chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Attempt to contact patient who has a wrong number listed to advise that 2nd dose was given 6 days to early.  Unable to contact at this time., he has not contacted the LHD to advise of any adverse reactions.
Dizziness, significant diaphoresis, pale skin. Blood pressure 81/50 mmHg. Pharmacist observed patient closely. In approximately 5 minutes, blood pressure returned to normal (125/88 mmHg), color returned, and sweating ceased. Patient reported previous vasovagal response to injections, although not to initial covid vaccination. Patient asked to step outside due to feeling cold, and later left under his own power.
Covid arm on both her left and right arms/Covid arm extends to her hands and fingers; Fingers are swollen; Itching in her fingers; Burning in her fingers; Tingling in her fingers; Numbness in her fingers/Due to the numbness in her fingers the patient is having trouble writing.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Covid arm on both her left and right arms/Covid arm extends to her hands and fingers), PERIPHERAL SWELLING (Fingers are swollen), PRURITUS (Itching in her fingers), BURNING SENSATION (Burning in her fingers) and PARAESTHESIA (Tingling in her fingers) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced VACCINATION COMPLICATION (Covid arm on both her left and right arms/Covid arm extends to her hands and fingers), PERIPHERAL SWELLING (Fingers are swollen), PRURITUS (Itching in her fingers), BURNING SENSATION (Burning in her fingers), PARAESTHESIA (Tingling in her fingers) and HYPOAESTHESIA (Numbness in her fingers/Due to the numbness in her fingers the patient is having trouble writing.). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and TRIAMCINOLONE ACETONIDE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Covid arm on both her left and right arms/Covid arm extends to her hands and fingers), PERIPHERAL SWELLING (Fingers are swollen), PRURITUS (Itching in her fingers), BURNING SENSATION (Burning in her fingers), PARAESTHESIA (Tingling in her fingers) and HYPOAESTHESIA (Numbness in her fingers/Due to the numbness in her fingers the patient is having trouble writing.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.   This case was linked to MOD-2022-485571, MOD-2022-485635, MOD-2022-485155 (Patient Link).
First dose given 01/21/21, 2nd dose February 11th 1:30 pm  Both first and second dose, first dose only soreness at injection site, second dose had soreness, nausea, cramps in stomach, wheezing, fatigued, chills, vomiting,, diarrhea Symptoms have mostly subsided, just a little stomach craming and fatigue
The patient's mom came in on Sat Oct 29th and showed me a picture of her daughter's arm and side where the flu shot had been given. She had a large rash covering her arm and shoulder and the side of her chest. I told her to inform her daughter's doctor of the reaction and that we would record it in her profile also. The mom came back later that day and said she took her daughter to urgent care and it was confirmed she had an allergic reaction to the vaccine.
swollen and sore lymph nodes; swollen and sore lymph nodes; 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 LYMPH NODE PAIN (swollen and sore lymph nodes) and LYMPHADENOPATHY (swollen and sore lymph nodes) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPH NODE PAIN (swollen and sore lymph nodes) and LYMPHADENOPATHY (swollen and sore lymph nodes). At the time of the report, LYMPH NODE PAIN (swollen and sore lymph nodes) and LYMPHADENOPATHY (swollen and sore lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided
Inability sleep.   Sleeplessness began the night of the vaccine.  I have been unable to sleep more than 30 minutes at a time without waking up.   Still happening 4 days later.
slight headache; chills; fatigue; heaviness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th July 2019, 6 hrs after receiving Shingrix, the patient experienced headache, chills, fatigue and sensation of heaviness. On an unknown date, the outcome of the headache, chills, fatigue and sensation of heaviness were recovering/resolving.   It was unknown if the reporter considered the headache, chills, fatigue and sensation of heaviness to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on left deltoid yesterday, the day of reporting and reported the side effects as noted. The patient reported that the side effects have now resolved and they only lasted for 24 hours. The reporter was consented to follow up. This case has been linked to US2019127871, reported by same reporter.
patient stated after the vaccine, his eyes were swollen very bad, headache and  swelling of the mouth. He did not go to the doctor . It just gone by itself
Tremor in both hands and a jerking of my right shoulder.  Some days the tremors are worse than other days.
