chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hepatitis A vaccine given mistakenly. Patient will come back for HIB vaccine. Low grade fever resolved with Tylenol. No swelling, no pain, no redness. Patient is ok per mom.
Full body itchiness 9/19/2022. Swollen hives from the neck down. Continued overnight, felt better the next day but still fairly swollen.  Self treated with Benadryl and cold shower
Baby cried and held her breath after vaccine, lasted few seconds. Couple of mins later, in the waiting area, her body turned blue and limp as per mom for a couple of seconds. Baby was brought back to the examining room. Exam and vital sign were normal at that time.
Information has been received from an investigator concerning a 2 month old female who received her first dose of Prevnar on 4/2/02 as part of a post-marketing safety surveillance trial. She also received her first dose of Hib-Titer, IPV, and DTaP that same day. On 4/3/02, she was seen in emergency room/physician's office for an unconfirmed possible non-febrile seizure event characterized by 5 episodes of arching of back and extension of all extremities, with no jerking, eye rolling, vomiting, post-ictal state, or known reflux. Physical examination was normal. She has since recovered and has had no recurrence. The child's experience was considered medically important. The investigator assessment of these events was unknown. (OMIC)
fever above 101, rash that extended from mid torso down to legs, lasted about 2 weeks
PATIENT SAID DEVELOPED A DOZEN ULCERS IN HER MOUTH AND THROAT. SHE WENT TO HER DENTIST WHO GAVE HER A DEXAMETHASONE MOUTHWASH THAT SHE USED FOUR TIMES DAILY. SHE ALSO DEVELOPED COLD SORES WHICH SHE USED ABREVA FOR.
This spontaneous report as received from a certified medical assistant refers to a 23 year old patient of an unknown gender. Medical history and concurrent conditions were not provided. The reporter stated that the patient was administered 5 doses of GARDASIL on the following dates: On 26-AUG-2008, first dose of GARDASIL (dose, route, lot number and expiry date were not reported). On 03-NOV-2008, second dose of GARDASIL (dose, route, lot number and expiry date were not reported). On 03-SEP-2013, third dose of GARDASIL (dose, route, lot number and expiry date were not reported). On 09-JUN-2014, fourth dose of GARDASIL (dose, route, lot number and expiry date were not reported). On 30-OCT-2014, fifth dose of GARDASIL (dose, route, lot number and expiry date were not reported). No adverse effect reported. The outcome of the events was unknown. Additional information has been requested.
Fever rising to 103, severe fatigue, joint pain.  Minor discomfort in left arm at site of injection as well as swollen lymph nodes in left armpit
unprovoked DVT of Right lower leg; This is a spontaneous report from a contactable physician. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in Arm Left on 15Apr2021 14:00 (Batch/Lot Number: ER873I) as 1st dose, single for covid-19 immunization. Medical history included Crohn's, HTN and ADHD. Concomitant medications included spironolactone and alfetamine aspartate, alfetamine sulfate, dexamphetamine saccharate, dexamphetamine sulfate (ADDERALL).CHLORPERAZINE EDISYLATE]) and experienced allergies. The  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took prochlorperazine (COMPAZINE [PROpatient experienced unprovoked DVT of right lower leg on 23Apr2021 08:00. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of unprovoked DVT of right lower leg including Xarelto 15 mg bid. The outcome of the event was not recovered.; Sender's Comments: The reported deep vein thrombosis leg was more likely an intercurrent disease, and less likely related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
He woke up the next morning with soreness and redness at the site of the injection (Left Deltoid). He had a doctor appointment that morning for an unrelated situation and the MD told him it looked like cellulitis and that he should go to the hospital.
Leg cramps, body pain and headache started when I woke up at 5:30 am. Weird vivid dreams (after trying to go back to sleep) along with shooting pain through my legs. When I got up at 8 am, I felt it was like a cold without any of the nasal issues. Symptoms persisted until I took ibuprofen at 10 am. The symptoms continued throughout the day but were faintly noticeable even up until I went to sleep. The second day I woke up at 10 am with symptoms of few leg cramps and a small headache. Not nearly as bad as the first day.
Patient had a red puffy "knot" that spread to her elbow as well. It was warm to the touch and partially resembled a bruise.
