chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs; a patient received improperly stored vaccine; This spontaneous report has been received from a consumer (office manager in the physician's office) concerning a patient of unknown age and gender.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 09-MAY-2023 the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # w023682, has been verified to be a valid lot number, expiration date reported and upon internal validation established as 21-MAY-2025) for prophylaxis (dose, anatomical location, and route of administration were not reported) (product storage error). The vaccine was stored at a temperature of -6.9 Celsius degrees (C) for 27 hours and 30 minutes and for 20 hours and 30 minutes. It did not suffer a previous temperature excursion.  No additional adverse event was reported.
This is a spontaneous report from a contactable consumer (patient). An 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  via an unspecified route of administration on 03Feb2021 (Batch/Lot number was not reported) as a single dose (at the age of 83-years old) for COVID-19 immunisation.  Medical history included the patient had known allergies (unspecified) and unspecified chronic health conditions from an unknown date.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient was not pregnant. The patient received unspecified concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 15Feb2021 at 13:00 the patient experienced getting out of breath, three blood clots/clots were in my leg heart and lung, and cough. The events resulted in emergency room visit and the patient was hospitalized (from an unknown date) for the events getting out of breath, three blood clots/clots were in my leg heart and lung, and cough for 6 days. The clinical course is as follows: 2 or 3 weeks after the patient got the vaccine she started getting out of breath when she walked. Each day she got worse. Then the patient was taken to the hospital where they discovered the patient had three blood clots. The clots were in the patient's leg, heart and lung. The patient stated the Doctors do not understand where the clots came from. The patient was in the hospital 6 days. The patient stated they are still having breathing problem and still on oxygen as needed and they still cough at night. The patient asked if there have been any other reports of this happening to other people who got the vaccine as the patient never had blood clots before this. The patient underwent lab tests and procedures which included COVID test (nasal swab): negative on 15Mar2021.  Therapeutic measures were taken as a result of getting out of breath, three blood clots/clots were in my leg heart and lung, and cough and included blood thinners and oxygen therapy and complete bed rest. The clinical outcome of the events getting out of breath, three blood clots/clots were in my leg heart and lung, and cough was not recovered.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The pharmacist reported that a patient got the dose Shingrix shot and then experienced shingles. The pharmacist asked how long they need to wait to give her the second shot. It was reported that the patient had been symptom free for 3 days. The reporter did not consent to follow-up.
Shortness of breath, chest tightening onset  approximately and hr to an 1hr and 15 mins after Pfizer  vaccine administered.   Oral steroidal treatment prescribed  Place on prednisone 50mg once a day for a total of 10 days
Tired, Dizzy, Lathargic, Forgetful, Sore injected arm,
Left upper arm was red, swollen, and tender, pt. went to dermatologist and got prescription for MEDROL dose pak.
Burning rash all over face and ears developed 10 days after second shot, on March 19, 2021. Skin burned, got extremely dry, got very itchy. Symptoms continue to this date.
Pleural rub chest pain. Intermittently worse pain around right lung with deeper breaths.  Albuterol inhaler and ibuprofen provides moderate relief of pain, but pain I s interfering with sleep.
Bivalent Covid vaccine administered to patient 7 weeks after 'beyond use date' and therefor dose is not valid. Patient did not have any adverse reactions after vaccine administration.
This spontaneous report as received from a healthcare worker refers to a 51 years old female patient. The patient was vaccinated in unspecified arm with 0.65 ml ZOSTAVAX (lot number 672675/0068AE, expiration date 12-SEP-2013) subcutaneously on 06-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. In approximately September 2012 the patient experienced a "huge water blister the size of a lemon, at the injection site". The outcome of adverse event was reported as recovered. The patient called for office medical attention. Additional information has been requested. This is one of several reports received from the same source.
Pt. came to the clinic on 10/12/2021 with cough and congestion. She tested negative for covid-19. Our Public Health Nurse checked on her on 10/18/2021 saying her cough was worse along with crackles in lower lobes.  Pt. was brought to clinic on 10/20/2021 and tested positive for covid-19.  She was sent to the ER from our clinic due to her low oxygen. She was admitted to the hospital and treated with IV dexamethasone, lovenox and remdesivir. She was discharged from the hospital on 10/22/2021 in stable condition
Bad hives on all over her body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Bad hives on all over her body) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A211A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced URTICARIA (Bad hives on all over her body). At the time of the report, URTICARIA (Bad hives on all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment information was not reported.