Pt presented with a full blown case of varicella, more than 200 lesions covering entire body including inside of mouth and genitals.
Agency user administered dose under age; CDC guidelines followed to vaccinate for second dose; Consent was signed by parent.
Patient reported to pharmacy on 10/24/2019, that she develop bruise in left shoulder area approx. 1.5 in in diameter
pt recvd vax & 2 days later presented self w/some facial swelling convinced that shots had caused this; denies any other sx; instructed to see MD;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 10Oct2022 at 10:45 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "recovered" (Mar2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It was reported that patient had no known allergies. The patient had COVID-19 treatment with Paxlovid from 08Mar2023 to 12Mar2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300118889 Same patient, same reporter, different product, different events;
Left arm swelled at site of injection for 2-3 days then had fever and shortness of breath. This cleared within 24 hours while taking benadryl and tylenol only
Started as fullness and ringing in the ears and now has become severe to debilitating.   Apparently, to date, there are no cures for Tinnitus only cognitive therapy and masking devices.
Patient stated to primary medical office that she received vaccinations 5/19/21 and 6/9/21. States she then had adverse reaction on or about 7/23/21 she began experiencing a change in her vision which has now escalated to feeling that her skin is tingling and the feeling she needs to shake something out of her skin. Also notes change in hernadwriting, more illegible, but no tremors or weakness noted. Feels intermittent electrical type impulses in her pelvis.
Patient returned 11/16/17 for next vaccines. At this visit, she reported no period since at least September, but maybe no period since June or July. Is unsure of dates. Pregnancy test was done, and showed positive for pregnancy. Unknown EDC due to unknown LMP dates. Referred to OB. No patient follow up since that time.
This is a spontaneous report from a contactable pharmacist received via Medical Information Team. A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced worsening control of blood glucose since receiving vaccine on an unspecified date. The patient outcome of the event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of worsening control of blood glucose.  The reported event likely represent intercurrent medical condition.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Abnormal sounding cry, crying consistently, not consolable, after receiving immunization  0n 1/8/09. Had swelling at injection site of DTAP for 1-2 days. Cried for 31/2 hours. Seen in ER, given TYLENOL, observed and sent home.
PATIENT RECEIVED A DOSE OF PFIZER BOOSTER PAST BUD. SPOKE TO HIS SON, PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AND AWARE TO SCHEDULE TO GET RE-VACCINATED
area was slightly warm; area was tender, achiness in the right deltoid; area was pink; area was swollen; small swollen lymph nodes; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (area was slightly warm), VACCINATION SITE PAIN (area was tender, achiness in the right deltoid), VACCINATION SITE ERYTHEMA (area was pink), VACCINATION SITE SWELLING (area was swollen) and VACCINATION SITE LYMPHADENOPATHY (small swollen lymph nodes) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE WARMTH (area was slightly warm), VACCINATION SITE PAIN (area was tender, achiness in the right deltoid), VACCINATION SITE ERYTHEMA (area was pink), VACCINATION SITE SWELLING (area was swollen) and VACCINATION SITE LYMPHADENOPATHY (small swollen lymph nodes). At the time of the report, VACCINATION SITE WARMTH (area was slightly warm), VACCINATION SITE PAIN (area was tender, achiness in the right deltoid), VACCINATION SITE ERYTHEMA (area was pink), VACCINATION SITE SWELLING (area was swollen) and VACCINATION SITE LYMPHADENOPATHY (small swollen lymph nodes) outcome was unknown.        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.   No relevant concomitant medications were reported.  Treatment information reported was antibiotic and two topical ointments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This patient had extreme continuous pain in his joints and limbs. She has tried various prescription medications to reduce the pain, but so far nothing seems to be working. The patient no longer had active life is now controlled by pain. For the 60 day follow-up pt states," I still have very bad pain resulting from the 2nd vaccination on 07/10/1999. I have tried many medications but so far nothing helps. It has comletely changed my life in a negatve way. In Doc 213373, annual follow up patient states the following: "I have pain throughought my body and it has increased in intensity. It is constant, residing in the joints and muscles, and so far. No medication seems to help much. Living hell! I am afraid that the pain will keep getting worse. I can barely stand it now. I hope that someone is studying this problem to find out how to reduce the pain and reverse the damage". 7/26/02 Per correspondence from patient, his MRI indicates "severe demyelination of the brain".
