chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortly after administration of immunization, child developed an erythematous eruption of face and trunk.  The exact time course is not clear from the history.  According to mother, patient has had similar skin eruptions prompted by eating eggs.  The family did not report this to us until 1/28/2011, when the child was evaluated for an unrelated problem and was noted to have the rash, which was resolving spontaneously per family.
Sweat through about three changes of clothes.; Felt extremely feverish.; Had chills for the whole day; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 24Mar2021 at 15:30 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to dust mites. Concomitant medication included clindamycin/tretinoin (MANUFACTURER UNKNOWN) via topical route for unspecified indication and unspecified birth control medication (MANUFACTURER UNKNOWN); both started from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 03Mar2021 at 15:30 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 10:00, the patient felt extremely feverish and had chills for the whole day. The patient also experienced sweating through about three changes of clothes. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of the events feverish, chills and sweating were resolved on an unspecified date in Mar2021.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # M031651, expiration date: 30-MAR-2018, dose, frequency and route were unknown) for prophylaxis. The ROTATEQ was exposed to 31 Fahrenheit degree or colder for a time frame of 13 hours. Data logger was involved. No adverse effects reported. Sender's Comments: US-009507513-1707USA010905.
This spontaneous report was received from a medical assistant and refers to a 4 year old patient of unknown gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On 21-MAY-2018, the patient was vaccinated with improperly stored dose of PROQUAD, lot# N035173, expiration date 09-JUN-2019 (strength, dose, frequency and route of administration were not provided) for prophylaxis. Concomitant therapies included sterile diluent. The vaccine underwent temperature excursion on a freezer. The dose of PROQUAD was exposed to a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit during a time frame of 15 minutes, which was detected by the data logger. There was a previous temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 minutes. No adverse effects were reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1805USA010447: US-009507513-1807USA001194: US-009507513-1807USA001195: US-009507513-1807USA001196: US-009507513-1807USA001198: US-009507513-1807USA001199: US-009507513-1807USA001200: US-009507513-1807USA001201.
Suspected vaccination failure; shingles; painful; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. Years before the date of reporting, the patient received shingles shot at the drug store and had shingles. The patient stated that you do not want them as they are painful. The would not be able to afford one now. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
1441Feeling flushed, denies dizziness BP 167/97, HR 115, sats 97%, Resp 16 First vaccine no Htn Hx.1451 feeling resolved. BP 129/79, HR 83 sats 98% Resp 16 1457 Left ambulating accompanied by husband
Within 45 minutes of getting the vaccine she started having a fast, racing heart beat.  This reaction lasted for about 15 minutes.  She has had no other reactions since the vaccine, no fever, headaches or anything.  This episode only happened once, and has not returned.  She laid down and it stopped.  She spoke with her allergist today while getting her allergy shot who told her to report the reaction to us.
I had the sore arm after 12 hours. Started running fever 102.8 then 103 for three days joint pain all over my body that was so severe you couldn?t touch me, for several days, headache, facial twitching, blurred vision, I
A rash on the back of his arm. I noticed it on 3/16/23. It spread down his arm and was just monitoring it with cream. It started spreading down his fingers. Doctor's ran the wrong test. The doctor said it looked like shingles.  He never said it hurt but that it was just itchy. They tested for herpes but they said it was shingles.  Every time they ran test they messed up on it.
6 hours later got chills body aches, headache, felt hot, difficultly sleeping, fatigue
I woke up the morning of 01/12/2021 unable to turn my head to the left. Any quick or sudden movement to the right was extremely painful. I took Tylenol 500mg and used Bengay cream on my neck with no relief. I saw my doctor at 0945 that morning. He prescribed Norco, flexeril, and diclofenac. By 1/13/2021 I was able to turn my head ¾ of the way to the left but still have pain. By today, 01/14/2021, I am able to almost completely turn my head but there is still pain, however it is improving and I have increased range of motion.
Presented to pharmacy at 11:25 am on 9/1/2015 with large, hot, red area at administration site. Pt was directed to go to physician and received BACTRIM DS.
swelling on his lower gums; sensitivity to his teeth; redness on his gums; This is a spontaneous report from a contactable physician (patient). A 67-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284), via intramuscular route of administration on 14Jan2021 at 12:40 at 0.3 mL, single in the deltoid left for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140) on 23Dec2020 at 0.3 ml IM injection for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021, the patient experienced swelling on his lower gums in the front of his mouth and sensitivity to his teeth, no other symptoms. The swelling gums went away, it was mild and it went away. A few hours after, there was redness on his gums, no drainage or anything and then the teeth sensitivity went away through the day. He was wondering if those things have been associated with the product or maybe just a coincidence. The patient recovered from the events swelling on his lower gums and sensitivity to his teeth on 15Jan2021 while unknown for the other event.
