chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse Reaction at this time. Vaccine was to be diluted with 1.8 ml and it was only diluted with 1.4ml, patient was made aware if he has any reaction to call the office.
swelling around nose & eyes; rash until 9MAY94; low grade fever of 99-100; sleepy; loss of appetite;
Fatigue, Dizzy, syncope x 3, pleuritic chest pain, chills, fever 99.7 and myalgias
Mild nausea right after injection, vomiting later in the night and throughout the next day along with excruciating head pain, slept in between vomiting all day, sweating, chills.
GENERAL FATIGUE; HEADACHE; INJECTION SITE PAIN; This spontaneous report received from a consumer concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol consumption (socially, about once per week), non smoker, and grass, tree and pollen allergy, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested.  On 19-MAY-2021, the subject experienced general fatigue. On 19-MAY-2021, the subject experienced headache. On 19-MAY-2021, the subject experienced injection site pain. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from general fatigue, and injection site pain, and the outcome of headache was not reported. This report was non-serious.
About 4 hours after the shot I saw difficulty breathing, wheezing, coughing and hives (about 2 on face, neck and chest).
Pt developed pain at injection site, fever, and tachycardia.  Pt had to go back to doctor's office due to symptoms.  Pt treated with NSAIDS and sent home.
Moderna COVID-19  Vaccine  At 2 PM I went blind in my left eye. Went to emergency room at Hospital Was told I have Blood clot in my eye causing the blindness and Ophthamologist says it will probably be permanent
falling injury; Lower back pain; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events patient fell 2 weeks after first shot, lower back pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the event(s) patient fell 2 weeks after first shot, lower back pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 17 Feb 2021 the outcome of event(s), patient fell 2 weeks after first shot was resolved. The outcome of event(s), lower back pain was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Pneumonia; sOCIAL PROBLEM; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sinus infection and cancer (Since 20 to 25 years).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pneumonia (serious criteria GSK medically significant) and social problem. On an unknown date, the outcome of the pneumonia was recovering/resolving and the outcome of the social problem was unknown.   The reporter considered the pneumonia to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was cancer survivor for 20-25 years and had recurrent sinus infections on and off but not lately. The patient wanted to know if there was any reason not to receive 2nd dose and briefly mentioned having a light, mild case of pneumonia back in January or February 2020.  The patient reported being healthy since pneumonia infection as chest x-rays were good as of 1st March 2020. The patient declined to provide further information for safety report due to knowing that pneumonia was unrelated to Shingrix.  It was reported that the patient was in good health and due to have 2nd Shingrix dose this coming week but there was concerned due to COVID-19 and therefore would be pushing it off. The patient's demographics not provided and limited information was provided.
woke up on 04/19/2021 with what seams to be shingles next left side of chest sore arm at injection site. , still sore today,
Information has been received from a physician concerning an 18 week old patient who, "two weeks ago," on approximately 25-SEP-2006, was vaccinated with a first 2 ml oral dose of ROTATEQ. It was reported that the patient regurgitated the dose. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested. 04/04/2010 Follow-up  information from the physician indicated that the patient did not experience any symptoms. The patient regurgiated a partial dose. Additional follow-up information from the physician indicated that the infant spit out some of the first dose but had no problem with it. Additional information is not expected.
This spontaneous report as recevied from a physician and healthcare worker regarding an unspecified patients of unknown age and demographics. The patients' concurrent condition and medical history was not reported. On an unknown date, the unspecified patients were vaccinated with ROTATEQ lot # K007911; expiry date 29-MAR-2016 (dose and route of administration was unspecified) which was inadvertently and improperly stored at 52 Fahrenheit for 2 hours. No adverse effects were reported. No product quality complaint was reported. No further information was provided. Additional information has been requested.
Heart palpitations and some lightheadedness.  Diagnosed as Atrial Fibrillation following ECG in cardiologist's office.  Confirmed in Hospital ER.  Admitted to Hospital for treatment.  Returned to normal sinus rhythm following 13 hours treatment with medicines to lower heart rate.  Discharged home the following day.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Date of service was 4/2/21 and patient is still currently hospitalized. Diagnosis is acute hypoxemic respiratory failure due to COVID 19.
