a spontaneous report from a contactable consumer or other non hcp. A 64-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: E_6198 (Patient was unsure of the second value), expiry date not reported) intramuscular in arm on 02Mar2021 (He had the shot around quarter), as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 02MAR2021, the patient experienced a headache. He said he was experiencing a little bit of headache and that the headache was not as strong as it was before and it was milder then. The outcome of the event was reported as recovering.  No follow-up attempts are possible. No further information is expected.
positive for covid; positive for covid; positive for covid; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. completely excluded.  More information such as laboratory findings on nucleic acid /PCR test needed for meaningful medical assessment.The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID on 20Dec2020. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  More information such as virus genome /nucleic acid detection needed for meaningful medical assessment
Severe chills - fever (100.5) - vomiting - lethargy - mild facial swelling - facial flushing - headache - feeling of restricted breathing.
Patient developed pain and swelling during the night of administration. Arm is currently red, swollen and bruised. Patient took ADVIL & TYLENOL to help.
to ED c/o SOB, already +COVID 10 days prior, already completed azithromycin and steroid pack, using inhaler; +pneumonia; TX: decadron, remdesivir, lovenox, singulair, zinc, O2; d/c'd home on O2 2lpm
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (Lot number, expiry date, route and dose were not reported). The time frame between doses 1 and 2 of GARDASIL was 8 months and the time frame between doses 2 and 3 was 6 months. On an unknown date, the patient experienced condyloma acuminatum, external genital warts. Patient sought medical attention for the same (details unspecified). The outcome of condyloma acuminatum, external genital warts was unknown. Additional information has been requested.
Heart pain,Pounding heart ( Like someone hit the heart and the heart had ~ one minute big pain. This happened around twice a day since ~ Jun. 14th),  feel tired.
FEELING AWFUL; BONE PAIN; JOINT PAIN; FEVER; HEADACHE; FATIGUE; MUSCLE PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced feeling awful, bone pain, joint pain, fever, headache, fatigue, and muscle pain. The action taken with covid-19 vaccine  was not applicable. The patient recovered from feeling awful, bone pain, joint pain, fever, headache, fatigue, and muscle pain. This report was non-serious.
This spontaneous report as received from a nurse refers to a 16 year old female patient (second client). The patient's pertinent medical history was not reported. On 24-APR-2014 the patient was inadvertently vaccinated with Dtap (unspecified), tetanus toxoid (manufacturer unknown) instead of GARDASIL. Reported as staff error only. Nurse states they are unsure which client the vaccine error occurred. For First client, this should had been the client's second dose of GARDASIL. For second client it should have been her first dose of GARDASIL. Both clients were vaccinated on the same day of 24-APR-2014. Nurse stated unsure which client got the Dtap (unspecified), tetanus toxoid (manufacturer unknown) instead of GARDASIL. No adverse effects reported. The outcome of inadvertently vaccinated with Dtap (unspecified), tetanus toxoid (manufacturer unknown) instead of GARDASIL and no adverse effects reported was unknown. This case is linked to 1405USA004705. Additional information is not expected.
Lt arm red, swollen tender whole upper arm w/some induration in 2cm area around the inject site, fever;
Difficulty breathing (cyclical) and dizziness for the first hour or two after injection. Took vitals: my Oxygen Saturation was 95% and heartrate in 90's. It resolved after a couple of hours.
The same night after receiving the vaccine, I developed chills. The next morning, I had major joint pain all over my body in my ankles, knees, and shoulders. By the next couple of days, it became an upper respiratory pain for about two weeks. I scheduled a telehealth appointment and went to my doctor to tell them my symptoms, and they prescribed antibiotics to help reduce the coughing, inflammation, and congestion. I tested negative for COVID-19 and influenza. They diagnosed me with acute upper respiratory infection. As of now using the antibiotics, I'm doing better with a slight delayed and lingering cough still.
