chrisvoncsefalvay/vaers-outcomes huggingface dataset:
antibody test done for shingles and the result was negative; received 2 doses of Shingrix vaccine 9 months apart / First dose was given in January 2020 / second dose was given in October 2020; This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 2nd dose of Shingrix. In January 2020, the patient received the 1st dose of Shingrix. In October 2020, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder and drug dose administration interval too long were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The case was reported by patient herself. The patient received 2 doses of Shingrix vaccine 9 months apart which led to drug dose administration interval too long. The patient had gotten antibody test done for shingles and the result was negative. The patient was referred to her healthcare provider.  The reporter disconnected the call and did not provide any further information
Until the time of the Rotateq vaccine administration (Jan 29, 2007)my son had a regular bowel pattern of once daily.  After the vaccine my son's bowel pattern changed drastically.  He stopped having a daily bowel movement and began going 5-7 days between bowel movements.  This was accompanied by gas, fussiness and at times painful screaming.  In order to relieve his symptoms I has to resort to warm baths, abdominal massages, rectal stimulation with a thermometer and eventually gylcerine suppositories and prune juice.  We had to consult our primary care facility regarding his constipation and even went to an emergency room at one point due to my son's apparent pain and the new Rotateq advisory posted on Feb. 13th.  This altered bowel pattern and painful symptoms lasted for a month before my son began to resume his daily pattern this past week.
11/18/2021 - Sudden Cardiac Arrest requiring CPR 45 minutes, 3 shocks, intubation, mechanical ventilation - transported to ER, Pneumothorax, chest tube placement, aspiration pneumonia -  Chest/Head CT negative, Cardiac Cath showed non-ischemic cardiomyopathy with decreased EF (25-30%). Transferred to Hospital for further care.  Extubated 11/21/2021.  Additional CT showed bilateral PEs, and Left Popliteal DVT - anticoagulation started.  Cardiac MRI completed.  AICD implant 11/23/2021.  DC to home11/30/2021 recovering.
This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 31-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with Medicaid-VFC (public fund). The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
pain; didn't feel well; redness; swelling for at least a week; This case was reported by a other health professional via sales rep and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain, feeling unwell, swelling and erythema. On an unknown date, the outcome of the pain, feeling unwell and erythema were unknown and the outcome of the swelling was recovered/resolved.   It was unknown if the reporter considered the pain, feeling unwell, swelling and erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported by the medical assistant. The age at vaccination was not reported. The patient experienced swelling for at least a week, redness, pain and did not feel well. The reporter agreed to follow up from GlaxoSmithKline (GSK).
This spontaneous report was received from a Certified Medical Assistant (C.M.A), regarding to multiple unspecified patients of unknown ages and gender. The patients' medical history or concurrent conditions were not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (therapy type: Digital Data Logger) (lot # L012479, expiration date 10-APR-2017 and Lot # L027432, expiration date 22-JUL-2017) (dose, route of administration and anatomical location were not provided). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint was not filed. This is one of several reports from the same source (MARRS #1606USA005737, 1606USA005738, 1606USA005739, 1606USA005740, and 1606USA005741). Additional information has been requested.
No adverse event; HCP reported patient received first dose of GARDASIL 9 vaccine in 2019 and will be receiving second dose outside of dosing schedule.; This spontaneous report was received from a nurse and refers to a male patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 03-SEP-2019, the patient was vaccinated with the first dose of human papillomavirus (HPV) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) and would be receiving second dose outside of dosing schedule (inappropriate schedule of product administration). No additional information or adverse event was provided (No adverse event).
Information has been received from a 62 year old female nurse who on 06-JUN-2008 was vaccinated subcutaneously with ZOSTAVAX vaccine (Oka/Merck). There was no concomitant medication. A nurse is reporting that after she had received ZOSTAVAX vaccine (Oka/Merck), on 07-JUN-2008, the injection site became red and swollen. The patient did not seek for medical attention. At the time of the report, the patient was recovering. There was no product quality complain. Follow up information was received from a 62 year old nurse with no known drug allergies who reported that on 06-JUN-2008 at 3:30 pm she was vaccinated subcutaneously on the right arm with ZOSTAVAX vaccine (Oka/Merck) (Lot number 659407/0295X). There was no concomitant medication reported. On 06-JUN-2008 in pm she developed a local reaction, red, warm, slightly swollen which lasted 10 days. The patient recovered. There was no illness at the time of vaccination. No further information is available.
