chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lymphoid under left arm; Right arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm pain) and LYMPHADENOPATHY (Lymphoid under left arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In February 2021, the patient experienced PAIN IN EXTREMITY (Right arm pain). In April 2021, the patient experienced LYMPHADENOPATHY (Lymphoid under left arm). At the time of the report, PAIN IN EXTREMITY (Right arm pain) had not resolved and LYMPHADENOPATHY (Lymphoid under left arm) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Computerised tomogram: Lymphoid under left arm thought being that it was small, do not even felt it..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported. On an unknown date, patient had Chest X-ray (result not provided).. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt was sitting in chair for recovery.  Fell out of chair from sitting to lying position face down on floor.  Pt immeditaly sat up on his own. A/Ox3. Sat up in a daze for a few seconds.  V/S obtained with b/p 98/56 HR 47 O2 98%.  EMS notified. Upon EMS arrival pt was lying back down but a/ox3.  Pt refused EMS for further care.  Monitored pt for extra 30 min and sent home with wife at side.
This case was reported by a consumer and described the occurrence of swelling arm in a female patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced swelling arm, fever and pain in arm. On an unknown date, the outcome of the swelling arm was unknown and the outcome of the fever and pain in arm were recovered/resolved. It was unknown if the reporter considered the swelling arm, fever and pain in arm to be related to SHINGRIX. Additional details were provide as follows: The age at administration was not reported. The patient had the SHINGRIX shingles vaccine on Saturday before the time of reporting, since that time the patient arm had swollen up. The patient experienced low grade fever and was achy for about 2.5 days. The patient was thinking that was a normal reaction but the patient arm was looked pretty bad. The patient was worried about having to get the second shot of SHINGRIX and wanted to know that the range of a normal response. The patient had attached picture of her arm. The patient said the patient's arm had actually got worse at the time of reporting.
Pt recv vax on 7/15/98; on 7/27/98 pt exp petechia &thrombocytopenia.  Pt imp in 1 wk.
she got the COVID 19 vaccine on the 16Dec2020 and got tested positive on the following day; she got the COVID 19 vaccine on the 16Dec2020 and got tested positive on the following day; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable nurse (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got the COVID 19 vaccine on the 16Dec2020 and got tested positive on the following day (17Dec2020). She is scheduled to take her second dose on 20Jan2021. The patient wanted to know what Pfizer recommendations are. Outcome of the event was unknown.   That information on the lot/batch number has been requested.; Sender's Comments: A causal role of BNT162B2 would seem unlikely based on the temporal gap between the vaccination and the event onset.
This patient received a Pfizer Bivalent Booster Dose of Covid 19 vaccine on 12/13/2022 instead of receiving dose 2 of Pfizer monovalent vaccine.   The first Pfizer monovalent vaccine was administered on 10/31/2022.  According to website, if a bivalent vaccine is incorrectly administered for the primary series and it is a Bivalent Pfzer-BioNTech vaccine, you do not need to repeat the dose. I sent this inquiry off to the team at that site.  Hello,  Correct. If a patient inadvertently receives a Pfizer bivalent booster instead of an indicated primary monovalent dose, we recommend the dose be counted as valid toward the primary series and not be repeated (as indicated in the table in the spot you marked).  And yes, we still recommend a bivalent booster dose per the usual schedule following completion of the primary series.  Health Education and Information Specialist  The patient would be eligible for the next booster in 2 months (8 weeks) from the last vaccine.  Patient was notified of the above. She verbalized understanding that the dose she received is valid and does not need repeating. She understands she would be eligible for a booster in 2 months.  Patient reports her arm was sore and she was a little day the day after but is fine now. Patient appreciated the follow up call and detailed account of how this occurred along with the plans to take corrective actions. Incident documented in RL Solutions and employee counseled.
