chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received from a healthcare professional on 14 January 2013. A 59-year-old male patient, whose medical history, concomitant medication and illness at the time of vaccination and any other vaccinations within 4 weeks of vaccinations were unknown, had received an intradermal dose 1 of FLUZONE ID vaccine, batch number: UT4466AA (site of administration was unknown) on 12 January 2013. On 13 January 2013 i.e. one day after receiving FLUZONE ID vaccine, the patient experienced welt the size of a softball. The corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was not reported. Follow-up information was received from a healthcare professional on 14 January 2013, which upgraded this to a serious case. According to the reporter, the patient received the FLUZONE intradermal on 12 January 2013, and the reaction actually started several hours later on that same day, originally reported as the next day on 13 January 2013, The patient then experienced swelling extending from the injection site to the entire arm and hand. The patient's outcome remained not reported. Documents held by sender: None.
Extreme fatigue  Irritable Pain in lower forearm where injection was Tightness in chest Coughing
Red rash from deltoid extending below elbow. Several papules 5 mm or less, several other raised areas 5 mm or less with visible yellow pus like intact tissue. Redness extend to right/left trunk and rt upper thigh.
Information has been received from LPN concerning an 8 year old female with microcephaly and a developmental delay who on 13-APR-1998 was vaccinated SC in the left arm with a first dose of Varivax (lot # 625131/0053H). Concomitant therapy that day included a first dose SC in the right arm of MMR II (lot # 619382/0102E) and a third dose PO of Orimune (lot 0787C). It was reported that the patient had cold symptoms 3-4 days prior to the rash. The "spots" started on 20-MAR-2006 and were multiplying by 22-MAR-2006. She was afebrile. She was seen at the office on 22-MAR-2006 with greater than 50 lesions and diagnosed with chickenpox. At the time of this report disease was "still active." Additional information has been requested.
Began experiencing aching near injection site a few days after Prevnar vaccine was administered; still persists as of 2/4/16; informed patient to follow up with her PCP.
C/o nausea and vomit (vomit x1). Pt verbalized similar experience with first dose and it was subside after 20 mins.  Code green called by lane controller . Paramedic on site to assess.  Bp 118/79, p 80, rr 18, sat 99%.
While sleeping with face into pillow I was awakened by my head violently shaking.  It went on long enough for me to consciously think, Will this ever stop!  It was like a Rottweiler shaking a rabbit.  When shaking finished I slept through the rest of the night and much of the following day.  Had a similar experience after the 2nd Moderna shot on 2/15/21.
facial paralysis; postherpetic neuralgia; bronchitis; painful rash, herpes zoster; Information has been received regarding a case in litigation from a lawyer referring to a currently approximately 63 years old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 20-SEP-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by providers for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: painful rash, herpes zoster, postherpetic neuralgia, facial paralysis and bronchitis. The outcome of the events herpes zoster, postherpetic neuralgia, facial paralysis and bronchitis was unknown.  Upon internal review, facial paralysis was determined to be medically significant.
Information has been received from a physician concerning an 19 year old patient who on 14-JUL-2010 was vaccinated with a third dose of GARDASIL (route not reported and lot number: 661758/0968Y, expiration date: 14-FEB-2011). On 14-JUL-2010 after vaccination the patient experienced a syncopal episode. Also, the patient had severe abdominal pain after the syncopal episode. The patient went  to the Emergency Room, but the pain resolved within 1 hour after the GARDASIL was given. The patient was not admitted to the hospital. The physician reported that the patient received the second and third dose late (second dose date unspecified). On 14-JUL-2010, the patient recovered. Additional information has been requested.
Patient presented on 8/17/18 with red raised 'bumps' and hives around/at injection site of ADACEL 6 days after administration. Patient advised to use hydrocortisone cream/ointment for itching and diphenhydramine at bedtime for allergic reaction. Patient advised that if site becomes warm or hot to touch or develops fever to contact PCP for follow up.
Starting about 5 days after injection I started having pain that feels like bone pain in my left shoulder. Progressively getting worse and has now moved into my upper back shoulder blade area and neck. SIRVA??
it was rpt fr person concerning pt who was vax in approx 1996 & subsequently devel a few chickenpox. on 9mar99 pt exp severe outbreak of chickenpox consisting of about 200-300 pox. mom state pt unable to eat due to pox in mouth
Presented w/ AMS/agitation. Covid+. Dx w/ subdural hematoma/acute encephalopathy.