This report describes the occurrence of hives in a male infant who was vaccinated with Infanrix. This report was received from the subject's mother and has not been verified by a physician or other healthcare professional. The subject reportedly experienced hives following each injection of Engerix B, (please see report A0388123A). Concurrent conditions and medications were not specified. On an unspecified date, the subject received his first injection of Infanrix. At an unspecified time post-immunization, the subject reportedly developed hives. The mother reported that the subject developed hives after each subsequent injection of Infanrix. The mother stated that the subject was evaluated by a dermatologist, who reportedly "suggested" that the subject "might have a reaction to the vaccines." Treatment and outcome of the hives were not reported.
Patient complained of redness around injection site on the arm that PREVNAR was injected in. She said it was a little itchy at first and then the redness started. She presented to pharmacy to show us. Her arm is red from lower shoulder and half way down her upper arm. Very red.
On Sunday 08Aug2021 my right arm, shoulder & forearm was very sensitive to touch.; On Sunday 08Aug2021 my right arm, shoulder & forearm was very sensitive to touch.; My right arm, shoulder & forearm was stiff/Still sore & stiff; On Sunday Aug. 8, 2021 my right arm, shoulder & forearm was very sore,/Still sore; My arm aches at night before & during bedtime.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Aug2021 12:00 (Lot number: EW0173) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NAPROXEN; ACETAMINOPHEN taken for pain, start date: 07Aug2021, stop date: 22Aug2021. Past drug history included: Acetaminophen, start date: 17Jul2021, stop date: 20Jul2021, notes: Reason for Use: pain, Route: oral. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot number=EW0173,, dose number=1,, vaccine location=Left arm, Route of administration:Intramuscular, No events reported), administration date: 17Jul2021, when the patient was 51 years old. The following information was reported: HYPERAESTHESIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 08Aug2021 09:00, outcome "not recovered" and all described as "On Sunday 08Aug2021 my right arm, shoulder & forearm was very sensitive to touch."; ARTHRALGIA (non-serious) with onset 08Aug2021, outcome "not recovered", described as "On Sunday Aug. 8, 2021 my right arm, shoulder & forearm was very sore,/Still sore"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 08Aug2021 09:00, outcome "not recovered", described as "My right arm, shoulder & forearm was stiff/Still sore & stiff"; PAIN (non-serious) with onset Aug2021, outcome "not recovered", described as "My arm aches at night before & during bedtime.". Therapeutic measures were not taken as a result of hyperaesthesia, pain in extremity, arthralgia, musculoskeletal stiffness. Therapeutic measures were taken as a result of pain.   Additional information:The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.List of any other medications the patient received within 2 weeks of vaccination as Naproxen 500mg.Prior to vaccination,the patient was not diagnosed with COVID-19.Since the vaccination,the patient has not been tested for COVID-19.Known allergies was None.Other medical history as None.  Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.  Follow-up (24Sep2021):This is a spontaneous follow-up report from a contactable female consumer reported that,Concomitant drugs,past drug history and product route of administration was added.  No follow-up attempts are needed. No further information is expected.
lot number AS1412B expired today but website said May; lot number AS1412B expired today but website said May; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT EXPIRATION DATE ISSUE (lot number AS1412B expired today but website said May), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (lot number AS1412B expired today but website said May) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT EXPIRATION DATE ISSUE (lot number AS1412B expired today but website said May), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (lot number AS1412B expired today but website said May) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT EXPIRATION DATE ISSUE (lot number AS1412B expired today but website said May), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (lot number AS1412B expired today but website said May) and NO ADVERSE EVENT (No adverse event) 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 considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT EXPIRATION DATE ISSUE (lot number AS1412B expired today but website said May) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (lot number AS1412B expired today but website said May).    No concomitant product was reported. No treatment information was reported. Reporter enquired about expiration date of lot number AS1412B, said it expired today but website said May. She wanted clarification about the Moderna primary series blue top vial with magenta label/stripe.
expired dose of infanrix was administered to a patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 7-month-old male patient who received DTPa (Infanrix) (batch number J947T, expiry date 30th May 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th June 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 14th June 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's comments: The health care professional reported that a dose of Infanrix was given to the patient and it was already expired. The reporter consented to follow up.