3 weeks after getting MMR and other listed vaccines, pt developed fever of unknown origin, that then lead to cellulitis of arm. She was hospitalized and pic line placed and on antibiotics for weeks. However, all of her cultures came back negative for any infection. It was not really reported at the time about getting the vaccines as a cause of the event. However, a few weeks ago, she was diagnosed with mumps. She showed no Ig M to mumps but had parotitis and + Ig G to mumps. Now, due to this infection had made us look back at the time she had the MMR vaccine and possible reason for no response to vaccine. CDC had also been contacted and no reported cases of mumps in our state or surrounding area. Trying to figure out now why pt got mumps and if related to the illness after vaccines and if related to the vaccines now.
Temp 102. Red rash QL LE BK LLE, red hot on RAT. Where Hib given. at 7AM on 8/20/04.
Reported fever of 100.8, nausea, headache, chills, arm pain- which is common reported side effects of vaccine. Patient reported walking up in the middle of the nights gasping for air- short of breath. Only lasted 3 times during the night, no interventions were done. Went away on it's own.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's information on m edical history, concurrent condiitions and concomitant therapies was not reported. On 29-NOV-2017, the patient was vaccinated with RECOMBIVAX HB lot # N009802, expiration date 19-DEC-2019, intramuscular (dose number was not provided) for prophylaxis. The pharmacist reported that, previous to administration, a temperature excursion happened: 11.3°C for 4 hours were data logged. The reporter sated that no previous temperature excursions happened before. The pharmacist did not report any adverse events. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1712USA013995:
Information has been received from a physician concerning a 22 year old female who on 24-JUL-2009 was vaccinated with a second dose of GARDASIL (lot # 659054/0315Y), intramuscularly in her left deltoid. On 20-MAR-2010 the patient experienced Low Grade Squamous Intraepithelial Lesion. The patient's outcome was unknown. This is one of several reports received from same source. Additional information has been requested.
Moderna COVID-19 Vaccine EUA Events: Swollen tongue and throat, difficulty swallowing, lip numbness, rapid heart rate. Treatment: Visit to local Urgent Care facility to treat allergic reaction by receiving a shot of epinephrine, oral steroids, and antihistamine. (2 hours spent at Urgent Care) Outcome: recovered from the allergic reaction
rebound infection/symptoms/test positivity; COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2022 (at 12:00 PM) as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: METFORMIN, start date: 07Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (01Aug2022) and all described as "COVID-19"; DISEASE RECURRENCE (medically significant) with onset 21Jul2022, outcome "recovered" (01Aug2022), described as "rebound infection/symptoms/test positivity". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (21Jul2022) Positive, notes: rebound infection/symptoms/test positivity. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 12Jul2022 to 16Jul2022. Therapeutic measures were not taken as a result of disease recurrence.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: A contributory role of BNT162B2 to event COVID-19 and rebound infection/symptoms/test positivity cannot be excluded based on temporal association and available information.
Pt received small pox vaccine 2/6/08; read 2/13/08 major reaction.  On 2/14/08 noted redness, tender warm area approx 3" diameter surrounding pustule, tender L axilla.  Diag: cellulitis L deltoid secondary to smallpox vaccine.  Rx: Levaquin 750 mg one PO qd #5.  Symptoms resolved after 3 days on Levaquin.
PATIENT FAINTED AT THE RECEPTION DESK AFTER HER VISIT. SHE HAD RECEIVED A FLU SHOT 10-15 MINUTES BEFOREHAND. SHE RECOVERED QUICKLY WITH NO INJURIES. MOM STATES PATIENT HAS FAINTED IN THE PAST WITH IMMUNIZATIONS AND LAB DRAWS. AFTER FAINTING SPELL BP WAS 108/58 AND PULSE 65-PHYSICIAN LOOKED HER OVER AND RELEASED HER TO HOME. SHE DID DRINK A GLASS OF JUICE WHICH SHE SAID MADE HER FEEL BETTER-SHE HAD ONLY EATEN A MUFFIN EARLIER MORNING.