Brain fog, fatigue, rapid heart beat, headache, late period, spotting  mid cycle, pain in arm, joint pain
Very tired the first day; pain in my arm for two days; sporadic palpitations; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: Ek5730, via an unspecified route of administration in the left arm, first dose on 18Dec2020 08:15 at a single dose for immunization. Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took oral aspirin but had intolerance. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with covid-19 prior to vaccination and she has not been tested since the vaccination. The patient was very tired the first day, she had pain in her arm for two days and sporadic palpitations that continued. The events started on 18Dec2020 at 10:30 AM. The outcome of the events 'very tired the first day, she had pain in her arm for two days and sporadic palpitations' was unknown.  The patient did not receive any treatment for the events.
Fully vaccinated with Covid vaccine x 3 (pfizer). Tested positive for Covid on 01/27/2022. Admitted to hospital on 02/02/2022. Expired on 02/04/2022 while still hospitalized.
hives; red; blood pressure raised; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and ERYTHEMA (red) in an 83-year-old female elderly exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011MZ0A) , while the parent received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): unknown.     MEDICAL HISTORY (Patient): Concomitant product exposures included APIXABAN (ELIQUIS) and CARVEDILOL for an unknown indication.    On 12-Feb-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 13-Feb-2021, the elderly was diagnosed with URTICARIA (hives) and ERYTHEMA (red). At the time of the report, URTICARIA (hives) and ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications also include  Medication for heart.  Treatment medications include Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: NNI
33 y/o female with past medical history of appendicitis and gallbladder removal, who presents with itching to head/hands and increased sweating post vaccination. Patient states that this is her second dose in the two-dose series. Patient denies difficulty swallowing, sore throat, difficulty breathing or shortness of breath. NP and Paramedics at patient side. Patient initial vitals 134/88 BP, 99%RA, 90 HR and 14 Resp. Patient immediately given Benadryl 25mg PO x1 and a bottle of water. Patient was observed for over 30 minutes with improvement of symptoms. Patient stated that the itching and sweaty had subsided. Patient vitals upon discharge were 117/66 BP, 99% RA, 93 HR and 12 Resp. Patient was cleared to go home in stable condition.
She developed inflamed lymph nodes (lymphadenitis), all over the body rash, ongoing fever for more than 3 weeks. She was diagnosed with MIS-C, her heart, intestines, lungs, skin and liver were inflamed. She was hospitalized and treated with immunoglobulin, steroids, anticoagulant, fever reducing medications, etc. By the second treatment, her belly started getting distended, her lungs were filled with liquids. She was transferred to ICU and her heart stopped beating right there.
Started having headaches, hypertension with blurry vision. Had MRI which showed diffuse FLAIR/T2 signal changes subcortically-> brainstem-> c spine. Ongoing work-up but thus far negative for malignancy, autoimmune process, toxidrome, infection.
father observed shaking of upper extremities & head x 5sec, day p/shot given-no phone call made to MD;mom observed same thing 3 days p/shot;MD notified in the evening of 1SEP96;seen by MD 3SEP96;
Significant increase in blood pressure, redness all over the body. Hot sensation, hives, and sweating for 4-5hours. Treated with Dexamethasone and Benadryl in the ER
Mother called Rn to the car. Pt is feeling shivery and shaky. BP 109/61 HR 90 RR 18 sats 99% Temp 98.1. Denies pain. Emt to carside to evaluate. Patient evaluated. Parent refused for pt to be transported to hospital.
Devel redness @ inject site w/in 24 hrs lasting for 3 days then resolved; area of erythema & induration spread to @ 12cm x 18cm area is now resolved;
After receiving the vaccine, patient became diaphoretic, lips were turning blue and patient seemed very weak. Vital signs were taken and oxygen administered. Patient was transferred to a stretcher and taken to the ED for observation. He was given some juice and crackers and went home. Patient's mom was present throughout all of the event and desired to take the patient home.
