chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Missed second dose of Vivotif; Spontaneous report received on 30DEC2019.  A pharmacist reported that a male consumer "missed second dose of Vivotif" (PT: Product dose omission), while being on Vivotif for immunisation. The consumer missed the second dose of Vivotif, and three to four days had passed since his initial dose. Action taken with Vivotif with respect to reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer missed second dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif. ; Sender's Comments: A consumer missed second dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.
Flu; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care provider in country.  This case involves patient of unknown demographics had flu (influenza) while she received influenza vaccine .  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect vaccine at an unknown dose produced by unknown manufacturer lot number not reported via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (latency unknown) after the suspect vaccine initiation, had flu (influenza).  Laboratory details were not reported. Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case. .
I hit my head and went to the hospital; This is a spontaneous report from a contactable other hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced i hit my head and went to the hospital on an unspecified date. The caller spoke to safety before being transferred. Caller stated she hit her head and went to the hospital. She had a CT scan and was given a tetanus shot on 31Jan2021. she received her first dose of Covid-19 vaccine on 27Jan2021. She was scheduled to receive the second dose 19Feb2021. Caller wanted to know if this would have an impact on her. The patient underwent lab tests and procedures which included computerised tomogram resulted to unknown on an unknown date. The outcome for event was unknown.   Information on the Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Patient came into the Health Clinic for a TB read on 9/13/19.  She reported to RN that she had received the pneumonia, influenza and TDaP vaccines at store on 9/11/19 following her TB placement.  She stated her right arm which she received 2 vaccines in was red, swollen and warm to the touch from her deltoid and almost down to her elbow.  She stated she had attempted to contact store but did not receive any help.  She stated she had taken some Tylenol and used an ice pack which seemed to help.  She planned to take Benedryl and use ice pack again and she will contact MD if symptoms do not improved or get worse.
From day one I have had increased numbness, muscle aches, joint pain, stiffness that comes and goes. Some days I feel better but tired then symptoms return. After 9 days the arm started to itch and hurt again and muscle spasms returned. But it was manageable until 02/24/2021 when spasms increased and I began shaking uncontrollably. My hands, torso, and feet would shake vigorously. I went to ER on 02/25/2021 as symptoms continued. They ran several tests and couldn?t find any other reason. Was told not to take the 2nd dose and was given a corticosteroids to help with possible inflammation and allergic reaction.
Hives  started presenting on random parts of my body approximately 24 hours after the first vaccine dose on 12/27. At the time, I was a few months into treating allergies with sublingual drops. After one week of continued hives, I stopped the drops per the request from the allergy clinic. I got the second vaccine on 1/25 and continue to get very itchy hives. Discontinuing allergy drops and taking Benadryl don?t seem to help.
After 4 months and 6 months vaccination, developed excessive crying, irritability, no sleep and appetite at 48 hours.  Lasted 5 days after 4 month vaccine and now 2 days after 6 month vaccine.  No fever, no vomiting, no seizure, no labor or PE evidence of infection.
Vasovagal reaction with pt feeling like he could pass out. + clammy skin with sweating. pt did not eat since 11am gave juice and crackers felt better and left with dad
Ran temperature that went from a normal 97.6 to 100.9, experienced chills, light headache, fatigue, swelling and soreness at injection site, body aches. Body aches lasted through the next day.  Took aspirin that did not help, after a few hours took two 650mg Tylenol and that made a difference.  Am better, really okay now, but five days later injection site is still tender and a little swollen.
Patient came to clinic with c/o pain, tenderness, redness, warmth to right deltoid. After previous Td inj to same area. Tx: patient prescribed Keflex 500mg CNP po 4 x's day x7 days, apply warm compresses/ cool compresses and apply Bacitracin ointment to affected area twice daily.
This non-serious spontaneous case, initially received from a pharmacist on 31-Oct-2018, concerns an 83-year-old, elderly male patient. On an unspecified date in the past, the patient had received unspecified flu vaccine for an unknown indication. On an unspecified date, the patient had received a high dose of FLUAD (TIV) [dose, route administration, anatomical location, batch number and expiry date: not reported] (explicitly coded as overdose). It was reported that the patient received 2 doses of FLUAD (TIV) in the same season (explicitly coded as inappropriate schedule of vaccine administered). No adverse events were reported after administration of the vaccine.
blood sugar has elevated; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's blood sugar has elevated on 2021. Outcome of the event was unknown.  Information regarding batch/lot number has been requested.