Suicidal thoughts; Numbness; Tingling; Anxiety; Depression; Insomnia; Anger outbursts; leg weakness; Still had some trouble walking at times; would forget what was working or go to the bathroom; So tired when walking; This is a spontaneous report from a Pfizer-sponsored program. Social Media Platforms from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 24Apr2021 at single dose, dose number unknown for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had leg weakness, numbness and tingling; insomnia; suicidal thoughts; anger outbursts; anxiety and depression. And patient would forget what was working or go to the bathroom, then came sit at desk, and then not remember what was doing. On 24Jun2021, things got a lot better. Patient still had some trouble walking at times. Patient just get so tired when walking. Outcome of events "had some trouble walking at times" and "tired when walking" was not recovered, of the other events was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
9cm X 5cm firm, fluctuant swelling on right thigh with surface erythema. No marked tenderness.
Second dose is worse than the first dose; her husband have the same event like sucker punch at his injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient (reporter's husband) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Second dose is worse than the first dose; her husband have the same event like sucker punch at his injection". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101116868 Same reporter/drug, different patient;US-PFIZER INC-202101116861 Same reporter/drug, different patient
I ended up with shingles 2 weeks after my second shot; This case was reported by a consumer via (facebook)interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but captured as adult as per vaccine indication. The patient ended up with shingles after the 2nd dose of Shingles vaccine. The patient stated that they told him/her that there was no connection between the vaccine and event and to get well soon, shingles was not for sissies. The information regarding consent to follow up was not reported.
Pulse rate 150/min; I felt warm on my left arm and whole back; tremors; Blood pressure check 150/89; This is a spontaneous report from a contactable Nurse (patient herself). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0217; Expiration date: unknown) an unspecified route of administration, administered in Arm Left on 15Jun2021 13:15 (Batch/Lot Number: EW0217) as single dose for COVID-19 immunization. Medical history included drug hypersensitivity. Concomitant medication included vitamin NOS (MULTIVITAMINS ) taken for an unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. It was reported that within 20 minutes after the vaccination on 15Jun2021 13:30 she felt warm on left arm and whole back, tremors. blood pressure checked and it was 150/89 and pulse rate 150/min. The adverse event resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events as patient received treatment with pepcid, cardiac monitoring and chest x-ray. The patient underwent lab tests and procedures which included blood pressure measurement: 150/89 on 15Jun2021, on Jun2021 cardiac monitoring, chest x-ray results not reported and heart rate: 150/min on 15Jun2021. The outcome of events was recovering.   Further information has been requested.; Sender's Comments: Based on strong temporal relationship, a possible causal association between the event "tachycardia" and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
1st occurence: Left collarbone, shoulder and armpit pain. Burning/ throbbing pain that lasted 12 hours.  Nothing helped - OTC pain relivers, heating pad, BIO-Freeze, Cold pack, hot shower, cold shower, movement Extreme pain that caused sleeplessness   2nd Occurrence on 6/25/2021 Same symptoms as above - nothing helped. Extreme burning/ throbbing pain  left side of face was swollen and skin near collar bone was swollen - this lasted 2 days after pain stopped  Still experience soreness in shoulder
24 hours after TDaP, felt achy-especially in back and had fever (exact temp unknown)and chills.  Two days later, developed migrane headache and itchy rash, mostly across chest.  Rash was little pink bumps that still looked pink two days later but not raised.  Migrane and rash lasted 2 days. At injection site, arm swollen, tender, warm and remained warm for 4 days.  Client did not associate ill feelings with vaccine until she looked at side effects sheet 2 days later and noticed she had many of them.  She did not require MD treatment.
