chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 5 minutes after injection I had stiffness in right hand and neck and shoulders.  The stiffness started to go away at 20 minutes later.  15 minutes after I left test site (35 minutes after injections, my tongue, lips, and face started swelling and had trouble swallowing an hour later).  I ate a frozen popsicle and the swelling in tongue and lips started to go down.  Hours later I took my blood pressure medicine (Lisinopril) I started to have tightness in face and jaw area, burning sensations in ears, jaws and back of my head and headaches.  I contacted health care provider after hours number. They scheduled a video appointment with doctor. The doctor advised me not to take blood pressure and any other medications for another day and to put warm compressor on shoulders to relieve some of the tightness in jaws. I was also advised to call 911 or immediately come to healthcare facility if swelling re-occurred.  A follow up appointment with primary care provider is scheduled on 3/17/21.  I do not have any symptoms at the time of this report, March 15, 2021 at 1:23 pm.
PT WAS SEEN BACK IN THE OFFICE ON 7-28-05 PT L THIGH WAS RED, EDEMA AND BLISTERING OVER THE THIGH AND WAS HOT TO THE TOUCH.
the wrong diluent - sterile water was used to reconstitute; the wrong diluent - sterile water was used to reconstitute; This non-serious case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Herpes zoster (Shingrix) (batch number 29GB3) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: the wrong diluent - sterile water was used to reconstitute) and inappropriate dose of vaccine administered (Verbatim: the wrong diluent - sterile water was used to reconstitute). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 17-OCT-2023  The reporter was a GSK field staff employee. Shingrix was administered to patient after having been reconstituted with the wrong diluent - sterile water was used to reconstitute which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Patient reported no complaints after incident. The reporter did not agree to follow up from GlaxoSmithKline.
Person completed their COVID-19 vaccine series with the Moderna vaccine.  Person came in and received a 3rd dose of the Moderna.
Sore arm hurting bad; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm hurting bad) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm hurting bad) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Sore arm hurting bad) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: follow up received on 09-JUL-21 with event outcome updated
Patient received his first dose of Pfizer Covid 19 vaccine.  Patient was screened and given vaccine with no incident.  Patient was waiting in observation area for 30 mins post the vaccine.  About 10 mins post vaccination patient felt sick to his stomach and spit up into his mask.  He called pharmacy staff over and we gave garbage pale to spit up into.  He spit up approximately 10ml of orange phlegm and that was all.  He asked for water to rinse his mouth so staff gave him a little bit of water to rinse with.  Pharmacist stayed with patient and monitored him for additional adverse effects.  Pharmacist took patient's blood pressure which was 174/98 at 3:21pm 14 mins post vaccination and a second time 19mins post vaccination at 3:26pm it was 150/90.  Patient reported having history of acid reflux and he had just had orange juice and Jax (cheetos) so he believed it was due to what he ate.  We continued to monitor patient.  He stated he was feeling fine and wanted to leave.  Pharmacist asked to recheck his BP at which he declined saying he was feeling fine and the 150/90 is normal for him.  The pharmacist help to escort the patient to the front registers to make sure he was not experiencing anything else and at that time patient stated he felt fine and was leaving the store.
This spontaneous report as received from a registered nurse refers to a 11 month old patient of unknown gender. No information on medical history, concurrent conditions or concomitant drugs was provided. On 05-FEB-2010, a few days prior to the patient's first birthday, the patient was vaccinated with M-M-R II, VARIVAX (Merck) and VAQTA. No lot#, expiration dates, doses, routes and sites of administration were reported for either of the vaccines. There was no adverse effect. Additional information has been requested.
RUE pain at injection site all night.   Woke up the morning after the injection and started to feel nauseated while brushing her teeth.  While in the bathroom first thing that morning she then suffered a syncopal event; felt like she could not see or hear anything and lost consciousness (not witnessed) and awoke on the floor.