Pt had pain in his arm for a month then came to let us know pain is  more in the back of his arm
Patient reports right shoulder pain beginning 2 days after the vaccination that was given on 10/10 in that arm and continuing through today, 10/18.
Started getting a rash around the injection site. After the first few minutes of taking the vaccine he started feeling dizzy and lightheaded. Vertigo had started getting real.
11-28-06 3:00pm vaccine administered in right deltoid. Advised Tylenol every 4 hours times 24 hour to combat any muscle soreness , aches. 11-29-06 08:00 complained of "feeling like have flu"-weak, achy, Temp 98.8. At 11:00 same day tem 99.9, complained of "weak", neck pain, "feet feel numb/tingling. Sent home to go to Dr.
Treatment included: water, snacks and laying down. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP
I had a very sore throat, headache, vomiting, coughing, diarrhea, malaise, and chills. I tested positive for COVID-19. My doctor prescribed me PAXLOVID. I started feeling better on the 3 day of me taking PAXLOVID. I still have some coughing.
patient received improperly stored Varivax; No adverse effect; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 26-AUG-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) injection for prophylaxis (lot number: S005078, expiration date: 19-FEB-2019 or lot number: R019237, expiration date: 04-JUL-2020) (exact dose and route of administration were not provided). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted in properly stored sterile diluent. No adverse effect was reported.  The vaccine experienced temperature excursion from -14 degree Celsius to -10 degree Celsius (-9.74 degree Celsius). Previous temperature excursion was not reported. The digital data logger was involved.
Excruciating pain in left arm at injection site, unable to move arm because any movement of muscle caused extreme pain.  As of 6/19 at 1:38 PM, still having trouble moving the arm, and when I do I have moderate pain.
This case was reported by a consumer via call center representative and described the occurrence of chills in a 73-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (1st dose, refer case US2018146939).  On 10th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In August 2018, 30 days after receiving SHINGRIX, the patient experienced injection site pain and injection site lump. On an unknown date, the patient experienced chills, pain in arm, influenza-like symptoms and tremor. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, pain in arm, influenza-like symptoms and tremor were recovered/resolved and the outcome of the injection site pain and injection site lump were unknown. It was unknown if the reporter considered the chills, pain in arm, injection site pain, injection site lump, influenza-like symptoms and tremor to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's daughter.  The patient received SHINGRIX in left arm. The patient experienced shaking all night, flu like symptoms, and sore arm. The events lasted for total of 4 to 5 days. After a month later patient was experiencing a lump at the injection site which was about the size of 0.5 by 0.5 inches and the site of injection was sore covering 4 inches of circular area. No further details were provided. The patient was referred to health care provider.
Pt reports COVID arm rash. About 4 hours after vaccine, patient's arm swole and arm was hot to the touch. About 2 hours after intial rash, it migrated down the arm. Patient reports is was about 3 inches in diameter. Pt took ibuprofen, and sat in salt bath for about 1.5 hours. After that the swelling started to reduce.  Patient has not contacted MD, due to office being closed over the weekend. Patient reports arm being hot, red, and hard, but it not itch. Any movement hurt while at the peak.
21OCT04: Pt presents with mild-moderate erythema (7cm x 9.5cm) left upper arm. Mild induration at vaccine site. Non-tender. No taxia rhinitis. Front left arm. Imp: local reaction to vaccine. Ice TID to arm. Tylenol as advised q 4 hours prn. Call if increase at all, if Temp greater than 102 F. Retrun to clinic tomorrow if not notably improved.  22OCT04: parent calle dclinic. Site better. Some itching. Denies need for follow up appointment.
Flushed, tongue feels heavy /weird Patient seen by onsite EMT Vital signs: init.HTN,  Secondary vital signs WNL. Lung sounds clear=Bilateral Patient discharged home @12:45.
Vaccine breakthrough, symptomatic. 9/12   Inpatient admit 9/17 to present,
Urgent Diarrhea 2 times, 1 hr apart; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6204), via an unspecified route of administration in the right arm on 14Mar2021 at 17:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic asthma, hypertension (HTN), arteriosclerosis and allergy to lisinopril. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included REPATHA, CRESTOR, amlodipine (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN) and probiotic within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17Mar2021 at 14:00, the patient experienced urgent diarrhoea 2 times, 1 hour apart. The patient did not receive any treatment for the event. Patient recovered from the event diarrhoea on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Continued and persisent nausea and abdominal/stomach pain.  Sometimes interfering with daily activities.  -No pregnancies in this time period and no history of IBS or related illnesses, etc.