Hot throwing up dizzy feeling like fire ants are inside of me headache fever weak tired muscle pain can't stand up without struggling
About a few weeks to one month after my Moderna booster shot, I started having constant tinnitus in both ears as well as pressure on my eustachian tubes. I believe that I was having some short episodes of it after my first two doses but it definitely has become constant and more pronounced after my booster shot in December.   At this time I am still dealing with a constant tone in my ears and some episodes of pronounced "ringing" in both ears. Despite taking two medications daily, Flonase and Azelastine sprays suggested by my doctors, I continue to be plagued with a feeling of pressure on my ears that causes discomfort and more severely so when there is loud noise.
8 hours after receiving vaccine , patient had c/o chills, rigors, vertigo, lightheadedness, no syncope , Patient was seen in office 4/6/2021with unstable gait, change in speech pattern , c/o feeling unstable when standing
Slow onset of various symptoms ranging from joint, muscle pain, fatigue, memory/dyslexia, caused by vasculitis. Most prominent persistent night sweats. Been on various antibiotics, pain medication for 1 yr plus. Symptoms still persist and moving throughout body.
Patient indicated that he had not received the vaccine previously.  Patients' mother comes in and says he has had the vaccine and she showed us the card and it said that he had received Pfizer.  Mother mentioned that child has intellectual disabilities and that someone should of been with him.  Technician went over form with him and he said that he had not received the vaccine.
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 86-year-old male patient received BNT162b2 (BNT162B2), on 21May2021 as dose 1, single (Batch/Lot number: unknown) and on 11Jun2021 as dose 2, single (Lot number: EW0176) at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing). Prior Vaccinations (within 4 weeks): No. Clarified that flu shot and pneumonia shot previously mentioned, were not within 4 weeks prior to Covid vaccinations and recently got pneumonia shot and flu shot. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "tested positive for COVID". Had both COVID shots. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information : It was reported that, patient is very weak got their shots, didn't got the booster though.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), in Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 31Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and in May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes type 2" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: negative testing twice; Negative, notes: negative testing twice. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medications were received in 2 weeks. Anti-viral treatment for COVID-19 with Paxlovid from 16Sep2022 to 20Sep2022. Rebound COVID-19 after negative testing twice and no fever for 3 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt presents today for an acute visit. Pt received a influenza vaccine in her right deltoid and a pneumococcal 23 vaccine in her left deltoid on 10/2/14. Pt states that approx 1 hour after the injection she had increasing pain. This morning pt has increased pain radiating to her left neck, left chest wall, and left arm. Pt c/o dizziness, feeling "hot", and nausea. Pt noted to have a baseball sized erythemic area on her left upper arm which is very tender to touch and warm. Pt is unsure if she has had this vaccine in the past.
Pt vaccinated with DTP/OPV developed low grade temp, fussy, parents noted staring, poor eating, "bubbling" at mouth then 1-4 min grand mal seizure. TX 0 barb.
lymph node; top of her arm where she got the shot was still sore; her underarm was very painful/ pain in her underarm.; This is a spontaneous report from a contactable consumer (reported for herself). A 32-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0181), via an unspecified route of administration on 14Jun2021 (at the age of 32-years-old) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0171), first dose via an unspecified route of administration on 08May2021 (at the age of 32-years-old) for covid-19 immunisation. On an unspecified date, the patient experienced lymph node and on 15Jun2021, the patient experienced pain in her underarm and it was a very painful sharp pain, and it started hurting. The reporter stated that, she got the second vaccine on Monday, so a couple of days ago, and the top of her arm where she got the shot was still sore and also under her arm like near her armpit so opposite of where she got the shot like her underarm was very painful and it started hurting yesterday on Tuesday. reporter stated the pain was not a sore pain it was a sharp pain. The reporter wanted to know has anyone else reported this before or should she go to the doctor. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
1 day after immunization mom noted a small area of induration and redness.  She was advised to use ice for the swelling and pain. Day 2 the area of erythema extended. Pt was seen.  Erythema was 12x 10cm with a wide streak starting to extend down the thigh.  The pt was treated for possible cellulitis. He did not have fever, and was not in any distress.
