chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fly like symptoms; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (fly like symptoms) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (fly like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (fly like symptoms) outcome was unknown.            No concomitant medication was reported. Patient had no fever or life threatening issues. Patient was in relatively good health and patient had O neg blood. No concomitant medication were reported. Patient took the offered four doses Covid Moderna vaccine, at the appropriate times. The vaccine gave fly like symptoms but no fever or life threatening issues. No treatment information was provided by the reporter.   This case was linked to MOD-2022-675330 (Patient Link).
received an expired dose of PENTACEL with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA350570.  This case involves a 1 years old female patient who received an expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 07-Nov-2023, the patient received an expired 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UJ804AA, Expiry date: 07-Oct-2023 with unknown strength)  via intramuscular route in the right thigh as immunization with no reported adverse event (expired product administered) (Latency: same day).  It was reported "The nurse was asking for guidance on next steps, and she also wanted to know what to tell the patient's parents on what to watch out for in terms of adverse reactions."   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.
After swimming I noticed a water bubble in my ear the day after the holidays 2021. The following Sunday and got violently ill, vomiting. I went to the doctor the next morning. I also had vertigo beginning at the same time as well. I have worn a hearing aid for about two years. But after this event I noticed over a period of a week that I lost my hearing in my right ear completely. I visited with an ENT and had an MRI taken.
3/12 - Received MMR vaccination. 3/17 - woke at 630AM with fever and chills. 1200 noon. Swollen lymph node. Fever. Controlling with MOTRIN and TYLENOL. Pediatrician appt 130. CT scan of lymph node. ROCEPHIN IM, Blood cultures. 3/17 - 3/19 - Fever. Admitted 3/19 - Rash bilateral trunk, blood shot eyes lethargic. Hospitalization from 3/19 - 3/23. Kawasaki diagnosed. IVIG given and high dose ASA.
pt had joint pain in her finger/thumb, knees, and feet lasting 3 weeks.
first day very sore shoulder, light tingling of lips, morning of second day hoarseness and a little trouble swallowing,  days 9-11 extreme headache, second and third week, on and off tiredness, muscle aches, anxiousness, and a blah feeling.
tired; chills; joint pain; muscle pain; nausea/wanted to vomit; blood pressure increased; heart rate increased; feeling unwell; injection site swelled; injection site bled had to band aid; headache; This is a spontaneous report from a contactable consumer (patient). A 59-Year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration in the left arm, on 03Mar2021 at 02:15 PM (at the time of 59-year-old) at single dose for COVID-19 immunisation. The patient medical history included obese, post concussion syndrome and surgeries. Concomitant medications included vitamins, zinc and iron health supplements. The patient previously took morphine and lanocaine and experienced allergies. On an unspecified date in Jun2020 and Dec2020, the patient underwent nasal swab test for covid (post vaccination) and the result was negative. On an unspecified date in Aug2020, the patient underwent blood test for covid (post vaccination) and the result was negative. On 03Mar2021 at 02:15 PM, the patient experienced tired, chills, joint pain, muscle pain, nausea, blood pressure increased, heart rate increased, feeling unwell wanted to vomit for four days, injection site swelled then on four-day injection site bled had to band aid it stopped after a bit while she went back to sleep and had headache for four to five days. Advised to go to emergency room but cannot afford emergency room. It was unknown whether the patient had covid prior vaccination. The patient did not receive any other vaccine in four weeks. The patient received Benadryl as treatment for the events. The outcome of the events was recovering  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
extreme fatigue; chills; fatigue; nausea; headache; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, fatigue, nausea, headache, extreme fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received second dose of mRNA-1273 (lot/batch: 029K20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the event(s) chills, fatigue, nausea, headache. On 25 Feb 2021, the patient experienced the event(s) extreme fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), chills, fatigue, nausea, headache, extreme fatigue was unknown.
This is a spontaneous report from a Pfizer-sponsored program: IBCC (Inbound Call Center for HCPs).  A contactable pharmacist reported that a 65 years old female patient received PREVNAR 13 (lot N05077, expiry date Sep2017, NDC number 00005197106, UPC number 00051971022) intramuscular, in arm, on 14Sep2016, at 0.5 ml, single, for immunisation.  The patient medical history was none. The patient's concomitant medications were not reported.  The patient experienced red, slightly swollen very warm arm and it had itches on 21Sep2016 with outcome of not recovered. The patient came back into the pharmacy with red and swollen arm and she wanted to know if that was normal. The pharmacist recommended the patient some treatment but she was not sure if the she had used it or not. No emergency room or doctor visit were required. The reporter considered the events were related to the administered vaccine.
