chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe pain; more hardness at injection site; Redness at injection site; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Severe pain), VACCINATION SITE INDURATION (more hardness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included Vaccination adverse reaction (severe swelling after flu vaccine, yellow fever. And passed out. ) and Osteoporosis. Previously administered products included for an unreported indication: YELLOW FEVER and flu vaccine. Concurrent medical conditions included Contrast media allergy and Lactose intolerant. Concomitant products included TRANEXAMIC ACID (TYRODIN [TRANEXAMIC ACID]) and VITAMINS NOS for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Severe pain), VACCINATION SITE INDURATION (more hardness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). On 16-Mar-2021, VACCINATION SITE PAIN (Severe pain), VACCINATION SITE INDURATION (more hardness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative: negative (Negative) NEGATIVE.         No treatment medication were provided by the reporter Company Comment :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 was linked to MOD-2021-285153 (Patient Link).; 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.
vaccine date 10/26/2020.  Left arm soreness next morning and itching across chest and back and both arms reported to start evening of 10/27. Welts reported on both arms and across chest and back and lower  extremities morning of 10/28 .  Patient reported to physician and was instructed to take diphenhydramine which gave some relief of symptoms.  Patient reports these are similar symptoms that she experiences when she consumes red meat due to tick borne illness.  Patient has received influenza vaccine yearly for many years.
Patient received the three vaccines and within 5 minutes developed fairly severe cramping in lower extremities only while shopping in the store for the monitoring period.  Specifically in the glutes to the point where it was painful to walk and cramping continued after sitting.  Had patient drink an electrolyte drink and sit in our waiting area.  After about 8 to 16 ounces of Gatorade and some rest, around 5 minutes, cramping subsided significantly and he was able to walk normally.  Continued to monitor for another 20 minutes and cramps did not return and no other symptoms developed.
Patient describes child as cry 1 hour then became very sleepy.  Was arousable but very sleepy
No additional adverse effect reported; The patient received the GARDASIL 9 at the age of 63.; Information has been received from a 63 years old female patient referring to herself. The patient's medical history and concomitant medications were not provided.   In January 2020 (reported as second week of January), the patient received 1 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot # and expiration date unknown) for prophylaxis at the age of 63 years (product administered to patient of inappropriate age). Prior to receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient had an unspecified human papilloma virus (HPV) type already. No additional adverse effect was reported.
pt recv vax 7AUG95 & 4-5 days later devel varicella-type vesicles progressed & became assoc w/low grade fever;eye became erythematous & watery;vesicular lesion on eyelid;skins shows >100 dry scabbing lesions;probable viral conjunctivitis
pt exp soreness in arm w/in 1hr p/vax; took APAP;swelling in arm 2hr later;5hr p/vax diff concentrating, malaise, felt hot & pt thought face was feeling puffy;went home 6hr p/vax entire arm & extending to mid back feet swollen;
Hep B #1 vaccine 1 ml given 4-29-14 about 3:30 pm. Presently at work (4-30-14 at 11:20 am) called with complaints of nausea, decreased appetite, not feeling well. No fever.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient called stating she had a lump on her arm at injection site. Stated it was red, raised, very itchy, and warm to the touch. I advised patient to call primary provider as it sounded as though she may have developed cellulitis. Patient stated she had no issues with prior two vaccine doses she received.
Pt fainted and convulsed after HPV and flu vaccine given. Pt hit head against wall, in sitting position, as he was being lowered to lying on the exam table. Vitals taken: 99% O2 sat and HR 68. MD called. MD examined patient. . Pt returned to baseline, neuro exam normal. Provided pt popsicles and apple sauce, which pt tolerated.  Advised to skip hockey practice tonight; OK to go to school tomorrow, per MD.  *Pt should lay down on table for next vaccine/shot. Mom and pt in agreement with plan.
Tested positive for COVID. Fever, chills, rigors, runny nose, headache, fatigue, cough, wheezing, shortness of breath, Chest Pain.
Has rash, itching (patchy red rash) around injection site. Pediatric. 7 am around injection site. Hives. 50 - IM BENADRYL administered
Soreness in same arm as injection; Stiffness in same arm as injection; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 10Apr2021 at 17:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received unspecified medications within 2 weeks of the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 20Apr2021 at 16:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. 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-19 vaccination. On 10Apr2021 at 23:00, the patient experienced soreness and stiffness in same arm as injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event soreness and stiffness in same arm as injection was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
fever; headache; body ache; major fatigue; 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 PYREXIA (fever), HEADACHE (headache), MYALGIA (body ache) and FATIGUE (major fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced PYREXIA (fever) and HEADACHE (headache). 25-May-2021, the patient experienced MYALGIA (body ache) and FATIGUE (major fatigue). At the time of the report, PYREXIA (fever), HEADACHE (headache), MYALGIA (body ache) and FATIGUE (major fatigue) outcome was unknown.            No concomitant and treatment medications were reported.