Chills and fever as well as severe fatigue developed approximately 12 hours after receiving the vaccine. A pounding headache, joint pains and muscle soreness over entire body followed shortly afterwards. Fever and chills ended approximately 10am the following morning, headache and joint pain lasted until approximately 3pm the day after the shot, and muscle soreness and fatigue lasted through the day and was gone the next morning (5/30).
Left arm hurting at site of injection; left arm swelling; half dollar size/quarter size redness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm swelling), ERYTHEMA (half dollar size/quarter size redness) and VACCINATION SITE PAIN (Left arm hurting at site of injection) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced PERIPHERAL SWELLING (left arm swelling) and ERYTHEMA (half dollar size/quarter size redness). On 01-Aug-2021, the patient experienced VACCINATION SITE PAIN (Left arm hurting at site of injection). In June 2021, PERIPHERAL SWELLING (left arm swelling) and ERYTHEMA (half dollar size/quarter size redness) had resolved. At the time of the report, VACCINATION SITE PAIN (Left arm hurting at site of injection) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant information was provided.  The patient reported arm swelling and redness got better prior to his second injection. The patient reported hurting in left arm at injection site goes down to muscle when he pressed down about an inch.  The patient had not taken anything for treatment.
Shot was given around 11:30 AM. Didn't notice arm swollen until evening. Was sleeping hrs. after shot. From elbow to shoulder was the size of my calf on leg. No pain. Next morning couldn't breathe. Went to E.R., took x-rays, monitor heart and pressure HIGH! Shot is on back of arm, move towards shoulder. Shot might have hit a vein?
Patient reported: fever greater than 101, redness itching at injection site, flushing, generalized body aches, headache. Was seen in emergency department, not in physician's office.
Patient was sitting in observation and felt tingling in throat and feels anxious. Taken to EMS room for observation. No swelling to face, tongue, or throat.
Pfizer 3/15 and 4/5. Positive on 9/10
Pt recvd 1s Engerix-B vax on 21MAY91 & 45 min post inject exp itching & hives from site of inject to upper middle back; treated in ER w/DPH; MD suggested allergic to Thimerosal;
Vaccines given 12-7-07.  1 week later (presumably unrelated) patient developed cough, runny nose.  12-17-07, office visit.  Bronchiolitis, Otitis media, fever.  In office: Febrile seizure.  Lasted less than 1 minute.  Recovered fully.
RECEIVED J&J/JANSEN INJECTION ON 3/09/21.  WHEN I WOKE UP THE NEXT MORNING MY LEFT KNEE WAS VERY SWOLLEN AND PAINFUL. I DID ICIING/HEAT, STRETCHING AND MOTRIM WITH ELEVATION. ON 3/21/21 I WENT TO URGENT CARE BECAUSE MY KNEE WAS STILL HURTING. THEY GAVE MY A X-RAY (JUST SHOWED EFFUSION), KNEE SLEEVE AND SOME MORE MOTRIM. TODAY IS 3/30/21 AND MY KNEE IS STILL IN THE SAME CONDITION.  WENT TO A ORTHO CENTER WERE THEY DRAINED FLUID FROM MY KNEE AND GAVE ME A CORTISONE INJECTION. PREV AND AFTER INJECTION I DID NOT SUFFER ANY INJURIES TO MY KNEE. I'VE NEVER HAD KNEE PROBLEMS
Fever up to 101.4 measured in urgent care office. Lymphadenopathy in the neck was also noted.
