chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received / second dose of Shingrix 37 days later than the 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the second dose of Shingrix 37 days after the first dose, less than the recommended interval, which led to shortening of vaccination schedule. No further details were provided at the time of call. No lot number or expiration date was available as vaccine was administered in different facility from where the call was made. No Information on batch number or expiration date was available as it was administered in a different facility. The reporter did not consent to follow up.
Right arm is swelled and painful to touch, also headache present around 6:00 AM. Throughout the day the symptoms have gone down and around 3:30 PM able to move arms but its not fully better still a bit swelled and bit painful will continue monitoring.
intermittent Facial flushing beginning 3 days after dose# 1 was administered
Vaccine was given 10/11/2004, complaint of poxs on 10/21 or 10/22; injection site red and swollen also.  Developed more poxs over the next week ( >50-100) complaint of feeling tired and denied fever.  Recovered by 11/05/2004.
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache". Therapeutic measures were not taken as a result of headache.  Additional information: patient could receive her 2nd dose today 06May2021 if she has a headache. Patient was not taken any medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt vaxed w/Hep B & devel severe diarrhea, dehydration & myalgia; hospitalized on 28SEP92; lab eval revealed an elevated BUN & serum creatinine; serum potassium was 6.0; pt hospitalized;
Pt. received Flu shot at 9:30 AM. That evening at approximately 6:00 PM pt. C/O soreness. Site was slightly red. The next morning pt. had swelling and increased redness at site. The circumference of R upper arm was 1 inch greater than L arm. Redness and 2/3 of upper arm. Pt. received ibuprofen and BENADRYL. Ice was applied. There were no respiratory or GI symptoms and no angioedema or urticaria. Pt. went to Urgent Care and received 10 ml prednisone, which she also took the next day. The swelling resolved in 2-3 days. The redness lasted for 1 week.
This case was reported by a physician via sales representative and described the occurrence of injection site rash in a 16-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included HAVRIX; GlaxoSmithKline; unknown; unknown given on 2 October 2012; MMR II (non-gsk); Merck; unknown; unknown given on 2 October 2012. On 2 October 2012 at 14:03 the subject received 4th dose of INFANRIX (unknown, right thigh). On 2 October 2012, 27 minutes after vaccination with INFANRIX, the subject experienced injection site rash. The subject had a local rash 4 to 5 centimeters on right upper thigh after administration of INFANRIX. The subject was treated with BENADRYL. The physician considered the event was clinically significant (or requiring intervention). At the time of reporting the injection site rash was unresolved. The physician considered the event was probably related to vaccination with INFANRIX.
Three weeks ago he tested positive for Covid; Three weeks ago he tested positive for Covid; This is a spontaneous report from a contactable consumer, the male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration dates were not reported) via an unspecified route of administration on an unknown date as single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported.  It was reported that, the patient supposed to get his 2nd dose 4 weeks ago. Three weeks ago he tested positive for COVID and the same day did antibody injection. The patient's HCP told him to wait 90 days so patient called to schedule appointment and the pharmacist told him that he could just come on with it and get the 2nd dose and the patient wants to know what is the correct information. The patient missed his 2nd dose and got Covid after 1st dose. The outcome of the event was unknown.  No follow up attempts are needed. No further information is expected.
Pt. was given flu vaccine & pneumonia vaccine (has asthma) in same arm - 1 inch apart 2nd day arm is red & inflamed.