PNEUMOVAX given 6/15/11, woke up 6/17/11 morning with a maculopapular diffuse rash on abdomen, back and chest. Treated with ALLEGRA. Patient refused treatment with steroids.
8 days after injection I had a delayed hypersensitivity reaction (?covid vaccine arm?), symptoms included firmness and a red patch on my upper arm near the injection site. The following morning, I woke up feeling well with the rash still on my arm (no change). 2 hours later I began feeling dizzy and fainted. I was unconscious for 5 to 10 seconds. When I woke up, the rash had vanished and the firmness was gone. No signs of the reaction were present after waking.
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 18 months old male patient received vaccine QUADRACEL which was not intended to. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE for Immunization; and HEPATITIS A VACCINE for Immunization. On 01-Oct-2018, the patient received a Fourth dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5325BA expiry date: 14-Nov-2019 via intramuscular route in the left thigh. It was case of actual medical error due to inappropriate age at vaccine administration. It was not reported that if any adverse event was experienced or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Intense pain and redness at injection site. Beginning shortly after injection and continuing through reported date to us of 09/14/2012.
Received influenza vaccination. Later in day became (according to co-workers) rambling in speech; completed a report wrong and otherwise seemed increased "happy" and very "talkative".
Received MMR on 07/18/07. On 07/25/07 running a fever of 103. Mom reports fever high the next day also. On 07/27/07 developed rash starting at diaper site and then it spread upward. Reports eyes starting to swell on 07/29/07. Saw Dr  today, 07/30/07. No treatment. Rx states Macular papular rash and fever likely secondary to MMR vaccine.
Development of two discreet subcutaneous nodules. In addition patient had erythema + swelling x approximately 3-4 days that resolved.
Information has been received from a physician concerning a 4 year old male child with no history of chickenpox who was vaccinated with a dose of varicella virus vaccine live 0.5ml. There was no recent exposure to chickenpox or herpes zoster. On 24JUL2003, it was reported that the patient "now has shingles", described as a "scabbed erythematous patch" about 50 cent sized on the right buttocks.There were no other systemic symptoms and a maximum temperature was reported as none. The degree of pain was unknown. Specimens for PCR and direct fluorescent antibody were not collected. A photo was not taken. It was noted that the child was vaccinated at another facility. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint involved. No further information is expected.
pt recv vax; c/o hair growth to inject site on lt leg; small patch approx size of 1/2 inch on lt leg w/ much darker hair growth on area;
This spontaneous report was received from a Licensed Practical Nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB single dose (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Corminaty- use for COVID-19 under Emergency Use Authorization (EAU):Patient bivalent covid vaccine on 11/4/2022 and began experiencing pain and swelling over the next 24 hours. Patient saw their primary physician 11/11/2022 and has a follow up appointment with them.
SLIGHT DROOP ON RIGHT SIDE OF FACE; TWO NOSEBLEEDS EACH ON A SEPARATE DAY; SLIGHT MEMORY ISSUES; TIREDNESS; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: Unknown) dose was not reported, with frequency 1 total administered on 28-JUN-2021 to left arm for prophylactic vaccination. Concomitant medications included amlodipine/olmesartan and gabapentin for hypertension. On 29-JUN-2021, the patient stated that the next day he felt tiredness. On JUL-2021, that roughly a week to two weeks ago (roughly ten days he added) his son noticed a slight droop on the right side of his face. He observed in the mirror that there was a slight difference at this time. Currently he reported that his son still notices a slight difference. On JUL-2021, He also stated that last week he experienced two nosebleeds each on a separate day and several days apart and he felt he had slight memory issues. Consumer has made an appointment to see his health care provider and will be seeing him on 23-JUL-2021. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from slight droop on right side of face, and the outcome of two nosebleeds each on a separate day, slight memory issues and tiredness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210747736 -Covid-19 vaccine ad26.cov2.s -slight droop on right side of face. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
MD reported pt recv vax & devel vaccine-associated paralytic poliomyelitis;it was later determined that pt had severe immune deficiency;the child died 8 or 9 years ago d/t the immunodeficiency;MD stated event poss reported to CDC;
Information regarding Prevnar (pneumococcal 7-valent conjugate (diphtheria crm197 protein) syringe pre-filled) was received from a consumer regarding a 2-month-old female patient who experienced injection site pain and injection site burning. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. The patient experienced injection site pain (injection site pain) and injection site burning (injection site irritation) following her 2 month vaccination. See related case(s): HQWYE776421AUG06 (injection site pain and injection site burning following 6 month Prevnar vaccination; non-expedited). No additional information was available at the time of this report.
