chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female child, with no allergies or pertinent medical history who was vaccinated with Varivax 0.5ml SQ "several years ago" (lot # 646362/0573N). Concomitant therapy included MMR II. Subsequently the week of 02 Oct 2006, the patient developed chicken pox after being exposed to another child with chicken pox. The patient sought medical attention. Her symptoms included 5-10 crusting and vesicular lesions with a runny nose. At the time of the report, the patient was recovering. No lab tests were performed. Additional information has been requested.
Narrative:  75 year old male admitted on July 28 2022 with difficulty walking, arm pain, and hypoxia. He had received Moderna vaccine x 2 on March 3 2021, March 31 2021. He was treated with remdesivir 200 mg x 1 then 100 mg IV daily x 4 days and dexamethasone 6 mg daily x 3 days. He clinically improved with treatment and was transferred back to long term care on 8/2/22.
Head ache feeling like I have  a fever on and off body aches discolored mucus  from allergies. Even when taking my allergy shot s
Initial information received on 03-Jan-2019 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a 38 years old male patient who received a 0.5ml dose of TENIVAC (Batch number: U5882AA, expiration date: 08-Mar-2020, site of administration: left deltoid and route was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered. The nurse accidentally vaccinated the patient with TENIVAC instead of ADACEL. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
Received call from mother. Says about 1/2 hr. after shot he was nauseated \ dizzy. These have gone but has HA. now. Taking him home from school. Says RA is swollen. Given TYLENOL. Called back at 2:45pm. Mother says he is feeling better. No HA.
Swollen lymph node in left arm pit (the size of a ping pong ball). Fever of 102.5F with chills, headache, joint and muscle ache.
05Oct90 pt vax w/ MMR; 24Oct90 pt vax w/ measles virus live.  11Nov90 devel peripheral polyneuritis.  pt hospitalized w/GBS
Rash on right arm; Hives on right arm; This non-serious case was reported by a consumer and described the occurrence of rash in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 44HD4) for prophylaxis.   Concurrent medical conditions included hypertension and blood cholesterol increased. Concomitant products included atorvastatin calcium.   On 28-MAY-2023, the patient received Shingrix (intramuscular, left deltoid) .5 ml. On 29-MAY-2023, 1 days after receiving Shingrix, the patient experienced rash (Verbatim: Rash on right arm) and hives (Verbatim: Hives on right arm). The outcome of the rash and hives were not resolved.   It was unknown if the reporter considered the rash and hives to be related to Shingrix.     It was unknown if the company considered the rash and hives to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-MAY-2023 Concomitant products included Hydroxycholorithiazide from 01-SEP-2021 and was ongoing for Hypertension. The patient self-reported this case. The reporter consented to follow up.
MINOR COUGH/NAUSEA/FATIGUE/CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced minor cough/nausea/fatigue/confirmed covid-19 infection. Laboratory data included: COVID-19 antigen test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from minor cough/nausea/fatigue/confirmed covid-19 infection. This report was non-serious. This case was associate with PQC no.90000176214 The suspected product quality complaint has been confirmed to be the patient received the vaccine on (18-apr-2021) and had a positive covid-19 test on (02-apr-2021) with (15) days elapsed between vaccine and test. there was not sufficient time elapsed for the patient to achieve immunity therefore this report is not considered a lack of effect. based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Lightheadedness; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Lightheadedness) and FATIGUE (Fatigue) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced DIZZINESS (Lightheadedness) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Lightheadedness) and FATIGUE (Fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Blood pressure measurement: 130/90 mmhg (High) at 17:45 pm. On 08-Apr-2021, Body temperature: 99.4 (normal) at 17:45 pm. On 08-Apr-2021, Heart rate (60-100): 70 (normal) at 17:45 pm. On 08-Apr-2021, Oxygen saturation (Unknown-100): 98 % (normal) at 17:45 pm.     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 concomitant medications were reported. Patient laid down and was given juice to drink. And was monitored an additional 30 minutes and started feeling better. Treatment information was not provided..   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Additional information received and Route of Administration Intramuscular, Anatomical site of vaccination was updated to Left Deltoid
p/vax pt devel swollen glands on lt;c/o pain on eating;temp elevated @ home but did not have thermometer;gave APAP;also c/o h/a;
SEVERE TINNITUS IN LEFT EAR AT ABOUT 3 AM THAT WAS UNBEARABLE RINGING AND LOSS OF HEARING.   AFTER 2 HOURS IT STARTED TO FADE TO NORMAL.   IT HAS RETURNED SEVERAL TIMES BUT NOT AS UNBEARABLE RINGING SOME HEARING LOSS.