2ND DOSE OF VACCINE WAS ADMINISTERED ON DAY 14 AFTER 1ST DOSE.
COVID a year ago Aug2021/caller was asymptomatic/didn't have symptoms; COVID a year ago Aug2021/caller was asymptomatic/didn't have symptoms; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-029797 (Moderna).  A 43-year-old male patient received BNT162b2 (BNT162B2), on 08Jul2021 as dose 1, single (Lot number: EY0586) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset Aug2021, outcome "unknown" and all described as "COVID a year ago Aug2021/caller was asymptomatic/didn't have symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2021) Positive. Therapeutic measures were not taken as a result of drug ineffective, asymptomatic covid-19. Clinical course: Medical History relating to the mentioned AE and both acute and chronic illnesses at the time of vaccination was reported as no complete information for each condition and no allergies (medications, food and other products). No history of Myocarditis/pericarditis. Flu vaccine was received by the patient at the end of 2021. No hospitalization due to COVID-19.
This 12 mo old patient received an adult dose of HAVRIX on Tuesday, May 1st.  No reaction noted or stated.  I called mom on May 4th to follow-up, and she said there were no issues (mom was informed same day the Hep A was given about this dose).
Allergies; This is a spontaneous report received from contactable reporter(s) (Physician) for a Pfizer sponsored program (005570).  A 74 year-old female patient received BNT162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Allergies: Adhesive Bandage" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Allergies: codeine, reaction(s): "Drug allergy". Vaccination history included: Pneumococcal vaccines, for Immunization, reaction(s): "Allergies to vaccine". The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Allergies". The lot number for bnt162b2 was not provided and will be requested during follow up.
This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program.  A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 24Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is a male nursing student. He received COVID vaccine 24Dec2020 and then realized he wasn't going to be available to receive the second dose at his facility until 26Jan2021 and was wondering if it would be too long to wait. He also reported he had a reaction to the 1st dose, a "tiny headache off and on, chills, low energy on 25Dec2020" all of which resolved within approximately 30 hours. He had also heard that the 2nd dose has "worse side effects". The outcome of events tiny headache off and on, chills and low energy was recovered in Dec2020.     Information on the lot/batch number has been requested.
received the Pfizer covid-19 vaccine yesterday 16May2022 and he was tested positive today 17May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID: (159558).  A 10-year-old male patient received BNT162b2 (BNT162B2), on 16May2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 17May2022, outcome "unknown", described as "received the Pfizer covid-19 vaccine yesterday 16May2022 and he was tested positive today 17May2022". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Product Description: Compound bnt162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1 pediatric. NDC number, UPC number and Expiry Date of COVID-19 Vaccine were Unknown. The reporter, (name withheld) said that her 10-year-old grandson received the Pfizer covid-19 vaccine yesterday 16May2022 and he was tested positive today 17May2022. The reporter didn't specify if it's the first or the second dose of the Pfizer covid-19 vaccine. Description of Product Complaint: Transferring agent stated, "I have a caller on the other line. She said that her grandson 10 years of age received the vaccine, the Pfizer COVID-19 Vaccine yesterday and today her grandson tested positive to COVID-19."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 13-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time of the first time was 80 hour with the lowest recorded temperature of 30 Fahrenheit degree. The total cumulative excursion time of the second time was 248 hours with the highest recorded temperature of 47 Fahrenheit degree. The total cumulative excursion time of the third time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The total cumulative excursion time of the fourth time was 1172 hours with the highest recorded temperature of -3 Celsius degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Went in to AFIB requiring conversion in ER on 05/10/2021 early AM
Fever of 101*, sweats, chills, general body fatigue and myalgias. Large erythematous rash to injection site that is warm and painful.