Patient developed herpes zoster approximately 24 hours after being immunized with ZOSTAVAX.
On 7/12/2001 the patient developed redness and swelling at the injection site. The patient was seen in the ER and diagnosed with a local reaction to the vaccination. The patient was treated with Ibuprofen and Benadryl. The patient experience a tympanic fever of 99.8.
A few days after the 2nd shot, fatique set in and continued getting worse as time went on. Finally went to my PCP and he ran tests and I was in kidney failure. This was June 3, 2021. Was on emergency dialysis within 12 hours. I had an AKI. I have neer had any kidney issues ever in my life.
Swollen Lymph Glands, (Swelling, Tenderness, Redness, and pain.) Hives on right side of body to include hands, right arm, and chest.    Personal physician advised to not get the second dose and also to monitor for worsening of symptoms.  Taking over the counter benadryl.
As vaccine was being administered, instantly arm was aching and burning. One minute or less later, my blood pressure dropped very low. The doctor said I was having a vaccine reaction. Every couple minutes either the doctor or nurse was repeatedly taking my blood pressure. I felt like I would pass out. This lasted about an hour and then my blood pressure started to go back up.
Water retention arms, legs ankles, feet, torso, face/fluid retention was travelling from my extremities to my chest/torso and face; I had both legs and feet swell and gained 11lbs in fluid within 4hours of the receiving the Pfizer shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (001774). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 09Apr2021 17:00 (Lot number: EW1051) at the age of 58 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "acid reflux" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing), notes: hypothyroid due to eradiated thyroid; "hypertension" (unspecified if ongoing); "known allergies yes" (unspecified if ongoing), notes: known allergies yes; "immune system is "Overactive"" (unspecified if ongoing), notes: My immune system is "Overactive"; "autoimmune disorders" (unspecified if ongoing), notes: I have been diagnosed with 3 autoimmune disorders in the last 40 years. Concomitant medication(s) included: OMEPRAZOLE; SYNTHROID. The following information was reported: FLUID RETENTION (non-serious) with onset 12Apr2021 08:00, outcome "not recovered", described as "Water retention arms, legs ankles, feet, torso, face/fluid retention was travelling from my extremities to my chest/torso and face"; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "recovered" (2021), described as "I had both legs and feet swell and gained 11lbs in fluid within 4hours of the receiving the Pfizer shot". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fluid retention, peripheral swelling.  Additional information: The patient stated that her immune system is "Overactive" already which is why she have been diagnosed with 3 autoimmune disorders in the last 40 years. This may be why her body overreacted to the shot. The fluid retention was travelling from her extremities to her chest/torso and face. The patient had no COVID-19 prior vaccination. The patient had not tested COVID post vaccination. The patient had known allergies. The patient had not received any other vaccine in four weeks. Patient was received treatment for AE.  No follow-up attempts are possible. No further information is expected.
Inactivated H1N1 vaccine administered on 11/2/09. Symptoms began 24 hr. later-elbows, knees, hands, feet were hurting-no swelling, pain: 5 on 1-10 scale. 11/4 Morning-pain in hands and feet only pain: 2. 11/4 Lunchtime-pain and swelling in ankle to toes and wrist to fingertips-skin red with underlying bruising and pain to a 5. Couldn't walk, couldn't hold pencil, couldn't button, shoes didn't fit. Given BENADRYL, ibuprofen and took her Urgent Care. Redness left hands, feet, legs after medication. Felt at Urgent Care this might be reaction to H1N1. 11/5 Woke with a raised, red strip from eyebrow to lips on R side of face, hive-like. No itching or pain. Resolved with BENADRYL. C/o being tired during last 3 days. No difficulty with breathing, no nausea, no fever.