mom says cried for 2 1/2 hrs p/vax was given; rt leg was red & swollen was using cold wash cloth;
Developed erythematous swelling the size of golf ball on right leg. Stayed swollen for long time. Now has indentation and 3mm hard lump at vaccine site.
Adverse: Right arm musculoskeletal cold feeling in joints and bones. Lasted about 48 hrs from time of vaccination.  Typical: pain at injection site for 2 days, starting 24 hrs after injection.
Patient received 2nd dose of COVID 19 Vaccination at approximately 0800, 20 Feb 2021.  While seated in observation area patient began to experience difficult swallowing and a hoarse voice.  0.3 mg epinephrine administered, 4 mg Decadron IM and 25 mg diphenhydramine PO provided at 0830.  Patient transported to local ER for further evaluation and care.
September 25, 2015 11:20 AM patient received FLUZONE HD vaccine experienced heart palpitations shortly after received shot.
Hives randomly appearing around body, lasting for several hours. Locations include, neck, back, chest, head and legs. Hives began on the 3rd morning post 2nd covid vaccine. I have had hives everyday since then, unrelieved by over-the-counter medication.
Vax given 22APR91 wk of 22APR91 t 101.6 highest t103.8 only fever no other sx; dx throat infect & placed on Septra x 10d; later developed facial rash;
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. In 2016 (after 29-MAR-2016), the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # K010216 with exp. 10-NOV-2016 and lot # K010216 with exp. 17-SEP-2016. The vaccines were exposed to 15C for 24 hours between 18-MAR-2016 and 29-MAR-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was taken. No concomitant medication was taken.
Pt. called on 9/9/2013 to report aching and redness of (L) arm that started 8/23/13. One day after receiving Yellow Fever vaccine sx are off and on. Relieved by Tylenol or Advil but sx keep reoccurring. Has also applied warm compress with some relief.
mom states 2-3 wk p/vax pt woke up Sunday AM w/t105 given APAP throughout day;came down in PM but @ 6:30-7:00 temp elevated pt had febrile sz;took to ER t107 p/sz;
Systemic rash all over the back, chest, stomach and thighs; Some spots on arms and legs; This is a spontaneous report from a contactable Nurse (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL3248), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  Medical history was none.  The patient's concomitant medications were not reported.  The patient stated, "I got my first dose yesterday at 4:30 and then everything was fine and then at about 10:30 that night, I got a systemic rash all over my back, my chest, my stomach and my thighs and there were some spots on my arms and my legs. So, I went ahead and had took some Benadryl and I just monitored the rash and made sure it wasn't going to my face, or my eyes or my throat. I never had any difficulty in breathing or anything but it definitely was a reaction to something that was in the vaccine." Treatment: Consumer stated, "I took Benadryl last night. It was a capsule, 25 mg. Indication: Consumer stated, "I work at a hospital and right now the hospital that I work at is not requiring that we get it but they just advised that we should. But they left it to us if we want to get it or not and they said that they just have the first doses available." The outcome of the events was unknown.
My arm felt bruised starting the evening of the injection & I had a hard bump for several months. The hard bump has since subsided, but the area of the injection site (my left arm) still habitually feels as though I was recently punched in the arm. It feels like a bruise inside of my arm. There is no mark on the outside, it's just that it habitually feels bruised.
