chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a person received a bivalent booster dose instead of the second dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (a person received a bivalent booster dose instead of the second dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (a person received a bivalent booster dose instead of the second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (a person received a bivalent booster dose instead of the second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was unknown if the patient received any other vaccines in the four weeks prior to covid-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that caller confirms that did not take place for them but that they have seen it at other stores.  Treatment information was not provided.   Reporter did not allow further contact
Patient is experiencing redness and swelling on her right arm. She was complaining of feeling short of breath and possible fever.
he cannot remember if he missed it or not; This is a spontaneous report received from Pfizer sponsored program. A Non-contactable male consumer (patient) reported for himself.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified 2021 as dose 1, single for COVID-19 immunization. No medical and concomitant medication history were reported. Caller would like assistance rescheduling 2nd dose of the COVID-19 vaccine since patient cannot remember if missed it or not (Read FAQ Faxed AE Not taking as prescribed/potential memory issues to Pfizer). The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 29MAY97 & began to have chills on 31MAY;2 days later 2JUN had diarrhea & urine was dark;4JUN was found to have inc bilirubin;the only tx reported was APAP PRN;
Client stated her arm at the injection site was itching and turned red the day after receiving MMRV. Also stated she had diarrhea and vomiting. Vomiting and diarrhea resolved by 12/26/14.
Received flu vaccine on 10-20-17. Started to itch (L) deltoid area where FLUZONE given. At 7:00 applied hydrocortisone cream and ice. (L) delt reddened and swelling and itching.
This spontaneous report was received from a nurse via a company represenatative and refers to a unspecified female patient of unknown age. Information regarding concomitant therapy, concurrent condition and medical history were not reported. On an unknown date, the patient was vaccinated with GARDASIL, intramuscular (dose, frequency, lot# and indication not provided).  Other suspect therapies included GARDASIL 9 (dose, frequency, lot# and indication not provided). The reporter stated that it was unspecified whether product involved was GARDASIL or GARDASIL 9. On an unknown date reported as fews days after administration of therapy, the unspecified patient experienced tingling in her arms (paraesthesia). The outcome of paraesthesia was unknown. Causality assessment was not provided. No additional information was provided regarding the unspecified patient. This is one of the two reports received from the same reporter. Additional information is not expected as no consent to contact the reporter. Sender's Comments: US-009507513-1707USA006261:
Information has been received from a registered nurse (R.N.) concerning a 7-year-old male with no pertinent medical history or allergies, who on 24-APR-2000 was vaccinated in the right thigh with a dose of Varivax (lot #632724/0087K). There was no concomitant medication. On 27-APR-2006 the patient experienced breakthrough chickenpox. Unspecified medical attention was sought and the patient was treated with topical acyclovir. No laboratory or diagnostic tests were performed. It was reported that the patient recovered on an unspecified date. The reporter considered the patient's adverse experience to be an other important medical event. Additional information has been requested.
Changes in taste and smell after vaccination; Changes in taste and smell after vaccination; This is a spontaneous report from a non-contactable consumer. This consumer reported for a female patient (reporter's family member). A female patient unspecified age (Patient age/age group: 55-60) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient got her second shot more than 3 weeks ago and is complaining of changes in taste and smell after vaccination. Yes it was clarified that the adverse event took place after pfizer product use. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 65-year-old female patient who received DTP (A or W not known). Co-suspect produces included Flu Seasonal QIV Dresden. In December 2017, the patient received DTP (A or W not known). In November 2017, the patient received Influenza vaccine. On an unknown date, less than a month after receiving DTP (A or W not known) and less than a year after receiving Influenza vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. The reporter considered the pain to be related to DTP (A or W not known) and Influenza vaccine. Additional details were provided as follows: While discussing the difference between subcutaneous versus intramuscular vaccination, the patient mentioned had pain associated with the flu and DPT vaccinations. The patient did not know the names of the vaccines but said she did not remember having pain with previous flu shots. The patient inquired about new SHINGRIX vaccine.
On 8th day Pt developed low grade fever 99-100 degrees F, fussy, gas, and constipation.  On day 10 developed an erythematous papular rash generalized on body excluding palms, soles and scalp.
