chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26F(Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding an unknown age and gender (previously reported as child), patient with no pertinent medical history reported. On 13-SEP-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). On 11-FEB-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Patient was given a dose of the Pfizer vaccine that was not yet constituted.  She was given 0.3 ml of unconstituted vaccine.  We became aware immediately after it was administered and had her remain in the clinic under observation for 40 minutes.  Patient did not display any discomfort and reported feeling fine.
patient experienced some normal post vaccine side effects (fever, aches) the day after her vaccine; however, she also experienced tachycardia (HR =120) the day after the vaccine as well. she has had trouble with heart palpitations since.
Moderna COVID-19 Vaccine, redness/itchiness/knot/heat from injection site. Feeling extremely tired,  thirsty, body aches (head to toes), dizziness, headaches.
get a shingles shot because they didn't think he had gotten his second one but he had / now he had 3.; This case was reported by a consumer and described the occurrence of extra dose administered in a 52-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date) and Shingles vaccine (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient was administered with 3rd dose of Shingles vaccine, which leads to extra dose administered. The physician did not think that the patient had gotten his 2nd dose, but he already received, so they had the patient to get a Shingles vaccine (3rd) dose. The reporter asked was that a problem, as the patient received 3 doses.
This spontaneous report was received from health business professional (HBP) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-MAR-2023, the patient was vaccinated with expired dose of PROQUAD recombinant human albumin (rHA) subcutaneous injection, lot #U029296, expiration date: 19-MAR-2023, administered for prophylaxis (strength, dose, and route of administration were not provided) (expired product administered). There was no adverse event reported.
Fever of 102.5, chills, rigors, and nausea starting 12 hours after the injection lasting 24 hours
Pt is a 34 y.o. female with PMH significant for HIV not on treatment, bipolar disorder, schizoaffective disorder presented to hospital due to generalized lethargy/myagia with fever and cough. Noted to be hypotensive on initial presentation and was started on empiric antibiotics coverage for potential sepsis. COVID-19 Positive   Constitutional: Positive for chills, fatigue and fever.  HENT: Negative for congestion.   Eyes: Negative for visual disturbance.  Respiratory: Positive for cough. Negative for shortness of breath.  #COVID-19 infection  - Febrile and tachycardic on presentation with cough, fever and general malaise, but not hypoxic, good saturation on room air. - Unknown onset date of symptoms. - COVID PCR 9/22/21. - Blood cultures in lab.   -Inflammatory markers are low. - Per chart reviewed, patient received J-J vaccine a month before.  - Chest X ray without consolidations. - Not a Candidate for remdesivir or dexamethasone at the time. - Not a candidate for Barcitinib at this time.   Discharge Disposition/Condition Disposition: Homeless, tentatively temporary shelter arranged  Condition: Stable (s/sx potential problems absent or manageable)
Day of Vaccination (1/12): immediate headache, fatigue 1/13: Severe fatigue, headache, fever, severe body ache, inflammation where shot was administered (large, red circle - extremely itchy - left arm ) 1/14: fatigue, headache, severe body ache, rash and itching to injection site (left arm) 1/15: fatigue, headache  1/19: rash to upper left arm, extremely itchy 1/20:  rash to upper left arm, extremely itchy
24 hours after vaccination of DTAP, client leg swollen mother states big as her fist, took to ER.  ER MD stated to wait another day.  Took pt to quick care next day 10/02/03, he put client on Biaxin 125mg twice a day and Claritin 5mg 1 z a day.  Mother states child ok today, no swelling 10/06/03.
FEVER, VOMITING. POSITIVE FOR H1N1 INFLUENZA BY PCR AT THE STATE HEALTH DEPARTMENT LABORATORY.
Received shot on 9-11-09 approx 11:00. At 17:00 her temp was 101.4. No sore arm at that time. By 19:00 R arm was swollen. By the next morning R arm was extremely red and tender. Swelling increased throughout Saturday 9-12-09 and fever continued throughout Saturday as well. On Sunday approx 48 hours after shot, fever returned to normal but she felt tired and slightly ill. She took BENADRYL without relief of arm pain and redness. On Monday she was seen at our Health Center around 16:00-R arm is slightly swollen in bicep area. Redness is pronounced and extends to elbow and slightly lower than elbow. R arm is still tender but improving. Redness and warmth are still present but improving. Pt had a cold on Friday 9-11-09 which started on Thursday 9-10-09. Her cold is improving with slight nasal congestion today. C/O infrequent cough.