Very hard big circle; Itchiness; Hottness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (Very hard big circle), PRURITUS (Itchiness) and FEELING HOT (Hottness of the arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol, Hypertension and Thyroid disorder. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, LOSARTAN for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS, TRAZODONE and OXYCODONE for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced INDURATION (Very hard big circle), PRURITUS (Itchiness) and FEELING HOT (Hottness of the arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INDURATION (Very hard big circle), PRURITUS (Itchiness) and FEELING HOT (Hottness of the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient received vaccination and for 10-15 minutes after, no adr reported. Pt went to next door grocery store and there was when pt felt symptoms of itchiness, sneezing, tingling. Later pt developed symptoms of acid reflux and face felt red hot. Pt called pharmacy to alert us of adr and pharmacist on duty recommended taking benadryl to alleviate symptoms. When pt got home, took 50 mg of benadryl (20 ml of benadryl).  About 1 hour later pt called pharmacy and reported symptoms were less severe but still present. Pharmacist on duty recommended to take a dose of benadryl before going to bed and to still monitor any signs and symptoms of difficulty breathing. Previously talking to the pharmacist, pt had talked to a teledoc and teledoc recommended to call the pharmacy to discuss adr. Teledoc didnt prescribe anything despite the pts symptoms that were reported. Warned pt that difficulty breathing is a key symptom indicating that pt will have to go to ER or urgent care as adr are progressing. Pharmacy will follow up with pt following day to see how pt's symptoms are
Had headache, fatigue , muscle aches arm and body. muscle aches upper chest and legs, chills, nausea,dry mouth,loss of appetite. I was tested on 1/6/21 result positive for covid. was prescribed azithtromycin 500mg , 1 tablet per day for 7 days. I took tylenol for pain and quarantined since then.
she has very bad lungs.; sitting down at the moment because she is very sick.; can't remember words because the chemo knocked it out of her brain; This spontaneous case was reported by a consumer and describes the occurrence of LUNG DISORDER (she has very bad lungs.), ILLNESS (sitting down at the moment because she is very sick.) and MEMORY IMPAIRMENT (can't remember words because the chemo knocked it out of her brain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A, 010M20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy since an unknown date. Concurrent medical conditions included Cancer (for a long time) and Chemo brain.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LUNG DISORDER (she has very bad lungs.), ILLNESS (sitting down at the moment because she is very sick.) and MEMORY IMPAIRMENT (can't remember words because the chemo knocked it out of her brain). At the time of the report, LUNG DISORDER (she has very bad lungs.), ILLNESS (sitting down at the moment because she is very sick.) and MEMORY IMPAIRMENT (can't remember words because the chemo knocked it out of her brain) outcome was unknown.            Patient got tested and there were no antibodies. No treatment details provided and No concomitant medications provided. Patient stated that she had she had "chemo brain" , she had cancer for a long time, she did chemotherapy, and she can't remember words because the chemo knocked it out of her brain. She had chemotherapy way before the vaccination with the Moderna Covid19 vaccine.
4 month old child received vax; one month p/vax, developed a cold & flu-like sxs; was treated w/penicillin & sxs got worse; on 12JUN68 pt died due to encephalitis;
Patient received 1cc of Moderna  COVID vaccine. Patient was notified, advised of potential side effects and what to do if they occurred. State of MD was notified.
crying nonstop from 745PM to 934PM, pale, restricted breathing, limp, diff swallowing, tongue swollen, palsy around mouth;sensitive to touch, didn't want to be held;APAP given, warm compresses to inj site;
Patient had all the Normal listed side effects but also presented blood while urinated. Started off being a small amount the first day being 04/28/2021. By day number 3 (04/30/2021). Patient had to attend to the ER. Patient has no prior pre existing condition related to the Bladder or the Kidneys.
administered a dose after temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 4-year-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th July 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 22-Jul-2022 Reporter's comment: Nurse practitioner reported that they administered a dose of Infanrix after a below temperature excursion, the vaccine reached 31.7 Fahrenheit. The reporter consented to follow-up. Additional supportive information: The vaccine was administered after a below temperature excursion, which led to incorrect storage of drug. The case was linked with case US2022110060, reported by same reporter.; Sender's Comments:  US-GSK-US2022110060:Same reporter
Documents reviewed. Vaccine administered, patient tolerated well. Patient reported sensation of tongue  numbness 20 minutes after administration. Numbness resolved after ~5 minutes, patient did not develop any   new or worsening symptoms after resolution of numbness. Vitals -   BP 171/73, then 153/96 HR 51, then 95   O2 sat 100% then 99% Patient was advised to call 911 if she develops any tongue swelling, throat tightness/itching or shortness of breath today.