concerned may have not received a full dose; syringe connection issues; A spontaneous report  was received from a consumer, who was also a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and during administration, some drops leaked out of the syringe (device connection issue) and she was concerned that she may have not received a full dose (underdose).  The patient's medical history was not reported. No concomitant product use was reported.  On 26 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 012A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Feb 2021, during administration, the patient noticed some drops leaked out of the syringe and was concerned that she might have not received a full dose and was asking what to do.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.  The outcome of the events was recovered on 26 Feb 2021.; Reporter's Comments: This report refers to a case of a female patient of unknown age who experienced non-serious unexpected events of some drops leaked out of the syringe ( syringe issue) and  she was concerned that she may have not received a full dose ( Incomplete dose administered) for  mRNA-1273 (Lot number: 012A21A) . There were no reported AEs associated with this case of syringe issue and incomplete dose administered
14JAN95 sudden onset h/a, malaise; 23JAN95 sinus congestion, muscle pain, t99.3; 24JAN95 body aches, t99.4; 25JAN95 joint pain, h/a; 26JAN95 rash pain @ inject site;
lump and swelling up under my arm after the second shot; lump and swelling up under my arm after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump and swelling up under my arm after the second shot) and VACCINATION SITE SWELLING (lump and swelling up under my arm after the second shot) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE MASS (lump and swelling up under my arm after the second shot) and VACCINATION SITE SWELLING (lump and swelling up under my arm after the second shot). At the time of the report, VACCINATION SITE MASS (lump and swelling up under my arm after the second shot) and VACCINATION SITE SWELLING (lump and swelling up under my arm after the second shot) had not resolved.            No concomitant medications were provided No treatment medications were provided Action taken with mRNA-1273 is not applicable   Reporter did not allow further contact
Primary immunisation: covid-19 vaccine - unknown manufacturer; Booster: BNT162b2; Has been down all week; Armpit is swelling; This is a spontaneous report from 2 contactable reporters, consumer (reporter) and consumer (Pfizer employee).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 03Jan2022 (Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Lot number: Unknown, Route of administration: unspecified) for COVID-19 immunisation and Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN, SINGLE, Lot number: Unknown, Route of administration: unspecified) for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 03Jan2022, outcome "unknown", described as "Primary immunisation: covid-19 vaccine - unknown manufacturer; Booster: BNT162b2"; DEPRESSED MOOD (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Has been down all week"; SWELLING (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Armpit is swelling".   Additional Information: It was reported that his old high-school friend indicated that his wife, "had been down all week and now her armpit was swelling" after getting the booster on Monday 03Jan2022 (in an email) and that was all the information the reporter had.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
57 yof that presented for her first dose of the Pfizer COVID-19 vaccine. She was slightly anxious before getting the immunization. Around 1620, patient received her first dose of the vaccine in her left deltoid and within approximately 10 minutes of her immunization she started to feel like she was going to faint. 1633 staff member applied an ice pack to the back of her neck and gave her water while another used a paper to fan her. Her vitals were taken Temp 97.7 Resp 20 BP (R) 218/181 HR 84. Recheck of BP (R) 202/116. Heart Rate: RRR and LS clear.  She has a history of hypertension and reports it is well controlled with a daily hydrochlorothiazide (mg unknown). She takes her medication every morning and checks her BP daily. She reports her BP is typically 120?s/80?s. 1702 Patient was feeling better and wanted to use restroom. Vitals: Temp 97.8 Resp 16, BP (R) 172/107 HR 72. 1717 She ambulated to the restroom with assistance and tolerated well. 1730 Temp 97.8, Resp 16, BP (R) 176/105 (L) 156/102 HR 67. Pt remained asymptomatic. 1748 (R) 173/105 (L) 195/107. Discussed with patient that I recommend she go to the ER for evaluation due to her near syncopal episode and her elevated blood pressure. Pt agreed to go to the ER. EMS was not called. One of her fellow staff members agreed to drive her to the hospital. 1612 Patient and staff member left at 1812.
crazy fatigue; she couldn't move any of the muscles in her arms, nothing; diarrhea; extreme head pounding; She says she finally got her sense of taste back a month ago and now she is losing it again; nausea; weakness; it was April 24th that she got her first dose/ got her second dose of the Pfizer COVID-19 vaccine on 11 May 2021; it was April 24th that she got her first dose/ got her second dose of the Pfizer COVID-19 vaccine on 11 May 2021; This is a spontaneous report from a contactable physician. A 70-years-old elderly female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in left arm on 11May2021 at 15:00 as 2nd dose, single for COVID-19 immunization. The patient medical history included multiple sclerosis from 1994 to an unknown date. She reported that she has only had the tetanus vaccine 10 years ago, not even the flu shot, since she was diagnosed she never got any vaccines because she is immunocompromised. She reported that   and barometric pressure, it was a beautiful sky blue day and she was miserable, She says that the way she feels waxes and wanes, sometimes she gets a little better, but the fatigue is ongoing, it never changes. She suffered from COVID-19 in Nov2020, she was wiped out for days and days and lost sense of taste and smell for months, which she had fully recovered from. She clarified she got her sense of smell back two months ago. On Saturday 24Apr2021 at 1:30 pm, the patient received first dose of COVID-19 Vaccination and 3 weeks and two days later was her 2nd dose. She had no other vaccinations the same day as her Pfizer COVID-19 vaccine doses or in the four weeks prior and has started no new meds before vaccine doses. She has only been taking her regular MS meds and she never changes those and did not report any medications. On 12May2021, the patient experienced extreme head pounding, diarrhoea on 14May2021, Friday and has persisted. On an unspecified date the patient experienced nausea every single day, crazy fatigue. She was fine until Wednesday night when she crashed and she could not move any of the muscles in her arms (muscle disorder), weakness (asthenia). It was April 24th that she got her first dose/ got her second dose of the Pfizer COVID-19 vaccine on 11May2021 as off label use and inappropriate schedule of product administration), She says she finally got her sense of taste back a month ago and now she is losing it again(Ageusia). No treatment has been done for the extreme head pounding or diarrhoea, Her MS medication did not help the head pounding or diarrhoea. She stated she guesses if it does not kill you, it is not serious. She says that the best word she thinks to describe it is troublesome, though maybe something more than troublesome. She says she thinks that the exhaustion is the worst part. The outcome for the events was unknown.  Information about Lot/batch number has been requested.