3/26 temp started of over 100F x3 days, severe ache in every joint, hard to concentrate or remember; on 3/28, started rash all over body so called MD, they did COVID-19 test which was negative; that afternoon, rash went up neck and side of face -went to Urgent Care, had elevated pulse (120 bpm) so did EKG and other tests, got IVs hooked up and provider thought he was having a heart attack so transferred from clinic to ER -received steroids and rash went away almost immediately, determined was not a heart attack, believed instead a side effect from COVID-19 vaccination. lingering effects of fatigue, shortness of breath, ears ringing. now has new diagnosis of asthma and on inhaler.
Sudden on set of Severe joint pain in shoulders,hips,hands,knees,forearm,elbow On going testing ,diagnostics,treatment  Saw family dr & orthopedic specialist both recommend seeing rheumatologist
Received phone call that patient was taken to hospital morning of 10/22/10. Patient presented with numbness in her left arm.
Four months to the day that I completed my Covid Vaccine series, my hair started falling out in massive chunks. I have never had hair thinning or Alopecia before. All blood tests have been ran and there is no other medical reason or event for the Alopecia to have been triggered. The only change in my life was the vaccine. I have never even had Covid. I was diagnosed by my PCP with Alopecia with no other diagnosis and was referred to a dermatologist. My hair has continued to fall out for 10 months. I have lost over 85% of my hair, despite early treatment with oral, topical and injection steroid treatments. I am now taking Methotrexate and folic acid and have some hair regrowth.
First dose of  covid vaccine administered was modern on  07/30/2021. Second dose of covid vaccine administered was Pfizer on 08/27/2021.  no adverse reactions
pt recvd vax 20JUN95 & 24JUN95 pt devel a localized varicella-like rash inside the burn;unk whether pt was exposed to virus prior to vax; No further details were provided;
I had a severe headache like a migraine the night before and then in the morning it was really severe. I couldn't stop throwing up. The night before I took the butalb-acetamin-caff. I went to an urgent care facility, and they sent me directly to the emergency room.
Information has been received from a health professional concerning a 7 yr old white male, with no medical history and no allergies who at 1 yr of age, in approx Jan 2000, was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccine administered on 18Jan00 included a first SC dose in the left arm of measles-mumps-rubella vaccine (lot628002/1007H). The pt had a classic rash and rhinitis at the time of vaccination. There were no adverse events following prior vaccination. It was reported that the pt presented to the office on 08Feb06 with a full blown case of chickenpox. The pt had 250-500 lesions covering his body. At the time of the report the pt had not recovered. There were no lab or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided.  Follow information from a health professional indicated that the pt developed clinical varicella disease on 07Feb06. The reporter felt that this represented vaccine failure. It was reported that the pt recovered. Additional information is not expected.
Red, swollen area with hard core at injection site.  Youth stated "it is itchy".
Leg cramping; Fever 100.0; Felt weak; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Leg cramping), PYREXIA (Fever 100.0) and ASTHENIA (Felt weak) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced MUSCLE SPASMS (Leg cramping), PYREXIA (Fever 100.0) and ASTHENIA (Felt weak). The patient was treated with CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Leg cramping), PYREXIA (Fever 100.0) and ASTHENIA (Felt weak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Body temperature: 100 (Inconclusive) 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient drank pickle juice and Gatorade. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
child was taken to local emergency room 1/20/23 for evaluation of high fever to 106.5 Tmax (rectal temp) that started around midnight 1/19/23.  infant was fussy and did not want to eat well.   ER felt Sx were vaccine related and did not perform any tests.  parents confirmed accuracy of their thermometer with one of ER thermometers.    I saw patient in our clinic 1/22/23 and she had continued to have fevers ranging from 103 to 106 (rectal temp).   she had developed clear runny nose, congestion and cough since discharge from ER.  she was not eating normally
patient received 2 doses of Pfizer Covid Bivalent vaccine on September 27, 2022 and October 31, 2022.
no additional AE reported; she was unsure if any of these vaccines had been administered since the excursion occurred; This spontaneous report has been received from a medical assistant, concerning a 2-years-old male of patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 09-SEP-2022, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (strength, dose, frequency, vaccination scheme, route of administration, and anatomical location were not provided) (lot number W002894 has been verified to be valid; expiration date reported and established as 06-MAR-2023). The administered dose of the vaccine was stored at a temperature of 52.2 degrees Fahrenheit (F), during a time frame of 2 hours and 53 minutes, and at a temperature of 33.6 F, during a time frame of 4 hours and 59 minutes. There was no previous temperature excursion reported. There was no adverse effect reported.  This is one of 5 reports received from the same reporter.  ; Sender's Comments:  009507513-2210USA009377: 009507513-2210USA004932: 009507513-2210USA009378: 009507513-2210USA009379:
Extreme chills from 2:00 until 7:30. Took hot bath. Got debilitating headache. Had to go to bed. Applied cold compress to head. Better in morning after taking extra strength tylenol.  8 April again got chills but not as bad. Bad headache but not as bad. Then I believe it to be a UTI with bleeding that looked almost like period but I am 72 years old.  Still a little blood in urine today 9 April.
