chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Became very nauseous about 18 hours after receiving the vaccine. Then got a headache shortly thereafter. Then came the extreme achy ness and lethargy.; Became very nauseous about 18 hours after receiving the vaccine. Then got a headache shortly thereafter. Then came the extreme achy ness and lethargy.; Became very nauseous about 18 hours after receiving the vaccine. Then got a headache shortly thereafter. Then came the extreme achy ness and lethargy.; Became very nauseous about 18 hours after receiving the vaccine. Then got a headache shortly thereafter. Then came the extreme achy ness and lethargy.; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included food allergy. Concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date about 18 hours after vaccination, the patient became very nauseous, then got a headache shortly thereafter, then came the extreme achyness and lethargy. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events very nauseous, headache, extreme achy ness and lethargy was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Nausea, vomiting, diarrhea, chills, sweats, vertigo, heart palpitations, tachycardia. Severe HYPERTENSION.
INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a 40 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 40 years old. No concomitant medications were reported. On 07-JUN-2022, the patient experienced out of specification product use. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20220759052, 20220759113, 20220759160, 20220759219, 20220759222, 20220759337 and 20220761815.
69 with temp excursion. Reported to Pfizer company and ok'd for use. Instructed by their staff to report each dose given in this system.Pfizer lot #FJ63
Young healthy patient presented with chest pain starting 3 days after vaccine. Profoundly abnormal EKG and marked troponin elevation. Workup consistent with acute myocarditis of unclear etiology.
5-10 mins after the vaccine, while patient was sitting for 15 mins in the pharmacy waiting area, he felt dizzy, sweaty and anxious. He walked back the vaccination room. We offered him water, then we checked his vitals at 11:24am (BP 111/62, HR 52 bpm). He took his mask off, took few deep breaths, took more water. Then rechecked his vitals again at 11:31 am (BP 115/79, HR 65 bpm). He said that he started feeling better and less sweaty. Per patient, he had a bagel, a Redbull and smoked marijuana few hours before the vaccine. He was nervous about getting the second dose and the possible side effects that he heard about. Patient left the pharmacy around 11:35am with his wife and son. His wife mentioned that she will be driving him home. Patient was counseled to seek medical help if he experience more adverse effects.
muscle and joint pain- hands and legs; deep pain in left arm; digestive discomfort and loose bowels
blotchy red patches and itchiness in the RIGHT arm even though vaccination side was LEFT deltoid. She was advised to take benadryl and consult MD for 2nd dose. Reports no Shortness of Breath or any other symptoms.
Caller has since contracted COVID-19 as a "break through case" last week; Caller has since contracted COVID-19 as a "break through case" last week; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in Apr2021 as dose 1, single; and later received second dose of BNT162B2 (Batch/Lot number was not reported) via an unspecified route of administration on an unknown date in Apr2021 as dose 2, single; both for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date in Jul2021 (reported as last week), the patient experienced contracted covid-19 as a "break through case".  Batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Redness, swelling from under deltoid to above elbow.  Referred patient to clinic
Swelling and redness at the injection site.  On day two, pain and hot to the touch along with a large red swollen patch.
pt recv flu & pneumococcal vax combined & given one inj & exp redness, swelling to elbow, site warm;given DPH & APAP per MD;
After receiving the vaccine I got a sharp pain on head near neck, they had me to wait to make sure I was ok, then I woke up and my shoulder and arm is in pain, the muscle hurts when i try to move my arm, my temp is 99.7 and I'm extremely tired. I took Tylenol.
Fever, headache, nausea, light headedness, body aches, severe low back pain, increased pain at injection site, chills
Left arm - injection site (L) deltoid became very firm but upper (L) chest above breast was swollen and pink as well as left upper shoulder and arm including elbow.
