chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient got a third dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) (batch number 7M7E5, expiry date 26th May 2023) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 07-Jun-2022 Reporter's Comments: Pharmacist reported that a patient got a third dose of Shingrix. The vaccine administration facility was the same as primary reporter. The agent did not ask if follow up was ok. Additional Supportive Information: The patient received 3rd dose of Shingrix vaccine, which led to extra dose administered.
1-12 hour mark : soreness at the injection site, headache  12-24 hour mark: soreness at the injection site, slight headache, exhaustion.  24-32 hour mark: soreness at the injection site, exhaustion, slight headache, brain fog.  32 hour mark: I began having HSV OB prodromal symptoms. I upped my acyclovir.
Five days after vaccinations, patient reported sensation of throat tightening and cheek swelling. BENADRYL was given, no adverse symptoms during follow up exam that day (8/8/18). Doctor that examined pt said unlikely it was due to vaccine reaction.
immediate 2 cm diameter wheal at injection site within minutes of injection; tenderness; redness at site of injection
hard time walking; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (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: GAIT DISTURBANCE (non-serious) with onset 31Mar2021, outcome "unknown", described as "hard time walking". Additional information: The patient called and stated that he got the first dose on 12Mar2021 and he will be having the second dose today, 31Mar2021 but he mentioned that when he woke up, he felt bad because he was having a hard time walking and might not able to attend the second appointment. He wanted to know if he can reschedule the second dose of the vaccine appointment if possible.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Didn?t have my period for 99 days. Typically a 33 day cycle.
Patient received immunization on 6/22/04, MMR and Varivax. ON 6/30/04, low grade temperature up to 101. 7/1/04: temperature up to 103-106 degrees F. Only anti-pyretes used focus of injection. Developed generalized maculopapular rash 7/3/04. Afebrile.
Arm extremely sore, ran fever for 4 days, arm became red for 3 days and now a knot has formed. Received both flu shot and pneumonia shot in the same arm.
Body ache; Bad headache; Chills; Pregnant at the time of vaccination?: Yes; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported) via an unspecified route of administration on 15Apr2021 (at the age of 30-years) as dose number unknown, single for COVID-19 immunisation. Medical history was not reported. Concomitant medication included quetiapine fumarate (SEROQUEL) for an unknown indication from an unknown duration. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021, at 16:00, the patient had experienced bad headache, chills and body ache. The patient received the vaccine during pregnancy and hence there was maternal exposure during pregnancy. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of adverse events. The outcome of the events, bad headache, chills and body ache was resolved with sequelae on 15Apr2021.   The lot number for [BNT162B2], was not provided and will be requested during follow up  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Remove Ethnic Group since not provided in source 2. Event description updated as Pregnant at the time of vaccination?: Yes 3. Update final sentence as The lot number for [BNT162B2], was not provided and will be requested during follow up
Patient reported more pain in right arm initially in right arm vs left arm.  By 11/07/19 there was swelling , redness and warmth moving about 4 inches from deltoid towards the elbow.  Swelling was reduced but patient saw PCP on 11/08/19 and was given the diagnosis of cellulitis and prescribed cephalexin.
After both first and second doses I got large boils in strange places on my body. Top of foot, side of thigh, back of hand. The second dose gave me a boil on my left side that stayed under the skin and hurt very badly. It required antibiotics to clear up. Also received an ultrasound test on it.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Medium
32 hours of vomiting, fever, chills, body pain, headache and tired.
Sever redness and swelling the next morning after vaccine was received. Injection site hot to the touch. Swelling continued to increase, covering the majority of my upper left arm. Center, injection site, bright red with swelling around the area. A knot formed at injection site. Area still hot to the touch for over a week after vaccine was received.
Localized swelling and redness. Then numb tongue itching and redness and hives.
COVID positive; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (COVID positive) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID positive). At the time of the report, COVID-19 (COVID positive) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.
vomiting after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting after 2nd dose) in an 18-year-old male patient 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 an unknown date, the patient experienced VOMITING (vomiting after 2nd dose). At the time of the report, VOMITING (vomiting after 2nd dose) outcome was unknown. Not Provided          No concomitant medication was provided by the reporter. No treatment information was given by the reporter   Reporter did not allow further contact
Abdominal cramping and diarrhea for 24 hours. Not reported to clinic for two months.
