chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A hard, red lump the size of a blueberry appeared behind his right ear (this was diagnosed as lymphadenitis by Dr.) the day after his vaccination, and was given an antibiotic for 10-days.  He also experienced a decrease in appetite, sleepiness, and fussiness.  To date (5/12/2009) the lump has decreased in redness and size (about the size of a pea), however it is still there.
Pt recvd vax 19NOV93 & devel fever, aches, vomiting; wondered if react to vax; talked w/MD prescribed ATB for sinusitis; poss GI virus;
This spontaneous report as received from a Healthcare Worker (CMA) refers to a patient of unknown age and gender. On 21-APR-2014, the patient was vaccinated with ROTATEQ SUSPENSION 2, lot # H017721, expiry date 01-APR-2014, dose (unknown), and route of administration (unknown), for vaccination, past its expiry date, in error. No concomitant medications were reported. No adverse effect reported. The outcome of event was unknown. No product quality complaint was involved. No other information to report. Additional infomration has been requested.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with the first dose of GARDASIL. Concomitant therapy included 2 other injections (therapy unspecified), prior to having GARDASIL. After receiving the first dose, the patient went stiff and then fainted for about 20 seconds. Lot number was not provided. The patient sought unspecified medical attention. At the time of the reporting the outcome of the patient was unknown. Additional information has been requested.
My wife and I had 3 healthy kids before receiving the Pfizer-BioNTech vaccine and became pregnant with our 4 child shortly after we both became fully vaccinated. We have had several problems with the pregnancy, including:  -The baby was diagnosed with a large Ventricular Septal Defect (VSD), essentially a hole in his heart -Velamentous cord insertion -2 vessel umbilical cord  While we of course have no proof that the vaccine caused these serious adverse events, we have submitted the case to Pfizer and heard nothing back (not even a confirmation of submission) and it doesn't appear that any govenment or regulatory body is tracking long term side effects such as the one I've described.
Dizzy and symptoms of Vertigo with severe exhaustion and body aches . It lasted 2 days and I still don?t feel right.
A non-serious spontaneous report of administration of expired product was received from a health professional concerning a nine-year-old male, subsequent to FLUMIST. Neither the patient's past medical history nor concomitant medications were reported. The product expired on 23-Jan-2011. The patient received the expired FLUMIST on 16-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. There were no late occurring adverse events. Additional information was received on 04-Mar-2011 and incorporated into the narrative: no late occurring adverse events were reported.
blood pressure increased; Felt so fatigued; had aching all over / muscle aches; was so nauseous; subsequently started getting headaches; chills; about 10-15 mins after, I started getting arrhythmia; started having trouble catching up my breath; also have lot of pressure on my head; felt very very weak; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (about 10-15 mins after, I started getting arrhythmia) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No  medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL SUCCINATE (TOPROL), LISINOPRIL (ZESTRIL) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced ARRHYTHMIA (about 10-15 mins after, I started getting arrhythmia) (seriousness criterion medically significant). 23-Apr-2021, the patient experienced DYSPNOEA (started having trouble catching up my breath), HEAD DISCOMFORT (also have lot of pressure on my head), ASTHENIA (felt very very weak), FATIGUE (Felt so fatigued), MYALGIA (had aching all over / muscle aches), NAUSEA (was so nauseous), HEADACHE (subsequently started getting headaches) and CHILLS (chills). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (blood pressure increased). At the time of the report, ARRHYTHMIA (about 10-15 mins after, I started getting arrhythmia), DYSPNOEA (started having trouble catching up my breath), HEAD DISCOMFORT (also have lot of pressure on my head), ASTHENIA (felt very very weak), BLOOD PRESSURE INCREASED (blood pressure increased), FATIGUE (Felt so fatigued), MYALGIA (had aching all over / muscle aches), NAUSEA (was so nauseous), HEADACHE (subsequently started getting headaches) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: Normal. On an unknown date, Blood pressure measurement: 177/90 (High) 177/90.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's EKG was done by EMT.  The patient received I Tylenol and Motrin.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
This patient was given a Kinrix injection by mistake.  He should have been given a Pediarix due to his age.
Pt called pharmacy next day complaining of tingling, numbness, slight redness, and itching in left hand (same side as injection).  Took Claritin for itching. Contacted patient next day to see if improvement, Pt reported slight improvement and stated that PCP is aware and monitoring  symptoms.
This spontaneous report was received from a 71 years old male retired nurse regarding himself. The patient's historical and concurrent conditions included aortic valve replacement, non-Hodgkin's lymphoma in 2002, 2005 and 2010 (in remission for over 5 years), melanoma in 2007 (in remission for over 5 years) and neuropathy in the toes (since approximately 2006, reported as "for 10 years"). The patient was reactive/allergic to NORVASC, ZOCOR, TENEX and FERAHEME. On approximately 17-JAN-2016 ("10 days ago"), the patient was vaccinated with ZOSTAVAX (lot# unspecified), vial, for vaccination. Concomitant therapies included COUMADIN and atorvastatin. The patient stated that since receiving the ZOSTAVAX, the numbness and tingling in his toes had begun to fade away, it got better with each day (unexpected therapeutic benefit). The patient related this improvement to ZOSTAVAX. No treatment was given. No lab diagnostics studies were performed. No Product Quality Complaint (PQC) was reported. No additional information was provided. This is one of several reports received from the same source. Additional information has been requested.
