chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The medical assistant reported that, on an unknown dates, an unspecified number of patients were administered improperly stored doses of GARDASIL (lot #, expiration dates, doses and routes of administration were not reported). No adverse event were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Rash developed/discovered 8/7 on the arm the injection was injected small papules developed on that arm but not everywhere pt also stated she was on Aldora at the time of injection. No treatment yet.
PATIENT RECIEVED 2ND DOSE IN SERIES 10 DAYS TOO EARLY. PATIENT REPORTED HAVING A 100 DEGREE FEVER, HEADACHE AND CHILLS THAT LASTED FOR ABOUT 2 DAYS. NO CURRENT SYMPTOMS
Not only did I get a reaction on the 17th but also the same reaction today on Jan 20th.  Fever of 101.3 Cold, and tired.  Took 2 tylenol and 2 pm and will take 2 more at 8 PM
Patient tested on 7/15 and found to be COVID negative. Symptoms since 7/8/2021
Pain at the injection side; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Menveo.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Menveo with lots of local reaction (pain) injection site pain.
DON'T FEEL RIGHT; ACHE; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported.  On an unspecified date, the subject experienced don't feel right, ache, chills, and fever. The action taken with covid-19 vaccine  was not applicable. The patient recovered from fever, and had not recovered from don't feel right, chills, and ache. This report was non-serious.
Severe sharp arm pain in upper left deltoid and deeper into the arm. For three days, it was too painful to lift, rotate, or move across my body. Acupuncture gave relief for 2 days so that I could lift it. Pain and ache returned. Ibuprofen and Tylenol do not lessen the pain at all.  Ache-type pain radiates down the arm and across the upper back. For the last 2 days, it hurts whether or not I?m moving it. The vaccine was given far too high in the arm.
1/27/21 "I was working and started to have some adverse reaction. I went to ER with shortness of breath , fever, headache  and some discomfort on my legs. On the 28th , I was still feeling unwell with nausea and fever but no other symptoms"
Pt developed a body rash. Physician diagnosed dermatitis and treated with Benadryl.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: EMS came and treated patient. was evaluated, blood pressure was normal, blood sugar normal. Patient did not go to hospital. Stayed for 10 minutes more and then left
p/vax that eve mom noted fever 103-105;saw FNP 10/13/99;reports FNP noted redness/swelling RAT, fever, red throat & swollen tonsils;also has bright red diaper rash;
This spontaneous report as received from a Doctor of pharmacy refers to a 69 years old female patient with no pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) SQ on 01-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that starting on 02-SEP-2012, the patient began to develop a bulge and itching at the injection site. The patient did not receive treatment for the adverse events. The outcome of bulge and itching at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Fever and lethargy, not feeling normally. Local area of redness/swelling at injection site.
Headache; fever 103; muscle aches; This is a spontaneous report from a non-contactable consumer (Patient). A 64-year-old male patient received second dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an intramuscular route of administration at left arm on 23Mar2021 15:30 as single dose for COVID-19 immunization. Patient had historical vaccine (at 64-year-old) first dose of BNT162B2 at left arm on 02Mar2021 03:30 PM for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's medical history included Cancer. Past drug event of patient was allergies with Penicillin. Concomitant medications included pembrolizumab (KEYTRUDA). On 24Mar2021 17:00, the patient experienced headache, fever 103, and muscle aches. Prior to vaccination, the patient was not diagnosed with COVID-19 and also not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included fever was 103 on 24Mar2021. Treatment was not received for adverse event. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Pt said he is not doing well and is extremely tired and has severe chest pains and a bad cough. Pt has experienced trouble breathing. Pt was admitted to the hospital on 7/15
pt woke up on 05/17/2019 with numbness and paralysis of the lower extremities, pt was taken by ambulance to local hospital, later transported by helicopter to hospital.
During the initial 24 hours following the injection, patient noticed fever of 101F and felt "shaky". Three days later patient noticed rash and pain around the injection site. Went to see PCP and was given course of corticosteroid treatment.