1/27/2021 & 1/28/2021: severe aching leg muscles; fever;  chills; headache; lightheaded; fatigue 1/28/2021 to now: extremely sore bicep & pectoralis major muscle under armpit
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided. On 05-SEP-2017, the patient was vaccinated with expired dose of ZOSTAVAX 19400 PFU vial, lot # M032651 with expiration date on 15-JUN-2017 for prophylaxis (dose, route and site of administration were not reported). Concomitant therapies included sterile diluent (MRK). There was no adverse effects reported.
I experienced chills, fever, horrible joint pain and muscle pain. I also had the worst diarrhea for days. I went to see my PCP where lab work, stool sample, liver function test and flu test was performed which were negative. After two weeks I had a UTI, but think it was from all the diarrhea I experienced. A Covid-19 test was performed which was negative.  I also received Iv fluids due to my dehydration. I missed two weeks of work due to my symptoms.
a nurse administered an Act-Hib vaccine which was reconstituted with sterile water instead of the provided 0.4 percent saline; Initial information received on 22-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old patient who was administered a 0.5ml fourth dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] which was reconstituted with sterile water instead of the provided 0.4 percent saline lot UJ119AA, expiry date: 11-Dec-2020  via intramuscular route in the right vastus lateralis on 21-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and HEPATITIS B VACCINE (HEPATITIS B VACCINE).  It was an actual medication error due to inappropriate reconstitution technique.  Adverse event was not 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.
Fatigued has been off and on to non-stop,  frequent headaches, chills, worst muscle all over my body(constricted non stop. Today is the worst.
1 hour, 45 min after vaccine: Difficulty swallowing. Tightness in chest noticed: symptoms worsening, eyes scratchy and blood shot. Dr.'s office said go to ER 3:00 pm (2 1/2 hr later) vomiting continuously. I was given BENADRYL IV, NaCl 0.9%, ZOFRAN. Stopped vomiting (approximately 3 1/2 - 4 hours) later. Throat symptoms reduced but didn't go away for 10 hours from onset. Tightness in chest reduced approximately 5 hours from onset. Headache 2 days continued from onset of reaction. Blood shot eyes and scratchy eyes cont. 2 days from onset. I was seen by MD at ER.
My lymph nodes in my neck are still enlarged as of today's date 12/13/21.  Left side lymph node is still slightly tender.
Rash around injection site. (R) deltoid under arm and chest, raised area (appears as contact dermatitis) 24 hours after shot Loradine and Benadryl.
Gave shot, pt said burned while injecting. Blood came out when needle came out about .25cc. Pt came back 1/2 hour later said itching & has latex allergy. Allergy not on form. Answered no. Showed her vinyl gloves, no latex syringe & called company. No latex in stopper. Gave her 2 x 25 mg diphenhydramine. She left 5 minutes later once no latex, but still itchy.
Bruised at injection site, itchy rash, red warm to touch, swollen localized by injection site just below injection site
Day after 2nd shot I had most all my covid symptoms (heavy fatigue, brain fog, bad constipation, stomach pain.  severe joint pain that moves all over my body.  5 plus nights get chills and bad head fever.  My breathing progressed worse as time went on and was hospitalized 7/1/21 with covid pneumonia,  they worked hard and got it controlled fast and was released late 7/2/21.  Now I am working from home on oxygen and quarantined.
Patient received Tdap and MENACTRA. Shortly after he became diaphoretic, pale and had a syncopal episode. Helped client to seated position, head between his legs. Felt better after 15 min. Left with mother.
11:07am - Pt complain of SOB/HA  BP 148/92  Tightness/congested. Pt has not eaten all day. States allergic to memoryfoam Refused txor emergency service. 11:16a - same sx + throat feel hot. 11:30a - BP 135/103 (72) refused tx. Thinking of going to ER w/ help from friend. 11:40a - HA worsens SOB same. 11:44a - 137/104 (79) 11:48a - called ambulance. 12pm - EHT check BP 188/132 (85) No Hives, will monitor for 10-20 min. 12:21p - Pt was released to go home. Sx stabilized.