9PM 13JUL92 pt taken to ER w/rash on face & body; t99.8 R; had diffuse scattered urticaria; pt acts like they are chilling; irritable; allergic reaction;
Symptoms - ?Patient reports when she woke up around 08:30 am with HA, neck stiffness, fever (Tmax 101.2).  Last day of work and shift - ? unknown, next shift on 2/6 Home remedies? -   motrin at 08:30 Any improvement? ? mild improvement Recommendation?  Patient educated to continue to monitor symptoms at home and to take Motrin and Tylenol as directed in the Medical Directive and to increase fluid intake.  Patient educated to manage her symptoms and to adhere to the Illness in the Workplace Policy.  Patient verbalized back understanding and denied further questions at this time.
Pt had swelling, redness, tenderness at injection site. Reports no trouble breathing, swallowing, non-localized rash = not indicative of allergic reaction. Pt only reports sore throat at time as well (pt thinks due to allergies). Started last night, 6 days after getting shot. Pt went to ER and they apparently told them it was an allergic rxn despite no signs to indicate this. Pt reports that today, next day after it started, that it is starting to improve slightly and that the ER did not actually give her anything.
Extreme Exhaustion,  Body Aches, Headache , Itchy Face and hands sore throat
Patient received booster dose of Moderna (0.25mL) just 91 days after completing her second dose of the series. 180 days (6 months) was not observed.
Post smallpox vaccination  Chest pain of one day duration on day 6,  March 6, 2003  ECHO cardiogram and EKG negative when done day 16March 26, 2003
This spontaneous pregnancy case reported by a consumer, describes the occurrence of pregnancy in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 003A21A) for an unknown indication. The patient's past medical history included asthma, migraine and hypothyroidism. Concomitant products included levothyroxine. On Mar 6, 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. The patient's last menstrual cycle was on Jan 10, 2021 and estimated date of delivery was Oct 17, 2021. On Feb 18, 2021, patient experienced pregnancy. The patient received mRNA-1273 (Moderna COVID-19 vaccine) beginning around the seventh week of the pregnancy. At the time of the report, pregnancy resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Treatment medication taken by patient not provided.
middle of the night awakened by terrible shakes, uncontrollable, feeling very cold. fever of 101.2, brain fog, severe body aches, every joint unable to eat forced myself to drink fluids; anxious and depressed, felt weak and unable to assist my husband who was having adverse effects as well(mobility issues: he fell on the floor and was unable to get up.  I had to call fire department to get him back to be.  Later on he could not reposition himself in bed and I had to do my best to help him. hydration, Tylenol x2 q6 hours, bed rest
Only immediate reaction was pain at the injection site and tingling in the fingers. However, when I awoke at 11:45p my upper arm (in the area surrounding the point of the injection) was itchy, swollen, hard, hot and red.
3 month neurological reaction after her first Covid vaccine; This spontaneous case was reported by a patient and describes the occurrence of NEUROLOGICAL SYMPTOM (3 month neurological reaction after her first Covid vaccine) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Chronic kidney disease and Vascular disorder.    On 14-Jan-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 NEUROLOGICAL SYMPTOM (3 month neurological reaction after her first Covid vaccine). At the time of the report, NEUROLOGICAL SYMPTOM (3 month neurological reaction after her first Covid vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported that patient was not taking the second Covid vaccine due to adverse event. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
precancerous dysplasia; HPV positive/HPV; Chlamydia; This spontaneous report was received from a nurse practitioner concerning her step daughter, a 25 years old female patient. The patient's concurrent conditions included gastrooesophageal reflux disease (GERD), hiatus hernia and haematuria. The patient's medical history included tonsillectomy. Concomitant therapies included unspecified birth control medication, folic acid and dicycloverine hydrochloride (BENTYL).  On an unknown date (reported as when the patient was younger), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (the dose, lot# were not reported; at the route of intramuscular) as prophylaxis.         In 2017, the patient was diagnosed with chlamydial (preferred term: chlamydial infection). In 2019, the patient was diagnosed with chlamydial and Human papillomavirus (HPV) (preferred term: papilloma viral infection). She completed a colposcopy. However, the reporter did not have the records available. The reporter did not know which HPV type which the patient had. However, the reporter was told it was the low risk HPV type. In 2020, the patient had another pap smear and was told she needed another colposcopy. In 2021, the patient was diagnosed with precancerous dysplasia (preferred term: cervical dysplasia) and was advised she would need another colposcopy and possibly a loop electrosurgical excision procedure (LEEP) procedure. No medical attention was sought. The patient had not recovered from all the events. Action taken with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not applicable.   The causality between the quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and all the events was not reported.   Upon internal review, the event of chlamydial infection was considered to be medically significant.
