chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed vocational nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot# L006386, expiration date 25-FEB-2017), dose and route of administration were not reported. Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter.  Additional information has been requested.
Approx 3 1/2 hrs after receiving PNEUMOVAX pt c/o hives on same forearm & also welts on forearm. Very painful at inj site & pt unable to lift arm.
Information has been received from a physician concerning a 13 month old male who on 03-APR-2006 was vaccinated with a dose of Varivax. On 04-APR-2006 the patient was progressively experiencing difficulty walking, and by 7:30 pm that evening the patient was not able to walk. The patient was evaluated in an emergency room, but it was not specified if the patient was admitted to the hospital. By 05-APR-2006 the patient was improving, and was recovered by 07-APR-2006. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
infant given Fluzone 0.25mg IM which is not indicated for her age. So far no reported adverse reactions. This was given in error
Fatigue  Muscle or body aches  Headache  New loss of taste or smell  Congestion or running nose
2/14/21: 10:30pm - 1:00am chills 2/15/21: 3:00am fever, 102.5 2/15/21: 7:30am and 12:45pm fever, 99.8
Influenza vaccine administered at 2 months age, not due until 6 months age.
Pt had a warm red and painful area at the sight of the vaccine.  She also felt dizzy and nauseated.  The redness was about 4 cm in diameter.
Oth complications following immunization, NEC, init on 2016-09-29.
Some fatigue off and on; Sensation in my left ear; Got  real dizzy, Could hardly get out of bed because I was so dizzy and could not focus my eyes, Severe dizziness; Took temperature 102.5 F; Big rash about size of apple below injection site; Feeling severely cold; I had a terrible bad day yesterday; Mild pain at injection site for two days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feeling severely cold), FEELING ABNORMAL (I had a terrible bad day yesterday), EAR DISCOMFORT (Sensation in my left ear), DIZZINESS (Got  real dizzy, Could hardly get out of bed because I was so dizzy and could not focus my eyes, Severe dizziness) and PYREXIA (Took temperature 102.5 F) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLINDAMYCIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATENOLOL, MIDODRINE and TIOTROPIUM BROMIDE (SPIRIVA HANDIHALER) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced FEELING COLD (Feeling severely cold), FEELING ABNORMAL (I had a terrible bad day yesterday), PYREXIA (Took temperature 102.5 F) and VACCINATION SITE RASH (Big rash about size of apple below injection site). On 18-Mar-2021, the patient experienced EAR DISCOMFORT (Sensation in my left ear) and DIZZINESS (Got  real dizzy, Could hardly get out of bed because I was so dizzy and could not focus my eyes, Severe dizziness). On an unknown date, the patient experienced VACCINATION SITE PAIN (Mild pain at injection site for two days) and FATIGUE (Some fatigue off and on). The patient was treated with MECLIZINE [MECLOZINE] on 22-Mar-2021 at a dose of 1 dosage form. On 07-Mar-2021, FEELING ABNORMAL (I had a terrible bad day yesterday) had resolved. At the time of the report, FEELING COLD (Feeling severely cold), EAR DISCOMFORT (Sensation in my left ear), DIZZINESS (Got  real dizzy, Could hardly get out of bed because I was so dizzy and could not focus my eyes, Severe dizziness), PYREXIA (Took temperature 102.5 F), VACCINATION SITE RASH (Big rash about size of apple below injection site), VACCINATION SITE PAIN (Mild pain at injection site for two days) and FATIGUE (Some fatigue off and on) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Added events mild pain at injection site, fatigue, sensation in my left ear , got real dizzy, could hardly get out of bed because I was so dizzy and could not focus my eyes and severe dizziness, all having outcome unknown.
Information has been received from a physician concerning an 8-month-old female who on 22-AUG-2007 was vaccinated orally, with the "first dose of series" of Rotateq (lot# 656196/0026U).  On 22-JAN-2008 the patient developed intussusception.  On 24-Jan-2008 the patient had surgery.  The patient was hospitalized but the length of stay was unknown.  On an unspecified date, the patient recovered.  No product quality complaint was involved.  The reporter considered intussusception to be an other important medical event (surgery).  Additional information has been requested. 5/2/08-records received for DOS 1/24/08-presented to ED with C/O blood and mucous stool and bilious vomiting times 2 days since 01/23/08.  7/22/08-records received for DOS 1/24/08-exploratory laparoscopy, laparoscopic reduction of ileocecal intussusception.
