chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Pfizer Vaccine #1 at the facility on 3/26/21. Approx 5 minutes after receiving the Vaccine, patient reported not feeling well. Complaint of dizziness. Then reported her tongue and throat didn?t feel right and then proceeded to report her throat was tightening up. Administered Benadryl 50mg PO and almost immediately patient reported feeling relief. She was monitored for an additional 30 minutes after improvement of symptoms and stated she felt well enough to go home. Her friend accompanied her to the vaccine site and was driving her home.
Information has been received from a nurse concerning a male who was vaccinated with a dose of VARIVAX (Merck). The patient experienced a serious local reaction and his arm blow up quite larger after receiving the dose of VARIVAX (Merck). The patient sought medical attention through a physician. The patient recovered. Additional information has been requested.
Arm of injection Numbness tingling aches pains in muscle and joint, with racing heart at times.
Enlarged lymph node, axillary, ipsilateral to vaccine administration site. 10.5 cm (4.0+ inches). Tender. Mobile.; This is a spontaneous report from a contactable physician.    A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 05Sep2021 12:45 (Lot Number: FE3592) as dose number unknown, single (at the age of 53 years old) for COVID-19 immunisation. Medical history included hypercholesterolaemia, no allergies. Concomitant medications were not reported. On 07Sep2021 02:00, the patient experienced enlarged lymph node, axillary, ipsilateral to vaccine administration site. 10.5 cm (4.0+ inches). Tender. Mobile. The outcome of the events was not recovered. No treatment required. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The event lymphadenopathy was considered related to suspect drug based on temporal association and known safety profile of the drug.   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 RAs, Ethics Committees, and Investigators, as appropriate
Sore Arm; Elevated temp from normal; Body Aches; Fatigue; Cold chills; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Sore Arm), PYREXIA (Elevated temp from normal), MYALGIA (Body Aches), FATIGUE (Fatigue) and CHILLS (Cold chills) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, Pre-diabetic (Borderline) and Drug allergy (Augmentin). Concomitant products included THYROID (ARMOUR THYROID), CETIRIZINE HYDROCHLORIDE, CYANOCOBALAMIN (VITAMIN B12), ZINC, IODINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), IBUPROFEN (ADVIL [IBUPROFEN]), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.   On 23-Dec-2020 at 2:38 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Dec-2020 at 11:59 PM, the patient experienced VACCINATION SITE PAIN (Sore Arm), PYREXIA (Elevated temp from normal), MYALGIA (Body Aches), FATIGUE (Fatigue) and CHILLS (Cold chills). At the time of the report, VACCINATION SITE PAIN (Sore Arm), PYREXIA (Elevated temp from normal), MYALGIA (Body Aches), FATIGUE (Fatigue) and CHILLS (Cold chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-050544 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: Follow-up information provided second dose therapy date. On 11-May-2021: Outcome of the event is updated.Dose-2 information is added.; 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 case concerns a 34 year old male subject with a medical history of hypothyroidism, borderline pre-diabetic, and Augmentin allergy, who experienced the listed events of body aches, sore arm, fatigue, cold chills, and elevated temp from normal. The events occurred  on the same day after receiving the first dose of IP. The event´s outcome are unknown. The reporter did not provide the causality assessment. The events were considered possibly related to IP. Further clarification is required.
1 week following H1N1 injection, noted diffuse joint pain, has progressed to fatigue, cognitive defects, extremity tingling, dyspnea, low blood pressure / pre-syncope.
Pain, redness, swelling in arm injection site swelling in hands, feet & ankles  Red rash on legs, severe headache Severe dizziness (Fell in bathroom)  Weakness in knees (I have arthritis) Diarrhea, Dark urine, loss of appetite Lack of energy. Lasted four days. Rash lasted one week.
Tdap given to an infant on 07/14/2023.   Tdap is indicated for ages 7 and above.  The patient was not in the age range indicated for Tdap.   Patient should've gotten pediarix.  I called parent.  Child had a fever and no other symptom.  Mother came in with child to be revaccinated with the correct vaccine (Pediarix) on 08/11/2023.
The patient started experiencing nausea/vomiting about 24 hours after vaccination. This was accompanied by abdominal pain. The patient was told to go to urgent care if it continues.
Patient complained of fever, cough, flu-like symptoms, and softball size redness and swelling of arm which lasted 48-52 hours
Onset diffuse papular rash 24 hours after flu vaccine (Evans # 765670) given.