Body aches; Joint pain; Chills; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (Body aches), ARTHRALGIA (Joint pain) and CHILLS (Chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced MYALGIA (Body aches), ARTHRALGIA (Joint pain) and CHILLS (Chills). On 21-Jan-2021, MYALGIA (Body aches), ARTHRALGIA (Joint pain) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2020-001273 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: No new information.
Hepatitis B vaccine given in error. HIB was intended. Contacted Health Dept she stated no adverse effects. Spoke with patients and she is doing good.
weakness; dry hives; fever; throw up; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), URTICARIA (dry hives), PYREXIA (fever) and VOMITING (throw up) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced ASTHENIA (weakness), URTICARIA (dry hives), PYREXIA (fever) and VOMITING (throw up). At the time of the report, ASTHENIA (weakness), URTICARIA (dry hives), PYREXIA (fever) and VOMITING (throw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient Conmeds include Blood pressure medications, Cholesterol medication, Indigestion medication .  Patient took Coricidin HBP , OTC for cold and flu symptoms .
dizzy/weird felling; metallic taste in mouth; slight soreness in jaw; sore arm at injections site; dizzy/weird felling; This is a spontaneous report from a contactable pharmacist (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included previous allergic reactions with hives, exposure to insulation and exposure to roof shingles. The patient's concomitant medications were not reported. It was reported that patient experienced about 10 seconds of dizzy/weird feeling about 10 minutes after vaccination followed by metallic taste in mouth and slight soreness in jaw. About 8 hours later sore arm at injections site. Patient mentioned event took place after use of product. Outcome of all the events was unknown.   Follow-up attempts completed. No further information expected.
This case was reported by a healthcare professional and described the occurrence of cut on middle finger in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On 27 June 2014, the subject received unspecified dose of ENGERIX B (unknown route and injection site). On 27 June 2014, during she was giving a vaccination with ENGERIX B, the subject cut on her middle finger. When removing plastic cap from vial, one vial shattered and one vial cracked at the neck. The subject consulted the healthcare professional for the event. There was unknown if a medical attention was required. At the time of reporting the outcome of the events was unspecified. This case was associated to a pharmaceutical product complaint. Pharmacy technician stated there were 2 affected vials. Only 1 was available for return. The vial that was cracked at the neck was available for return. The product was purchased directly from GSK. The pharmacy will return sample vial. GSK will replace to pharmacy. Follow-up information received on 15 August 2014 from the medical assistant: Previous vial from box shattered when attempting to remove the plastic top. Other vials were also noted to be defective. QA final report was received on 02 September 2014: According to the thorough investigation performed at the different production steps, GSK Biologicals concludes that it is unlikely that the root cause of this complaint took place during the manufacturing process. GlaxoSmithKline Biologicals therefore considers this complaint as unsubstantiated. Follow-up information received on 03 September 2014 from the medical assistant: Additional information was not reported.
I HAD HEADACHES, CHILLS, DIARRHEA, ACHES AND TIREDNESS BUT MY BIGGEST CONCERN IS THE FACT THAT I WOUND UP IN THE HOSPITAL ON FEB 8 WITH BLOOD CLOTS DOWN MY ENTIRE RIGHT LEG AND IN MY LUNGS. I NEED TO KNOW IF THE MODERNA CAUSED THESE OR MADE THEM WORSE. I HAD NO IDEA I HAD BLOOD CLOTS BUT MY FOOT, LEG WERE SWOLLEN  AND I ACHED FROM MY HIP DOWN THAT LEG. I ACTUALLY THOUGHT IT WAS SIADACA.
Donor states she has muscle cramps over both shoulders, back neck, these symptoms appeared 15 minutes after shot, nausea, sweating. 3 hours after shot patient complains of neck stiffness, 6/12/2009.
My fever has varied from about 99.3 to 100.4 (from 4pm until 10:30pm day of vaccine). The fever is accompanied by chills. I have aches in my legs, neck, arm, and lower back (I?m supposed to have my period soon, so it?s possible that the back pain is not vaccine related). I have a headache that has persisted since about 11:30 am. I have not taken any medication. I would say on a pain scale of 1-10, the pain is about a 4 (quite uncomfortable but bearable).