Immediate pain at injection site which progressively became more sore as the day went on. Pain started spreading to entire arm. By 6:00pm started experiencing headache, chills, low grade fever, tiredness which lasted until the next morning at about 8:00am. Pain in the arm persisted and the injection started started to swell and redden. Redness at injection site continues to expand but pain and swelling has decreased 72 hours later.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 14-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided. The vaccine was administered after 4 days from  time from first puncture.   This case was linked to MOD-2021-332638 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up contains no new information , but the vaccine was administered after 4 days from  time from first puncture was missed and added in narrative
Entire left shoulder area is extremely painful after second shot. Arm cannot dangle; it must always be in propped position.  Pain reliever, whether oral or topical, does not work.  Hot nor cold compresses do not work.  There is marked weakness and range of motion present.  Unable to lie on back or side at night while attempting to sleep.    Extreme tiredness began on second day after first vaccine with lower fever.
Initial unsolicited report received from a nurse on 30 July 2015. A ten years old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of ADACEL (batch number- C4774AA, exp. date: 15 July 2017) in left deltoid and an intramuscular dose of MENACTRA (batch number- U5155BA, exp. date: 13 January 2017) in right deltoid on 22 July 2015. The patient did not have any known allergies. Illness at the time of vaccination was reported as none. On 27 July 2015, five days after vaccination, the patient experienced Bell's Palsy. The patient required emergency room/doctor visit. Laboratory investigations were reported as none. Corrective treatments included Amoxicillin and Prednisone. At the time of this report, the patient had not recovered from the event. Upon medical review, the case was considered as serious due to important medical event: Bell's Palsy. Documents held by sender: none. Follow-up information received from physician on 24 August 2015. It was reported that other vaccination within 4 weeks prior to vaccination, illness at the time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects and medical conditions was reported as mild intermittent asthma. The patient was vaccinated at private doctor's office/hospital and was purchased with private funds. Corrective treatments also included VALTREX. The patient's mother reported that the patient was recovering with some symptoms of Palsy but improvement and was expected to recover over next few weeks.
Initial case was retrieved from the scientific literature on 15 April 2013. Verbatim from the report: "A 31-year-old healthy man developed slowly progressive distal symmetric paresthesias and numbness, poor balance, and gait instability 2 months after influenza vaccine. His symptoms worsened over the following 4 months. At his nadir, numbness affected his hands below the wrists and legs below the knees. Balance was unsteady, especially in the dark. He was not able to run. Walking short distances could be achieved with minimal support but he used a wheelchair for longer distances. Examination was notable for decreased vibration and pin sensation in his hands and feet, areflexia, and mild weakness of toe extension. Gait was slow and broad based. Serum laboratory studies revealed normal vitamin B12, anti-Ro, anti-La, and serum immunofixation. MAG antibodies were absent. Cerebral spinal fluid demonstrated mild albuminocytologic dissociation (protein, 55 mg/dL). NCS showed prolonged distal latency in median, ulnar, peroneal, and tibial motor nerves (30%-50% above upper limit of normal) and median, ulnar, and sural sensory nerves. The F waves were absent (median) or mildly prolonged. Partial conduction block was present in the right ulnar nerve forearm segment (30% amplitude reduction). Martin-Gruber anastomosis was not present. Limb temperature was more than 33 degrees C. Two grams per kilogram of IVIG was initiated 4 months after symptom onset. One gram per kilogram of IVIG was repeated every 3 weeks. Over the following 6 months, symptoms and signs improved. He continued to experience mild intermittent paresthesias in his fingers and toes but numbness resolved. Examination revealed normal perception of vibration and pin in his hands and feet. Reflexes normalized. Gait was narrow, and he could perform tandem gait without difficulty. He was able to resume exercise, and reported running 3 consecutive miles at 8 hours and 30 minutes per mile pace. IVIG was discontinued without relapse in symptoms." The reporter for this case is the same as for case 2013-05405. Documents held by sender: none.
had 101 fever; muscle fatigue; very tired; This is a spontaneous report received from a non-contactable reporter (Consumer).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: unknown), for covid-19 immunization and BNT162B2 (Dose 2, Batch/Lot number: unknown), for covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "had 101 fever"; MUSCLE FATIGUE (non-serious), outcome "recovered", described as "muscle fatigue"; FATIGUE (non-serious), outcome "recovered", described as "very tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received booster dose of Covid vaccine and had 101 fever and muscle fatigue and very tired Symptoms lasted two days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.