Eye floaters; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW6199) via an unspecified route of administration in the left arm on 04Mar2021 at 17:00 (at the age of 59-year-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Mar2021, the patient experienced eye floaters. The patient did not receive any treatment for the event. The clinical outcome of the event eye floaters was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
The patient awoke the next morning with a red swollen itchy wheal at the injection site.  The wheal slowly expanded until she presented to the pharmacy after her dr appt on Monday 1/25.
Given  patient First dose of Pfizer at  5:25 pm  on 4/08/21  after 5 minutes  patient  had difficult breathing . told patient  to lie down gave epipen and called emergency number
1.  Very sore arm diminishing over 36 hours    2.  diarrhea around 36 hours after    3.  mildly lethargic for about 4-5 days    4.  Mild headache for about a week.    5.   after one week a large red, itchy, swollen area appeared at the injection sight (approx. 2" x 4") reduced over 12 hours to small area swollen and red at injection sight and that still exists 2 weeks later.
nurse gave 1/2 of unual dose for hep b & checked w/pharm to see if drugs were compatible pharmcist said they were;Hep B & hep B mixed together & given same time;
Fussy infant, fever up to 102.  I saw the child 3/1/2011.  Had OM again and is treated with Septra susp.  Had red indurated area approx. 1 inch across at the injection site.
pt recv vax & exp rheumatoid arthritis p/vax in 1990;MD reported 2 patients;they were assigned WAES95030732 & 95030733;no further details were provided;
Injection site has a black round spot/bump from vaccination; Injection site has a black round spot/bump from vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old male patient received BNT162b2 (BNT162B2), on 11Jan2022 as dose 3 (booster), single (Lot number: 331308A) at the age of 16 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Lot Number: EW0182, Anatomical location: Right arm), administration date: 02Jun2021, when the patient was 15-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, Lot Number: EW0167, Anatomical location: Right arm), administration date: 12May2021, when the patient was 15-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious), VACCINATION SITE MASS (non-serious) all with onset 11Jan2022, outcome "not recovered" and all described as "Injection site has a black round spot/bump from vaccination". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site discolouration, vaccination site mass.  Additional information: The patient did not have any medical history or allergy. The patient did not have covid prior to vaccination. It was unknown if other vaccine was administered in four weeks. In two weeks, other medications were not administered. On 03Jun2022, the patient was tested for covid post vaccination (Nasal swab test) and at home test done. The result of test was negative.
Headache, Fever, 48 hrs of fever, HA,back pain, myalgias, and fatigue occurred 24 hrs post vaccine. Narrative: 48 hrs of fever, HA,back pain, myalgias, and fatigue occurred 24 hrs post vaccine. Employee was off work or he would have missed work.
