chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right eyelid swelling; Eye can still open but painful; This is a spontaneous report from a contactable consumer, the patient. A 23-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 23Mar2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history includes immune thrombocytopenic purpura (reported as ITP) and lupus. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications received within two weeks of vaccination include multivitamins for unspecified indication from an unknown date. On 23Mar2021 at 12:00, the patient experienced right eyelid swelling and eye can still open but it was painful. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of eight eyelid swelling and pain eye was not resolved at the time of this report. No follow-up attempts are needed; information about lot/ batch number cannot be obtained.
Patient presents to the ED on 1/14/22  with a Chief Complaint of Extremity Weakness after receiving covid vaccine 01/12/2022. Per guidelines, all hospitalizations are reported.
Left upper arm pain since injection of flu vaccine 10/22/14. Bursitis in (L) shoulder.
Patient received dose two of Shingrix earlier than the indicated; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) (batch number H25YE, expiry date 4th December 2021) for prophylaxis.   On 24th March 2020, the patient received the 2nd dose of Shingrix. On 24th March 2020, 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 details were received as follows: The age at vaccination was no applicable for this report.  The patient received dose two of Shingrix earlier than the indicated 2 to 6 month time frame. The reporter did not consented to follow up.  HCP notes the patient received dose two one month after dose one. HCP could not provide date of birth of patient.  No additional details were reported.
This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Tested positive for Omicron/tested positive for COVID-19) and DRUG INEFFECTIVE (Tested positive for COVID-19 after completing more than 14 days of second dose) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031BZ1A and 036AZ1A) for COVID-19 vaccination. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced COVID-19 (Tested positive for Omicron/tested positive for COVID-19) and DRUG INEFFECTIVE (Tested positive for COVID-19 after completing more than 14 days of second dose). The patient was treated with MOLNUPIRAVIR (oral) for COVID-19, at a dose of 400 milligram twice a day. At the time of the report, COVID-19 (Tested positive for Omicron/tested positive for COVID-19) had resolved and DRUG INEFFECTIVE (Tested positive for COVID-19 after completing more than 14 days of second dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2022, SARS-CoV-2 test positive: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test negative: negative (Negative) tested negative for COVID-19. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. Patient heard that booster shots should be held for 90 days after antiviral treatments. Patient was recovered and does not have any symptoms, and was tested negative for COVID-19. Company comment: This is a spontaneous case concerning a 44-year-old male patient with no reported medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), more than 9 months after the administration of second dose of mRNA-1273 vaccine. SARS-CoV-2 test was performed with positive result. According to the genomic test, he had the Omicron variant. The patient was treated with Molpunavir (oral) 400 mg twice a day for 5 days. At the time of the report COVID-19 had resolved. Drug ineffective was also captured as an event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: Company comment: This is a spontaneous case concerning a 44-year-old male patient with no reported medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), more than 9 months after the administration of second dose of mRNA-1273 vaccine. SARS-CoV-2 test was performed with positive result. According to the genomic test, he had the Omicron variant. The patient was treated with Molpunavir (oral) 400 mg twice a day for 5 days. At the time of the report COVID-19 had resolved. Drug ineffective was also captured as an event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
3/16/04 started lesion of chickenpox. 2 large but rest were tiny, about 25 on body, slightly itchy, T99-100 degrees, ate well, played.
Muscle aches and pains; Bad headache but getting better; Feeling nauseas; "I wont be able to get the 2nd dose due to a family emergency."; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE ("I wont be able to get the 2nd dose due to a family emergency."), MYALGIA (Muscle aches and pains), HEADACHE (Bad headache but getting better) and NAUSEA (Feeling nauseas) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE ("I wont be able to get the 2nd dose due to a family emergency."). On 30-Apr-2021, the patient experienced MYALGIA (Muscle aches and pains), HEADACHE (Bad headache but getting better) and NAUSEA (Feeling nauseas). On 24-Apr-2021, INTENTIONAL PRODUCT USE ISSUE ("I wont be able to get the 2nd dose due to a family emergency.") had resolved. At the time of the report, MYALGIA (Muscle aches and pains), HEADACHE (Bad headache but getting better) and NAUSEA (Feeling nauseas) outcome was unknown. Not Provided          Concomitant medication was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up received on 03-MAY-2021. (2nd Dose) events added. It contains significant information.
On day 8 i began to have itching at the sight of the injection around noon and then by that evening there was redness and heat to the deltoid area along with itching and tenderness.  The next morning the warmth and induration spread up the deltoid into the shoulder.  I was treated for cellulitis with 1 gram of Rocephin and I am currently on Keflex 750mg bid for 7 days.
