chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician and described the occurrence of unresponsive to stimuli in a 3-year-old male patient who received BEXSERO. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced unresponsive to stimuli (serious criteria GSK medically significant), injection site pain, injection site swelling and somnolence. On an unknown date, the outcome of the unresponsive to stimuli, injection site pain, injection site swelling and somnolence were unknown. It was unknown if the reporter considered the unresponsive to stimuli, injection site pain, injection site swelling and somnolence to be related to BEXSERO. Additional details were provided as follows: Patient's previous vaccination included 1st dose of BEXSERO. Right after vaccination with 2nd dose, of BEXSERO, the patient experienced pain, swollenness of the injection site, somnolence and non responsiveness to external stimulus. Further follow up would be requested.
On May 6th I started having congestion, headache, runny nose, and cough. I had a fever of 101 only for one day. I took Paxlovid.
Received MMR shot on 1/16/09. Diagnosed with measles on 1/15/09. Broke out entire body with red bump. Fever up to 105. Irritable. Rash and symptom lasted 5 days.
hot; red; Rash on left arm that is itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (Rash on left arm that is itchy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029120A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical History reported).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (Rash on left arm that is itchy). At the time of the report, VACCINATION SITE WARMTH (hot), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (Rash on left arm that is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Laboratory details provided. No concomitant information was reported. Treatment information was not reported.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I am currently nursing. My 3 month old infant who has gone to no outside locations has developed 101 F fever
feeling tired; achy; chills; This is a spontaneous report from a contactable consumer (patient), reported for himself. A 67-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on 30Sep2021 as dose 3 (booster), single for COVID-19 immunization. Medical history included cardiac amyloidosis from an unknown date and unknown if ongoing (Takes Vyndaqel (tafamidis) for cardiac amyloidosis, otherwise healthy and active). Concomitant medication included tafamidis meglumine (VYNDAQEL) taken for cardiac amyloidosis, start and stop date were not reported. Historical vaccine included dose 1 and dose 2 (Lot number was not reported), received on an unknown date in 2021, for COVID-19 immunization and experienced fatigue, pain and chills, after first and second dose. On an unspecified date in 2021, the patient experienced feeling tired and achy with chills for 24 hours after receiving third dose. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
The patient reports that she had a lot of pain, itchiness on the arm at the vaccination site with swelling and redness (almost the size of a small hand). She also reported that she had a headache. She took acetaminophen for the pain and used ice and Vicks on the arm. We encouraged her to visit the doctor but she specified that she feels better and for the time being she won't go.
This spontaneous report as received from a license practical nurse (L.P.N.) refers to a 13 year old patient. The patient's medical history was not reported. On 13-AUG-2014 the patient received a dose of GARDASIL (Lot # J006850, exp. date 31-MAR-2016; dose and route were not reported) that were exposed to a supported temperature excursion. No adverse experience has been observed or reported. Also, it was reported not all doses with this lot # were affected by the temperature excursion, it was not known which clients received the affected doses. None of the clients have reported an adverse event from receiving the vaccine. This is one of several cases from the same source. Additional information has been requested.
Client stated she experience a low grade fever until the 2nd week of November. Experienced "horrible muscle pain all over by body" 10 days after vaccination. Hx: sclera derma last orthostatic injection 9/30/25.
605PM MMR adm RA resulting in lg red hive @ site; MD notified; 610PM epi ordered, lungs clear, no resp distress @ this time per MD exam; 613PM epi administered per MD; 617PM circumoral cyanosis & dusky skin color noted; O2 given to ER;
This is patient's first Moderna shot. Patient was given the vaccination by our trained technician and was instructed to sit for 15 minutes post administration to make sure patient tolerates the vaccine. Approximately 10 minutes after the shot, patient's friend came to get our attention to come take a look at his friend. The patient was stated he was dizzy and that he was cold, however there were perspiration on the patient's forehead. We grabbed water for the patient and a fan to give patient a cool breeze with his feet on a stool to help with elevation. We came to check on patient a few minutes later and he was not feeling dizzy anymore but stated his throat hurts but cannot confirm if he has anaphylaxis. Pharmacist asked patient a series of questions such as what are you feeling? Can you breathe or do you have a hard time breathing? Patient stated he has a hard time breathing but clearly can breathe although with difficulty. It was hard to determine if patient was having a hard time breathing due to panic or his throat closing up and/or both. EMS was called and patient was taken by EMS at approximately 11:56am. No epinephrine was administered as anaphylaxis shock cannot be determined and EMS did not give epi pen either upon arrival. Pharmacist asked his friend if he has a primary care physician to send a copy of this report to and his friend stated he doesn't think patient has a primary care. Patient was too stressed to be able to answer a lot of questions
Dizziness roughly 3 hours  after injection that lasted for ~2hrs. Ongoing headaches for 3 days straight.  Migraine and light sensitivity 2 days after vaccine for the entire day.  Followed with a severe migraine later that evening leading to extreme nausea and vomiting.