Palpable area (2 cm) at injection site that is subcutaneous and tender; Palpable area (2 cm) at injection site that is subcutaneous and tender; Information has been received from FDA (VAERS # 842809) on 23-OCT-2020.  This spontaneous report was received from a physician referring to a 12 years old White female patient. The patient's concurrent condition included achondroplasia. The patient was allergy to doxycycline, polmyxin. The patient's concomitant therapies included meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL).     On 29-AUG-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (manufacturer reported as ; lot # ARDE5523 is an invalid lot number for  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).  Lot number ARDE5523 does not match any Company product as confirmed by Lot Verification team) dose 1, intramuscular in the left arm for prophylaxis.      In 2019, the patient experienced palpable area (2 cm) at injection site that was subcutaneous and tender. The outcome of both events reported as not recovered. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) was not provided.  Follow-up information was received from the same reporter on 03-FEB-2021. The lot number of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) was reported as 1602284 and it has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as 26-SEP-2021. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Swollen eyes and face; swollen face and eyes; This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number CE45H, expiry date 1st October 2022) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In October 2020, less than a day after receiving Shingrix, the patient experienced facial swelling and eye swelling. On an unknown date, the outcome of the facial swelling and eye swelling were recovered/resolved.   The reporter considered the facial swelling and eye swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but it could be 51 or 52. The patient was vaccinated with Shingrix in left arm. The patient had a swollen face and eyes within 24 hours after vaccination. The patient was treated with steroids and recovered from the side effects about 2 weeks. The reporter consented to follow up.
Information has been received from a consumer concerning her 11 year old daughter with allergic reaction to most antibiotics (products not reported) and a history of "deflux surgery for her kidneys" who in November 2007, was vaccinated with the first dose of GARDASIL, injection, single dose and concomitantly with meningococcal vaccine (unspecified). In January 2008, the patient was vaccinated with the second dose of GARDASIL, injection, single dose, left arm and concomitantly with varicella virus vaccine live (MSD). On 31-MAR-2008, the patient was vaccinated with the third dose of GARDASIL, injection, single dose, right arm and concomitantly with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, injection, left arm. In November 2007 following the first dose GARDASIL, the patient experienced a burning sensation while GARDASIL was being administered and had a little tenderness around the injection site. In January 2008 following the second dose GARDASIL, the patient experienced burning sensation while GARDASIL was administered and had a little tenderness around the injection site. Approximatley two weeks after receiving the second dose of GARDASIL, the same arm where she was given GARDASIL (left arm), the patient began shaking uncontrollably and she had severe pain in this arm. The patient was taken to the hospital where she was admitted and stayed for 24 hours. X-rays, EEG, and blood tests were performed which determined that she had not had any seizures. On 31-MAR-2008 following the third dose of GARDASIL, the patient's right arm turned bright red and was also hot to the touch. On 01-APR-2008 one day later, the patient developed a huge welt on her right arm which persisted for 72 hours. Subsequently on unspecified dates, the patient recovered from the events. No product quality complaint was involved. Additional information has been requested.  5/1/08-office notes received-2/22/08-seen in ER previous night for C/O hyperventilation. After ER slept without incident. 3/31/08-Tdap and Gardasil #3 given. 4/2/08-C/O pain at injection site of both vaccines. Redness and swelling size of 50cent piece. C/O doesn't feel well, stomach ache. Subsequent call to patient later same day feeling better with some discomfort of arms and at base of neck. No headache or fever. 4/3/08-phone call-half dollar size welt from tetanus a little bigger today. No other symptoms. 4/4/08-4 days after vaccines increased edema to both size. Induration upper arm, tender and swelling decreased over past 24 hours but erythema and C/O severe pain. Skin warm, no streaking. Assessment-allergic reaction to vaccine .