On July 20, the day after the vaccination, my son experienced general tiredness and pain in his arm.  He spent most of the day sitting around and reading/watching tv.  Around 5:00 PM, he mentioned that he felt like his heart was beating fast even though he was sitting on the couch.  He took some deep breaths and seemed better.  He didn't mention his heart again until the morning of July 23.  He was swimming and I noticed his hand over his heart after he had swum a lap.  I asked him if he was okay and he said he felt like his heard was beating too fast.  Since he had just been swimming, I though it was from the intense exercise.  He rested and seemed better.  Then after going to bed on July 23, he got up to go to the bathroom and told me that he felt like his heart was beating fast when he was trying to go to sleep.  He further said that since the COVID-19 vaccine, his heart hasn't felt right.  After further questioning, he said he had been having similar episodes 2-3 times a day since the vaccine.  I called Health nurse line and was advised to take my son to the emergency room.  We went to Health's Hospital where they checked his vital signs and administered and EKG.  The EKG was normal so my son was sent home with instructions to rest and take fluids.  Assuming no prolonged heart palpitations, we are to follow-up with the pediatric cardiologist on July 25 if the periodic heart palpitations continue.  If he has prolonged heart palpitations, we are to return to the emergency room.
burning sensation on my upper back; prickly feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jul2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BURNING SENSATION (non-serious) with onset 2021, outcome "unknown", described as "burning sensation on my upper back"; PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "prickly feeling".  Additional information: Since the patient received the Covid-19 vaccine (two doses) back in Jul2021, felt a burning sensation on upper back (all the way across from shoulder to shoulder) with a prickly feeling. The skin does not feel hot to the touch. This happened numerous times each day. It lasts for around 20 seconds.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200116511 same reporter, suspect product and AE/different dose;
Patient reported severe redness, swelling and itching at the site by evening to ER at 22:00.  Got Benadryl and ATB from MD 9/02/2003.
TISSUE AROUND INJECTION SITE STARTED TO SWELL SOON AFTER INJECTION GIVEN. BY 8:00 PM 8/9/11, SWOLLEN TISSUE THE SIZE OF A SOFT BALL. MOM TOOK CHILD TO ER AND MD DIAGNOSED AS A REACTION TO VACCINE. GIVEN TYLENOL AND BENADRYL. ARM REMAINS SWOLLEN 8/11/11. SWELLING MEASURES 3 CM X 3 CM. RED AND PAINFUL TO TOUCH. INSTRUCTED MOM TO CONTINUE TYLENOL AND BENADRYL AS DIRECTED BY ER AND TO RETURN TO ER IF PATIENT EXPERIENCES INCREASED SWELLING, PAIN, OR DIFFICULTY BREATHING.
He reported that an administered dose of VARIVAX underwent temperature excursions prior to being administered; no adverse effect; This spontaneous report as received from a physician refers to a patient of unknown age. The patient's concomitant medications, pertinent medical history and drug reactions/allergies was not provided.   On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S012036, expiry date: 17-APR-2021, strength, dosage information, route were not reported) for prophylaxis. The vaccine underwent temperature excursions prior to being administered to the temperature and time frame of 8 fahrenheit (F) for 40 minutes (product storage error). The previous temperature excursion was 14 F for 30 minutes. Data logger was involved. No known adverse effects were reported. No further information was reported. The outcome of product storage error and no adverse event was unknown.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER8727), in arm, on 10Apr2021 as dose 2, single (Lot number: EW0162), in arm and on 15Oct2021 as dose 3 (booster), 0.3 ml single (Lot number: FD0810) at the age of 58 years, in arm for COVID-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19.
99.8 fever/for 2 days/not hungry or thirsty/ broken sleep pattern cold clammy skin when fever broke Runny nose & eye not wanting to be comforted by touch,especially back and head  Childrens Motrin given/fluids and food wanted after fever broke/wet cloth to clean eyes
hot flashes, persistent fevers, headaches and arm pain with general fatigue and myalgias for several weeks and the hot flashes and fatigue lasting months ( through office visit 5/13)
Reaction after one and half weeks at vaccine site. Red, swollen, itchy, painful. This is after initial pain in arm went away.
Arm swelling, erythema, induration, pain - clearly demarcated cellulitis.
Injection pain, redness; under arm pain;  fever -100.7; headache; body aches; chills;  Rotating Tylenol/Advil for 24 hours.  Still have headache, under arm pain and injection redness/pain at 48 hours after injection.  Fever, chills, aches resolved ~ 36 hours after injection.
In order experienced: 1) muffling effects in ears 2) head ace 3) rash and ich on ears (both,  worse on right) 4) sore spot across forehead, center/right 5) rash and ich on throat and neck (right side)
Right arm swollen, red, and hot to touch. Patient is unable to lift right arm. Very painful.