Pt began w/fever of 102; taken to hosp t103; meds given in ER; x-rays, blood tests urine sample taken; arrived @ ER 715PM left @ 11PM; meds given & mom given instructions to give meds to pt if temp >101;
Seizure for about 5 minutes. Went to the hospital via ambulance and was diagnosed as a febrile seizure.
Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech, Dose Number: 4; Moderna, Dose Number: 1, 2, 3, 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 66 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Dec2020 as dose 1, single (Batch/Lot number: unknown), on 03Feb2021 as dose 2, single (Lot number: 032L20A), on 02Nov2021 as dose 3 (booster), single (Lot number: 012F21A) and on 10Sep2022 as dose 5 (booster), single (Lot number: AS7415B) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Apr2022, outcome "unknown", described as "Pfizer / BioNTech, Dose Number: 4; Moderna, Dose Number: 1, 2, 3, 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the patient was treated with Paxlovid from 25Jun2023 to 30Jun2023.
The patient is a 41 yo male with a history of seasonal allergic rhinitis who experienced DVT and PE temporally related to Pfizer BioNTech COVID vaccine dose #2 receipt.  He is a Service Member and reported  high levels of baseline activity, including running 10 miles each Saturday. He received vaccine #1 25 JAN 21 (EN5318) without AE. He received dose #2 on 16 FEB 21, (EN6200). He experienced no immediate symptoms suggestive of IgE event. On day 1 he reports feeling cold, mild fatigue but no other symptoms. On day 2 he was baseline. On day 3 he noted numbness, tightness  and discomfort to his right  calf. On day 4 (Saturday), his usual long run day, he experienced dyspnea and lightheadedness after running 20-30 feet. He states he noted tightness in his calf and instead walked the track while his wife completed her run. He rested day 5.  Day 6 he noted significant edema to his calf, which he describes as double normal in size, and iced it. Day 7, he tried to schedule with PCP and based on triage was sent to ER. ER diagnosed R DVT and bilateral PE's. He was admitted overnight, started anticoagulation therapy. He saw hematology, and the workup was negative for other causes.
Redness, swelling, itching & discomfort at injection site. Warmth & increasing symptoms 2nd day - initiated antibiotic & Hydrocortisone cream topically.
Developed generalized erythema to both arms approximately 1.5 hours after second dose of the Moderna COVID-19 vaccine. Also pruritus to lower arms.  Also had redness to her neck area.  Also c/o being diaphoretic and hot.   Medicated with benadryl and pepcid.
He got his vaccine and was told he had to get the shot.  He was having some off and on issues.  One morning he woke up 15 months later and was intense pain.  He found himself in the hospital for 3  weeks on his death bed, and then recovered.  He had inflammation throughout the body and the records are with the hospital.  He started speculated that he was given MRNA and that it affected 9/10 patients and damaged pituitary glands.  Now the studies show that it is happening again, correlation with doctors how the vaccine is affecting people.  He still continues with the inflammation in his body and that his immune system is basically wiped out and has a hard time retaining B12.  According to surgeon everything that is going in the shot is going to the brain stem and to the pituitary area as soon as the shots are given.     His daughter has cranial stenosis and other medical issues that were passed down to her from him from the vaccines he took.  States that this is wiping out peoples immune systems from the MRNA.    They took his appendix out when he was in the hospital in 1992, and was diagnosed with inflammation of the colon.  He also had inflammation of his heart and his brain from the vaccine too.   This is for most patients that experienced inflammation and blood clots from the vaccines.  Brain clots in the lungs, heart, brain.    He has not had a vaccine since that one.