Case number PHEH2013US023968 is an initial spontaneous report received from a pharmacist on 12 Nov 2013. This report refers to a 74-years-old male patient. His medical history and concomitant medications was not reported. He was vaccinated with an intramuscular dose of FLUVIRIN (batch number: 1309301) on an unknown date. It was reported that 8 hours after vaccination, on 11 Nov 2013, he experienced pain inside his mouth. The event outcome was reported as condition unchanged.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 28-OCT-2015, the patient was vaccinated with an improperly stored dose of MMRII (lot # K024036 exp date 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
The patient developed a fever of 101.8F the evening after receiving the vaccine, 06/18/2001. The patient's fever was 103.9F the next day, 06/19/2001 and 106.4F on 06/20/2001.
PT. HAD SWELLING IN THE LEFT THIGH AND KNEE THAT IS RED AND HOT TO THE TOUCH.
Severe (ongoing) skin reaction (like chicken pox).  Several weeks now with ongoing eruptions.
Pt complained of L upper arm pain starting the day of vaccination. On 8/18/2017, she started to notice redness and warmth to anterior and lateral aspect of left upper arm.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 28-DEC-2017, the patient was vaccinated with expired dose of ROTATEQ, orally for prophylaxis, lot # M019708, expiration date 25-OCT-2017. No adverse effects were reported.
I contracted COVID-19 on 08/15/22 with symptoms of fatigue, headache, body aches, and slight cough. I was not prescribed any medication during my initial illness. I was ill for 4 days before my symptoms began to improve. I had a lingering cough that persisted for 6 weeks, and I was prescribed benzonatate by my PCP. I am now fully recovered with no lingering symptoms.
This spontaneous report as received from a nurse refers to a patient of unknown age, who on an unknown date was vaccinated with a dose of PNEUMOVAX23 (lot#, dose and route not reported) that was 20 days past expiration date. No symptoms reported. Additional information has been requested.
Mother states date of #2 HBV child started having a rash on face, chest and back.  This rash lasted for 6-7 days.  She denies any other problem and did not bring him in for medical evaluation and treatment.
Fever 103.5-101 x 3 days; headache, chills, muscle aches, earache, swollen glands, sore throat (severe), cough & erythema of face.
Pt recvd flu vax & 4 days later the pt claims to have devel GBS; This report was recvd as result of legal proceedings; No further info is known;
Developed sparse varicella rash, no other sx.  Treated symptomatically w/ Benadryl.
Pt received PREVNAR 13 on 4-25-16. She returned to the office with a large red and swollen area on her upper left arm just below the injection site. Pt treated with BENADRYL 25 mg q 6 hrs and KEFLEX 500 mg BID.
Dose 1 received on 17Nov2021 and Dose 2 not received; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Dose 1 received on 17Nov2021 and Dose 2 not received) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 prophylaxis.     The patient had no allergies to medications, food and other products. The patient had no acute illness at the time of vaccination and up to one month before. The patient had no chronic or long-standing health conditions.  Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT) for an unknown indication.    On 17-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Dose 1 received on 17Nov2021 and Dose 2 not received) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Dose 1 received on 17Nov2021 and Dose 2 not received) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (Dose 1 received on 17Nov2021 and Dose 2 not received).    Patient reported no adverse event.  Treatment medications were not reported.   This case was linked to MOD-2022-665491 (Patient Link).
