chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse and described the occurrence of chest tightness in a 42-year-old female patient who received hepatitis A inactivated and hepatitis B recombinant vaccine (TWINRIX) for prophylaxis.  The patient's past medical history included "sensitivity" to yeast.  She had no adverse experiences following receipt of the first injection of Twinrix.  There were no concomitant medications.  On an unspecified date, the patient received the 2nd dose of Twinrix.  On the same date, the she also received injections of MMRII (Merck), and Tetanus Toxoid (AP).  On the same date, an unspecified time post-immunization, the patient experienced chest tightness, "aches all over her body", and fatigue.  Additionally, she developed a rash on the arm where MMRII vaccine was injected.  The events resolved after seven days. The follow up received on 10/13/03 states the nurse reported the pt tested positive for both the hep A antibody and the hpe B surface antibody. No furthe rfollow-up is expected.
77 yo male presented to the ED given unresponsiveness at SNF via EMS, found to be hypoglycemic- intubated/sedated on admission - he was recently admitted, and had prolonged hospital stay (4/30 - 5/10) after orthopedic intervention / ORIF 4/30 Rt hip Fracture- s/p. - Acute hypoxic and hypercarbic respiratory failure, on mechanical ventilation - Bibasilar infiltrates, Lt > Rt, will small bilateral pleural effusions, HCAP - COVID PNA - Small bilateral pleural effusions - Encephalopathy - A-Fib - HFrEF, EF 45%, Mild MR - Acute on CKD - UTI
Information has been received from a mother concerning her son who was vaccinated with MMRII, at the age of 15 months. Subsequently, the pt developed a high fever, bumps and welts all over his body. The mother stated that "she no longer goes to the doctor that vaccinated her son". Unspecified medical attention was sought. Additional info has been requested.
Took the flu shot around 2pm and went for a nap two hours later and left eye is swollen.
Swollen lymph nodes under arms. Prescribed doxycycline and naproxen on naproxen on 11/8/2013.
Nausea, vomiting, fever, chills. Diagnosed with cellulitis, n/v, viral syndrome. Given Keflex 500mg 1 qid x 10d and Zofran tabs 4mg prn q6-8 hrs and given Rocephin 1g IM.
Patient already received the vaccine and was in the pharmacy waiting area for observation when he developed a seizure.  Area was clear to give him space and EMS arrived on the scene within 15 minutes. Patient was conscious again after about a minute of seizing. Patient was transported via EMS to ER for further evaluation.
Pt recvd vax & exp area uncomfortable, became hot in 1 day; 6 days later 21FEB; exp hot area 4" circumference w/many hive like bumps-very itchy; also felt tired;
On 02/09/2021, the patient received his first dose of the Pfizer COVID-19 vaccine.  Two days later, the patient presented to ER at Hospital on 02/11/2021 after noticing right arm weakness, slurred speech and facial droop while in the shower at home.  Patient was evaluated and determined to have an ischemic stroke, treated with tPA.  Patient transferred to hospital ICU for monitoring on 02/12/2021.  Patient transferred to step down care on 02/12/2021 and then was discharged  home on 02/13/2021 with improvement in his right sided weakness and the ability to ambulate independantly.
Vaccine was administered, patient became dizzy 30 seconds after shot.  Patient was pale,   diaphoretic & nauseous.  Symptoms lasted about 45 minutes.  BP dropped to 90/50 & pulse to 50/min.  8/20/09 PCP note received DOS 8/4/09.  After shots pt became naseated, pale, diaphoretic, dizzy and had difficulty breathing.  BP dropped to 90/50 and pulse into the 50's. Sx lasted ~45 minutes with return to baseline.  Vax record states pt "passed out".
Pain reported upon insertion of needle in upper left arm.  Patient said the pharmacist saw him wince in pain and ask if he wanted to continue and patient said yes.  Pharmacist finished administering vaccine and patient reports pain has been consistent in the area of administration since the time of the injection. It is now a week later and he is still reporting pain in the area of the injection site and he is not able to fully use his arm for lifting/etc at work.  It is not red or warm to the touch, hard or inflamed in any way when we observed it today.  Advised to use ibuprofen, tylenol or ice  and if it continues to seek medical attention.