Information has been received from a medical assistant concerning a 21 month old black male patient with no known drug allergies, who on 09/27/2002 was vaccinated subcutaneously in the left thigh with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 643498/0609M).  Illness at the time of vaccination included a sinus infection.  On 10/08/2002 the patient presented to the doctor's office with a diffuse maculopapular rash over his entire body.  No other symptoms were noted and no treatment was given.  Subsequently, the patient recovered.  Additional information is not expected.
This case was reported by a nurse via sales rep and described the occurrence of pain in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, erythema and swelling. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain, erythema and swelling were recovered/resolved. It was unknown if the reporter considered the pain, erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: The patient's age was above 65 years. The age at vaccination was not reported. The provider stated that she had patient who complained of pain, redness and swelling. The provider recommended Tylenol and warm compress and issues resolved. No additional details were available. The reporter did not agree to be contacted for follow up. This case has been linked with case US2018GSK167499, reported by the same reporter.
Soreness in L arm; soreness in L axilla; Soreness in LU torso; Numbness/tingling in lips and tongue; Metal taste; Numbness/tingling in lips and tongue; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 29Dec2020 08:00 at a single dose for COVID-19 immunization. Medical history included hyperlipidemia, chicken allergy. Patient was not pregnant at the time of vaccination. Patient previously took BACTRIM and experienced allergy. There were no other medications received within 2 weeks of vaccination. The patient soreness in L arm, L trap, L axilla, LU torso, numbness/tingling in lips and tongue and metal taste on 29Dec2020 09:00. Outcome of the events was recovered. Treatment was not received for the events. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 05Oct2020 and negative on 08Nov2020. Patient was not diagnosed with COVID-19 prior to vaccination and has been tested post-vaccination. The events were considered non-serious.
sudden onset of high fever (104.5) w/sz anaphylactic shock; tx-02, fluids, ATB, APAP @ hospital MD;
Patient received a PNEUMOVAX-23 IM injection in the left deltoid. Patient returned the next day stated that her arm had severe pain radiating from mid-way up the upper arm and into the shoulder cap. The upper arm was warmer to the touch, but did not have any clearly defined redness or raised area around the injection site. Patient also stated she had began feeling light headed and dizzy. Patient stated she would monitor and seek medical attention if not resolved or worsens.
About two weeks after the second dose, I developed pulsatile tinnitus. At first I did not associate it with the vaccine. I went to an ENT, checked my blood pressure every day, had my hearing checked and had an ultrasound of my carotid arteries. None of those tests showed any risk of causing tinnitus. Additionally, after about a month, I also developed a constant buzzing in the ears. Neither of these two types of tinnitus has shown any sign of letting up or going away. They are continuous and consistent.
Pt. given GARDASIL in LA, also received first DEPO injection immediately broke out in sweat with complaint of dizziness and ears roaring, pt. placed in reclining position with knees bent, cool compress to head. B/P 113/71, P 67, O2 sats 100%, Dr. informed and B/S ordered, B/S 89, pt. in sitting position after about 10 min slowly stood with no additional sx present.