Severe diarrhea  Fever Severe body pain Severe tiredness Chest pains Dizziness
No additional AE reported; PROQUAD was administered following a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 04-JAN-2022, following a temperature excursion (product storage error), the patient was administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # U002534, expiration date on 24-JUL-2022, for prophylaxis (strength, dose, route of administration and anatomical location was not reported). Vaccine were improperly stored at a temperature of -11°C, during a time frame of 3 hours. Previous temperature excursions were reported at -14°C to -10°C for 8 hours and -10°C to 8°C (-8-8°C) for 1 hour. No additional adverse event (AE) was reported (no adverse event).
I was approximately 19 weeks at the time of the injection. I have had 2 previous pregnancies, both resulting in normal deliveries. Approx. 6 hours after the injection I began to feel short of breath, severe fatigue, body aches, and acute pain in the upper arm of the arm with the injection site. Symptoms lasted approximately 18 hours.
A few hours after the shot I started experiencing chills, tiredness, then in the evening my left arm started to develop a large red hot bump that hurts and very itchy. During the night, fever of 101.1, chills, could not get warm, my whole body ached from head to toe. Headaches. Symptoms continued through the whole next day. Fever broke in the evening, Today, arm is still swollen, red, raised injection site, hot to touch. I had dizzy a dizzy spell when I got up this morning, almost passed out in the shower.  Dizzyness passed after a half hour. Still very tired and achy today.
Information has been received from a registered nurse concerning a 20 year old female with no past drug history, who on 06-DEC-2008 was vaccinated with a 0.5 mL second dose of GARDASIL (lot # 661703/0651X), subcutaneously. There was no concomitant medication. It was reported that in January 2009 the patient had a pregnancy. On 23-MAR-2009 the patient had a spontaneous abortion. There were no laboratory studies performed. On 11-APR-2009 the patient received her third dose of GARDASIL. Follow up information received on 16-APR-2009 from a registered nurse stated that the patient received the first dose of GARDASIL on 03-AUG-2008; second dose on 06-DEC-2008 (lot # 661703/0651X) and third dose on 11-APR-2009 (lot # 661846/1312X). There was no mention of pregnancy at the time of the 06-DEC-2008 dose (second dose). The LMP date was not indicated in the chart, nor was the # of weeks from LMP to the time of the spontaneous abortion (not an elective termination). Also not indicated in the notes was whether or not the products of conception were examined. This was the patient's first pregnancy. Upon internal review spontaneous abortion was determined to be an other important medical event. No further information is available.
Information was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. The patient received 2 dose of M-M-R II injection (dose and route unknown) separately at 13 months and 17.5 months of age (product use issue). No adverse symptom was reported. Additional information has been requested.
Patient received vaccine on (PREVNAR) on 0/25/15. She said that 2 days afterward she experienced excessive gum bleeding, anal bleeding, trouble breathing, heaviness in chest, dizziness, blurred vision and itching at injection site. She did not go to the doctor for symptoms when she came into pharmacy her symptoms has subsided.
Mild rash on face, arms and hands with mild itching.  Headache.  Fatigue.