Information has been received from a licensed practical nurse referring to 3 patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Since 14-MAR-2016 the patients were vaccinated with doses of ROTATEQ which were improperly stored (dose unknown, lot# L027719, expiration date 28-APR-2017; lot# reported as L037291, expiration date 31-MAY-2017) orally. The vaccines were stored at 34.1F for 38 minutes and previously stored at 33.6F for 40 minutes. No adverse effects were reported. Lot# L037291 is an invalid lot number for ROTATEQ. Additional information has been requested.
has only been getting worse by the day; keeps her up at night and she cannot sleep; sick, very sick for the first 24 hours; Initial serious tingling in her entire body and face, face her nose her arms are tingling; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Initial serious tingling in her entire body and face, face her nose her arms are tingling), CONDITION AGGRAVATED (has only been getting worse by the day), INSOMNIA (keeps her up at night and she cannot sleep) and ILLNESS (sick, very sick for the first 24 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PARAESTHESIA (Initial serious tingling in her entire body and face, face her nose her arms are tingling). On an unknown date, the patient experienced CONDITION AGGRAVATED (has only been getting worse by the day), INSOMNIA (keeps her up at night and she cannot sleep) and ILLNESS (sick, very sick for the first 24 hours). At the time of the report, PARAESTHESIA (Initial serious tingling in her entire body and face, face her nose her arms are tingling), CONDITION AGGRAVATED (has only been getting worse by the day), INSOMNIA (keeps her up at night and she cannot sleep) and ILLNESS (sick, very sick for the first 24 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. Concomitant medications were not provided.
Client received her first dose of COVID vaccine (Pfizer Pediatric COVID vaccine on 12/07/21 lot: FK5618). Interpreter assisted RN with translation to Spanish during entire conversation. Client's mother reported that client has mild seasonal allergies, no chronic conditions and is currently not taking any medications. Client reported, "2 hours after her COVID vaccine that she experienced dizziness. The first time was at 7PM, the second time was at 7:15 PM and the third time was at 7:20 PM and they all lasted for 5 minutes." No other reaction reported aside from fatigue and arm pain. Client's mother did not report the reaction to her daughter's Pediatrician due to she was not aware of the dizziness. Client's mother is requesting for her daughter to receive the Pfizer Pediatric COVID vaccine 2nd dose. RN, submitted a medical consult via text to Vaccine Operations Lead and approval via text from Dr.  was obtained for client to receive Pfizer Pediatric COVID vaccine second dose. RN educated client's mother to have client stay 30 minutes after her Pfizer Pediatric COVID vaccine and educated on ER precautions and when to follow up with daughter's Pediatrician, if her daughter experiences the same symptoms. Client's mother verbalized understanding. Client received Pfizer Pediatric COVID vaccine second dose lot: FL0007 exp: 03/01/22.  Client completed 30 minutes observation with no adverse reactions and left facility at 4:39PM.
Did not cry with PENTACEL RT; or the hep b in LT, started to cry after PREVNAR 13 in LT. ROTATEQ orally first. Nurse looked up at baby after PCV13 to note circum oral cyanosis. Resolved in decreased 3 min with stimulation, observed 10 minutes after.
SORE SHOULDER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sore shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore shoulder. This report was non-serious.
10/4/2021 got chilled, joint and muscle high pain 10/5/21 fever to 99.7  fatigue, slept most of day, loss of appetite,   10/6/21 Extreme sweating of back of head more that when hot flashes to ears (entire back of head  thick sweatt  Nape of neck First with no movement, then became any movement, tapered off on Saturday 10/09/21
This spontaneous report was received from a physician and refers to a 6 week old patient. The patient's current conditions, medical history and concomitant medications were not provided. On 11-MAY-2016 (on patient's date of birth), the patient was vaccinated with first dose of RECOMBIVAX HB. On 14-JUN-2016, the patient was vaccinated with second dose of RECOMBIVAX HB. On 28-JUN-2016, the patient was then inadvertently given a third dose of RECOMBIVAX HB (inappropriate schedule of vaccine administered). The patient inadvertently received an extra dose of vaccine, because the patient's mother had not given the physician the patient's complete vaccination history. No symptoms were reported (no adverse event). Product quality complaint (PQC) was not involved. Additional information has been requested.
I got the flu; Initial information regarding this unsolicited valid non-serious social media from a consumer (patient) on 19-NOV-2020.  This case involves a patient got flu (Influenza) when received vaccine INFLUENZA VACCINE (flu shot).   Relevant 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 INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, it was reported that the flu vaccine was not for the flu virus that was going around that's how the patient got the flu (Influenza).   Relevant laboratory test was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.  There will be no information available on batch number for this case.
This spontaneous report has been received from a nurse via field representative referring to a female patient of unknown age. The patient's medical history and concomitant conditions were not informed On an unknown dates the patient was vaccinated with doses of GARDASIL 9, at 0, 2, 6 months. On an unknown date the patient experienced fever and flu like symptoms for an unspecified rason. The patient did not seek medical attention. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
DIZZINESS; NOT FEELING WELL; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and other pre-existing medical conditions included no known allergies or medical conditions. the patient was currently taking anti-depressants. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced not feeling well. On MAY-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and not feeling well. This report was non-serious.