23MAY91 fever 101ax; 25MAY91 fever 103ax; 26MAY91 fever broke; Rash appeared; 28MAY91 diarrhea; MD notifed PAPA given; 29MAY91 recovered;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Ehlers Danlos Syndrome" (unspecified if ongoing); "MCAS" (unspecified if ongoing); "OI" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Allergy:Tetracycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 06Sep2023 to 11Sep2023.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300302455 Same reporter/patient, different drug, different AE;
Allergic reaction; broke out in hives; blood pressure was low; heart rate was pounding; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EN6203), via an unspecified route of administration, administered in left arm on 23Feb2021 (age at vaccination was 71-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included atrial fibrillation (diagnosed two years ago; treated with unspecified medication), arthritis (diagnosed quite a while ago; probably been since the 90s), a lot of allergies (especially food allergies that come on in her 60s, she didn't have many before that, then she got old, and doesn't know what happened. The patient cannot have any dairy products at all and allergic to almost all of it), GERD (gastrooesophageal reflux disease) from an unspecified date on 2000, glaucoma from an unspecified date on 2005, nerve injury (right leg from her right total knee replacement) from 29Jan2008, and generalized anxiety disorder from an unspecified date on 2019. Concomitant medications (other products) were reported none. The patient have not had any other recent vaccinations or started any new medications. On 23Feb2021, the patient experienced allergic reaction (5-10 minutes after vaccination), broke out in hives, blood pressure was low and heart rate was pounding. It was reported that her appointment of vaccination was at 11:15. The patient took two diphenhydramine (BENADRYL) after she broke out in hives, and talked to the nurse who had her go lay down on the cot and took her blood pressure which was low. It was reported that her heart rate was pounding, but she didn't have any way to test that and neither did they. The patient's hives went away after she went home then fell asleep because of the medication and reported that she felt better. The reporter wants to know if she needs to do anything (like take diphenhydramine) before getting her second dose on 16Mar2021. The patient underwent lab test and procedure which included blood pressure with a result of low on 23Feb2021. Therapeutic measures were taken as a result of the events (allergic reaction and broke out in hives) included receiving two diphenhydramine of unknown dose (reported as normal dose that you can buy at the store). The outcome of the event broke out in hives was recovered on 23Feb2021, allergic reaction and heart rate was pounding were recovering while unknown for blood pressure was low.   No follow-up attempts are needed. No further information is expected.
Onset of Shingles approximately two months after second dose of Moderna's COVID vaccine.  I've received both the Zostavax and Shingrix vaccinations for shingles. The two-dose Shingrix series was done in 2018.
Approx 3 hours after vaccine pt reports swelling and tenderness in left axilla.  Also had tenderness at injection site.  Swelling progressively worsened over next 48 hours + was accompanied by nausea and headache.  Felt feverish, but not checked.  Afebrile in office.  Also with left pinky + ring finger numbness.
Patient got shot on 10/8/18. On 10/9/18, by 5pm it was red, hot, hive swollen at the injection site, also swollen throat. Patient took 2 tablets of Benadryl and used cortisone cream. She felt better now as I spoke to her at 3:30PM today 10/13/18.
Feverish feeling not 100% fatigued, hoarse throat with fever.  Occasional cough.  Symptoms similar to flu.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 51-year-old female patient 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.       Concomitant medication information not provided.  No treatment information was provided.
Head and neck aches that forced me to bed with dizziness and nausea   Blurred vision and became light adverse and unable to focus  Arm became incredibly black and blue over next three days and was unable to lift arm above head for days  4 mos post injection 1 i am still feeling as if in a bit of a daze and have headaches which I have never felt before.   Feels almost like have water or fluid on brain...neck always stiff
Again, I am completing this report to update and correct the information I previously submitted in the V-safe app system, to inform that the menstrual cycle anomalies I experienced were NOT associated with the vaccine, but rather symptoms and side effects of what was later diagnosed as endometrial hyperplasia.
Patient stated that after receiving the Tdap injection, he went home and drank a couple beers, ate dinner, then went to bed around midnight. He stated that at 3:00 AM he awoke feeling weak, hot then cold, and dehydrated. He stated that he felt as if he had the flu without vomiting. He stated the symptoms lasted for approximately two days. He stated that he did not seek medical attention, but treated himself by drinking a large amount of water and refraining from alcohol intake.
Pt presented to clinic with fever, chills, site of injection with intense pain, swelling and redness, with right sided body pain and feeling like she has knots to her right arm and right legs.  States she feels like her fingers are cramping up.  Pt also with bilateral wheezing (has a history of COPD).
Information has been received from a health professional concerning a one year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 06-MAR-2007, the patient was diagnosed with chickenpox. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of several from the same source. Further information has been requested.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported.  No treatment information was provided.  Date the vaccine placed in refrigerator was on 18-Oct-2021. No adverse events were reported.   This case was linked to MOD-2022-491837 (Patient Link).
Three days after vaccination went into pre-mature labor called with PProm at 36 weeks 1 day.  Went to ER and they had to Induce labor. Son born at 6 pounds 2 ounces. No previous pregnancies.
Hives immediately after receiving vaccines from waist down, swelling. Given TYLENOL, started resolving 20-30 min afterwards.
Severe chest and abdominal pain never felt before in life. Pain caused difficulty breathing lasting 4-6 hours, fading and remaining uncomfortable for 12-24 hours.
Urticarial rash on same day patient received immunizations as listed: Hep A, Hib, MMR, Varicella, influenza, PREVNAR.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Previously sick with COVID.). Concurrent medical conditions included Sulfonamide allergy (sulfa drug allergy), Allergy to antibiotic (ciprofloxacin allergy), Drug allergy (Celebrex allergy), Contrast media allergy (dye), Iodine allergy (betadyne allergy), Soy allergy, Food allergy (Wheat ), Fish allergy, Shellfish allergy and Bee sting.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 05-Sep-2021, HEADACHE (Headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided
Case number PHEH2015US026840, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 21 year old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 19 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Received just before 1800 10/27/17 - by 1830 local itching at site, erythema, swelling, burning, nausea. 1900 urticaria spreading to torso, neck, scalp. Increased site swelling, erythema, tenderness burning, 2100 - peach sized swelling warmth extending to 3" above elbow.