Red, warm, tender at site of injection. ZYRTEC for itching and ice to apply to site.
No adverse reaction, A 0.5ml dose was given for the booster dose instead of the correct 0.25ml dose. No treatment needed.
pt recv vax 1MAY96 & lab eval in FEB96 indicated a negative titer for varicella antibodies;pt became pregnant 15APR96;ultrasound 27wk from LMP indicated fetus was nl;11NOV96 pt exp sinusitis;1996 pt exp preeclampsia;
No adverse event. Patient received MMR, Varicella, and Hep A vaccines wrongfully.
Non stop screaming and crying, tenderness redness and swelling localized at left thigh vaccination site. Inability to move left leg.
Received the vaccine at 3pm Friday 10/22/2010. Woke up next morning with facial swelling and erythema over cheek, nasolabial & circumoval area. Seen today facial swelling is 60% better erythema is 80% better.
RED BLOTCHES, ENTIRE BODY; SORE ARM; This spontaneous report received from a consumer concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, the subject experienced red blotches, entire body. On 30-MAY-2021, the subject experienced sore arm. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, and red blotches, entire body. This report was non-serious.
Initial unsolicited case received from a pharmacist via Merck (reference number: 00531824) on 03-AUG-2017. This case involves a patient (age and gender not reported) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) (Batch number, expiry date and dose were unknown, dose in series, route and site of administration were not reported) on an unknown date. The patient is allergic to statins and phenothiazines. Other medical history was not reported. Concomitant medication were not reported. On an unknown date, following the vaccination, the patient experienced super allergic reaction that affected her breathing. Patient other lab tests and corrective treatment was not reported. The outcome of all the events was not reported. List of documents held by sender: none.
Right shoulder/upper arm: pain started late June/early July 2021. Increase pain into August/September 2021.  Mobility restriction started in August 2021.  Mobility & tightness in shoulder and upper arm. At times shooting pain from shoulder to finger tips, sporadic, non-predictable.  Left Shoulder/upper arm: pain started August 2021, increased into September. Mobility restriction started with the pain in August 2021. Mobility & tightness in shoulder and upper arm. At times shooting pain from shoulder to finger tips, sporadic, non-predictable.  Both shoulders/upper arms: Could not reach in front, behind, side of my body - shoulders would not allow for that range of motion. Daily living activities such as washing hair, shaving, toileting, and dressing were difficult. Had to move extremely slow or find alternative ways to move my body to allow for those activities. Needed assistance from family members to complete some ADLs.  Treatment: Receiving acupuncture treatment, including electrostimulation, cupping, and wet cupping  Began September 2021 attending weekly sessions.  Increased to 2x a week in late December 2021 and have been attending 2x a week to current day. Pain in both shoulders ceased in January 2022. Mobility issues remain in both shoulders into upper arm, left shoulder/upper arm has greater restriction than right shoulder/upper arm.  Mobility has improved, but still have issues reaching  my arms behind my body and extending to sides (both arms). Tightness of muscle in both shoulders and upper arms remains, is decreasing. Able to move more freely now, however still have restrictions in movement. ADLs are not as difficult to complete, though dressing can still take some manipulation. I do not require as much assistance from others to complete ADLs.
Bad headache, currently 102 fever, aches and pains, chills for over an hour. Similar reaction to my first booster shot in October, that one lasted two days.
Pt recvd 1st dose of Hep B vax on 27JAN92 & on 28JAN92 devel a small, pruritic, petechial rash as well as pain @ the inject site; pt also had arthralgias w/no inflammation in lt arm;
DIFFUSE PAPULAR RASH APPROXIMATELY 30-45 MIN AFTER INJECTION
reported to the ER and later admitted with shortness of breath and cough X 1 week. decreased appetite, and diarrhea. fully vaccinated with booster. treated with supportive care, O2, steroids and remdesivir
I received my second vaccine by Pfizer on 04/21/2021. I had a severely red and swollen arm for about 5 days.  I then seemingly recovered.  4 days ago, I work with my entire body covered in red rash with uneven borders. It is focused on my left leg, less on my right leg and a few rash patches on my chest and back.