Patient is fully vaccinated. COVID + on 12/14/2021.  ED visit on 12/14/2021.  Vaccinated patient whose wife is currently admitted with Covid presents with a one week h/o loss of apetite, nause and vomiting. Denies any fevers or chills, no chest pain or dyspnea. Positive for cough. BP 92/52  | Pulse 73  | Temp 99.6 °F (37.6 °C) (Oral)  | Resp 18  | Ht 167.6 cm (5' 6")  | Wt 98.9 kg (218 lb)  | SpO2 94%  | BMI 35.19 kg/m² Patient states she feels better after meds and fluids.  He is asking to be discharged.  Patient's oxygen saturation remains in mid 90's at rest.  Per the patient's request discussed his case with the patient's daughter, who expressed some concerns about his oxygenation when active. We ambulated the patient and monitored his pulse ox and it never dropped below 92% and when he returned to his room his pulse ox ws 97%. He never experience any dyspnea or chest pain while ambulating. CXR: Right basilar airspace change consistent with infiltrate. Information were sent to Dr. office for them to contact him in regards to Monoclonal Antibody Treatment. It was emphasized both to the patient and his daughter that if his pulse ox drops below 90% for him to return immediately to the ER.  Patient back to the ED on 12/16/2021 for SOB.  The patient states he woke up to go to the bathroom tonight and he felt weak. Approximately 1 week of sx, vaccinated, tested positive for covid 2 days ago. He is nauseous. He has not vomited. He does not have diarrhea.  He has been taking tylenol every 4 hours, ibuprofen intermittently. Has not yet received mAB therapy but has been referred for it. BP 131/63  | Pulse 82  | Temp (!) 103 °F (39.4 °C) (Oral)  | Resp 16  | Ht 167.6 cm (5' 6")  | Wt 98.9 kg (218 lb)  | SpO2 93%  | BMI 35.19 kg/m² CXR with patchy infiltrates, consistent with covid. Will DC home; encouraged to f/u with monoclonal ab therapy as previously referred Continue conservative care at home.  Return to the ED if worse.
12/2 - Blood clot that caused a TIA. Was put on blood thinners by healthcare professional.
Within 10 minutes my face and head was tingling and went numb. Eyes felt swollen/numb.  This lasted for 4 hours. Both hands also were numb even longer. EMT's on site checked my vital signs. My blood pressure and oxygen were OK so they said I could drive home when I felt ready.
I started experiencing a chaffing feeling and pain in the right side of my vagina and buttocks. That continued through the next week and became worse with extended time spent on my feet. I felt run down and sick to my stomach at times throughout the next week, also experiencing headaches. The following Monday, 3/18/13, I felt extreme amounts of pain and now had severe swelling on the right side of my vagina. I also had pain in the right side of my buttocks and right leg. The following day I went to ER thinking I had a bartholin cyst in the vagina. I did not but it was noted I had swelling on right side of vagina, buttocks, and leg. That night I developed a very painful headache. I woke up the next morning with a mild, very painful, and itchy rash on the right butt cheek and inside near the rectum. I was and still am experiencing extreme pain and spreading of rash as of today 3/27/13.
Approximately 2 weeks after vaccination patient reports breaking out in chicken pox. Red bumps on her arm and upper body.
Initial and follow up information has been received from a registered nurse concerning 78 year old (also reported as 80) retired female patient, with an unknown medical history and unknown drug reactions/allergies, who on 10-OCT-2005 at 11:30 AM was vaccinated intramuscularly in the right deltoid with a dose of pneumococcal 23v polysaccharide (Lot# 649989/0579P). On 10-OCT-2005, the patient developed a severe local cellulitis-like reaction. Follow up information indicated that on the evening of 10-OCT-2005, the patient developed pain and swelling at the injection site. Ice was applied. The swelling decreased by the AM on 11-OCT-2005. At the time of report it was noted that area was very tender to touch. There was no illness at the time of vaccination. Subsequently, on an unspecified date the patient recovered. No product quality complaint was involved. Additional information is not expected.
Mom requested that her child, who was 12yrs old at the time of the vaccination, receive a pediatric dose because of his small size. The vaccinator administered the pediatric dose instead of the adult dose that he should have received.
Suffered severe dizziness beginning 56 hours after receiving 2nd shot. The dizziness last approximately  2 hours and the light-headed feeling continued  for an additional  12 hours.  All symptoms ceased by 7:00 am Feb 22, 2021
had numbness and tingling in left arm and foot after dose on 1/19/2021 that has since resolved, but still has dull pain in foot at 3 out of 10 pain scale 1/25/2021 has seen PCP . this info relayed by director of nursing to vaccine lead.