Pain at injection site; Pain at shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site) and ARTHRALGIA (Pain at shoulder) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site) and ARTHRALGIA (Pain at shoulder). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency.   At the time of the report, VACCINATION SITE PAIN (Pain at injection site) and ARTHRALGIA (Pain at shoulder) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
Vaccine given at 1039.  At 1051, pt complained of increased facial swelling, redness, and throat itching.  Rapid response called. Pt evaluated- O2 95% room air., resp rate 24, HR 136, and BP 148/104.  Per pt, she has multiple allergies and this happens often.  Her blood pressure is always elevated like this.  Her face was swollen already as she was evaluated in the ER and monitored in the hospital overnight on 4/9/21.  Pt able to hold a conversation without difficulty.  Liquid Benadryl (25mg) given by mouth as pt denied any swallowing difficulties. EpiPen ready for administration.  in the meantime, rapid response team arrived and transferred patient immediately to ER.  RN had EpiPen with her to give if needed.
Headache, Myalgia, Arthralgia, Localized itching, pain; lightheadedness, chills, fatigue Narrative:
This spontaneous report as received from a licensed practical nurse refers to a 17 year old female patient. Pertinent medical history, drug allergies or reactions were not reported. On 30-JAN-2014, the patient was vaccinated with PROQUAD (Merck), 0.5 ml, subcutaneous (lot # reported as "J007206", expiry date: 20-DEC-2014) for prevention of measles, mumps, rubella and varicella. the nurse stated that the patient received PROQUAD (Merck) in place of MMR II and VARIVAX (Merck). No adverse event reported. Additional information is not expected.
Fever greater then 39. Pelvic pain, rust colored Urine. Treatment with antibiotics and corticosteroids. Rash skin on the arm with the same path as venous torrent. Inflammation of joints (wrist and knees), sputum with blood. Hospitalization in sanatorium for 6 days. Altered laboratory (FAN) analysis antinuclear results 1/320.
After a few days my arm swelled up, became red and itchy and painful. Also hurts when raising my arm.
migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine) 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 MIGRAINE (migraine). At the time of the report, MIGRAINE (migraine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
I21.4 ACUTE NON ST ELEVATION MI 4/13/2023 NON-ST ELEVATION MYOCARDIAL INFARCTION
Swelling, redness, pain, around elbow area, evening 9/15/04.  Seen at local ER. MD gave pt pain meds, returned to hospital within 1-2 weeks- was given physical therapy, saw local nurse practioner. Dr talked with another doctor on Dec/04; still having problems.  Doctor was seeing pt for ? pneumonia, did not address issue with arm.  Seen by several MD's at hospital- told that "shot" given to low and "you need to have something done before you loose your arm".  Still has pain, more at night-limited ability to lift, ROM causes pain Rt. arm. 1/25/05 Spoke with patient, continues to c/o of pain in rt arm "difficult to sleep at night, can only carry light groceries, but anything heavey "will pay for it later".  Has mobility of are, can feed self.  Is right handed.
pt recv c/o of chest tightness, face became flushed, stated had thickened feeling in throat; recv epi & transported via ambulance to hosp;recv pred, DPH, pepcid;
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. Developed life threatening autoimmune condition, Guillain Barre Syndrome following vaccination and was placed on a respirator, in intensive care for weeks. According to a medical journal, the prevalence of this autoimmune condition occurs year round at a rate of one case per million, per month, or 3,500 cases per year in the US and Canada.
From initial information received on 3/22/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 58 year old female patient received TD ADS ADULT vaccination, lot number U1017BA, administered IM in the left deltoid on 3/18/04. The next day, on 3/19/04, the patient phoned the reporter stating that the injection site was red and hot to the touch. She was seen in the physician's office on 3/22/04 and had a 9-15cm red, warm area at the injection site. Recovery status of the events is unknown. At the time of vaccination the patient was taking aspirin and conjugated estrogens. From additional information received on 8/30/04 from a health professional, it was reported that the patient recovered from these events. No further information is anticipated, this case is considered closed.
Patient reported that she commonly passes out with vaccination or piercing.  I advised patient to remain in counseling room seated after for observation.  After administering shot, she was fine for the next 30 seconds.  Within a minutes time she passed out and I held her head to prevent further injury as she lost muscle control.  She had difficulty breathing with mask so I instructed her to remove mask and to take deep breaths.  She regained consciousness after approximated a minute.  She reported dizziness but said feeling better and asked for water as that commonly helps her feel better.  I monitored patient for about 20 minutes and stayed behind her while in chair in the event to catch her if sycope occurs again.
Pfizer / BioNTech 17Nov2021 / Paxlovid Treatment of COVID-19 11Jul2022; Pfizer / BioNTech 17Nov2021 / Paxlovid Treatment of COVID-19 11Jul2022; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; ACETAMINOPHEN; ADDERALL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Pfizer / BioNTech 17Nov2021 / Paxlovid Treatment of COVID-19 11Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound infection or rapid reinfection. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received other medication in 2 weeks. Anti viral details product COVID 19 Treatment (brand=Paxlovid) on 11Jul2022 to 16Jul2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.
Progressive numbness developed at site of injection in left deltoid area. Spread down to fingers of left hand, up side of neck on left and onto left side of face. Progressed to maximum area over two week period, lasted about 2 weeks, then retreated spontaneously over 2-3 weeks.