Paxlovid as COVID 19 Treatment; Paxlovid as COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 79 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid as COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received Tdap as a booster on 6/7/06. A few hours later developed fever, returned on 6/9/06 with a swollen right deltoid and complained that her bones still ache. MD reported as ADR to Tdap vaccine with a viral syndrome and delayed hypersensitivity to the vaccine
About two days after the vaccination she woke up and had itching on her chest.  She noticed a red rash, that looked like little bites. Over the next couple of days she continued to break out with the rash, which she concluded were hives. She had them all over her body, on her chest, back, abdomen and legs.  They were very itchy.  She had no fever and did not have any difficulty breathing.  Today which is three weeks out most of the rash has gone away, but she still has a few small patches.  She did not seek medical attention and did not use anything to relieve the symptoms.
I got Delayed Cutaneous Sensitivity from this vaccine .It was painful and debilitating - headache pain, painful vaccine site, red rash lasted several days.  Don't as I am still    in it.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. It was stated that the date of refigeration was 19-SEP-2021.   This case was linked to MOD-2021-365135 (Patient Link).
Pt was given PCV 13 at age 9 when he had 2 doses before. No actual adverse event. Pt did not have reaction.
One week later woke up to swelling around injection site, feels like a bee sting. Hard, itchy, warm  and lymph nodes on that side are painful and very sore.
Swelling starting about 6 inches below the injection site. Redness. Severe pain at the arm that was injected (left). Still on going 2 days after administration.
Client states on 8-26-12 - started having rash on face, neck and chest. Went to Urgent Care on 8-27-12. Gave her Prednisone IM and a PO script. Also c/o tightness in chest and throat, feeling dizzy/faint with aching joints, arms and legs heavy. Bumps now on stomach and legs - very bright red - also c/o having a cluster rash on face, "sunburn looking". Bumps itch and resemble chickenpox (had C-pox as child). Advised to return to ER Urgent Care if tightness in chest does not go away. 09/17/2012 F/u call. Spoke to client this morning. Stated the rash has since disappeared. Client stated that she did have an adverse reaction to the MMR, but also is allergic to the Prednisone that was given in Urgent Care. Any all symptoms have dissipated.
Gastro-symptoms; Gastric pain; Pain in the arm; Nausea; Headache; Muscle aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of EPIGASTRIC DISCOMFORT (Gastro-symptoms), ABDOMINAL PAIN UPPER (Gastric pain), VACCINATION SITE PAIN (Pain in the arm), NAUSEA (Nausea) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CANDESARTAN CILEXETIL (ATACAND) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced EPIGASTRIC DISCOMFORT (Gastro-symptoms), ABDOMINAL PAIN UPPER (Gastric pain), VACCINATION SITE PAIN (Pain in the arm), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Muscle aches) and PYREXIA (Fever). At the time of the report, EPIGASTRIC DISCOMFORT (Gastro-symptoms), ABDOMINAL PAIN UPPER (Gastric pain), VACCINATION SITE PAIN (Pain in the arm), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Muscle aches) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided.   This case was linked to MOD-2021-370262, MOD-2021-370460 (Patient Link).
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Additional Details: After giving the vaccine to the patient he fainted and fell off the chair hitting his head on the floor. This was a few minutes after the vaccine was administered. After fainting the pt was a little out of it and was bleeding on his nose/forehead. I gave him a water and ice pack for his head. I had him stay sitting on the floor and after 20 mins we decided to the ambulance because his family was not coming. He was checked out and decided not to go to the hospital.
This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with VAQTA for prophylaxis. On an unknown date the patient experienced drug administered to patient of inappropriate age and no adverse event.  The outcome of drug administered to patient of inappropriate age and no adverse event is unknown.   The reporter considered drug administered to patient of inappropriate age and no adverse event to be not related to VAQTA.