This spontaneous report as received from a licensed practice nurse refers to 4 unspecified patients of unknown age and gender. The patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (doses, lot numbers and expiration dates were not reported) between 12-MAY-2014 and 30-OCT-2014 (exact dates were not reported). No adverse effects were reported. Additional information is not expected as there is no consent to contact the health professional.
pt recv vax 27JUN97 825AM & 8:35 c/o weakness, limp & pale conscious & talking;no response to inhaling aspirits of ammonia;weak, cold, Bp n ot audible, P60;8:45 BP 70/40, P64;c/o spots a/eyes, numbness of arms;DPH given;8:50 BP 110/70;
Feeling Terrible; 3 inch by 3 inch inflammed rash that is angry red; rash has left her arm yellowish and bluish; very weak and can not get it together; confusion; Can not sleep; losing weight; sore arm, inner and outer elbow area; very tired,complete exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling Terrible), RASH ERYTHEMATOUS (3 inch by 3 inch inflammed rash that is angry red), SKIN DISCOLORATION (rash has left her arm yellowish and bluish), ASTHENIA (very weak and can not get it together) and CONFUSIONAL STATE (confusion) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety. Concomitant products included CLORAZEPATE DIPOTASSIUM (CLORAZEPATE) for Anxiety, PROPRANOLOL for an unknown indication, DESIPRAMINE.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced FEELING ABNORMAL (Feeling Terrible), RASH ERYTHEMATOUS (3 inch by 3 inch inflammed rash that is angry red), SKIN DISCOLORATION (rash has left her arm yellowish and bluish), ASTHENIA (very weak and can not get it together), CONFUSIONAL STATE (confusion), INSOMNIA (Can not sleep), WEIGHT DECREASED (losing weight), MYALGIA (sore arm, inner and outer elbow area) and FATIGUE (very tired,complete exhaustion). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH STOPPING CREAM) for Itching, at an unspecified dose and frequency; CEFALEXIN (CEPHALEXINE) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feeling Terrible), RASH ERYTHEMATOUS (3 inch by 3 inch inflammed rash that is angry red), SKIN DISCOLORATION (rash has left her arm yellowish and bluish), ASTHENIA (very weak and can not get it together), CONFUSIONAL STATE (confusion), INSOMNIA (Can not sleep), WEIGHT DECREASED (losing weight), MYALGIA (sore arm, inner and outer elbow area) and FATIGUE (very tired,complete exhaustion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient taking Desipramine for Sleep
Anaphylaxis & Angioedema Narrative:  Employee reports symptoms of tickling/tingling lips/tongue/throat swelling and right hand tingling, which reported began about 10 minutes after receiving first dose of Moderna vaccine. Patient also reports headaches and body aches. Patient reports use of Epi-Pen when symptoms began. Per report, patient did not go to PCP, hospital, or urgent care. No other medications were reported. No further information provided.
Moderna Bivalent Booster 0.25mcg was given to patient which is only half dose, was to be given 0.5mc g.  Wrong dose given.
Received a booster dose beyond the use date (beyond 30 days at 2-8C).BUD: 12/28/21 Notified manufacturer Moderna & Immunize Manager.
SYMPTOMS: SEVERE HIVES >right/left arm >right/left leg > right/left thigh >buttocks >upper right side shoulder > right/left side of the chest >right top foot  The above outbreak hives symptoms began September 12, 2021 and continue for about seven days. THe hives were treated by benedryl (pill) but unfortunately the symptoms continue progressing. Therefore, I had no choice but to seek medical attention on September 19, 2021 at a HCF. I was seen by ,PA-C and it was confirmed that my outbreak was due to the J&J COVID 19 vaccine.   I am sharing my experience because these severe outbreak caused me to be very emotional and distressed.          T
Pfizer booster dose (3rd dose)  given to patient at 15 years of age. Patient does not meet the minimun age of 16 years for  qualification of Pfizer booster.  Patient had received two previous Pfizer doses, with the second dose on 6/7/21.   No adverse reaction was observed during 25-30 min  after vaccine was administered. Spoke to mother at 6pm; no adverse reaction and not concern regarding the age. Mother wanted the patient get the booster and was aware of the age issue.