This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included, gallbladder removal, and concurrent conditions included, irregular heart rhythm for years (reported as never waiver, never different), weak immunity, kidney problem, and sepsis, and other pre-existing medical conditions included patient was very sick from an unspecified date in JAN-2021 to on an unspecified date in APR-2021. Patient stated one day she even passed out and her heart stopped for a second. She was hospitalized and her white blood cell count was 22,000 (Unit not specified). She stated her heart rhythm still behaved the same way even after the sickness. Number of days hospitalized and discharge information was not reported. Patient looks younger than she was and she takes care of herself. She was very beautiful and slender. She is a very active person but since receiving the booster she was a very different person. The patient received Covid-19 vaccine ad26. cov2. s (suspension for injection, route of administration not reported, batch number: unknown, and expiry: unknown) dose was not reported, dose number in 01, 01 in total, administered on left arm on an unspecified date in JUL-2021 for prophylactic vaccination. On an unspecified date, following vaccination with Covid-19 vaccine ad26.cov2.s, it was unknown if patient had any side effects (dose number in series 01). The patient additionally received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1855194, and expiry: unknown) dose was not reported, dose number in series 02, 01 in total, administered on right arm on an unspecified date in NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, concern started since the rhythm was intermittent. Due to booster vaccine her heart beats faster than usual. According to patient rhythm mostly came from heart atrium but sometimes from ventricle. She had bad tachycardia, also had dizziness and vertigo (dose number in series was 02). Patient went to an electrophysiologist and got some tests done but she won't hear back. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad tachycardia/heart beats faster than usual, and the outcome of dizziness and vertigo was not reported. This report was non-serious.
This spontaneous report was received from a licensed practical nurse and refers to a 4 month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-AUG-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered dose of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794:
About 9:30 PM back began to ache, about 10:05 began shivering and chilling continuing for about 2 hours. Had noticeable fever and aching in large joints rest of the night. Fever began to break about 6:30 AM. Was very lethargic the next 24 hours.
This spontaneous report was received from a registered nurse and refers to unspecified multiple patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX23 injection, lot# M018624, expiration date: 28-MAY-2017, lot# M036728, expiration date: 20-MAY-2018 (dose and route of administration were not reported). The temperature excursion ranged from 32 to 35 degrees Fahrenheit for 24 hours. There was no previous temperature excursion. Digital data logger was used. Product quality complaint was not involved. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA009342: US-009507513-1703USA013068:
large induration @ inflammatory response @ inj site w/subsequent development of cellulitis;hosp given IV ATB & warm compresses;
Patient started feeling light headed. She stated that she felt like she was going to pass out. Vitals were BP 110/P  HR 88 R 24 SPO2 100. Patient did not feel worse standing up. EMS crew had here lay down on the gurney for 5-10 minutes and she then felt well again. Probably anxiety.
Fever 101 degrees/ Headache/ joint aches (hips, arms, legs, neck)/ fatigue/  hives - 2 raised spots on right hand, 1 cluster of raised blister like on left ankle, 1 cluster of raised blisters on bottom of right foot arch area/ redness, soreness and pain at injection site/ mild nausea off and on. All side effects were present at the same time with the exception of the "hives". Hives appeared during the late afternoon of 6/12/2018.
This spontaneous report as received from a Registered Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the unspecified number of the patients were vaccinated with the dose of improperly stored VARIVAX (Merck), (dose strength, route and lot number was unknown). No concomitant medication was reported. The patient experienced no adverse event. No product quality complaint was involved. The outcome of the event was unknown. Additional information has been requested.
Headache, arm-ache starting at 6pm Slight dizziness starting around 8pm Dizziness got worse overnight and prevented sleep Got out of bed at 4:15.  Lots of fatigue. Slight dizziness Nauseous around 4:45 and vomited at 5:15 Nausea and dizziness subsided. Slept from 6 to 10:30 Fatigue, headache (which is not fully quelled by IBU), arm-ache and fogginess continue at 3pm following day