Shots given on 06/26-06/28 left leg red and swollen full but not tense.
10/14/18 patient woke with joint pain, fever 101.4, fatigue. Symptoms continued, joint pain and muscle pain worsened. Went to ED on 10/18/18, diagnosed with serum sickness and pneumonia. Patient's 3 yr old daughter history of cough x 4 weeks- she was also seen on same day and dx with pneumonia. Patient treated with IV abx and fluids and pain meds. Admitted overnight. Treated with ZITHROMAX, and Ceftriaxone, DILAUDID, TORADOL, ATIVAN, NORCO. Discharged on 10/19/18 with ZITHROMAX 1 pill, Ibuprofen NORCO. Is recovering but not back to work yet. Will follow up with PCP on 10/24/18.
4/20/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  dizziness.   Assessment : Time of assessment 1229 Alert and oriented.   Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN. VS are BP- 155/94, P- 55, O2- 100%. Water given, patient refused food, she reports that she has not eaten today and refuses any food.       Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 40 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.      Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/20/2021 12:11 PM 0.3 mL 2/25/2020 Intramuscular   Manufacturer: Pfizer, Inc
I GOT TIMED OUT WITH ALL THE DETAILS I GAVE ON MY FIRST ATTEMPT.  THEREFORE, I WILL GET STRAIGHT TO THE POINT.  PATIENT WAS FOUND AFTER 15 MINUTES OF ADMINISTERING THE VACCINE TO BE PALE , COLD SWEAT AND NOT DOING WELL.  I GAVE HER SOME WATER AND AT THAT POINT SHE LOST CONSCIOUSNESS FOR APPROX 30 SECONDS. 911 WAS CALLED.  SHE COMPLAINED OF HAVING BLURRY VISION AND FEELING MALASE.  EMTS AND FIRE DEPT. ARRIVED. HOOKED HER UP TO SEVERAL MONITORS.  THE ONLY ONE THAT WAS OF CONCERN WAS HER BLOOD PRESSURE OF ABOUT 84/43.  IT WAS RECOMMEDED THAT SHE BE TRANSPORTED AS SHE LIVES ALONE.  SHE HAD ONLY EATEN EGGS AND POTATOES AT 11AM AND WAS FOSTERING 3 KITTENS. RAN ERRANDS ON A HOT DAY AND SAID SHE WAS HYDRATED.
Developed cellulitis at injection site and radiating down entire forearm. Saw MD and recieved antibiotic therapy.
I already went through menopaused 15 years ago. Now, I started having a period again. I went to my OBGYN about it.  They are not sure why I am having my periods again. They did ultra sound, normal results. They did biopsy, normal results.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced nausea and vomiting on an unspecified date with outcome of unknown.
Gave flu shot and patient was bleeding and there was a welt and knot at injection site. Followed-up patient and patient was fine - knot subsided and is okay.
After receiving his Covid vaccine, patient sat with me for about 5 minutes and then moved to an observation chair.  As he sat down he had a brief syncope event with jerks.  Was aware and coherent afterwards but pale, and cold sweat.  Called 911.  Took bp and it was 84/50. Paramedics were on seen in roughly 5 minutes.
PATIENT WITH FOLLICULITIS, CURRENTLY TAKING CIPROFLOXACIN 1 DAY IN EVALUATION AS PRESCRIBED BY HIS PCP. MILD LYMPHADENOPATHY,NO DISTRESS, NO URTICARIAL RASH, NO FACIAL OR ORAL MUCOSA SWELLING, NO DISTRESS, PT DISCHARGED HOME WITH FOLLOW UP WITH PCP
Pt felt dizzy. Stated she did not have breakfast. Was given juice and crackers and stated she felt better. Discharged by Dr.
ARM PAIN; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm pain was not reported. This report was non-serious.
anaphylactic reaction , -- shortness of breath, cough, sore throat, swelling, itching.  Treatment Epi pen injection and 2 rounds or benadryl outcome : resolved