This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (173415). A 36-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 36, single dose,  for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for immunisation. The patient experienced vaccination site discomfort (arm soreness after Pfizer COVID-19 vaccine), with outcome of unknown. Additional information: Other medications (including over-the-counter medications, nutritional and herbal supplements, etc.), past medical history, family history, social history (including occupational history, use of alcohol, tobacco, or recreational drugs) and other relevant information: Unknown. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Long lasting symptoms headache, soreness, weakness, chills.  5 days since injection...  Moderna.. do not know the lot number..
Pt reported temp 100.4 overnight and tenderness at site.  Upon assessment--Erythema and warmth noted at injection site. No edema, eccymosis, or pain upon palpation. Vital signs WNL.
Headache; Tired; This is a spontaneous report from a Pfizer sponsored program .  This consumer (reporters mother) reported for a male patient (son). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller reported that her son, the patient, took both doses of the Covid-19 vaccine with very minimal, usual side effects. Caller declined to complete safety report. Caller reported that the patient experienced just the usual, expected side effects. Caller reported that the patient had a headache and was just tired. The event seriousness could not be specified by reporter. The outcome of the event was reported as unknown.  Information about lot/batch number has been requested.
Became dizzy, shaking, pale white, drop in pulse and BP, stomach pain, shortness of breath, disorientation, hearing loss, red vision, panic attack. Was monitored after code blue was called. Given water and rested while monitored. Fine for the rest of the day.
9/9/90-seizure like activity lasted 20 minutes, taken home from school. 9/14/09-seizure like act.,lasted 40 minutes,taken by squad to ER found out that Hemaglobins were 8.0 and she now had severe iron defiency anemia,and released. 9/21/09-chest pain/ER visit released. 9/22/09 seizure like act. for 2 hrs.-squad to ER and Admitted for 4 days. 10/1/09-seizure like act, lasted 2 1/2 hrs.squad to Er admitted 3 days. 10/2/09-seizure like act.lasted 45 min. in hospital. 10/28/09-seizure like act.-last 3hrs. taken home. 12/27/09-seizure like act,trouble breathing, ER visit released. 1/2/10-seizure like activity, stopped breathing, CPR performed,paralises for 15 minutes, Squad to ER/released. 1/14/10-seizure like act,trouble breathing,tubed because oxygen level below 70%,squad to ER/transported to another hospital admitted and released after 1 day.
A non-serious spontaneous report of FLUMIST given to patients greater than 49-years-old was received from a physician concerning a 57-year-old female. As per the reporter, there was inadvertent administration of FLUMIST to two patients who were more than 49-years-old. On 03-Nov-2010, the patient received FLUMIST. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Patient developed redness, swelling two days after injection, went to emergency room 07/21/2006, diagnosed with reaction versus cellulitis on Ancef, seen in office 07/22/2006. 8cm by 10cm mildly erythematous area.
Fever, generalized vesicular eruption. Still symptomatic. Antipruretics used.
Bell's Palsy; This is a spontaneous report from a contactable consumer (patient).   A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 22Sep2021 10:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE, vaccinated at the age of 32 years old, for covid-19 immunisation. Medical history included penicillin allergy, covid-19. There were no concomitant medications. Patient received the first dose of bnt162b2 on 01Sep2021 10:00, at the age of 32 years old for covid-19 immunisation. The patient experienced bell's palsy on 24Sep2021 with outcome of not recovered. The event was reported as serious with criteria medically significant. Event resulted in Doctor or other healthcare professional office/clinic visit and treatment included Steroid  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
pt recv vax;devel gen rash consisting of approx 36 scattered papules,some w/ vesiculation of varying sizes on chest,hand & neck;
inflamed arm; quite sick; This case was reported by a nurse via sales rep and described the occurrence of inflammation localized in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced inflammation localized and sickness. On an unknown date, the outcome of the inflammation localized and sickness were unknown.   It was unknown if the reporter considered the inflammation localized and sickness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient after vaccination had really inflamed arm and was quite sick.