I received my 4th dose of the covid vaccine on 5-6-22 at ~1100 ET. At ~1630 I had a bout of odd vocalizations, an abnormal feeling, and gross motor symptoms of flailing of my head and extremities. I was AOx4 the entire time. This resolved after a few minutes and recurred again at 1645 to a lesser extent. After those two events, there were no further occurrences and I felt normal after ~ 15 minutes. I remember all the events in their entirety (I was alone at the time, but called my parents between the two events to ensure someone was aware). I wanted to report this as I feel it was related to the vaccination (these symptoms have never occurred before in my life). The only other symptom I experienced (which didn't occur until 5/7/22) was muscle soreness and fatigue.
hives, rashes, nausea, entire body dumb, body gets hot, daily outbreak of hives, tightness in chess, heart pounding, numbness around mouth, difficulty focusing, not feeling like myself
PATIENT REPORTED THAT SHE HAD A BUMP AT THE INJECTION SITE, SORENESS AND BRUISING. SHE PRESENTED ON 9/19 AT THE EMERGENCY ROOM WITH REDNESS AND WARMTH EXTENDING DOWN FROM THE INJECTION SITE TOWARDS THE ELBOW. SHE WAS GIVEN MEDICATION FOR INFECTION.
Woke in the night following injection with fever, chills and headache this persisted for approximately 24 hours
Patient stated that she went to church the next morning and became faint, and pale white. She got dizzy and left church early. Complained of left arm pain for 3-4 days.
After the application of the vaccine, it was discovered that I suffer from N-189 chronic renal failure, my treatment is daily peritoneal dialysis to be able to live, and I need a kidney transplant to be able to live.
Individual initially felt fine after receiving the vaccine with just sore arm. 24-hours later on 12/29 around noon she started feeling tachycardic (resting heart rate was 107-125 bpm).  She vomited and felt anxious.  Developed fever of 101.8 and was very achy.  Day 2: low grade fever treated with ibuprofen.  Day 3: fever free but dizzy feeling.  Day 4: symptoms resolved.  Of note, patient was 30 days out from having had COVID-19 at the time of vaccination.  Patient states her course of COVID was "serious" but did not require hospitalization.
Dizziness, Headache, FATIGUE,CHILLS, INTERMITTENT BURNING/SHARP PAIN AT INJECTION SITE THAT ONLY LAST SECONDS Narrative:
Increase heart rate around 3 days after injection Resting heart rate fluctuates between 60s and low 100s Low activity (moving, waking to the restroom) causes heart rate to increase to 100s- mid 100s  11 weeks pregnant at time of first injection  Currently 13 weeks.  Had similar issues with higher rates post Covid Early 2021 following positive covid Nov 2020
This report was received from a pharmacist via Pfizer (manufacturer control number 201582322 and refer to a patient of unknown age and gender. Concurrent or medical conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, strength, route and lot number were not reported). Secondary suspects and concomitant therapies were not reported. The pharmacist reported that patient was administered with the second dose of PNEUMOVAX23 and the patient developed adverse reaction that was redness around the area where it was administered. The outcome of redness around the area was not reported. Additional information has been requested.