Recvd 3 shots on 18SEP91 & 2 days later broke out w/blisters on ankles, wrist, armpits, shoulders, bottom; MD dx erythema multiforme caused by having immun together;
pt lt leg (DTAP) swelled to twice it's regular size w/in 48hr of vax;pt warm & tender to touch;had a fever also;
patient received an expired dose of daptacel with no reported adverse event; Initial information received on 27-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient who had patient received an expired dose of daptacel with no reported adverse event after receiving vaccine diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Feb-2023, the patient received a dose 5 0.5 ml once of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection lot C5816AA, expiration- 26-feb-2023 via intramuscular route in the left arm for immunisation.  On 27-Feb-2023 the patient developed a non-serious patient received an expired dose of daptacel with no reported adverse event (expired product administered) (latency: same day).  Lab data was not reported.  Action taken was not applicable.  corrective treatment: not reported for the event (patient received an expired dose of daptacel with no reported adverse event).  Outcome: Unknown for the event patient received an expired dose of daptacel with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Worst headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 10Jul2021 at 16:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. 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 included spironolactone (MANUFACTURER UNKNOWN) from unknown date for unknown indication. The patient had no allergies to medications, food, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0196), via an unspecified route of administration in the right arm on 19Jun2021 at 04:30 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. On 10Jul2021 at 17:30, the patient experienced worst headache she had in life, at the base of her head and behind her forehead. It was accompanied by nausea and had been consistent for 3 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events worst headache and nausea were not resolved at the time of this report.
2 adverse events  occurred after 1st shot.  1st 4-5 hrs afterward shot had dizzy spell (lasted only a few seconds) and then again 12-13 hrs after shot I had a second dizzy spell that was stronger and I took my blood pressure.  It was high about 180/90.  Called EMS, they checked heart (EKG I believe) and monitored  blood pressure that started going down and was back to normal mid-morning following day.  Second shot I did not experience any adverse reaction except the usual sore arm.  I later went to cardiologist who ran tests because I was preparing for hip replacement surgery.  All heart tests were normal.  Mentioned my experience to Dr. and he said about 10 patients had similar experience.
Red, swollen, knotted down to elbow. Cleared up in 2 days, was out of town reported to us 12 days later.
After 11 days arm became swollen, itching and red . Hurting ,kept up for about 5 days
Mom states the baby ran a fever of 104 degrees for 48 hours. She gave the baby ADVIL q 6 hours, which took fever to 101 degrees. The fever finally broke on 1/26 in the evening. The dr says the fever is from the shots. Baby was examined by the doctor.
DOB ON CONSENT IS INACCURATE. DOB IN DATABASE MAKES CHILD YOUNGER THAN 12 YEARS OLD.
Really hot to the touch; The injection site itchy; The injection site is red; The injection site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Really hot to the touch), VACCINATION SITE PRURITUS (The injection site itchy), VACCINATION SITE ERYTHEMA (The injection site is red) and VACCINATION SITE SWELLING (The injection site is swollen) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Really hot to the touch), VACCINATION SITE PRURITUS (The injection site itchy), VACCINATION SITE ERYTHEMA (The injection site is red) and VACCINATION SITE SWELLING (The injection site is swollen). At the time of the report, VACCINATION SITE WARMTH (Really hot to the touch), VACCINATION SITE PRURITUS (The injection site itchy), VACCINATION SITE ERYTHEMA (The injection site is red) and VACCINATION SITE SWELLING (The injection site is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Red rash down R arm, itchy, pt used allegra and benadryl with some mild relief, no anaphylactic sx
Breakthrough case admission after 2 vaccines: Moderna 2/11/21 Lot# 015M20A; Moderna 3/11/21 Lot# 044A21A.
Fever, aches, chills, sweating, headache, soreness at the site of the injection.  Flu-like symptoms lasted 18 hours.
Redness, swelling and itching spread over back of left arm and last for a week before turning dark like a bruise. Intense burning nerve pain started in upper back Rt side only 2 wks later. It stopped for a few days and then returned with a vengeance 1 wk later. Rash developed 1 wk after that.
Right Clavical swelling within first 2 weeks; but no pain right away until after 2nd vaccination.  After 1 month of the 2nd vaccination  there was pain in the Clavical muscle and a new growth on the left shoulder at the top end of the clavical bone.