I had a fever; weird strange dream; This is a spontaneous report from a contactable consumer (patient).  A 82-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced fever with outcome of unknown , weird strange dream with outcome of unknown.    Follow-up attempts are completed. No further information is expected.
Patient hospitalized and diagnosed with COVID-19 after her COVID Pfizer vaccines on 2/27/2021 and 3/20/2021
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 69-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020). Concomitant products included pramipexole. On 21st May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced rash and flushing. On 22nd May 2018, the patient experienced upset stomach. On 22nd May 2018, the outcome of the upset stomach was recovered/resolved. On an unknown date, the outcome of the rash and flushing were not recovered/not resolved. It was unknown if the reporter considered the rash, upset stomach and flushing to be related to SHINGRIX. Additional details were provided as follows: The patient started Pramipexole the same day as the SHINGRIX. In less than a week after receiving SHINGRIX, the patient experienced a rash on neck down to waist and flushing. The patient also experienced sickness to the stomach, just for the day. No additional information was provided.
Moderna arm?sore arm resolved 3 days after vaccination but then returned 8 days after injection
Postpartum thyroiditis with goiter.  Followed by hypothyroidism.  Receiving levothyroxine for thyroid function.
11/14-- >itchyness, nodules on body-- >went to ER given 1 dose prednisone and 1 benadryl---11/15  developed swelling on b/l hands and hives throughout body
Patient Received her second dose Pediatric Pfizer COVID vaccine (LOT#: FL8094) at 1142 on 2/07/22. Patient received first dose Pediatric Pfizer COVID vaccine (LOT#: FL8095) on 1/17/22. No adverse reactions to first dose. Patient alerted EMT at 11:48. Patient stated that she felt dizzy, hot, muffled hearing and saw black. Patient stated that she had not eaten today. Patient was moved to anti-gravity chair. EMT took patients vital signs. BP: 104/72, O2: 99%, HR: 99. RN gave patient a juice and crackers to eat. Patient drank juice and ate crackers without any difficulty swallowing. Patient denied any SOB or trouble swallowing. After eating and drinking patient stated that she was feeling better. Patient stated she was "feeling normal." EMT retook patients vital signs at 1155. BP: 106/68, O2: 99%, HR: 88. Patient stated she is "feeling good." Patient was asked to stay an extra 30 minutes for observation. Patient and her Dad agreed to stay. RN educated patient and her Dad on adverse reactions to Pediatric Pfizer COVID vaccine and when to seek EMS. Patient and patients Dad verbalized understanding. EMT retook patients vitals at 1205. BP: 104/68, HR: 90, O2: 99%. Patient completed 30 minutes of observation. Patient did not report any new symptoms. Patient left vaccine site unassisted and with a steady gait with her Dad at 1220.
Patient was minor, age 16, at time of first Moderna dose on 3/29/21.  He presented with mother and received  COVID-19 vaccination with Moderna instead of Pfizer.  Moderna not authorized for use in patients less than 18 years of age.  Patient presented with his mother on 4/26/21 (28 days after 1st dose of Moderna)  for his scheduled 2nd dose of Moderna vaccine, as instructed.   At patient check-in, it was discovered that patient had received the wrong vaccine for his first dose; all info was verified by 2 staff members.  Patient still age 16 at time of presentation for 2nd dose of Moderna.  CDC guidelines for 'Recommendation for COVID-19 Vaccine Administration Errors and Deviations'  for 'Unauthorized age group' were consulted to determine how to proceed with 2nd dose.  Per guidelines, patient was administered a 2nd dose of Moderna as off-label use 'because Moderna vaccine is not authorized in patient's age group of 16-17 year olds.' (source: CDC.gov).  A copy of the CDC guidance for this situation was explained to, and dispensed to, mother & patient.  Both wished to proceed with 2nd dose of Moderna to complete the vaccine series.