Headache,  nausea, dizziness, swelling in injection site arm and pain from site location to wrisg
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 08-MAR-2013 at 04:20 pm, the patient was vaccinated with GARDASIL (lot # H010915, expiration date 13-FEB-2015) (dose, therapy route and anatomical location unspecified). The physician reported that on unknown dates, GARDASIL was exposed to multiple low temperature excursions. Excursion time at -1:66.50 hours (also reported a 17 hours, -1, 172, 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Pt recvd 1st dose of vax in OCT or NOV90; At an unspecified later date, pt devel a fever & elevated SGPT levels; pt improved by December;
Information has been received from an MA concerning a 5 year old male who on 7/17/01 was vaccinated with a 1st dose in the left leg of varicella virus vaccine live and a 1st dose, in the left leg, of diphtheria toxoid/pertussis vaccine/tetanus. There were no other concomitant medications. That night, the pt's leg became very swollen and stiff and he was unable to bend it. He went to the ER on 6/18/01 and they did a tap on the knee to make sure that there was no bacteria in the knee. The cultures were reported as negative. It was noted that the pt did not stay overnight at the hospital. The pt was seen in the doctor's office on 7/19/01 and seemed better and on 7/20/01, the day of this report, the pt was seen again in the physician's office. The swelling had gone down slightly, however, it was still swollen and he was still unable to bend his knee. The physician recommended continuing treatment with ibuprofen. The reporter stated that the lower extremity edema and muscular-skeletal stiffness was a reaction to the varicella virus vaccine live and the diphtheria toxoid/pertussis vaccine/tetanus. Follow-up information from a nurse, indicated that the pt reported to his mother that he had fallen on the left leg around the same time as the vaccination. It was reported that the swelling and stiffness were "documented to be probably related to the Varivax administration". The nurse indicated that the office has not heard from the pt's mother and they are "assuming the child is OK". Upon internal review, the pt's experience was considered an "Other Important Medical Event". Additional information has been requested.
Red warm area about 3-4 inches wide and about 2/3'ds around arm. Rash below injection site. Spread to below elbow and towards shoulder. KEFLEX antibiotic given 10/24/16 for 7 days.
Pt presented with sweating, nausea, muscle cramps and contractility after receiving 1st Moderna Vaccination
For the last two and a half weeks, since receiving the high-dose flu vaccine, I have had many confusing symptoms.   Feeling extremely exhausted, very sleepy, very weak all over. Unable to do even simple things around the house.    (This is very unlike me - I am an extremely active woman, used to exercising and having boundless energy.)   Inflamed Achilles Tendon for several days, very painful bump under my chin, for several days.  Low appetite.
7-10-year-old patients were administered Boostrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report The reporter stated that 7 to 10 year old patients were administered Boostrix, which led to inappropriate age at vaccine administration. The reporter did not consent to follow up.  No more information was provided.  This case was linked with US2016177194 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE INC.-US2016177194:same reporter
PATIENT EXPERIENCED SYNCOPE/DIZZINESS SHORTLY AFTER GETTING A SHOT
Shortness of breath off and on Chest pain of and on Nerves heightened Allergies heightened  Senses, hearing, smell heightened  Medication not tolerated,  even tylenol and stomach meds Stomach irritation  Terrible odor when sweating  Headache  Medication, taken for 25 years, stopped working correctly  Difficult to eat most days Difficult to sleep most nights
Fever started the evening of 5/21/10, 99 degrees, but on 5/22/10, temp reached 105 degrees. Tired, sleepy, poor appetite. Rash developed 5/25/10.
fatigue; headache; arm pain; joint pain; rash; welts; itching painful bumps; This is a spontaneous report from a contactable other health care professional reported in response to vaccine HCP letter sent in cross reference case. A 46-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: E23320, expiration date: unknown) via unknown route of administration at left arm on 11Feb2021 (at the age of 46-years) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no predisposing factors. The patient had second dose was much worse, experienced extreme fatigue, headache, arm pain, joint pain continued for 2 weeks, rash appeared on back and front mid section, welts and itching painful bumps all over on an unknown date. On 05Mar2021, the patient still had some evidence of mild rash. The patient was self treated with OC medication advil, aloe plus chamomile lotion and had rest. The patient had no chills and nausea. It was reported that the reaction recure on re-administration of product. The patient was not deceased. The patient was not recovered from the event rash while outcome of all other events was reported as unknown.  No follow-up attempts were needed. No further information was expected.
Initial report received on 23 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3608AA received on 03 June 2010, lot number C3682AA received on 06 August 2010, lot number not reported on 12 October 2010 and 20 July 2011 (routes and sites of administration not reported). The subject developed a cough and cold-like symptoms on 02 August 2012, approximately one year after the last dose. On 06 August 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 09 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 10 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 16 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Tired, painful arm @ site of inject; lethargic, fever of 101(a); sz @ 1030AM; To ER seen by MD;
Patient.  While giving vaccine at the patient requested to receive one, as with any patient I went over the information and patient signed and consented to vaccine.  Returning back to it was found that patient had already received a Janssen dose in 5/2021 at another facility.
pt recv vax 21JUN96 & 22JUN96 exp a gen rash on arm then legs & trunk; gen urticaria;
Redness, swelling, and pain. Patient was prescribed cephalexin and medrol dose pack.