Reported rapid heart rate and chest heaviness and weakness. Symptoms resolved after 1 hour. Eval by MD on site. Employee put in Uber  and told to rest at home. Texted us later and said she arrived home safely and symptoms had resolved. During call 1/6 stated she is still having heaviness in her chest and is using her inhaler. she is  following up with her PCP.  .
pt recv vax;had a severe local rxn,erythema,pain,swelling at site lt deltoid;whole arm itched;to md given dph & sx resolved;
red, raised, itchy area 10 x 10mm @ site p/1st dose;
Swollen lymph node in armpit on injection side: pain all the way around to the back and down to fingertips
Patient reports that after getting the Pfizer 1st dose that her arm has had constant pain. Her arm has also felt weaker, making it more difficult to pick up things. This has lasted at least 3 weeks.
I developed a skin rash that seems to shift position depending on time of day. Blood Tests were run to determine if this was an "internal" issue. Results normal. Doctor prescribed antihistamine that helps, but not completely at night.
Patient's left upper arm (deltoid area) was mildly swollen, red, and warm to the touch. Patient also complained of itching.
first shot August 2019, second on October 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 81-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on August 2019).   On 25th October 2022, the patient received the 2nd dose of Shingles vaccine. On 25th October 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient asked pharmacist for 3rd dose however pharmacist stated that patients do not need to restart the vaccine. Additional supportive information: As patient received 2nd dose after too long duration which led to lengthening of vaccination schedule.
Pt has swelling, redness, low grade fever, streaks up, warmth to left arm on sunday 03/13/2005..Seen by on call physician. Placed on Cephalexin 250mg/5ml 1tsp PO TID x 7 days starting 03/13/2005
Patients father stated patient started not feeling well a few days after the flu shot. Symptoms included not being able to stand/or walk straight.
Red swollen around injection site. Blister at injection site.  Sore arm, fatigue, headache.
A non-serious spontaneous report of positive influenza A test has been received from a pharmacist concerning an adult female, subsequent to H1N1, Intranasal. The patient's past medical history and concomitant medications were not reported. The patient received H1N1, Intranasal on 16-Oct-2009. On 30-Oct-2009, the patient developed symptoms of fever, cough, sneezing and had a positive influenza A rapid test. The outcome of the event of positive influenza A test was not reported.
WEAKNESS; PAIN & NUMBNESS STARTING IN LOWER EXTREMITIES; RASH LOWER EXTREMITIES (MILD, ERYTHEMATOUS; NO VESCICLES) 3/3/09-records received for DOS 1/11-1/16/09 DC DX:Medication reaction to varicella-zoster vaccine. Aseptic meningitis. Schomberg rash most likely hepatitis.hyponatremia. Presented with rash and ascending pyelonephritis, weakness and numbness in legs times 2 weeks. Rash on chest and legs and face.  urinary tract infection.
Loss of long term memory; Feeling weakness.; Fell down twice on floor from standing position; Looks confused; Out of mind/feels likes somebody has raised hard disk; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Loss of long term memory), ASTHENIA (Feeling weakness.), FALL (Fell down twice on floor from standing position), CONFUSIONAL STATE (Looks confused) and FEELING ABNORMAL (Out of mind/feels likes somebody has raised hard disk) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 022M20A) 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 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced AMNESIA (Loss of long term memory), ASTHENIA (Feeling weakness.), FALL (Fell down twice on floor from standing position), CONFUSIONAL STATE (Looks confused) and FEELING ABNORMAL (Out of mind/feels likes somebody has raised hard disk). At the time of the report, AMNESIA (Loss of long term memory) had not resolved and ASTHENIA (Feeling weakness.), FALL (Fell down twice on floor from standing position), CONFUSIONAL STATE (Looks confused) and FEELING ABNORMAL (Out of mind/feels likes somebody has raised hard disk) outcome was unknown.      The patient stated that she is not on concomitant medication. No treatment information was reported.