Not feeling well; she did not get the 2nd dose yet because it has been more than 6 weeks since she had the 1st dose; Really small red itchy rash marks underneath the skin; Really small red itchy rash marks underneath the skin; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Really small red itchy rash marks underneath the skin), RASH ERYTHEMATOUS (Really small red itchy rash marks underneath the skin), VACCINATION COMPLICATION (Not feeling well) and PRODUCT DOSE OMISSION ISSUE (she did not get the 2nd dose yet because it has been more than 6 weeks since she had the 1st dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C214) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included ASA for Anticoagulant therapy, SIMVASTATIN for Blood cholesterol abnormal, AMLODIPINE for Blood pressure abnormal.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced RASH PRURITIC (Really small red itchy rash marks underneath the skin) and RASH ERYTHEMATOUS (Really small red itchy rash marks underneath the skin). On an unknown date, the patient experienced VACCINATION COMPLICATION (Not feeling well) and PRODUCT DOSE OMISSION ISSUE (she did not get the 2nd dose yet because it has been more than 6 weeks since she had the 1st dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in May 2021 for Rash pruritic and Rash erythematous, at an unspecified dose and frequency. On 30-May-2021, RASH PRURITIC (Really small red itchy rash marks underneath the skin) and RASH ERYTHEMATOUS (Really small red itchy rash marks underneath the skin) had resolved. At the time of the report, VACCINATION COMPLICATION (Not feeling well) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (she did not get the 2nd dose yet because it has been more than 6 weeks since she had the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 25-May-2021, the itchy rash started out from the left arm, then further 1/2 the way from the shoulder (6-7 inches down the arm), and 1/2 the way from the upper chest. The patient reported treatment with diphenhydramine (BENADRYL) cream did not help.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments     Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Additional information received on 02-07-2021 contains significant information. New events are updated.
Severe pain in left scapulae; Chronic left arm pain; Swelling and chronic left armpit pain; Chronic left armpit pain; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6208) via an unspecified route of administration administered in left arm on 12Mar2021 at 05:30 (at 38 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included asthma from an unknown date. The patient had no known allergies. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. There were no concomitant medications. The patient experienced chronic left arm pain, swelling and chronic left armpit pain, and severe pain in left scapulae; all non-serious on 13Mar2021 at 19:30. No treatment received for the events. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
12 hours after injection.  Fever,chills, 99 temp. Vomiting, headache, eye ache, fever 103 24 hours later.  Symptoms lasted 3 days
Patient vaccinated on 4/21/20, developed tenderness,  edema and redness in left leg, and low fever after receiving vaccines.  Seen on 4/24/20 and was already improving, no s/s of cellulites
Swelling in the Right arm that extended to the elbow. The area was warm to the touch. She took OTC NSAID (Ibuprofen). The swelling did get worse so she went to the ER. The ER told her she had cellulitis and prescribed an antibiotic.
This spontaneous report as received from a nurse refers to a female nurse of unknown age. On an unspecified date in October 2013 the patient was vaccinated with a dose of PNEUMOVAX23, injection, (lot#, strength and indication not reported), 0.5 ml, intramuscular. On an unspecified date the patient experienced a rash at the PNEUMOVAX23 injection site and an unspecified, systemic reaction and "had to stay in the hospital for a few days". At the time of reporting, the outcome of events was reported as recovering. Additional information has been requested.
allergic reaction to the cream; it made her sick for a while; was just not feeling well; This is a spontaneous report received from a contactable consumer (Patient). A 56-year-old female patient received first dose of bnt162b2 (BNT162B2, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 29Apr2021 as single dose for covid-19 immunisation. Medical history included ongoing skin cancer. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced allergic reaction to the cream, it made her sick for a while and was just not feeling well. She got her first Pfizer covid vaccine but then she had a lot of stuff come up physically like she has skin cancer and she had an allergic reaction to the cream she was given for it and it made her sick for a while, then she was just not feeling well. Now she felt better and wanted to get the second dose. The outcome of events was unknown.    Information on the lot/batch number has been requested.
OUTSIDE OF GUIDELINESS THIRD PARTY STAFF ADMINISTERED FULL DOSE (0.5ML) OF MODERNA VACCINE INSTEAD OF BOOSTER DOSE (0.25ML)
This case was reported by a physician via sales rep and described the occurrence of feeling unwell in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX, the patient was not feeling well for a few days. The reporter did not agree to receive follow up from GlaxoSmithKline.