Received Flu shot on Friday Sept. 17, 2010 - shot a little low at 5 fingers from (3AT) shoulder and a little lateral. No pain at time of the shot but next morning had pain in shoulder blades down to fingers. Got worse & worse. By Sunday AM went to Urgent Care & sent home with prescription for Ibuprofen. Iced/heating pad. Monday PM went to PCP & put on LYRICA and pain meds. Pain continues went back to PCP on Friday & has appt. for "Accelerated " pain center recovery specialist appt. on Thursday.
Information has been received from a physician concerning a female who was vaccinated with a first and second dose of varicella virus vaccine live (Lot #'s not available) in 1998 and 1999, respectively. On 09/26/03 it was reported that titers were done "recently" and they do not show seroconversion. Unspecified medical attention was sought. There was no prescription drug required.  There was no product quality complaint involved. Additional information has been requested.
Cervical Dystonia, intermittent, favoring right rotation.  Progressively worsened over last several months Neruo exam otherwise normal.
Injection site pain; redness; tiredness; headache; muscle pain; chills; This is a spontaneous report received from a contactable consumer (patient). A 71-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via unspecified route of administration in left arm on 11Mar2021 12:15 PM (at the age of 71-year-old) as 1st dose, single dose for COVID-19 immunisation. Vaccine facility type was reported as doctor's office/urgent care. The patient's medical history included heart attack, thyroid, lupus and COVID prior vaccination. Patient's known allergies were reported as none that she knew off unless you want to include this vaccine (as reported). The patient was taking unspecified concomitant medications administered in two weeks (reported as there was not enough room to list). No other vaccine administered in four weeks. On 11Mar2021 07:00 PM the patient experienced Injection site pain, redness, tiredness, headache, muscle pain and chills. No treatment was received due to the events. The patient was not tested for COVID post vaccination. The outcome of the events was resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Headache fatigue, swollen glands, loose stools, shoulder soreness Narrative:  Other Relevant History:
hit them like a ton of bricks/ maybe it is because they got like 3 shots; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (hit them like a ton of bricks/ maybe it is because they got like 3 shots) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (hit them like a ton of bricks/ maybe it is because they got like 3 shots). At the time of the report, VACCINATION SITE PAIN (hit them like a ton of bricks/ maybe it is because they got like 3 shots) outcome was unknown.            Reporter stated that the doctor had COVID-19 and then 2 shots.  No relevant concomitant medications were reported. No treatment information was provided.
Cold chills, headache, lightheaded, red rash on abdominal area front and back.
pt recvd vax; swelling about size of 50 cents piece & redness around area; lasted 2 days; several fly shots in the past;
Red tiny dimple; Huge oval shape hard (real hard and bony) bump; Burring when touched; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red tiny dimple), VACCINATION SITE SWELLING (Huge oval shape hard (real hard and bony) bump) and VACCINATION SITE PAIN (Burring when touched) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Shingles.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red tiny dimple), VACCINATION SITE SWELLING (Huge oval shape hard (real hard and bony) bump) and VACCINATION SITE PAIN (Burring when touched). At the time of the report, VACCINATION SITE ERYTHEMA (Red tiny dimple) and VACCINATION SITE PAIN (Burring when touched) outcome was unknown and VACCINATION SITE SWELLING (Huge oval shape hard (real hard and bony) bump) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included no  only used (baking soda mixed with water).
18MAR97 pt was taken to ER mom states pt was told it was muscle spasms;19MAR97 pt was taken to MD having dense stare, jerking head, arms arching back, eyes rolling to back of head;
given the adjuvant portion only.; given the adjuvant portion only.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number D4PA4, expiry date 10th February 2023) 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 inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The clinical coordinator reported that, the patient received the adjuvant portion of Shingrix only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021180796, US2021180797, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021180797:same reporter US-GLAXOSMITHKLINE-US2021180796:same reporter
Vial was not gently swirled before dose was withdrawn from vial and then dose was administered. Information says to gently swirl before withdrawing.
got vaccine 18Dec2020.Got COVID infection 30Dec2020; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Dec2020 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included rheumatoid arthritis (RA) from an unknown date, had been off medication since Jan2021, covid-19 from 25Sep2020 to an unknown date. The patient's concomitant medications were not reported.  The patient got vaccine on 18Dec2020 and got COVID infection 30Dec2020, the patient received monoclonal therapy on 05Jan2021 and out of work for over 100 days. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Administered 0.5 ml of Moderna Covid EUA vaccine IM to patient's left arm. Patient went out to waiting room after told to wait 15 minutes before leaving store. Approximately 2 minutes later caregiver and patient approached register and stated patient wasn't feeling well.  Brought patient back into consultation room. Patient was slouching and not responding to questions. "Are you okay" & "Can you sit up" Patient continued to slouch. Administered EpiPen 0.3mg to patients left thigh and called 911. Patient then began to respond to questions. Paramedics showed up and assessed patient. Paramedics took patient to emergency room after their evaluation of patient.