Severe lymph node swelling under left armpit (left arm injection site), mouth ulcers, thrush/white patches on both tonsils, migraine, fever, nausea, severe fatigue - still continuous 49 hours later (current time)
Small itchy blister/zit like bumps.  Started on back of legs and back.  Now some sporadically showing up on arms, belly, shin.; Small itchy blister/zit like bumps; This is a spontaneous report from a contactable Other Health Care Professional (HCP).  A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/lot number: EJ1685), intramuscularly at an unspecified dose in the left arm on 18Dec2020 at 04:00 (at the age of 48-years-old) for COVID-19 immunization. Medical history included allergy to sulfa drugs from an unknown date and unknown if ongoing. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.The patient was not pregnant at the time of vaccination.The patient was administered the vaccine in the hospital. Concomitant medication included cetirizine hydrochloride cetirizine hydrochloride (ZYRTEC). The patient did not receive any other vaccines within four weeks prior to vaccination.  On 21Dec2020 at 20:15,the patient experienced small itchy blister/zit like bumps which started on back of her legs and on her back.  Some are sporadically showing "now" up on arms, belly and shin.The patient did not receive any treatment for the events.The clinical outcomes of small itchy blister/zit like bumps was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
about 1-2 days after the first vaccine, I was unsble to walk at all. To the point I was literally crawling on my floor. I had a dcotors appt, not sure of exact date, to which I had to use a wheel chair to get in her office.  At the time no one had heard of such an effect so everyone chalked it up to a coincidence. Now I am hearing about people that can't walk and some are even paralyzed.
Information has been received from a LPN concerning a 5 year old male with no medical history who on 08/14/02 was vaccinated SQ in the lower arm with the first dose of varicella virus vaccine live. There was no illness or concomitant therapy at the time of vaccination. The LPN reported that on 11/19/04 the pt developed chicken pox. AT the time of this report the outcome was unknown. No further information is available.
Extremely lightheaded. Vertigo. Confused. Dizzy. Cramps, Shortness of breath, Decreased cognitive function, Swollen lymph nodes,
7:30 am woke up with a throbbing headache (whole head), body aches and nausea .  Injection site aches. Treatment- by self took Aleve 200 mg.
"Following the 4 immunizations, pt sat in chair for a few minutes. Upon standing up, patient lost consciousness & fell. Pt was partially caught by the nurse but continued to fall, striking her head on the edge of the counter. Immediate assistance was provided by nurses and NP. Vitals were obtained smelling salts were used, O2 was administered via nasal canula".
patient received first dose on 23-Jan-2021 and second dose on 16-Mar-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 23-Jan-2021 and second dose on 16-Mar-2021) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 23-Jan-2021 and second dose on 16-Mar-2021). On 16-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 23-Jan-2021 and second dose on 16-Mar-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-435687 (Patient Link).