swollen lymph nodes in arm pit; low grade fever (101F); Booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 18-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 10:00 (Lot number: 33026bd) at the age of 18 years as dose 3 (booster), single for covid-19 immunization; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 24Nov2021 (Batch/Lot number: unknown) as unk unk, single.   The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Allergy", notes: known allergies: ibuprofen. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ep6955, Location of injection: Arm Left), administration date: 17Apr2021, when the patient was 17 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ep6955), administration date: 27Mar2021, when the patient was 17 years old, for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 10:00, outcome "unknown", described as "Booster shot"; LYMPHADENOPATHY (non-serious) with onset 25Nov2021, outcome "recovering", described as "swollen lymph nodes in arm pit"; PYREXIA (non-serious) with onset 25Nov2021, outcome "recovering", described as "low grade fever (101F)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, pyrexia.
Patient had transient dyspnea and palpitations x 15 minutes after immediately following Astrazeneca Vaccine.
heart problems; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose), for COVID-19 immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart problems". The event "heart problems" was evaluated at the physician office visit.  Additional information: It was reported that a boy who was allegedly rushed to the hospital after having heart problems, claimed to have been caused by the second Pfizer shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2014US000820 is an initial spontaneous report from the consumer received on 09 Jan 2014. This report refers to a male patient of an unknown age. On 27 Sep 2013, the patient was vaccinated with FLUVIRIN (batch number: 1307601) in the right deltoid muscle. On 03 Jan 2014, the patient was diagnosed with type A flu. The outcome of the event was not reported.
I had a sore arm for about a day after receiving the vaccine. I tested positive for COVID-19 on 03/07/2023. I contacted my doctor via telehealth, and I got a prescription for Paxlovid.  I tolerated the medication without any side effects. As of today, I do not have any lingering symptoms.
pt c/o lightheadedness and vision turning white; pt able to ambulate with 2 guards at his side to private obs room; wife present; pt placed on exam table and HOB put flat and legs elevated; eyelids fluttering, pt warm and diaphoretic; remained responsive and answering questions; pt states that he has fainted in the past, also has "sensitivity" to certain anesthetics; initial VS at 1013:cuff not registering BP, HR 38/dinamap,RR 18,Sao2 100%. Switched to smaller BP cuff and Vs at 1015: BP 78/43,HR 40,RR 18, Sao2 100%. Pt c/o nausea. VS at 1020: 98/51, HR 58, RR 18, SaO2 100%.  Pt states that he is feeling better except still nauseous. VS at 1025: BP 112/59, HR 68, RR 16, SaO2 100%. HOB raised to 45 degrees, no c/o. Pt given cold pak and drink of water. 1030:pt states less nauseous, still "cloudy". 10:45:HOB placed at 90 degrees, BP 114/67, HR 66, RR 16, SaO2 98%. 10:50:pt states that he is feeling much better, talkative, ambulated WNL in room. 1055: BP 112/72, HR 56, RR 16, Sao2 100%. Pt states that he feels a "little tired" but fine to leave. Wife will drive pt home. 1100 Pt leaves clinc; no c/o.
In January 2022, I experienced a 5-day migraine followed by conjunctivitis in my right eye, a rash on my forehead, and blistering on my forehead and scalp. My Ophthalmologist diagnosed me with Oculofacial-Herpes Zoster-Herpes Zoster RT and Iris-Iridocyclitis, primary acute OD and put me on a one-week prescription of Valacyclovir HCL 1 gram, 3*day*7 days. I was also put on a series of eye drops: Timolol Maleate 0.5%; Dorzilamide HCL 2%; Difluprednate .05%; Alrex 0.2%; Inveltys 1%.