Patient WI clinic c/o pain Rt upper arm pain after receiving Tdap and Flu vaccine for 2 days. RN assess site with clinic supervisor NO Redness no swelling no hot to touch noted, after shot instruction given with cold pack to use at pain site.
it was rpt pt vax & on 7/23/98 pt presented w/approximately 4-5 varicella like lesions. MD felt skin lesions were not related to therapy w/varicella
Tuesday 1PM lt arm burning sensation from shoulder to finger tip-large swelling & much pain;felt feverish w/chills did not take temp
Maybe this is not what is qualified as "adverse", but  i have not been able to get out of bed, eat, or do anything but sleep for 2 days.  Runny nose and stuffed up sinuses, low grade temp not above 100.5.  Muscle aches  It is now almost 6 pm Sunday.  I think I can eat some soup now.  Temp is gone  I think I'm recovering.
Patient received 2nd Pfizer Covid 19 vaccine dose. Patient was showing no symptoms directly after vaccine and entered pharmacy lobby. Patient was walking with sibling and fainted, falling and hit her face damaging teeth
On 2/28/2023 I just phoned my physician because of my age and hypertension and said that i had a positive COVID-19 test. He said that he could treat it or prescribe Paxlovid and I chose to take the Paxlovid.
The patient was diagnosed with cellulitis; the patient reported redness around the injection site; the injection site was red and warmth to touch; This spontaneous report has been received from a medical assistant, concerning to a 55-year-old female patient. The patient was a nurse.  The patient's concurrent conditions included diabetes, sarcoidosis, osteoarthritis, thrombocytopenia, hypertension, reaction to atorvastatin (Muscle cramp, joint pain), reaction to fluoxetine hydrochloride (PROZAC) (nausea), reaction to eszopiclone (LUNESTA) (bad dreams) and reaction to dapaglifozin (FARXIGA) (nausea). The patient's concomitant medications included glimepiride, magnesium (unspecified), tramadol hydrochloride, lisinopril, bupropion hydrochloride (WELLBUTRIN), metformin and naproxen.  On 13-AUG-2019, the patient received a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml administered once, intramuscularly on the left arm (lot#: S009237, expiration date: 22-DEC-2020) for prophylaxis (indication also reported as pneumonia prevention).  On 14-AUG-2019, the patient experienced redness around the injection site (injection site redness); the patient sought medical attention and after a further examination by a provider, it was determined that the injection site was red and warm to touch (injection site warmth) and the area or redness was about 4 inches, coming down the upper left arm and going to the inner left arm. On the same day, the patient was also diagnosed with cellulitis and she was started on therapy with prednisone 10mg, 6 tablets daily, as treatment for the events. On 15-AUG-2019, the patient received prednisone 10 mg, 5 tablets daily. On 16-AUG-2019, the patient received prednisone 10 mg, 4 tablets daily. On 17-AUG-2019, the patient received prednisone 10 mg, 3 tablets daily. On 18-AUG-2019, the patient received prednisone 10 mg, 2 tablets daily. On 19-AUG-2019, the patient received prednisone 10 mg, 1 tablet daily, and then, the prednisone was discontinued. On an unspecified day in August 2019, the patient was recovered from the events of cellulitis, injection site redness and injection site warmth.  The causal relationship between the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and the events of cellulitis, injection site redness and injection site warmth was unknown.  Upon internal review, the event of cellulitis was considered to be medically significant.
Information has been received from a consumer and follow up information has been received from the physician concerning a 26 year old female who on 11/19/02 was vaccinated with penumococcal vaccine 23 polyvalent (lot # 644104/0873M). There were no concomitant medications and the patient had no known drug allergies. According to the physician, the patient had never received the pneumococcal vaccine 23 polyvalent prior to this one. The patient was well at the time of vaccination on 11/19/02. On 11/22/02 the patient developed severe cellulitis of the arms going to the neck beginning at the injection site. The patient was hospitalized on 11/22/02. The patient was treated with antibiotics (ampicillin sodium (+) sulbactam sodium (Unasyn) and clindamycin) and was referred to an infectious disease specialist. The patient was discharged from the hospital and has since recovered from severe cellulitis. The reporter expressed a concern regarding the lot number. *F/UP report on 12/23/02: The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. Add'l info. is not expected.*
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patients "may" had received unspecified doses of MMR II injection (dose, route of administration, expiration date and indication were not reported) that had been exposed to light. No adverse effects were reported. Additional information has been requested.