Rec'd shot 2/07/14 - Pain started 2/08/14 and has persisted until the present - feels like she can't lift her arm up - It is a deep pain that sometimes radiates to elbow and down to her wrist - taking Ibu around the clock.
patient received Pfizer  vaccine for his first dose and was mistakenly given Moderna for his second dose. no adverse effect reported.
indication: Treatment of COVID-19; indication: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 25Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovering" and all described as "indication: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative, notes: Tested Negative for 3 days after finishing 5 day TX. But symptoms returned and Tested positive on day 4, 5 6. Post Paxlovid TX; (Jul2022) positive, notes: Tested Negative for 3 days after finishing 5 day TX. But symptoms returned and Tested positive on day 4, 5 6. Post Paxlovid TX; (Jul2022) positive; (Jul2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes treatment with Paxlovid from 17Jul2022 to 22Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt has a low grade fever, pale skin and uncontrollable crying for 1wk.
Information has been received from a nurse via field representative concerning a 21 year old female patient. There was no concurrent condition, medical history or concomitant therapy reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot# and dose not provided) intramuscularly and she completed the series of the vaccine in approximately June 2011 (reported as five years ago). In approximately 2016 (reported as recently), test showed that she was positive for HPV. The outcome of the event and causality were not reported. Additional information has been requested.
10:50 am: received vaccination, no adverse events immediately afterwards, went back to work. 9pm: felt ill, took temp., temp was 98.6. Then felt nauseous, went to the bathroom to vomit. Felt faint, sat with head between legs for 1 minute, then passed out on the floor. Woke up 30 seconds later and vomited. Still felt lightheaded 10 minutes after adverse event. Called EMS and went to Emergency Room.
3 weeks after varicella administered-abscess with 6x8cm cellulitis (onset 17 days after vaccine) and 10 incidental mild varicella eruption-trunk.
Within a few minutes of receiving the Janssen vaccine, patient became sweaty and lightheaded, then  an additional symptoms of blurred vision. Shortly afterwards  he gagged and coughed and slouched in chair and  passed out for less than 30 secs  then became alert .  Comfort measures of damp cloth on forehead and neck were used as well as giving patient water ..  He had a designated driver  and was walked to the car for safety precautions
Got the shot and got sick; This case was reported by a consumer and described the occurrence of sickness in a 73-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient had shingles on the whole right side of head into the neck). Previously administered products included Shingles vaccine with an associated reaction of illness (patient received 1st dose on an unknown dose and got sick, refer linked case US2021AMR197141).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had shingles in the past for almost a year on the whole right side of head into neck which felt like it divided the head in half. The patient was vaccinated with 2nd shot of vaccine and got sick. The patient does not take any kind of medicines presently and it worried them as per their current age.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR197141:Same patient, same reporter, same suspect, different dose (1st dose)
The day of the second shot (07JUN2021@11AM), my son complained his arm was sore and was not feeling the best but was eating, drinking, and seemed fine.  The next day (08JUN2021 @10AM) my son came down from his room to eat breakfast and still was not feeling the best but seemed fine after eating.   Around 12PM my son came down the stairs to get some water in the kitchen and then shortly thereafter after passed out, fell against the wall and slid down to the floor.  I was in the location and found him unresponsive, very cold, and eyes looking straight ahead -not moving.       My older son and I then carried him to the couch where I laid him down and elevated his feet. He started coming around approx. two minutes later and broke out in a sweat but also had chills.  At that point, I did not call an ambulance and started to hydrate. After an hour or so, he started feeling better and then ate some food but was weak most of day and rested.  The next day he seemed fine.
A bump and a 3 inch rash at the site of administration of the vaccine; A bump and a 3 inch rash at the site of administration of the vaccine; This spontaneous case from  was received on 24-Sep-2020 from other non-health professional via The Agency (reference number: SEQW20-02263) and concerned a patient of an unknown age and gender.  The patient's medical history and concomitant medications were not reported.   On 17-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 283849 and expiry date was 30-Jun-2021.   On the same day, after receiving Flucelvax QIV, the patient developed a bump and a 3-inch rash at the site of administration of the vaccine. The patient did not receive any treatment measures associated with the events.  On an unspecified date in Sep-2020, the patient recovered from the events.  The reporter did not provide a causality assessment to Flucelvax QIV.   The case was assessed as non-serious.  This case is linked to cases 202004678, 202004696, 202004697, 202004698, 202004699, 202004700, 202004701, 202004702, 202004703, 202004704 and 202004705  due to the same reporter.  Additional non-significant information received on 06-Jan-2021 from other non-health professional via The Agency (reference number: SEQW21-00065) with additional information received on 12-Jan-2021 from other health professional (reference number: SEQW21-00149) (being processed together): Two reporters were added. Reference numbers added. No changes in narrative.  Company comment: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed vaccination site rash and vaccination site mass. The patient's medical history and concomitant medications were not reported. Chronology is plausible. Causality is assessed as possibly related for both events.; Sender's Comments: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed vaccination site rash and vaccination site mass. The patient's medical history and concomitant medications were not reported. Chronology is plausible. Causality is assessed as possibly related for both events.