pt recvd DTP vax on 10SEP92 & on 11SEP92 pt had t104; temp remained between 102 & 104 for 1 1/2 days; 12SEP92 mom states pt was limp & had no feeling in extremities; pt had muscle & joint soreness x 1 wk;
Weakness, extremely tired & nauseated, muscle & joint pain, headache, feeling unwell, lightheaded/dizzy
Vesicular rash; Shingles outbreak; This is a spontaneous report from a contactable other healthcare professional (patient's daughter). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208), via an unspecified route of administration, administered in the right arm, on 12Mar2021, as 1st dose, single, for COVID-19 immunisation; and the second dose of hepatitis B vaccine (trade name unspecified, lot number not reported), via an unspecified route of administration, on 15Mar2021, at an unspecified dose, for immunization. The patient's medical history included hemodialysis from 2016 and ongoing (has been on hemodialysis for maybe 5 years), possible shingles and chickenpox when she was a kid. Concomitant medications were unspecified, there is quite an extensive list of medications (unspecified) the patient is on. It was reported that the patient had the hepatitis B shot too close to the COVID-19 vaccine. On 12Mar2021, the patient received the COVID-19 vaccine. On 15Mar2021, at her dialysis treatment, the patient received the second shot of the hepatitis B vaccine. It was reported as an error as it was administered too close to the Pfizer COVID-19 vaccine. By that Friday, 19Mar2021, the patient had a vesicular rash that the reporter would guess was a shingles outbreak. The patient was taken to her primary doctor for the events. The reporter thought this was related to the patient's immune system dealing with 2 vaccines and the virus had the opportunity. Treatment for the events included a whole course of antiviral (unspecified) which started on 19Mar2021. The patient then received her second dose of COVID-19 vaccine on 03Apr2021 (lot number: ER8732) in her right arm. The dialysis clinic said they would continue to give the next hepatitis B shot and the reporter asked them to hold on while she gets more information. The reporter asked about the implications of receiving the hepatitis B vaccine too close to the first dose of COVID-19 vaccine and asked when they should resume the hepatitis B shots. The patient recovered from the events on an unspecified date (reported as "went away at the end of the 10-day course of the antiviral").  No follow up attempts are needed. No further information expected.
After receiving the vaccine she has been feeling bad side effects; Achy/sore; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (After receiving the vaccine she has been feeling bad side effects) and PAIN (Achy/sore) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 29-Sep-2023, the patient experienced FEELING ABNORMAL (After receiving the vaccine she has been feeling bad side effects) and PAIN (Achy/sore). At the time of the report, FEELING ABNORMAL (After receiving the vaccine she has been feeling bad side effects) had not resolved and PAIN (Achy/sore) outcome was unknown.            No concomitant medication was reported.  Patient felt like she has been poisoned. Patient was a lot worst 3 weeks ago. No treatment information was reported.
he was a little bit swollen; his head was ice cold/his arm was ice cold; he is shaking; I cannot move the legs; been in bed all week; he feels like he is going to pass out; cannot walk,; I ca n't walk I feel weak; becomes hot; nauseous; arm being swollen; painful; still red around where he took the shot; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (he was a little bit swollen), FEELING COLD (his head was ice cold/his arm was ice cold), TREMOR (he is shaking), MOBILITY DECREASED (I cannot move the legs) and BEDRIDDEN (been in bed all week) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 SWELLING (he was a little bit swollen), FEELING COLD (his head was ice cold/his arm was ice cold), TREMOR (he is shaking), MOBILITY DECREASED (I cannot move the legs), BEDRIDDEN (been in bed all week), FEELING ABNORMAL (he feels like he is going to pass out), GAIT INABILITY (cannot walk,), ASTHENIA (I ca n't walk I feel weak), FEELING HOT (becomes hot), NAUSEA (nauseous), VACCINATION SITE SWELLING (arm being swollen), VACCINATION SITE PAIN (painful) and VACCINATION SITE ERYTHEMA (still red around where he took the shot). At the time of the report, SWELLING (he was a little bit swollen), FEELING COLD (his head was ice cold/his arm was ice cold), TREMOR (he is shaking), MOBILITY DECREASED (I cannot move the legs), BEDRIDDEN (been in bed all week), FEELING ABNORMAL (he feels like he is going to pass out), GAIT INABILITY (cannot walk,), ASTHENIA (I ca n't walk I feel weak), FEELING HOT (becomes hot), NAUSEA (nauseous), VACCINATION SITE SWELLING (arm being swollen), VACCINATION SITE PAIN (painful) and VACCINATION SITE ERYTHEMA (still red around where he took the shot) outcome was unknown.            Patient mentioned that no medications outside of Tylenol or Aspirins.  No concomitant medications were provided.   This case was linked to MOD-2021-418188 (Patient Link).
Swollen left eye and rash on right face the evening of vaccination. Took allergy meds and was gone by morning. Four days after the vaccine, I got a hot rash, which was incredibly itchy, on my upper left arm, where I was vaccinated, every evening for about two weeks.
