chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller states she has a patient who received their first dose of Comirnaty and then shortly afterward was diagnosed with Covid-19 infection; Caller states she has a patient who received their first dose of Comirnaty and then shortly afterward was diagnosed with Covid-19 infection; This is a spontaneous report from a contactable pharmacist. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0158; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in left arm on 28Apr2021 (at the age of 58-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated she has a patient who received their first dose of Comirnaty and then on an unspecified date in May2021 afterward was diagnosed with Covid-19 infection, the patients doctor instructed them to wait 3 months prior to receiving the second dose of the vaccine. Caller asked on behalf of the patient when the patient can safely and effectively receive their second dose of Comirnaty. Caller stated that she heard that the second dose can only be given between 21 and 42 days. Caller asking if this was true and informed that the Pfizer BioNTech COVID-19 Vaccine were administered as a 2-dose series, 3 weeks apart, into the muscle. If received one dose of the vaccine, should received a second dose of the vaccine 3 weeks later to complete the vaccination series. Per interim considerations: "The second dose of Pfizer-BioNTech vaccine should be administered as close to the recommended interval as possible, but not earlier than recommended (i.e., 3 weeks [Pfizer-BioNTech]). But if it was not possible to give the second dose at 3-weeks and a delay cannot be avoided, it may be given up to 6 weeks (42 days) after the first dose. If the second dose was given later than 6 weeks (42 days), the vaccination series does not need to be repeated. There were only limited information available on how well the vaccine protects against COVID-19 if given after this amount of time. The patient underwent lab tests and procedures which included Covid-19 test (sars-cov-2 test): positive on an unspecified date in May2021. Outcome of the events were unknown. Communication: PC filed. The caller stated that the patient was going to go back to the original clinic and declined to complete the remainder of the report. Full details unable to be obtained.  No follow-up attempts are possible. No further information is expected
(R) arm red and hot to touch 3 1/2-4" diameter (site of varicella vaccine).
Vasovagal event approximately 15 hrs. post vaccination. I found myself on the bathroom floor at 6 am. Got myself back to bed, woke my husband confused, asked him if I had been to the doctor as I felt a bandage on my arm. Then slept straight through until 12:30 pm.  B/P 100/59 when I did wake up and stayed in bed dizzy with sore arm and low B/P rest of afternoon. Notified MD office but not connected to MD who administered vaccine. Symptoms largely resolved by evening, except for myalgia and headache. Discovered later red, abraded left cheekbone and yellow ecchymosis L orbit. I have no recollection of striking my head or falling to bathroom floor.
Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown.            The concomitant medications were not reported. The treatment information was not provided.   The action taken with mRNA 1273 with the events was considered as not applicable.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: The Follow up document was received on18-MAY-2021 and patient date of birth was removed.
Injection site was red, inflamed, approximately 5 mm wheel and patient reported itching at site.   Patient also had shortness of breath and wheezing. Used albuterol inhaler for wheezing/shortness of breath and given diphenhydramine/Zyrtec.  Patient given prescription for Advair 100/50 to resume therapy and prednisone dose pack.  Wheezing resolved 12 hours post injection.
Lab tests indicate a thrombosis caused a cardiac event, triponin and other labs indicate damage to the heart. Son had to perform CPR until EMT
about 3 1/2 hrs p/vax pt woke up screaming & screamed for about 2 1/2 hrs; lt thigh had raised red area; mom applied ice & gave APAP; pt calmed down @ 4PM & is OK now;
This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (delayed hypersensitivity) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (delayed hypersensitivity). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (delayed hypersensitivity) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Ever since then I've been experiencing severe headaches; missed my monthly cycle; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Ever since then I've been experiencing severe headaches) and MENSTRUATION IRREGULAR (missed my monthly cycle) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced HEADACHE (Ever since then I've been experiencing severe headaches) and MENSTRUATION IRREGULAR (missed my monthly cycle). At the time of the report, HEADACHE (Ever since then I've been experiencing severe headaches) and MENSTRUATION IRREGULAR (missed my monthly cycle) outcome was unknown.            Concomitant products were not provided. Treatment products were not provided.
Fever, tiredness, sore arm, giant red circle around injection site hot to touch appeared has a red border kinda middle is swollen.
On 3/26/22 Patient (13 yo) received Moderna booster instead of Pfizer. Parents made an appointment online and requested Moderna vaccine. Contacted the parents on 3/28/22. Parents reported that patient had no adverse events. Recommended parents to contact and notify PCP as soon as possible. Father reported that PCP did not want to disclose contact information.
13 mm X 9 mm area of erythema and mild swelling noted at injection site.  Mother noted mild erythema and swelling the evening of the 23 May which had increased over night.