It was reported that an adult male pt received a Menomune A/C/Y/W-135 vaccination on 3/6/00. Reportedly, the pt died on 4/14/00. dx'd with purulent meningitis. Autopsy done at medical examiner's office. Further medical follow-up is requested and ongoing. On 05/22/2001, the autopsy and medical examiners reports were received. Autopsy report revealed the following findings from the head and central nervous system. "The leptomeninges overlying the frontal lobes have yellow-green opacified material present, consistent with purulent meningitis process." From the correspondence received from a physician it was stated "This case was associated with large numbers of gram positive diplococci having the morphology consistent with S. pneumonia. A silver stain and a PAS did not support the presence of any other organism."
Woke up with rash all over back, less severe on arms and chest. Most likely molluscum contagiosum.
pt said she has a bulge in her arm as wide as 2 knuckles and as long as an index finger that has been there for over a week. she tried ice
Pt received flu shot at clinic on 11/3/08. States she started with discomfort to left upper arm from flu shot area to her elbow and states "it feels bruised" - the pain from (L) shoulder to (L) elbow is exactly in line where shot was given. Saw MD on 12/29 and Xray done; 1/6/09 MRI (L) arm and neck; 2/2 saw MD; 2/13/09 has procedure to deaden nerve; next MD appt 3/16/09.
About 72 hours after the shot, I got a sore throat, then a cough. Severe congestion followed. No fever, but cold-like symptoms increased. Very bad cough. Went to urgent care twice; two COVID tests were negative. Continued worsening illness. Diagnosis on 25 Jan was Bronchitis and small lung cell collapse. Prescribed antibiotics, cough medicine, steroid shot, steroid aerosol.
Participant received vaccine at 6:05 pm. She was observed for fifteen minutes then left the clinic at 6:25pm. She returned to the clinic  c/o " feeling oozy" with itchy throat. Face flushed and c/o of itching all over upper extremities. Pulse Ox 99-100% 6:45P BP 149/79  P80 R18  7P BP  143/77 P82 R18  7:15P   BP  141/83 P 82 R20 Participant taken to the ED for further evaluation.
Information has been received from a female licensed practical nurse of unknown age reporting on herself. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 07-NOV-2017, the patient received an expired dose of M-M-R II subcutaneous, lot # L043702, expiration date 03-NOV-2017, for prophylaxis (strength and anatomical location were not reported). No adverse effects were reported.
Tenivac was given to a 6 year old in error, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 6 years old patient who was vaccinated with a dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] lot number not reported via unknown route in an unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to Inappropriate age at vaccine administration. It was reported that the Tenivac was given to a 6 year old in error.  At the time of reporting, no adverse event was reported.  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.  Information on the batch number was requested  List of documents held by sender: none.
48hr p/vax pt noticed swelling in hands like instant arthritis;the became painful;MD advised DPH, which alleviated itching, but not swelling;cortisone helped decrease swelling;
Information has been received from a pharmacy student with Pharm. D degree, referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (lot #, expiration date, dose, route and excursion details unspecified) (incorrect product storage). No adverse effects had been reported post vaccination. This is one of several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
BLOOD CLOTS; This spontaneous report received from a consumer (heard from pharmacist) concerned multiple adult female patients (28) of age in between 18-48 of an unspecified race and ethnic origin. No past medical history or concurrent conditions were reported. The patients received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported frequency 01 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date the consumer heard from pharmacist that , "28 women got blood clots and that is why the vaccine was paused for a while. Her words: Comment about side effects when it was paused, pharmacist said, 15 million shots, out of those only 28 people, all women, had blood clots, and those women, age range 18-48, all women having periods, not  menopausal." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211058383.; Sender's Comments: V0: 20211059158-COVID-19 VACCINE AD26.COV2.S-blood clots. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
pt recv vax 29APR98 & 29JUN98 pt was fussy & exp pain & swelling of joints;13JUL98 pt exp swelling & was limp & had a fever off & one;AUG98 pt hosp & dx w/juvenile rheumatoid arthritis;
This spontaneous report as received from an office manager, refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 27-SEP-2017, the patient was vaccinated with a dose of with PROQUAD lot # M007965 expiration date 15-AUG-2017 (dose and route were not provided) for prophylaxis. No adverse effects were reported. This was one of two reports received from the same source.; Sender's Comments:  US-009507513-1710USA001813:
Patient received a full third dose of Moderna vaccine but was supposed to receive the Booster  dose of 0.25ml.
Received vaccine 2/14/22. A little tired on the day of the vaccine and for the next 24 hours. 2/17/22 he was acting like he was not feeling well, temp 101. No other symptoms. Took tylenol at 12 pm. At 3:50 pm he was fussing, eyes rolled back and started shaking. lasted about 1-2 minutes. Was tired and slept more afterwards. Fever continued on and off for the next 24 hours. Patient was transported to the ER by ambulance after the seizure. Reported as tonic clonic seizure. He did not stop breathing, no emesis. No other symptoms. Patient later seen in PCP office on 2/21/22 for follow up. 2/21/22 patient had scattered blanching macules on chest, abdomen, and back. The physician suspects roseola.
Generalized muscle soreness, generalized fatigue, low body temperature. Mostly resolved by 24 hr, but mild muscle weakness and strange sensation in lower body muscles persisted for about a week after.