Post vax the patient experienced vesicular eruptions, erythema, warmth and induration  at the injection site, a mild headache, myalgia and a low grade fever.
threw up; bad headache; became very tired after the shot; This is a spontaneous report received from a contactable consumer. The reporter is the parent.  A 23-year-old female patient (unknown if pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 22Mar2021 11:00 (Batch/Lot number: unknown) at the age of 23 years as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 22Mar2021, outcome "unknown", described as "became very tired after the shot"; HEADACHE (non-serious) with onset 22Mar2021 17:00, outcome "unknown", described as "bad headache"; VOMITING (non-serious) with onset 23Mar2021 13:30, outcome "unknown", described as "threw up". Therapeutic measures were not taken as a result of fatigue, headache, vomiting.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient called her parent at 14:48 and said she was tired and was going to go to sleep. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
panic attack; tiredness; thirsty; throat and tongue completely dry; Fever 100.4; throat and tongue completely dry; itchiness, not sure if that is brought by anxiety/itching on face and arms; turned red from top of the head to waist/redness /solid bright red; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution injection; Batch/Lot Number: EN6206; Expiration Date: 21Jun2021), via an unspecified route of administration, administered in Arm Left on 09Mar2021 at 13:20 as single dose for covid-19 immunisation. Medical history included highly allergic to Iodine, type 2 diabetes mellitus and she had two aortic stents in place. She stopped smoking in 2016. Concomitant medication included levothyroxine sodium taken for thyroid disorder from 2017 and ongoing. The patient previously took iodine and experienced drug hypersensitivity. Patient did not receive any vaccinations within four weeks prior to the first administration date of the suspect vaccine. After vaccination, patient experienced a reaction. She was not sure if it was considered an allergic reaction. Caller stated she is highly allergic to Iodine and they asked that she stay 30 minutes instead of 15 minutes after the shot for monitoring. Caller stated she waited the 30 minutes and got up and felt fine. Caller stated she was very thirsty, her throat and tongue were completely dry. She got up and went to the pharmacy because it was the closest place for her to get a bottle of water. Caller stated that the thirst and dryness went away right after drinking some water. Caller within 30 minutes of leaving where she got the shot, she turned red from the top of her head to her waist, she turned bright red on her arms, chest and face. She had itching on her face and arms. She kept scratching her face. Caller stated she is not sure the itching is due to her anxiety about the situation or the Pfizer COVID-19 vaccine. Caller stated she had a fever of 100.4. She came home took Zyrtec and Tylenol and the fever came down immediately and the redness lasted approximately 45 more minutes and then it went away. The next day on 10Mar2021, she was just tired, and she went to bed in the middle of the day and slept for 6 hours. She had a little bit of scratching, but she thought it was more from the anxiety of the circumstance. She did not have welts, she was just solid bright red. Caller stated that she was scheduled to get her second shot today at 1320 and was almost into a panic attack about having another one. She was concerned since reactions get worse, not better. She can deal with the fatigue and fever, she just does not want to have problems breathing. The outcome all the events was recovered on 09Mar2021. The outcome of the event tiredness was recovered on 10Mar2021.  No follow-up attempts are possible. No further information is expected.
Immediately following injection patient developed painful numbness in her right 3rd, 4th and 5th digits.
No additional adverse event; Expired product administered; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 06-JAN-2023, the patient was vaccinated with an expired dose of Hepatitis B Vaccine (Recombinant) thimerosal free (RECOMBIVAX HB) intramuscular injection (lot number U019135 has been verified to be valid; expiration date reported and established as 22-NOV-2022) (expired product administered) (strength, dose, route of administration, and anatomical location were not provided). No additional adverse event had occurred.
pain lt chest; SOB started 6 hrs p/DT booster; evaluated for cardiac disease;
Extreme pain in shoulders, hips, wrists, and neck. Treated with Percocet 5mg, masked pain temporarily. Incapacitated patient. Worsened with time, diagnosed with Polymyalgia Rheumatica, treatment 60mg Prednisone.
No additional AE/no PQCs; Nurse reported VARIVAX was administered after TE; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 21-SEP-2023, the patient was vaccinated with a varicella virus vaccine live (oka/merck) (VARIVAX) injection after it had suffered a temperature excursion (product storage error) (lot number W025274 has been determined to be valid for varicella virus vaccine live (oka/merck) (VARIVAX), with an expiration date established as 10-AUG-2024), administered for prophylaxis (strength, and anatomical site of administration were not provided). The temperature excursion took place within a timeframe of 3 hours at a temperature of 8.1 Fahrenheit (F). No adverse events were reported for this patient.