2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch throat; body aches; dizziness; headache; lymp nodes tender; eye swelling; blurred vision; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; tooth pain; jaw pain; i also had leg and bilateral foot pain x 4 days; all my mucos membranes were red, irritated and blistered; all my mucos membranes were red, irritated and blistered; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 19Jan2021 10:45 at a single dose on left arm for COVID-19 immunization. Medical history included allergies: sulfa. Concomitant medication included bupropion (BUPROPION). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient experienced 2 hrs after 2nd injection, 'felt like I was burning from inside out', Skin red, flushed, rash, scratch throat, temp, body aches, dizziness, headache, lymph nodes tender, eye swelling, blurred vision, 'blisters on the trunk of my body as well as lips and gums', tooth pain, jaw pain. All of these symptoms lasted 3 days (as reported), blisters and gum issues lasted 4 days (as reported). Patient also had leg and bilateral foot pain x 4 days. All mucous membranes were red, irritated and blistered. The adverse events were experienced on 19Jan2021 12:30. Therapeutic measures were taken as a result of the events which included Benadryl, steroid injection. The outcome of the events was recovering (as reported). Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship.  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.
temp up & down from date of vax until 17MAR92 when mom found swollen gland neck & temp of 101;
Headache, injection site pain and swelling, redness at injection site, myalgia, diarrhea.
Caller received 1st shot last 11Jan , then on 22Jan she had Covid; This is a spontaneous report from a Pfizer- sponsored program via a contactable non-HCP consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unknown route on 11Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reportedly, patient received 1st shot on 11Jan2021, then on 22Jan2021 she had Covid. She will receive her 2nd dose on Saturday and ask if the intervals for the vaccine should be 90 days or 6 weeks. Especially for those that who had Covid. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Vaccine on 7/29/15-Arm sore on 7/31/15-chills, muscle aches, back ache, chest ache 7/31/15-symptom, improving a little.
Minutes after administration of the vaccine Proquad (MMR and Varicella) this 12 month female experienced projectile vomiting (4-5x), dry heaves, became difficult to arouse and her eyes rolled to the back of her eyes. She was transported to the nearest ER and received fluids, Benadryl oral solumedrol. Admitted for observation. She also experienced several episodes of diarrhea. 06/30/06-3 page office note for date of vaccination 5/10/06, received from pediatrician's office. Documentation of events subsequent to Pediarix, HIB and Prevnar: 2 minutes after injections pt was fussy, alert appeared well hydrated and cardiovascular and pulmonary exams were normal, abd soft, nontender, no redness @ injection site. During injection patient was bottled fed. Discussed with mother that patient likely vomiting secondary to crying or possible new onset virus. Patient had 2nd small emesis, unlikely secondary to injection to occur so fast after the injection and no other symptoms. According to nursing staff, patient worsened significantly in following minutes became pale, limp with continued vomiting. During preparation for transfer to ED physician observed patient to appear pale, limp and appeared to have altered mental status by not responding appropriately to surrounding stimuli.  07/17/06-received lab test result from facility-Sickle Screen:negative.  8/03/06-contacted hospital, no records available. contacted DO office, will fax copy of DC summary to my attention.  8/8/06-DC Summary for DOX 6/23-6/24/06 DC DX: Altered level of consciousness-rule out reaction to immunization.              Vomiting-Rule out viral syndrome             History of trauma 10 days previous-negative CT of the brain. PMH: positive for allergy requiring hospitalization in the past.              CT of brain, toxicology screen, drug screen, CBC and lytes normal. While in hospital patient had continued diarrhea with multiple stool cultures pending results. The patient, however, neurologically was stable and had no  further episodes of any of the above reaction.   On 6/12/06 seen in ER :Outdoor and hit face on cemet, no LOC no emesis. At that time, alert, dental exam: tooth #7 concussed not loose, lip swollen, forehead abrasion.
Pt vaccinated with DT within 5 - 10 min after pt fainted hit back of head, LOC was only a few seconds; afterwards awoke; kept supine BP 90/100 systolic, P 48-60 developed HA & n/v required hospitalization with IVF
On the date listed previously the patient developed ophthalmic shingles. This was confirmed with a viral culture. No long term visual effects at ths time.