Nausea, emesis, diarrhea, new onset A. fib RVR, auditory hallucinations
received 2nd dose of Pfizer COVID-19 vaccine @ 1355.  At approximately 1630 began to feel heart racing and lightheaded.  Hear rate in 130's without exertion.   Patient walked over to the ED, heart rate when up to 170's and patient was treated in ED and discharged at approx. 2200.
The day after the vaccine in her right deltoid, she started developing sharp shooting pains in her right shoulder and up to her right neck. 3 days later she developed painful blisters. I diagnosed her with shingles and provided her with 7 days of Valtrex 1g BID and Tylenol #3 for pain. On 8/26/13 she called still with severe pain and I provided her with Neurontin 300mg TID prn pain and more Tylenol #3. I have not heard from her since. She refused to come in because of the cost of the doctor visit, but we did recommend she get seen by a doctor.
Information has been received from a pharmacist concerning a 47 year old male with a history of hepatitis C and drug reactions/allergies reported as none who on 12-OCT-2006 was vaccinated with Pneumovax 23 (lot #653283/0001F).  Concomitant medication was reported as none.  On 12-OCT-2006, the patient experienced fever with a temperature of 101 degrees, 12 hours after immunization with Pneumovax.  The patient also had redness and swelling to their right arm, at the injection site.  The patient sought unspecified medical attention, was hospitalized and treated with ZOSYN, LEVAQUIN and vancomycin.  On an unspecified date, a chest X-ray was performed which showed left lower lobe consolidation.  Subsequently on an unspecified date, the patient recovered from fever with a temperature of 101 degrees, redness and swelling to their right arm at the injection site.  Follow-up information has been received.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  No further information is available.
High fever/ chills to  increased 104.6 on 2nd day , not controlled by 400 g of ibuprofen and 500 mf of Tylenol. Finally additional 500.mg was taken in 4 hrs span to break the fever. Severe body aches and inability to sleep.  Next day was better qith fever only raging to 100 deg. 4rh day,  Monday went to work  feeling very weak.  Passed out suddenly an hour into work,  luckily passed out sitting in chair.  911 was called, all things normal , except weakness,  aching, dizziness,   Declined er transfer.
got her first dose of the Pfizer BioNTech Covid-19 vaccine /Afterward, she breastfed her 14 month old son; got her first dose of the Pfizer BioNTech Covid-19 vaccine /Afterward, she breastfed her 14 month old son; Sore arm; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. This is 1 of 2 reports. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 15Sep2021 20:30 as dose 1, single for COVID-19 immunization. Patient got her first dose of the Pfizer BioNTech Covid-19 vaccine yesterday (15Sep2021) at about 20:30 afterward, she breastfed her 14-month-old son. Around 03:00 he started throwing up.   Stated she got the vaccine yesterday (15Sep2021) around 20:30. Around 03:00 this morning (16Sep2021) her baby started throwing up. Stated she had breastfed him after receiving her vaccine last night. Said she just had a sore arm for herself on an unspecified date in Sep2021. She stated that her son had no symptoms prior to this. The outcome of the event sore arm was unknown.   The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.  Information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101218735 Same reporter/drug, different patient/event (mother/baby case)
local rxn-redness-swelling-itching;30min p/inj;DPH given per MD
Breakthrough case admission after 3 vaccines Pfizer 2/16/2 Lot# EN6200;  Pfizer 3/9/21 Lot# En6207;  PFizer 11/20/21 Lot# 30145BA  THIS IS THE LOT NUMBER LISTED IN THE STATE DATABASE
Problems to sleep because of the rash; Inflamation at the injection site; Rash in whole body; Little fever; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Problems to sleep because of the rash), VACCINATION SITE INFLAMMATION (Inflamation at the injection site), RASH (Rash in whole body) and PYREXIA (Little fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 21-Apr-2021, the patient experienced INSOMNIA (Problems to sleep because of the rash), VACCINATION SITE INFLAMMATION (Inflamation at the injection site), RASH (Rash in whole body) and PYREXIA (Little fever). At the time of the report, INSOMNIA (Problems to sleep because of the rash), VACCINATION SITE INFLAMMATION (Inflamation at the injection site), RASH (Rash in whole body) and PYREXIA (Little fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
CoughWheeze  fatigue, rhinorrhea  Narrative:  Received vaccine on 12-29-20. States on 12-31-20 started having  fatigue, runny nose and some coughing with congestion. Thirteen days later c/o  rash, itching and warmth to site of injection. States no pain unless applying  pressure to site.
Myocarditis. Discomfit and pain have continued intermittently since first Covid vaccination. Often the associated discomfort/pain will also directly precede and then accompany symptomatic expression of any similar illness (minor cold for example) suffered since vaccination.