left arm doesn't feel very good; left arm is more sore, sleeps on it at night and it is sore the next day right where the shots were; Shoulder pain over the last two weeks; Fatigue that lasted a day and a half; Started having trouble breathing after walking a flight of stairs; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Started having trouble breathing after walking a flight of stairs), LIMB DISCOMFORT (left arm doesn't feel very good), FATIGUE (Fatigue that lasted a day and a half), MYALGIA (left arm is more sore, sleeps on it at night and it is sore the next day right where the shots were) and ARTHRALGIA (Shoulder pain over the last two weeks) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 04-Feb-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced DYSPNOEA (Started having trouble breathing after walking a flight of stairs) and FATIGUE (Fatigue that lasted a day and a half). On an unknown date, the patient experienced LIMB DISCOMFORT (left arm doesn't feel very good), MYALGIA (left arm is more sore, sleeps on it at night and it is sore the next day right where the shots were) and ARTHRALGIA (Shoulder pain over the last two weeks). On 07-Feb-2021, FATIGUE (Fatigue that lasted a day and a half) had resolved. At the time of the report, DYSPNOEA (Started having trouble breathing after walking a flight of stairs), LIMB DISCOMFORT (left arm doesn't feel very good), MYALGIA (left arm is more sore, sleeps on it at night and it is sore the next day right where the shots were) and ARTHRALGIA (Shoulder pain over the last two weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Additional initial document received
Patient described pain as severe at the time on injection and followed up a week later with pain in arm that was only a little better
6:00 a.m. on 2/5/21 I got up feeling nauseated. By 11:30 a.m. I also had body aches, fatigue, general malaise, and headache. I took the afternoon off work, went home and took Tylenol, and went to bed.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt received first dose of vaccine and had a syncopal episode within 5 minutes of  the event. Serial vitals were taken by this NP and she was initially hypotensive in the systolic 90's, but after 30 minutes had returned to 122/72. Durring the event the patient fell and sustained an abrasion to her left forearm and cheek. A full neuro exam was conducted after the event (normal) and the patient was instructed to have someone pick her up to transport her home and to follow up with her PCP.
diagnosis was near syncope; Sweats; Dizziness; He took his blood pressure and it was 85/49; Low potassium; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRESYNCOPE (diagnosis was near syncope), HYPERHIDROSIS (Sweats), DIZZINESS (Dizziness), HYPOTENSION (He took his blood pressure and it was 85/49) and BLOOD POTASSIUM DECREASED (Low potassium) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PRESYNCOPE (diagnosis was near syncope), HYPERHIDROSIS (Sweats), DIZZINESS (Dizziness), HYPOTENSION (He took his blood pressure and it was 85/49) and BLOOD POTASSIUM DECREASED (Low potassium). On 11-Mar-2021, HYPERHIDROSIS (Sweats), DIZZINESS (Dizziness) and HYPOTENSION (He took his blood pressure and it was 85/49) had resolved. At the time of the report, PRESYNCOPE (diagnosis was near syncope) and BLOOD POTASSIUM DECREASED (Low potassium) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood potassium: low (Low) low. On 11-Mar-2021, Blood pressure measurement: 85/49 mmhg, after 30 minutes was normal (Low) 85/49 mmHg, after 30 minutes was normal. On 11-Mar-2021, Electrocardiogram: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. The patient went to ER and was observed for 3 hours. No treatment information was provided.
Idiopathic thrombocytopenic purpura dx'ed 30JUL92; rx'ed w/IV gammaglobulin 31JUL-3AUG; plts now in nl range;
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 13-year-old female patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 20-DEC-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Pt developed whelps, 3 to 4 hours, post vax, on entire body. Whelps faded but returned in the AM of 9/26/01. Faded by the time of the office visit.
Tested positve for covid-19 after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positve for covid-19 after first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positve for covid-19 after first dose). At the time of the report, COVID-19 (Tested positve for covid-19 after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) tested for Covid-19 positive after vaccination.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment was not reported.  It was reported that the patient gets his second dose vaccination on 05-Feb-2021.
Hives over face, neck, scalp, ears (whole head); Rash over face, neck, scalp, ears (whole head); This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 at 10:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy, migraine and allergic to penicillin (PCN), sulfa and nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC), oxcarbazepine (MANUFACTURER UNKNOWN) and fluticasone propionate (FLONASE); all taken for an unknown indication from an unknown date and unknown if ongoing. On 21Apr2021 at 14:00, the patient experienced hives and rash over face, neck, scalp, ears (whole head). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hives and rash over face, neck, scalp, ears (whole head) was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Migraine-type headache day following immunization with ZOSTAVAX. Self treatment with ibuprofen.
side and back rash; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number C7734, expiry date 14th June 2021) for prophylaxis.   Concomitant products included vitamins nos (Vitamins).   On 21st May 2019, the patient received Shingrix and Boostrix. On 26th May 2019, 5 days after receiving Shingrix and Boostrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix and Boostrix.  Additional details were provided as follows: The case was reported by the office manager. The Health care professionals described rash as very large on the patients side and back. The patient was taking vitamins, but the health care professionals could not provide identifying details.
Case number PHEH2014US016235, is an initial spontaneous report received from a nurse on 11 Aug 2014. This report refers to an 18 year old male patient. Nurse reported that the patient received only the MenCYW-135 liquid component of MENVEO (batch number: M41024) intramuscular on 09 Aug 2014, without being reconstituted with MenA lyophilized component. No adverse event was reported. No further information was provided.