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. The patient received first and second dose of VAQTA (dose, lot#, expired date and route were unknown) on 11-JAN-2010 and 12-APR-2010, respectively (inappropriate schedule of drug administration). No adverse symptoms were reported. Additional information has been requested.
he had a sly bad reaction,; bruising and still hard tissue about 4 inch about 2 and a half inches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (he had a sly bad reaction,) and CONTUSION (bruising and still hard tissue about 4 inch about 2 and a half inches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (he had a sly bad reaction,) and CONTUSION (bruising and still hard tissue about 4 inch about 2 and a half inches). At the time of the report, VACCINATION COMPLICATION (he had a sly bad reaction,) and CONTUSION (bruising and still hard tissue about 4 inch about 2 and a half inches) outcome was unknown.            No concomitant medications reported. No treatment information was provided.  The patient have bruising and still hard tissue about 4 inch about 2 and a half inches , visible bruise and one time discolored the whole arm.
Pt had 2 episodes of forceful large volume emesis the day following administration of 2 month immunization. The episodes were about 12 hrs apart.
Oct 30, 1995 was vaccinated with a first dose of vax, that same day included a first dose of measles virus vax, mumps/measles rubellla virus. On July 17, 1995 pt was vaccinated with a third dose of hep B recombinant. On June 07, 1999 the pt developed full-blown chickenpox that consisted of > than 200 lesions. It was noted that the pt was exposed to a child at daycare that had the varicella virus and developed a varicella rash 14 days post vax. It was also noted that the pt was never treated with steroids and is normal child with no hx of immunodeficiency or immune depression. Follow up work reported that on June 10, 1999 a sample of vesicle was sent for analysis via polymerase chain reaction. Follow up information from the lab reported that preliminary results of the vesicular lesion was pos for wild type varicella. On June 9, 1999, pt reported to MD with varicella out break.
Hand tremors in morning, later in the day fever, post nasal drip, muscle pain, backache, general extreme fatigue. 10/29 symptoms persisting, with added scratchy throat, itchy ears and a cold sore eruption on lower lip.
LOSS OF TASTE; COUGH TORE HER UP; CONGESTION; LOSS OF SMELL; SORE THROAT; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 55 year old female. 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: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-AUG-2021, the patient experienced loss of taste. On 10-AUG-2021, the patient experienced cough tore her up. On 10-AUG-2021, the patient experienced congestion. On 10-AUG-2021, the patient experienced loss of smell. On 10-AUG-2021, the patient experienced sore throat. On 10-AUG-2021, the patient experienced headache. On 10-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of taste, fever, sore throat, cough tore her up, congestion, headache, and loss of smell. This report was non-serious.
About 6 hours after receiving the shot, I developed a fever. I had a fever (100.1) for about 36 hours. Today my fever stopped and now I am nauseous and vomiting. I am also having dizzy spells.
This spontaneous report was received from a Registered Nurse referring to unspecified patients of unknown age and gender. No pertinent medical history, concurrent conditions, drug reactions allergies or concomitant therapies were provided. From 10-MAR-2017 to 09-JUN-2017, the patients were vaccinated with unspecified improperly stored doses of PEDVAXHIB for prophylaxis (lot # M036057 with an expiration date of 18-MAY-2019) (dose, route and anatomical location were not reported). The administered doses of the vaccine experienced a temperature excursion from 32 degrees Fahrenheit  to 35 degrees Fahrenheit for 72 hours, no data logger was involved and no previous temperature excursions were reported. There was no adverse reactions. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1706USA005041.
Hives on face 20 minutes after injection, angioedema follow with swollen face, eyes and itching on face. Within 5 hours all over itching, drainage from eyes throat itching
Child came in to have a check-up and received the PENTACEL vaccine in the left leg around 6:30 pm on Monday night. On Tuesday night around 7:00 pm Mom was giving the child a bath when she noticed that the area around the injection site - had a red rash around it with several scratches where child had been scratching at it. By the next morning on Wednesday it appeared to have doubled in size and was warm to touch. Area is red, bumpy (rash), swollen, and warm to touch and appears to be slightly larger than a softball. There is a history of MRSA in the family so originally treated as a cellulitis with cephalexin and BACTROBAN. When rechecked on Thursday - reddened area was only the size of a baseball, cool to touch, slightly reddened but fading not swollen. Child was acting as if this area was not bothering him throughout the reaction. Determined it was a large, local reaction but continued the cellulitis treatment as precautionary.
8/27/10 3 days ago pt. received TDAP - By the next day pt. had pain, redness on area of injection radiating over her shoulder - which subsided with cold compresses. On exam she had 5 cm round, red, warm area at the injection site (8/30/10).