Site of injection, L deltoid, swollen, red and warm. Extending to mid-forearm. About 10 cm in diameter.  No fevers.  No treatment given.
felt like she was catching a cold; Diarrhea; Flu like symptoms; Hot & Cold; Achy all over the body; Hot & Cold Sweats; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (felt like she was catching a cold), DIARRHEA (Diarrhea), INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING OF BODY TEMPERATURE CHANGE (Hot & Cold) and PAIN IN EXTREMITY (Achy all over the body) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced NASOPHARYNGITIS (felt like she was catching a cold), DIARRHEA (Diarrhea), INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING OF BODY TEMPERATURE CHANGE (Hot & Cold), PAIN IN EXTREMITY (Achy all over the body) and HYPERHIDROSIS (Hot & Cold Sweats). At the time of the report, NASOPHARYNGITIS (felt like she was catching a cold), DIARRHEA (Diarrhea), INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING OF BODY TEMPERATURE CHANGE (Hot & Cold), PAIN IN EXTREMITY (Achy all over the body) and HYPERHIDROSIS (Hot & Cold Sweats) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment details not provided
Swelling of throat (10/1 -> almost better now). Difficulty breathing (9/29 only). Hoarseness (10/3 only). Blurred vision (9/28 - present).
My breast started leaking; looking like when you touch, like milk comes out like I am breastfeeding and I am not like I don''t have any baby; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200174707 (Pfizer).  A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2022 (Lot number: FH8027) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "pregnant 9 years ago" (not ongoing), notes: pregnant 9 years ago. Concomitant medication(s) included: LABETALOL taken for blood pressure measurement. The following information was reported: BREAST DISCHARGE (non-serious) with onset 29Jan2022, outcome "not recovered", described as "My breast started leaking; looking like when you touch, like milk comes out like I am breastfeeding and I am not like I don''t have any baby". Therapeutic measures were not taken as a result of breast discharge. Additional information: Patient was taking a shower and noticed it, and thought it was soap but then she realized it was milk, and that she was still lactating at the time of report. She was last pregnant 9 years ago and she has no "tubes", so she can't get pregnant anymore. Patient reported that everything was fine with her until she received the vaccine.  Follow-up attempts completed. No further information expected.
This spontaneous report as received from a pharmacist refers to a adult male patient of unknown age. Patients concurrent conditions and relevant medical history was not reported. On an unknown date 15-20 years ago, the patient was vaccinated with M-M-R II (dose, frequency, route and lot number unspecified). Concomitant medications were not reported. On an unknown date the patient went to the hospital and the staff at the hospital believed that the patient had broken out in measles because the patient has spots all over the body. No treatment was given for the adverse event. The patient was not admitted to the hospital. The outcome of the event was unknown. The causality of the event with MMR was not reported. Product quality issue was not reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with lot #(670978/0750AA) ZOSTAVAX on 31-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 31-AUG-2012 the patient received expired ZOSTAVAX. No known adverse effects were reported. This case is linked to case 1210USA0002505 by same reporter link. Additional information has been requested.
COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: 02-OCT-2021) dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-DEC-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.
The pt devel a red, warm, raised area 3-4 cm in diameter) @ the inject site p/recvd Td; also noted pain @ the site & the shoulder area; tx APAP & DPH;
Dose 1 Pfizer 5/3/2021 lot EW0168  Pt has Covid 19 8/11/2021
The day after the injection swelling, pain and a rash developed at the site of the injection.  The area affected is about 2 inches wide by 4 inches long.  I learned later that pharmacy had a RSV vaccine from Pfizer but it was not offered to me at the appointment for the shot. This was reported via email to my doctor.
Pt was given the Pfizer Covid Bivalent booster for the 5-11 year age group rather than the >12 year age group.  Parent was contacted. No known physical adverse reaction.  Plan reviewed to follow up with age appropriate booster dose.
14:18-vaccines administered. 14:19-sob bilateral wheezing x 5 lobes with uchal urticaria, pulse 130, rop 18, bp 132/12 O2 sat-unable to obtain. Given Benadryl and 5PI. Symptoms improved with in 2 minutes. Transported to acute cart area-vitals bp 136/76, p 84, r 18, T 97.9, O2 sat 99% at 14:35. Pt monitored then to drill instructor. Pt seen next AM with no sequela.