DOA hosp ER 8APR92 AM; death not felt to be vax related;
Back of heel on left leg hurting the same night as of shot, next morning it was very painful. Never had any pain let that.
Patient reports pain and numbness within a week of receiving second shot. Has been seeing physician regarding pain and receiving treatment including medication and physical therapy. Still reports some numbness and pain, but states that he is improving.
going to therapy every week "because of what I saw/Possible AE; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (going to therapy every week "because of what I saw/Possible AE) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (going to therapy every week "because of what I saw/Possible AE). At the time of the report, ADVERSE EVENT (going to therapy every week "because of what I saw/Possible AE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  It was reported as patient was going to therapy every week. No treatment medication information was given.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow up received contains no new information
INCORRECT PRODUCT STORAGE; EXCURSIONS FOR UNPUNCTURED VIALS ADMINISTERED TO PATIENT; This spontaneous report received from a physician concerned a 24 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 216D21A expiry: 06-MAY-2023) dose was not reported, administered on APR-2023 for covid-19 prophylaxis. The drug was associated with Medication error. excursions occurred on 02-JAN-2023: 0.2 C for 15 minutes and 0.4 C for 15 minutes then 1.5 C for 15 minutes then 1.5 C for 15 mins. and on 02-APR-2023: Minimum 0.2 C and maximum 1.5 C for 1 hour total. Age at time of vaccination 24 years old. No concomitant medications were reported. On APR-2023, the patient experienced excursions for unpunctured vials administered to patient. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the excursions for unpunctured vials administered to patient and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked.
approx 2 hrs & 15 mins p/vax pt was ready to take a nap & all 4 extremities shook, actually shook all over x 15 sec; did not become cyanotic or pale; temp nl;
severe edema in lower legs; horrible pain in his lower legs; swelling comes and goes in his feet; redness in his feet; feet are super sensitive to the touch; extreme pain in his lower extremities; he was sick as a dog; woke up in so much pain he was afraid to put his feet on the ground; couldn't push down on the gas pedal in his car; softball sized swelling in his feet; severe nausea; headaches; felt like someone hit him with a 100 mile per hour fast ball the next day, clarified he had pain at his injection site; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 543654.   A 31-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0164), via an unspecified route of administration, administered in left arm on 19Apr2021 09:45 (At the age of 31 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing migraine. Concomitant medications included Aimovig taken for migraine, start and stop date were not reported. The patient was taken to emergency room due to swelling and pain in lower legs. No prior vaccination was taken within 4 weeks. The patient experienced severe nausea and headaches on 21Apr2021, severe edema in lower legs, horrible pain in his lower legs, swelling comes and goes in his feet, redness in his feet, feet are super sensitive to the touch, felt like someone hit him with a 100 mile per hour fast ball the next day, clarified he had pain at his injection site on 20Apr2021, softball sized swelling in his feet on 29Apr2021 with outcome of unknown, woke up in so much pain he was afraid to put his feet on the ground, couldn't push down on the gas pedal in his car on 30Apr2021, extreme pain in his lower extremities and he was sick as a dog on an unspecified date. The patient underwent lab tests and procedures which included blood test: unknown on 28Apr2021, investigation: no blood clots on unspecified date. At the time of reporting the outcome of the events severe nausea, felt like someone hit him with a 100 mile per hour fast ball the next day, clarified he had pain at his injection site, softball sized swelling in his feet, woke up in so much pain he was afraid to put his feet on the ground and couldn't push down on the gas pedal in his car was unknown. For events severe edema in lower legs, horrible pain in his lower legs and extreme pain in his lower extremities was recovering. And for the event headache was recovered. For the events swelling comes and goes in his feet, redness in his feet and feet are super sensitive to touch was not recovered.    No follow-up attempts are possible. No further information is expected.
Complaint of headache after receiving COVID vaccine then lip and face swelling  2 days later. 5 days later complaints of joint redness and warmth at joints.