Soreness, swelling and redness at site, lasted 4 days. Nausea, chills, and body aches through the first day after the injection.
Information has been received from a company representative concerning a 6-8 month old female who was vaccinated with ROTATEQ.  It was reported that the patient had diarrhea and vomiting after ROTATEQ.  The office was not sure if it was the second or third dose.  "The child was off schedule a little bit."  The patient was hospitalized for an unspecified duration and tested positive for C. difficile.  The mother has an unspecified immunodeficiency disorder and doctors are unsure if the child has it as well.  At this time, it was reported that the patient has not recovered from the events.  No product quality complaint.  Additional information has been requested.
Dizziness, Headache, Fever, Fatigue, Swelling at injection site Narrative:  Other Relevant History:
Between time frame of Nov 1 to Dec 31, 2022 started feeling pain on my left elbow. Doctor recommended to put compression sleeve and put ice and heat on it. Now my right elbow is also hurting.
Patient lost her appetite Friday and began vomiting Saturday morning after receiving the vaccine on Wednesday. She had a low-grade temperature most of the day Saturday (highest was 100.4). Sunday morning vomiting persisted and increased in frequency, plus she was lethargic. We took her to urgent care and receive a prescription for Zofran. She  seemed to improve, but developed diarrhea, then vomited again Tuesday afternoon and the following Wednesday morning. Every bowel movement has been diarrhea the past three days. She still refuses most food and drinks. Her pediatrician suspects it?s a virus, but we wanted to report it.
Staggered around while out of bed to go to john. Collapsed. Did not lose consciousness. Had no strength. Could not pick myself up. Crawled around on floor for an hour or so. Called 911 and emerg. came and took me to hospital. Stayed 3 days no problems found.
Severe Axillary Lymphadenapathy shown in left side, with pain radiating into back and chest. Slight  Axillary Lymphadenapathy shown in right side, tender to touch. Moderate headache treated with ibuprofen.
Immediately after receiving the vaccine, patient reported significant arm pain radiating to the neck on the left side.  She also reported headache and tingling behind the left eye/head. She also reported metallic taste in the mouth. I told her headache was a possible side effect but that if the tingling behind the eye and the neck pain continued, she should be evaluated. She described the neck pain as whiplash-type pain, not shooting like possible nerve pain.  She stayed for 30 minutes and was still having symptoms, so I asked if she needed paramedics. She declined and decided to drive herself to urgent care/ER for further evaluation.
Headache, nausea, muscle aches and pains, joint stiffness began 12 hours following 2nd vaccine and lasted about 36 hours. Tylenol and Aleve did not offer much help. Excedrin in one dose on 12/24/21 offered relief. A second Excedrin was taken 6 hours after first dose. I am prone to stomach ulcers so had to be careful of the Excedrin use. 12/25/21, 3 days post vaccine I was much better but got worse over night. 12/26 4 days post vaccine, I am not well with painful headache to right side of face and neck. I can not get pain control relief.
Normal pain at injection site, but realized she could not lift arm very high, but that went away. She felt lethargic and tired on Friday and Saturday night (4/13 and 4/14 respectively). Come the morning of Sunday 4/15, she took a shower and noticed 4 raised bumps on deltoid of the arm she received the injection. These are almost in a curved line from the injection site, though there is not a raised bump at the injection site. Patient is not upset or mad, just felt the need to tell a healthcare professional about the occurrence and will still get the 2nd dose in the SHINGRIX series.
Patient is a 28 year old male in the observation area presents tingling sensation from right hand that jumped to left arm then to left leg then resolved after 2-3 minutes. Endorsed had the same  No CP, SOB, angioedema, blurry vision, slurry of speech, facial droop. Physical exam unremarkable. Vital signs stable. Neuro intact. Given ED precautions for CP, SOB, angioedema, sudden focal weakness. Sent home stable with resolved symptoms.
Redness, swelling of upper arm. (reporting office received increased number of similar complaints following DTaP during previous week of this report date). Resolved w/out treatment.
had the shots, still got them / suspected vaccination failure; still got them; This case was reported by a consumer  via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had the shots, and still got shingles. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.