Pt was given second dose of Shingrix prior to 2-6 month recommendation. It was given 32 days after first dose. Staff called GSK on 10-23-19 and was told that any Shingrix given less than 4 weeks is invalid. They recommended calling the CDC to verify if the second shot was valid over 4 weeks. Staff then called the CDC and was told that any shot given past 4 weeks is valid. Pt was told that shots were both effective. He did not have any side effects as of 10-23-19 approximately 1pm.
My WBC is low today / had my 2nd Shingrix / on Monday; This case was reported by a consumer via interactive digital media and described the occurrence of white blood cell decreased in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th June 2021, the patient received the 2nd dose of Shingrix. On 18th June 2021, 4 days after receiving Shingrix, the patient experienced white blood cell decreased. On an unknown date, the outcome of the white blood cell decreased was unknown.   It was unknown if the reporter considered the white blood cell decreased to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient had received  2nd dose of Shingrix dose on monday and today experienced white blood cells low. The reporter stated that, if the low WBC could be related to shingrix.
11/5/03 Pain right kidney spreading midsection front and back. Skull felt on fire; front chest pressure. 11/7/03 ED; told injection from flu shot; week in hospital.  No pain.  11/15 back home. 11/16 ED; testing done; nothing found. So question flu shot. The discharge summary state myalgia and gastric erosion. Annual follow up on 02/10/04: "Pt has recovered from adverse events."
burning sensation on my upper back; prickly feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jul2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Jul2021, for COVID-19 Immunization, reaction(s): "burning sensation on my upper back", "prickly feeling". The following information was reported: BACK PAIN (non-serious), outcome "not recovered", described as "burning sensation on my upper back"; PARAESTHESIA (non-serious), outcome "not recovered", described as "prickly feeling".  Additional information: Since the patient received the COVID-19 vaccine (two doses back in Jul2021), they felt a burning sensation of their upper back, all the way across from shoulder to shoulder, with a prickly feeling. The skin did not feel hot to the touch. This happens numerous times each day. It lasts around 20 seconds.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s): PFIZER INC-PV202200116510 same reporter/patient/drug/events, different dose;
12 hrs post vax pt exp pain in arm & middle heart area; rash on lt arm anticubital fossa moving to rt; sl discomfort still in inject area & chest;
Since the shot on 3/30, it was a bit itchy starting on a Friday 4/2 then some redness  over the weekend and by Sunday  overnight, I woke up with large  red lesion around the injection site. It has firmness but not painful.
Developed redness, tenderness and swelling of the left arm  Developed 2 weeks following dose Resolved
Herpes zoster-like reaction with serous vesicles and pain to Right side of chest and Right upper arm and wrist.  Received third Anthrax immunization on 1/8/03 and reported to the medical clinic on 2/17/03 with the complaint of possible Anthrax reaction.  Did not have any reaction to previous two Anthrax immunizations on 10/5/02 and 10/23/02.  Did have varicella zoster as a child without complications.  Has not received vaccinia vaccine.
Dizziness, Myalgia, NauseaVomiting, FATIGUE/SHAKY LEGS Narrative:
Allergic reaction - tachycardia, weakness, rash.  Patient sent to outside clinic for further evaluation.
Developed strong tinnitus in left ear, which continues to this day (4/16/21).
On 8/23/15 pt woke up with swelling in (R) hand. He went to acute care and was given a 7 day course of cephalexin.
Had arm discomfort 5 hrs after injection. 11/21/02 noticed redness-slight swelling, pain, warm. 11/22/02 large area of redness and swelling lower 1/2 of upper arm extending to just below elbow (22cm area length). Tx with Rocephin 1gm Im and oral Keflex 500 tid.
very low-grade fever; having side effects; pain is really bothering her; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (having side effects), PAIN (pain is really bothering her) and PYREXIA (very low-grade fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Osteoporosis (broken bones in her foot for osteoporosis).    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced VACCINATION COMPLICATION (having side effects) and PAIN (pain is really bothering her). On 25-Oct-2021, the patient experienced PYREXIA (very low-grade fever). At the time of the report, VACCINATION COMPLICATION (having side effects) and PAIN (pain is really bothering her) had not resolved and PYREXIA (very low-grade fever) outcome was unknown.            No treatment medications were provided by the reporter.  Patient reported that usually takes ibuprofen for arthritis. Patient had broken bones in her foot for osteoporosis and the pain was really bothering her.   This case was linked to MOD-2021-364277 (Patient Link).   Reporter did not allow further contact