This case was reported by a sales preventative and described the occurrence of decreased therapeutic response in a 19-year-old female subject who was vaccinated with ENGERIX B pediatric (General Nutrition CA), ENGERIX B. A physician or other health care professional has not verified this report. There was no concurrent medications. On unspecified dates (about 20 years ago) the 19 year old subject received 1st, 2nd and 3rd dose of ENGERIX B pediatric to complete the three dose series. Titers taken 20 years later were low. The subject experienced decreased therapeutic response. No additional details were provided.
Pt recvd vax & was seen @ local hosp 19OCT92 w/swollen & painful red knees & ankles, fever, arthritis & target lesions on skin; dx erythema multiforme;
Neck hurting, tongue swelling and numbness, ear and face swelling and hot to touch. Benadryl,2 epi pen shots,steroids
Face and neck went completely numb 15 minutes after vaccine given and lasted for 24 hours straight, followed by occasional similar episodes up to weeks after vaccine
Syncope approximately 5 minutes after dose given. Pt recovered on floor 1-2 minutes after. Family requested 911 called. Pt taken to hospital.
This case was reported by a pharmacist via call center representative and described the occurrence of redness in a 17-year-old female patient who received MENVEO (batch number M15122, expiry date 30th May 2017). On 19th August 2016, the patient received MENVEO .5 ml. On 19th August 2016, unknown time after receiving MENVEO, the patient experienced inappropriate preparation of medication. On an unknown date, the patient experienced redness and induration. On an unknown date, the outcome of the redness, induration and inappropriate preparation of medication were unknown. It was unknown if the reporter considered the redness and induration to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The patient inadvertently received just the liquid conjugate of the MENVEO vaccine, which led to an inappropriate preparation of medication. After being vaccinated with MENVEO, she experienced a red hardness on the arm. No other details of the reaction were obtained and it was not known how long the redness and hardness persisted.
6/5/2021- Dizziness, loss of consciousness, nausea, vomiting, diarrhea, shaky arm
prepared a vial for patient use on 01AUG2023 but the patient did not come and the product was administered on 02AUG2023 to another patient (with no reported adverse event); Initial information received on 04-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient for whom a vial of meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] was prepared for use on 01aug2023 but the patient did not come and the product was administered on 02aug2023 to another patient (with no reported adverse event) while receiving vaccine   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV vaccine VLP RL1 4V (Yeast) (Gardasil) and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix) for Prophylactic vaccination.  On 02-Aug-2023, the patient received 0.5 ml (dose 1) of suspect meningococcal A-C-Y-W135 (T CONJ) Vaccine, Solution for injection lot U7643AB via intramuscular route in the left deltoid for immunization,a vial was prepared for patient use on 01aug2023 but the patient did not come and the product was administered on 02aug2023 to another patient (with no reported adverse event) (poor quality product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event poor quality product administered.  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 the 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.   Additional information was received on 04-Aug-2023: Case upgraded from non case to valid case and narrative amended accordingly.
High fever, 104F-105F, post vax, on 4/23/01. To ER on 4/23/01 that evening with continued seizures, vomiting, lethargy. No overnight stay. On 4/24/01, child is better. On 4/25/01, mom reports child had afebrile seizure with no lethargy following. Child has PMD follow-up and will have EEG.
Herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 28-OCT-2010, at age 61, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a nurse practitioner (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Loss of taste and smell and other minor covid symptoms - chills/fatigue 2 and 1/2 weeks after receiving the vaccine, two negative COVID tests led dr. to believe was just adverse delayed reaction to the shot.
Psoriasis scalp; Nasal drip; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis scalp) and RHINORRHOEA (Nasal drip) in a 94-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PSORIASIS (Psoriasis scalp) and RHINORRHOEA (Nasal drip). At the time of the report, PSORIASIS (Psoriasis scalp) and RHINORRHOEA (Nasal drip) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes Shampoo for an unknown indication.  Patient self-administered unknown shampoo for an unknown indication.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Report follow-up received and contains no new information.
Orthostatic hypotension; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 16:00 as dose 4 (booster), single (Lot number: GH9693), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 02, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 03, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: ORTHOSTATIC HYPOTENSION (non-serious) with onset 30Sep2022 at 06:00, outcome "not recovered". Therapeutic measures were not taken as a result of orthostatic hypotension.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Bilat thighs increased reddened area encompassing entire upper thighs with increasing amount of white pustules lasting approx 1 wk - "worse than 1st episode".