My son was given Menactra today in error.  He had already received the vaccine on 03/27/2015.  We requested meningitis B vaccine. The office gave him Menactra. This represents an overdose of the stated dose of vaccine. Doctor office did not think it required reporting but I disagree. Overdose should be considered an adverse event.
Whole right arm was hurting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Whole right arm was hurting) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 003A21A.) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Whole right arm was hurting) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form three times a day. On 06-Feb-2021, PAIN IN EXTREMITY (Whole right arm was hurting) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was not reported. No treatment medication was not reported    This case was linked to US-MODERNATX, INC.-MOD-2021-116503 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: No significant information added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-116503:dose 2
Pt is nurse who received TYPHOID VI, and AVA #1 yesterday in prep for deployment on 13 Aug 2010. Has had 6 previous typhoid vaccinations with no reactions. Twelve hours after receiving the vaccinations she noted pruritic, erythemic papules (non-vesicular) on the antecubital space bilat and behind lt knees bilat. Also c/o malaise, slight HA, and required sleep for 3 hours yesterday due to fatigue. Today her VS are stable, and she is afebrile. Denies new foods, lotions, soaps, etc. Denies hx of Atopic derm and states she has never had rashes. Occasionally has allergic rhinitis sxs but not currently. Takes no chronic meds. Hx Breast CA and had chemo and radiation in 2003 and took tamoxifen x 3 yrs.
Patient received first dose of moderna covid-19 vaccine EUA. She is an employee of the nursing home. While waiting for 15 minutes, patient fainted and fell. She became alert immediately after. Patient reports no allergies or chronic medical conditions. No epipen or Benadryl were administered. Her vitals were taken immediately after: bp 128/80,  temp98.0, Osat 99%, HR 88. Patient also reports not remembering if she has anything to eat that day .
Typical soreness to left arm especially under armpit for less than a day. However my back pain that started the evening of injection day only got worse the following day n despite IBU n Tylenol it has not gotten better at all. Im a very active person run at least 2mi a day but now i can barely walk.
Rebound COVID; Rebound COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 01May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for COVID-19 immunization; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 27Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for COVID-19 immunization. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "IBS" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing). Concomitant medications included: ADDERALL; ALBUTEROL [SALBUTAMOL]; LEXAPRO. Past drug history included: Effexor, reaction(s): "Drug allergy", notes: made her super agitated and hyper; Effexor, reaction(s): "Agitated". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022, outcome "not recovered" and all described as "Rebound COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Negative; (29Jun2022) Positive; (08Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, COVID-19. Clinical course: The patient had symptoms and tested positive on 29Jun2022. She started Paxlovid on the same day and took all her doses on schedule. She had mild to medium symptoms, with worst symptoms from 30Jun2022 to 02Jul2022. The last of her Paxlovid was on 03Jul2022 and was feeling much better. On 04Jul2022, she was just tired. On 05Jul2022, she felt great and tested negative. On 06Jul2022, she felt great too. On 07Jul2022, she woke up with sore throat again, tired, bad headache all day, but she was able to work. On 08Jul2022, she woke up feeling even worse, with symptoms progressing all day. The patient felt sick as she did on days 0-2 of the initial infection, possibly even worse. She decided to test again on a Binax test, and it was a very strong line of positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
felt unwell; fever; chills; pain; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: MALAISE (non-serious), outcome "recovered", described as "felt unwell"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "recovered"; PAIN (non-serious), outcome "recovered".  Additional information: the patient got pain and chills following booster of COVID vaccine. She got flu vaccine on the same day as the booster of COVID vaccine and felt unwell for a day and a half. She had fever and chills. The patient considered the event as caused by the suspect product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Swelling and redness around the injection site immediately after injection at 10:50 AM, 12/22/20. Site was slightly raised with erythema, about size of a quarter (coin). Symptoms lasted >5 hours after vaccination; still ongoing at time of writing (3:18 PM). No other symptoms noted.  Patient monitored for 30 minutes post-administration and line drawn around area with swelling to monitor for growth/worsening.
Patient left the store and called to report an itch in her throat. She said she was just a few minutes away. I requested she return immediately for further observation/ intervention.  She reported the same feeling upon arrival and I was preparing a diphenhydramine injection when she started to have difficulty breathing. I gave an epinephrine .3mg injection into left thigh.  Her breathing  improved after about 5 minutes . EMS was called as I was giving epinephrine.  The grad intern assisted and gave diphenhydramine 50mg injection Im while we waited for EMS to arrive. Patient was transported to emergency room.
Couple days after they release patient from the hospital she start with Pain, we take her to the emergency room and they made a  CAT scan finding a Blood Clot on the Porta vein, she start with Blood thinners and she still on treatment because that.