Pain in left arm at injection sight.  Mild pain when lifting left arm and when I move it back.
8:45am wife notified RN that pt was having a reaction. Clients symptoms: pale cyanotic, cold, clammy to touch. BP 62/50. Epinephrine  1:1000 0.5 cc given SP, REV BP 106/52 AP 56 Irreg, resp 21 shallow. 911 called previously did arrive and clients care was turned over to EMS. Client was transported to hosp ER to care of DR. Client was admitted to hosp for evaluation.
Patient called the store around 6 PM complaining of hives after vaccine administration. Patient denied any signs of difficulty breathing or swelling of airway. Pharmacy manager counseled to administer Benadryl and report to nearest emergency room if symptoms continue to progress. Pharmacy manager attempted to call the next day to check in on the patient, but the patient was unavailable.
This case involves a cluster of 4 patients (a mother and her 3 sons). This case represents one of the 4 patients (the mother). The other 3 patient are captured in case numbers 2012-09094, 09095, and 09096. Initial report received from a company representative who provided a link to non-scientific news report on 26 September 2012. On the same date, another company representative provided additional information obtained from an internet source that is maintained by the patient and her husband. A female consumer, who is the mother of 4 children (3boys, 1 girl), had received a PERTUSSIS VACCINE (manufacturer, date, route, site of administration not reported) and later developed whooping cough. She first noticed a cough in her 4-year-old son who was reportedly lacking one dose of PERTUSSIS vaccine because of his age and vaccine schedule. Because the patient's 2-year-old daughter was undergoing chemotherapy, the patient and her 3 sons went away for a family vacation, to avoid the risk of her daughter getting sick. The patient and her 2 older sons (ages 7 and 9) quickly came down with nagging coughs that wouldn't go away and seemed to be getting worse. After approximately 2 weeks, the 4-year-old son developed a cough where he was gasping for breath during coughs and he would turn blue, vomit, and dry heave. The next day, the family presented to the pediatrician and asked for a pertussis test (unspecified). Her 4-year-old son was diagnosed with pertussis and the whole family was treated with antibiotics (unspecified). according to the blog posting on 14 September 2012, the patient and her 9-year-old son were reported to have a lesser, but still nasty, cough while her 7-year-old son was doing great. The patient had not received the recommended booster shot for pertussis, but her 7 and 9 year old sons were up-to-date on their vaccines. Outcome was not reported. Documents held by sender: None.
COVID-19 Infection; symptoms began 22 April, Swabbed positive 27 April. Direct contact to infant son who tested positive day before.
Death Narrative:  95 yr old Renal failure, renal anemia, Died on Hospice service. No vaccine complications reported.
Varicella - Information has been received from a physician concerning a 6 year old female patient who on 25 sep 1995 was vaccinated with the first dose of varicella virus vaccine live (site unknown) on 21 apr 2000 the patient developed breakthrough chickenpox with vesicles noted on the patient's trunk.  She sought unspecified medical attention.  On an unspecified date the patient recovered.  No further information is available.
2 days after vaccine was given, patient went to emergency room because arm was red, swollen, hurt, and couldn't move it. Doctors said she had cellulitis and gave her a weeks supply of antibiotics. One week later antibiotics finished and arm looks like there is a bruise.
Patient became nausea dizzy sweaty.  Blood pressure was checked and apperared to be elevated at 168/98, pulse was 71 and o2 was 97.  patient requested that he wanted to go to er so was sent via ambulance to Medical Center.
TINGLING IN FEET; TIGHT MUSCLES/TIGHTNESS IN LEGS; PAIN IN LEGS; WEAKNESS IN ARMS; TORSO FEELS STIFF; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-JUL-2021, the subject experienced torso feels stiff. On an unspecified date, the subject experienced tingling in feet, tight muscles/tightness in legs, pain in legs, and weakness in arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in feet, and tight muscles/tightness in legs, and the outcome of pain in legs, weakness in arms and torso feels stiff was not reported. This report was non-serious.
Rash spreading inferior from injection site, with rash at injection site slightly raised.  Entire rash appx 1.5"x1.5"; raised rash area within larger rash appx 1" wide, 0.5" high/tall.