This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician) from medical information team. Other Case identifier(s): US-PFIZER INC-202101206131. A 21-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 13Sep2021 (Lot number: FE3592, Expiration Date: Nov2021) at the age of 21 years as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ACCIDENTAL OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 13Sep2021, outcome "unknown" and all described as "Received entire vial of undiluted Covid-19 vaccine"; VACCINATION SITE PAIN (non-serious) with onset 14Sep2021, outcome "recovered" (2021), described as "arm soreness at injection site"; DIZZINESS (non-serious) with onset 14Sep2021, outcome "recovered" (2021), described as "slight dizziness". The events "arm soreness at injection site" and "slight dizziness" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination site pain, dizziness. Additional information: A patient yesterday was given the vaccine. Caller initially stated, today they realized that the health assistant did not dilute it and drew from the vial the 0.5ml from the vial and administered to the patient. Patient Details: Age of onset: 21 years 11 month. Event Details: Caller later clarified the patient did not receive 0.5ml from the vial that was undiluted. She clarified it was the entire vial, so whatever that would be. The health assistant decided to give it to the patient. She is a new employee and still needed to go through the training. Nurse seeking guidance for a dose of the Pfizer Covid-19 Vaccine that was administered to a 21-year-old female patient yesterday. The dose was undiluted, and the entire volume of the vial was administered. Patient was given full vial of undiluted Pfizer Covid-19 Vaccine. Patient came in next day for office visit. Symptoms noted were arm soreness at injection site and slight dizziness. Follow-up attempts are completed. No further information is expected.
Day #1: sore arm and tiredness Day #2: cancer sore on my tongue Day #3:  Significant pain in my left jaw Significant pain in all of my upper and lower teeth on the left side only The same teeth were super sensitive to cold My left cheek was slightly numb Day #4 (same as Day #3) Day #5 (same as Day #3)
Case number PHEH2014US009685 is an initial spontaneous report from the nurse received on 09 May 2014. This report refers to a 22-year-old female patient. On 02 May 2014, she was vaccinated with RABAVERT (batch number: 5400011A) intramuscularly along with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN). On 05 May 2014, the patient went to the emergency room due to kidney stone. The patient was advised to continue with the RABAVERT remaining doses. The patient was doing fine and was unaware if it was related to RABAVERT. No other information was available.
Patient came up to the counter several minutes after receiving his vaccination and stated he was not feeling well. His face was ashen. I sat down with the patient and asked if he had vomitted. He said No, then stated he was not sure as he thinks he lost consciousness for a minute. He denied any shortness of breath, wheezing, or feelings of numbness or enlargement of his lips or tongue. He then stated he felt like he was going to vomit and did. I took his blood pressure and it was 97/80 with a pulse of 80. He said he did not eat lunch today. He said he has vomitted after having blood drawn before but never after receiving a vaccine, he said he had his seasonal flu shot last year. EMS arrived and checked BP and did an EKG. EKG was normal. Patient did not go with EMS.
This spontaneous report as received from a mother's consumer concerning a 22 year old female patient who was vaccinated with a first dose of GARDASIL at the end of July 2012 (on 31-JUL-2012). No other co-suspects were reported. No concomitant medications were reported. The patient's mother reported that her daughter began suffering from leg pain and bruising two to three days later after receiving GARDASIL. The patient sought medical attention, she was seen in the emergency room (unspecified hospital) and was prescribed ibuprofen for the pain. The mother was hesitant to allow her daughter to receive the remaining shots in the series. Ultrasound and blood works were performed. At the time of the report, the patient's had not recovered from adverse events. The relatedness for leg pain and bruising was unknown for GARDASIL. Additional information has been requested.
Reported soreness 24 hours post, then ring of redness around injection site and rash on opposite arm. Took Aleve to alleviate symptoms . No itching, told pt to monitor, if worsens contact doctor.
Patient had expected reactogenicity (low grade fever, injection site pain) that night, but had severe right knee swelling and edema (site of previous meniscal injury years ago) by day #2.  She was seen by physician on 1/21/2021 and aspirate was drawn with labs and culture pending.  On 1/14/2021 she developed new severe erythema extending from injection site, down left arm and into the left chest pectoral area and up to left neck.  This lasted 2 days and resolved.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (lot #, expiry date, dose and route unknown). The patient developed shingles at an unspecified time after receiving ZOSTAVAX. The outcome of the event was unknown. Additional information has been requested.