STARTED DAY OF INJECTION 6/10/21. HURTS, ARM, INFLAMMED, SWOLLEN, OVER 6 INCHES OF AREA AROUND INJECTION SITE AFFECTED, INJECTION SITE IS STILL RED WITH SERUM LEAKING. MENTAL CLOUDY OCCASIONALLY. NO COMPLAINTS OF SHORTNESS OF BREATH
pt states that  she started running fever 99.8 with chills, headache, body aches, vomiting and diarrhea later on the day of the vax.  Next day she only had body aches.  She stated that today 2/5/2021 she has body aches, headache and dizziness.  Pt has not contacted her PCP at this time.
Restricted respiration , muscle ackes and pain on my body, severe menstrual cramps from my abdomen to my armpit ( new and not experienced before).
C/O pain right deltoid and RUQ soon after TIV and MCV4 were administered on 1-4-11.  Presented in office 2-10-11 with complaints of pain in right shoulder and RUQ since vaccines administered, no pain in right deltoid at OV.  C/o pain with rt arm extension and shoulder rotation. Arms/ shoulders symmetrical, warmth equal. Was seen in the ER on 2-8-11 with same complaints, GB US neg, 16,000 WBC with no focus of infection.  Pt continues to bench press 90 #'s 3 times per week.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On an unspecified date in July 2013 the patient was vaccinated with GARDASIL dose 1 (lot number and expiry date unknown) (dosing regimen and frequency unknown), a second dose of GARDASIL on an unspecified date in December 2013. On 29-NOV-2013 the patient was vaccinated with GARDASIL dose 3. No adverse events were reported. No product quality issue was reported. Additional information has been requested.
runny nose; Initial information regarding this unsolicited valid non-serious social media case received from a consumer and transmitted to Sanofi on 12-Oct-2020.  This case is linked to cases 2020SA294157, 2020SA294158 and 2020SA294166 (same source).  This case involved a patient of unknown demographics who experienced got the INFLUENZA VACCINE runny nose (rhinorrhoea).  Relevant medical history, medical treatment, vaccination details, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient runny nose (rhinorrhoea), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was runny nose.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case is linked to cases 2018SA279965, 2018SA279966, 2018SA279967, 2018SA279973, 2018SA281633, 2018SA281638, 2018SA281636, 2018SA281637, 2018SA281634, 2018SA281632, 2018SA279979, 2018SA281687 and 2018SA281692 (same reporter). This case involves a four-months old female patient who was vaccinated with a 0.5 mL dose of PENTACEL (Batch number, expiration date, route and site of administration was not reported) on 12-Sep-2018. The patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage. It was reported that patient was given vaccine after temperature was at 30 F for 4 hours: below freezing. No adverse event was reported. 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.
After receiving the vaccine at 7:30pm on Monday, I started to get the anticipated chills, fatigue, soreness and light fever at noon on Tuesday which lasted to Wednesday/Thursday evening. In addition to these symptoms I have also gained a sore throat and stuffy nose, and headache which has lasted too today, Sunday.
Patient developed flushing, diaphoresis, tachycardia approximately 7 minutes after injection into L deltoid, while waiting under observation. The symptoms resolved spontaneously after approximately 3-5  mintues. Patient was then observed for 45 more minutes and felt fine the entire time. Upon leaving to have her spouse pick her up, patient developed symptoms again while walking out of the building. Patient was then taken to the emergency department for further monitoring. Telemetry and further observations for 4 hours revealed no further abnormalities and the patient was discharged home with no more issues.
Patient vomited at the observation station after receiving the Pfizer vaccine. EMS was called and treated individual on-scene, transport was not needed.  Patient was given longer observation time.
Fell three times in home on May 15th.  Was taken to Emergency Room by Ambulance.  In hospital for two days and then released.  Ordered Home Physical Therapy and Walker.  Cleaned the wounds from the fall.  Difficulty breathing and swallowing.  Released and told to schedule echocardiogram with Primary Care to follow up on heart's pumping function.  Still had difficulty breathing when home and walking.  Started diarrhea on Monday 22 had appointment on the 24th with doctor, but died at home before she could make appointment.
postherpetic neuralgia; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 08-NOV-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as after received zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered herpes zoster and postherpetic neuralgia. As a result of these symptoms, the patient was saw and treated by health care provided and was still under their care. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had resulted in physical limitations not presented prior to used zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulted physical limitations and seriousness of the patient condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffered, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate resulted, the patient had suffered and incurred damages, included medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster and postherpetic neuralgia were not recovered. The reporter considered herpes zoster and postherpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).
Stiff neck and head with headache, extreme fatigue.  The next morning, it was fever, stiff neck, back and body.  Sensitive to any touching.  Arm hurt.  On call nurse was contacted and pediatrician notified.    Symptoms resolved in 72 hours.