blood pressure was 180; woke up and her heart was going bananas; her Red Blood Cells, her HCT, and HGB were all high; her HCT were high; HGB were high; 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-2021268865.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 (Batch/Lot number: unknown) at the age of 75 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sensitive to caffeine" (unspecified if ongoing). The patient took concomitant medications.The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 10Mar2021, outcome "unknown", described as "blood pressure was 180"; HEART RATE ABNORMAL (non-serious) with onset 10Mar2021, outcome "unknown", described as "woke up and her heart was going bananas"; RED BLOOD CELL COUNT INCREASED (non-serious) with onset 10Mar2021, outcome "unknown", described as "her Red Blood Cells, her HCT, and HGB were all high"; HAEMATOCRIT INCREASED (non-serious) with onset 10Mar2021, outcome "unknown", described as "her HCT were high"; HAEMOGLOBIN INCREASED (non-serious) with onset 10Mar2021, outcome "unknown", described as "HGB were high". The events "blood pressure was 180", "woke up and her heart was going bananas", "her red blood cells, her hct, and hgb were all high", "her hct were high" and "hgb were high" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated that she took her Blood Pressure pill before she went, but the only other medication she took was her Cholesterol pill that evening, and both of those, the patient had been on for year. Patient had no idea if this was from the shot or not, but she was sensitive to things and any change in a medication like a change in the fillers of a pill, can cause a reaction. And she drank coffee and she was so sensitive and does not drink caffeine that much. Patient had no other vaccines on the same day as the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician via a company rep, and a nurse concerning a female pt in her early 50's, with unk medical history and unk drug reactions/allergies, who on approx 15Nov05 was vaccinated (route unk) with a dose of pneumococcal 23v polysaccharide vaccine (651523/0604R). On approx 16Nov05 (in the same week) the pt developed cellulitis involving the whole arm. There was no medication given. The pt was instructed to apply hot or warm compresses. Outcome unk. The nurse could not provide additional details. However, she reported that the office would keep track of additional reactions involving pneumococcal 23v polysaccharide vaccine. The doctor also re-trained staff on how to store and administer the vaccine. Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Left arm at the injection area has been sore since injection.  Soreness felt when moving arms in all movements.
Influenza vaccines rec'd 10/18/07 and 11/20/07. 3 mos later developed Guillain-Barre syndrome/was hospitalizsed for acute lower extr. weakness.  5/19/09 hospital records received DOS 2/13/08 to 2/18/08. FINAL DIAGNOSIS: Acute lower limb weakness, possible Guillain-Barre Syndrome. Post vaccination: Choking episode, weakness and inability to bear weight on lower limbs. Fails to sit up or crawl. Otitis media. Decreased tone and power lower limbs. Biceps/triceps reflexes weak. Absent patellar reflexes. Weak ankle reflexes. Tachypnea, limp 3 doses of intravenous immunoglobulin.  7/7/09 Medical records received DOS 11/20/07 to 3/30/09. Assessment: Acute infective polyneuritis, Guillain-Barre syndrome. Patient presented with absent knee, achilles reflexes and absent superficial reflexes of feet. No rolling, no tactile sensation back. No weight bearing on legs, falls forward when sitting. Keeps legs extended, scissoring. Gradual improvement of neurological findings. Left side of gluteal fold 2 inch erythematous ring surounding pustule.
Varicella - Information has been received from a physician concerning a 7 year old white female who on 18 Apr 2000 was vaccinated with the first dose of varicella virus vaccine live sc in the left deltoid lot 631065/04453 .  The reported stated that on 19 Apr 2000 the patients was exposed to wild type varicella by her brother who had devloped wild type chicken pox and chicken pox is going through the school right now.  On 10 Apr 2000 the patient developed chicken pox with multiple lesion (> 100) with fever for 2 days.  the patient sought unspecified medical attention on 10 may 2000 the patient recovered.   also reported was the patients sister who was vaccinated and experienced similar evernts (waes 00030236.)
Non Viable Vaccine Administered with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a other health professional on 05-Nov-2020 via email. This case involves patient of an unknown demographics who had non viable vaccine administered (wrong product administered), while he/she received vaccine influenza usp trival a-b high dose subvirion vaccine [fluzone high dose] (QIV 120-65 ) of 1 dose via unknown route with batch number : UJ541AA and expiry date: unknown  for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event Wrong product administered (latency: unknown).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: 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 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..
On the inside of his elbow on both arms he has a red spot; red spot itches; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (On the inside of his elbow on both arms he has a red spot) and RASH PRURITIC (red spot itches) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced RASH ERYTHEMATOUS (On the inside of his elbow on both arms he has a red spot) and RASH PRURITIC (red spot itches). At the time of the report, RASH ERYTHEMATOUS (On the inside of his elbow on both arms he has a red spot) and RASH PRURITIC (red spot itches) outcome was unknown.            no concomitant drugs were reported. no treatment drugs were reported