Received shot around 1:10pm, a few hours later around 4pm felt tired. Pain at injection site lasted a few days felt like a bruise. Around 8:30pm lips became bright red, felt like there were sores on the roof of the mouth that were painful and interfered with eating for 3 days after shot ate soft foods, eyes really dry, extremely thirsty for about 2 days after shot. On 4/3/21 around 9pm took a 25mg tablet of Benadryl and that helped a little bit with the symptoms. On 4/13/21, 10 days after the shot, felt extremely fatigued, body and joint aches intense, nauseated, headache lasted a couple of days. By 4/16/21 felt better and was able to go to work in retail.
Got the shot and then got shingles, Suspected Vaccination Failure; Got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot and then got shingles, Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by the consumer via interactive digital media. The reporter reported that his or her coworker got the shot and then he got Shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Patient was given 0.5ml of Moderna vaccine for her booster dose instead of the recommended dose of 0.25ml.  Patient was notified by phone and states she has no adverse reactions at this time.
Information has been received from a health professional concerning a patient who on 27-JUL-2006 was vaccinated with a second dose of Varivax. Subsequently the patient developed blisters at the injection site measuring 2-3 cm in diameter with a surrounding 8cm of erythema. The outcome was unknown. It was also reported that the patient's sibling experienced a reaction (WAES # 0608USA00025). No additional information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Lot number: FJ6369), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 29Mar2021 as dose 2, single (Lot number: ER8732), in left arm and on 30Nov2021 as dose 3 (booster), single (Lot number: FH8027), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "known allergies: Tetracycline", notes: known allergies: Tetracycline. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jan2023) Positive, notes: Positive COVID 3 days after testing negative,; (Jan2023) Negative, notes: Positive COVID 3 days after testing negative,. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid treatment from 27Dec2022 till 01Jan2023 and got positive COVID 3 days after testing negative, with return of symptoms, took full 5 day course of paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report was received from a medical assistant concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M024261, expiration date:30-JUL-2018 and lot # M009378, expiration date: 23-APR-2018, as prophylaxis (Strength, route and dose were not reported), which experienced a temperature excursion of 28 Fahrenheit degrees for 7 days. No previous temperature excursions were reported. Data logger was not involved. No adverse effects were reported. A phone call was placed on 22-MAR-2017 to the medical assistant, who reported that, she was waiting for the office manager to download the information and then she would fax it in. This is one of several reports received from the same reporter. CORRECTION FOR E2B PURPOSES ONLY (20APR2017): This safety report was previously submitted with incorrect E2B WWID: US0095075131701USA005974. The WWID US009507513 1701USA005974 refers to the linked report (and therefore not being nullified). The correct WWID is now referenced in this safety report (US0095075131704USA006956). Additional information has been requested.; Sender's Comments: US-009507513-1701USA005974: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1704USA007611:
Acute h/a, muscle spasms, pain in weight bearing joints, loss of movement (voluntary) to legs; sl T began on 28APR seen by MD; bed rest ordered-Soma prescribed-inability to move began 5MAY & lasted to the 7th hospitalized & released 8MAY92;
Took last dose 3 days late; Spontaneous report received on 01JUN2020.  A consumer reported that her son "took last dose 3 days late" (PT: Inappropriate schedule of product administration) while being on oral Vivotif for immunisation. He took his last dose of Vivotif three days late on 30MAY2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took last dose of vivotif three days late than the scheduled date (Inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of the event is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took last dose of vivotif three days late than the scheduled date (Inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of the event is assessed as not applicable to Vivotif.
tested positive greter than 14 days post fully vaccinated Narrative: tested positive greater than 14 days post fully vaccinated
Local reaction at vaccine site increase in redness, swelling, warmth and tenderness at site. Pt is afebrile. Red area marked with pen.
After child left our pediatric office after receiving varicella vaccine, he developed wheezing and itching.  He was given BENADRYL and albuterol.