Pt had well baby check up 2/22/10 and administer MMR, VARICELLA, PREVNAR and HEPATITIS A vaccine (Had been seen 2/8/10 for cough, fever  seen 3/2/10 for "URI" low grade temp 100.2 @ home called 3/5/10 - "child with rash "afebrile" ?MMR reaction. called 3/7/10 rash persists - 3/8/10 seen in office.
Day1- headache, achy body, little shorter on breath within 3 hours. That night around 7pm was also getting nauseous and headache turned into migraine. Woke in the middle of the night from a fever, was light headed, passed out trying to walk. Day2- that morning was still feeling all side effects, and threw up. Was very tired, slept until 2 when my fever broke. Rest of the day was just tired, achy from the top of my neck to the base of my spine with an emphasis on my shoulders, very short of breath. Day3- mostly just a headache, mild aches in body
3 day history of pleuritic chest pain, fever, chills, myalgias, arthralgias approximately 9-10 days after smallpox vaccination.
pt recvd vax & began feeling tired 730PM; slept from that time until 5 or 6AM following AM; devel severe abdo cramping @ noon;arm,neck & scapular pain same side, area pain on same side;adv APAP, ice to site; noted blueness, swelling of arm;
After the vaccine, I had fever, chills, fatigue,  and arm soreness. On 9/4/2021,  I woke up at 6:30AM and noticed I could not spit or smile and could not control my mouth  movement.  I also could not close my left eye.   The right side of my face was not affected.  I went to the ER and was diagnosed with Bells Palsey and discharged with antiviral medications and steroids.  I have finished the course of medications.   I am still having symptoms of unable to control the  left side of my face and mouth movement. I am having no trouble swallowing.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 43 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: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210949302, 20210949996, 20210949808, 20210949322, 20210950004, 20210950006 and 20210950120.
Pain in muscles and joints Fatigue Foggy thinking Fever Chills Upset stomache Swollen lymph nodes under left arm and very painful
After extensive review of patient consent form, patient received 1st Moderna COVID19 vaccine dose. Approximately 10 minutes later, patient complained of increased shortness of breath (patient experiences shortness of breath daily) and chest tightness. Pharmacy staff called 911 per patient request, patient was given water, and staff waited with patient until ambulance arrived. Patient was able to communicate and move self to stretcher where EMTs took patient from there.
Information has been received from a physician concerning a female with a history of shingles whose husband was vaccinated with a dose of Zostavas on an unspecified date. Subsequently, shortly after her husband's vaccination, she developed shingles on her face and eye. The patient was sent to an eye doctor for treatment. The patient's husband had no symptoms. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
mom states pt turned pale, eyes rolled back & pt started jerking all over;took to ER & t105;treated by ER MD for sx;seen by MD next day;
On return home after work, patient felt shortness of breath, generalized body aches, and as if torso "was in a vise".  Previous flu vaccines w/o difficulties.  Patient went to Urgent Care.  She was told her symptoms "were probably a reaction to the flu shot", and prescribed ibuprofen 600 mg po tid prn.  A chest x-ray and EKG were done and were WNL per patient.