hives; itching all over her body; This is a spontaneous report from a contactable consumer.   A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Left Arm on 17Mar2021 16:00 (Batch/Lot Number: EP7534) as SINGLE DOSE (at the age of 51 years) for covid-19 immunisation.  Medical history included mycotic allergy from an unknown date, seasonal allergy from an unknown date ( Grass/ Weeds allergies), allergy to animal from an unknown (various animals), asthma from an unknown date, sinusitis from 2021 to an unknown date, fruit allergy from an unknown date (she has had reactions to strawberries, apples, basically every fruit  except bananas). Concomitant medications included loratadine (LORATADINE) taken for outside allergies; triamcinolone acetonide (NASACORT) taken for sinus infection and budesonide, formoterol fumarate (SYMBICORT) taken for asthma.  Patient states that she started immunotherapy around Oct2020 and gives herself unspecified "allergy shots" every other day. Dr. did not know how they would interact with Covid vaccine and sent her a letter advising her to stop allergy shots 48 hours before and 48 hours after receiving Pfizer COVID-19 vaccine, which she did. She started taking her allergy shots in 16Feb2021 and had no problems, no hives, no reactions, no itching until she got the Pfizer COVID-19 vaccine.  The patient experienced hives on 18Mar2021 with outcome of recovering and itching all over her body on 18Mar2021 with outcome of not recovered.  She had hives on her feet, neck, and legs. Therapeutic measures were taken as a result of hives and itching all over her body.  She has taken Calamine lotion, oatmeal baths, and Benadryl (not brand name) to treat her symptoms. She has seen a doctor who prescribed steroids to take. She was prescribed Prednisone 20mg tablets twice a day on 13Apr2021. She states her doctor advised her to take a break on the allergy shots since on prednisone. She does have an Epi pen but didn't feel any kind of respiratory distress, she did not feel she needed to use it. No additional vaccines administered on same date of the Pfizer product.  No other vaccines were given within 4 weeks of the Pfizer product. She states on 07Apr2021 she was supposed to get her second Pfizer COVID-19 vaccine, but she was advised not to take the second dose by her MD. She never had a reaction to any vaccination, and she has had unspecified pneumonia and flu vaccinations.  No follow-up attempts are possible; No further information is expected.
p/vax 10/99 pt exp uncontrolled movements, described as tonic-clonic, resulting in biting tongue & loss of consciousness/memory;next day exp another episode;to ER hosp overnocfor observation;given MRI & neuro exam;
Rash, sore arm, chills headache, Nausea, stomach ache,
Pain at the injection site right after vaccination.  Localized swelling,  tender,  warm,  without erythema; oval shape, about 2x4 inches diameter - noted 2 hrs after the vaccine. Transient macular rash on upper chest / neck, and mild generalized pruritus - during evaluation (2.5-3 hrs post vaccine).
2-26-14 Red and raised rash; prior to date somewhat sensitive. 2-27-14 Blistering rash site of injection, 1 spot on her side. 2-27-14 Prescribed triamcinolone cream 0.1% twice daily. 3-6-14 Rash area is smaller, raised at site blisters did not break open or scab.
Developed mono and was out sick and laying on bed for over a month.  Could not work.  Mostly slept all day, all night.  Also developed chronic Fatigue syndrome.  And many many many allergies.  Prior to this vaccine series I had no allergies!  I believe my liver was also damaged due to this vaccine.  I have a hard time digesting many foods.  It has been a very long road to finding recovery.   I sought treatments with drs and none could help me.
This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received PREVNAR 13 via an unspecified route of administration in the arm at a single dose in Oct2018 for immunization. The patient's medical history was not reported. Concomitant vaccine include influenza vaccine (manufacturer unknown) via an unspecified route of administration in the arm at unknown dose in 01Nov2018 for immunization. It was reported that 9 days after pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) vaccination, the patient was vaccinated with flu shot in the same arm, almost same spot. On an unspecified date, the patient reported pain on the injection site and trouble moving her arm. The outcome of the events was unknown. It was reported that the patient attributed that events to pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). Information on the batch number has been requested.
This spontaneous report as received from a health professional refers to a 12-month-old patient (gender was not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient brought in a copy of discharge instructions from a urgent care visit. Patient went to the urgent care center and was diagnosed with skin infection (cellulitis) around the injection site. Patient was prescribed cefprozil on discharge and was instructed by the urgent care center to follow up with PCP especially if redness does not get better or gets bigger in 3-4 days.
Swollen lymph nodes left armpit, pain along arm, some pain in jaw Extreme tiredness, lots of naps, bit of brain fog
Red, warm, indurated, itching area at injection site, 2x3 inches. Although not reported to VAERS at the time, this also occurred after receiving pneumococcal 13 vaccine on 06/30/2016.
Patient was given Pentacel with an expiration date of 5/4/2023.  Patient tolerated well, no signs of reaction noted.
Pt completed Engerix-B series 912JUL90, 16AUG90, & 25JAN91; titers w/in last month (?APR92) & were found to be neg;
I HAVE BLUE TOES , SOMETIMES BLUE FEET AND SOME BLACK DEAD SKIN ON THE TOP OF ONE TOE