No adverse event occured. Patient was a walk-in Covid vaccine. She requested Moderna as her booster. Her first two doses were Pfizer and given following the correct dosing schedule. This booster dose of 0.25ml was at least 6 months after last Pfizer dose. Error was that the patient was only 17 years old and should not have received a booster or Moderna. Neither, at this point, is approved under the age of 18.
Pt exp apnea episode about 2 hrs p/recvd DTP/TOPV/HIB vax; Chronic cough for several wks; Pneumoccal sepsis during newborn period thought to be due to mom having no spleen & having pneumonia @ time of delivery; septic w/u done; Meds given;
large hives covering the trunk, arms, and upper legs; Vomiting; This is a spontaneous report from a contactable (Patient, self-reported). A 54-years-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6203), dose 2 via an unspecified route of administration, administered in Arm Right on 01Mar2021 11:45 as 2ND DOSE, SINGLE; dose 1 of bnt162b2 (lot number: EL9269), via an unspecified route of administration, administered in Arm Left on 08Feb2021 11:45 as 1ST DOSE, SINGLE for covid-19 immunisation. Patient did not have any relevant medical history. Concomitant medications included vitamin d [vitamin d nos]. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. Reportedly, patient had daily episodes of large hives covering the trunk, arms, and upper legs. These started on the evening of 05Mar (accompanied by one episode of vomiting that night). The hive appear every evening between about 4-9 pm and last for several hours. By the morning, they are gone and I feel normal - no evidence of the hives. Then they redevelop in the evening. Vomiting was only the first day of the hives. The hives have appeared for 7 evenings in a row, always going away overnight and redeveloping the next day. Patient finally purchased some Benadryl five days. A couple of doses seem to blunt the hives within approximately an hour. Patient sometimes need to take another dose a few hours later. patient went to urgent care today, 11Mar, and was put on Prednisone. The episode tonight has not been nearly as significant as the past ones. On 05Mar2021 18:00, the patient experienced large hives covering the trunk, arms, and upper legs and vomiting. Therapeutic measures were taken as a result of large hives covering the trunk, arms, and upper legs, vomiting. Outcome of the event large hives covering the trunk, arms, and upper legs was not recovered, for vomiting was recovered on 05Mar2021.  No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse practitioner concerning an approximately 22 year old female patient who in 2006 was vaccinated with a first dose of Gardasil (yeast). In 2006, the patient experienced a raised, red, itchy lump at the injection site. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
1021: Patients mother alerted medic that son was experiencing respiratory distress. Medic immediately radioed Personnel Personnel notified another Person and both arrived at car at 1022.  1022: Patient stated he felt like his throat was being to close up and appeared to be gasping for air. Pt also stated he was beginning to lose sensation in his extremities; extremities tense and contracting; denied changes in vision.   Mother stated no food or medication allergies but pt had previous anxious reaction to Hep B two years prior.   Initial vitals on arrival:   BP: 80/52 SpO2: 89% Resp: 26  1025: 0.3 mg Epinephrine administer into left vastus lateralis by 2 personnel  1026: repeat vitals  BP: 111/57 Sp
Within  a couple hours of dose, I was feeling really awful as if I had the flu with a pounding headache, all of my body hurt, naseau as if I was going to vomit, and my arm was really hurting. It progressively got worse throughout the day with feeling hot and cold so I took an Extra Strength Tylenol in case of fever. I went to bed around 10 pm and woke up out of a dead sleep around 2 am feeling like I was having trouble breathing. All of my body hurt, I was freezing cold and shaking with chills, and really dizzy and my head was still pounding. My arm where the injection site was also felt like it was burning. I thought I would take a hot bath to ease the chills and go back to sleep, but when I got out my naseau was even worse, my head was really hurting, and I began getting really dizzy sitting on the floor. I called my roommate in and said, "I think something's wrong. I'm going to vomit or black out" and that's the last thing I remember. I did black out and my roommate said I had what looked like three seizures and he called 911. I was shaking for several hours after that at the hospital.  It is now the same day, 4.27.2021, 9 am and I am home from the hospital. I still feel weak, dizzy and nauseaous and my entire body hurts.
pt recv vax 21JAN98 & slept poorly & devel a high fever 105, a very fine macular rash & irritability;22JAN98 devel jaundice on torso & buttocks & a rash on upper torso;28JAN98 lab eval revealed WBC count 16.03;
Immediately following vaccination, the infant suffered from fever averaging 102 F which fluctuated for the next 2 days, despite use of Tylenol. The infant vomited post intake of bottle (follow up formula) and lunch or dinner meal at least twice a day for 3 days. He exhibited "common mild reactions" of sore leg, fussy, tired and less appetite as well.
pt recv vax 7APR95 & 2wk later exp neck & joint pain, h/a, swelling of knee & elbow & weakness which persisted for one month;tx w/pred;reporter felt that there was a possible problem w/lot of vax
Vaccine may have been administered too high on right shoulder. Patient reported reduced movement of shoulder and provider confirmed signs of bursitis. Patient still reports limited movement and some discomfort.
Pt in ER c/o fever, diarrhea, cough, SOB.
Patient was seated when the shot was administered. Moments after administration the patient lost consciousness for about 10 to 15 seconds and slumped back in the chair. Patient came to and said she was fine. The patient refused EMS. The patient was monitored for 10 minutes and left with her caregiver. Patient does not drive and was instructed to go to ER if any other symptoms occur in the next 48 hours
Pt was taking ibuprofen and heat treatment to help alleviate pain. Pt contacted pharmacy morning of 11/09/2017. Pt stated she was having severe pain and scheduled an appointment with her PCP for later in the day. Physician prescribed Rx for tramadol and possible follow up on 11/13/2017 if pain persists.
This spontaneous report as received from a healthcare worker refers to a 14 year old female patient. The patient had not pertinent medical history or drug reactions/allergies. On 18-FEB-2013, the patient was vaccinated with a first dos eof GARDASIL (lot # H017598; expiration date: 02-JUL-2015) (dose, frequency route was not provided0 and fainted in the office. The patient sought medical attention, was treated with orange juice, cool cloth to her head. On the same date, the patient recovered. The relatedness for the adverse event was unknown for therapy with GARDASIL. Additional information is not expected.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 12-month-old male patient who experienced diarrhea. At 12 months of age, the patient received the first dose on an unspecified date. The patient was administered PREVNAR 13 and experienced diarrhea within days and was hospitalized. The patient recovered. See related case: US-WYE-H16986310 (adverse event, non-expedited). No additional information was available at the time of this report.
Febrile seizure 3/20/14. MMR/VARIVAX/Hep A vaccines given 10 days prior on 3/10/14
Rash, hydrocortisone cream, 25mg BENADRYL; rash appeared on day 15.
Extreme muscle and body aches Fever - 101 Chills Migraine Loss of appetite Nausea
15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; They reported significant body aches.; This is a spontaneous report from a contactable Physician. This Physician reported similar events for fifteen patients. This is 14th of fifteen reports. This Physician reported for a patient that. An unspecified age and gender patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, It was reported that during a second clinic 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL. They reported significant body aches. Many had GI symptoms (nausea, vomiting and diarrhea) They have reported this to VAERS and have reviewed how to avoid this issue going forward. The outcome of the events was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient
neuropathic pain and herpetic-appearing eruption under left breast onset 3/31/21.  Clinically diagnosed as zoster at urgent care on 4/15/21. Treated on 4/15 with Medrol + Valtrex without benefit. Standing trazodone dose increased on 4/19/21.   She had prior zoster in 2009 and had Shingrix vaccine in late 2019 and early 2020.
6SEP91 pt recvd 1 dose of Engerix-B & 1-2 days p/inject pt devel hives & a non-specific reaction in the abdominal area w/no other sx;
Lots of pressure in the head and vertigo to the extent that it felt that I was going to faint. It lasted several days and gradually subsided.