Initial information received on 31-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a seven months old patient (gender not reported) who received third dose of PENTACEL lot C5462AA, expiry date: 26-Jul-2019, via intramuscular route in the right thigh and a dose of ACT-HIB lot UI894AAA, expiry date: 28-Sep-2019, in the left thigh on 20-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation. It was a case of actual medication error due to extra dose of HiB component administered. It was reported that the patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by sender: none.
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling left finger-vaccine was on left hand. sat for 20minuts. felt better. offer emergency service or to call relative to drive him. he said he was ok. called to check on him. no response from phone.
Intense enough Chest pain; jaw pain; back pain; nausea; This is a spontaneous report from a contactable consumer.   A 62-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in left arm, on 18Feb2021 at 14:00 (Batch/Lot Number: EL9267) as SINGLE DOSE for covid-19 immunisation   Medical history included hypertension and allergy to penicillin. Concomitant medication and pravastatin (PRAVASTATIN. On 19Feb2021 at 100am, the patient experienced chest pain and jaw pain where she seriously considered going to the ER. Also, the other common side effects of back pain and nausea. The outcome of the events was recovering. The patient was not hospitalized nor was  treatment received.
My thyroid is way up/ TSH is 4.46/ My thyroid level is dramatically different; Felt crummy; Exhausted/ Feel so tired; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of THYROID DISORDER (My thyroid is way up/ TSH is 4.46/ My thyroid level is dramatically different), FEELING ABNORMAL (Felt crummy), FATIGUE (Exhausted/ Feel so tired) and PYREXIA (Fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A, 042L20 and 016M20A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy in March 2021. Concurrent medical conditions included Cancer and Thyroid disorder. Concomitant products included GABAPENTIN (GABA [GABAPENTIN]) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced FEELING ABNORMAL (Felt crummy), FATIGUE (Exhausted/ Feel so tired) and PYREXIA (Fever). On 22-Sep-2021, the patient experienced THYROID DISORDER (My thyroid is way up/ TSH is 4.46/ My thyroid level is dramatically different). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, THYROID DISORDER (My thyroid is way up/ TSH is 4.46/ My thyroid level is dramatically different), FEELING ABNORMAL (Felt crummy) and FATIGUE (Exhausted/ Feel so tired) had not resolved and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: 102.5 (High) Seven hours after third shot, the patient had fever of 102.5 F. In September 2021, Heart rate: 105 (High) Pulse was 105. On 22-Sep-2021, Blood thyroid stimulating hormone: 4.46 (High) TSH is 4.46. On 22-Sep-2021, Hepatic enzyme: 1.12 (High) liver enzyme slightly up 1.12.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received third shot while being on chemotherapy (1 week on, 1 week off).   This case was linked to MOD-2021-328294, MOD-2021-328337, MOD-2021-328294 (Patient Link).
he felt really hot and sweaty like a hot flash. VS are WN (BP 130/83 P94 o2sat97)  Told to wait 10 more mins and took vitals again which were WNL.. He felt better and left on his own
This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. The patient's medical history, current conditions, drug reactions and allergies were unknown. On 09-JAN-2015, the patients were vaccinated with doses of PROQUAD (Merck) (route of administration, anatomical location and exp. date were not reported) that have been exposed to a supported temperature excursion (also reported as supported defrost cycling). No adverse effects have been observed or reported. The outcome of the event was unknown. This is one of two reports from the same source. Additional information has been requested.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.).
dark bruise around the injection site and draining down toward the elbow area. bruise looks like fading away as yellow color aroun bruise area shown
Initial report was received from a health care professional on 16 Dec 2009: This patient inadvertently received 2 doses of Novartis H1N1 vaccine on the same day. It was reported that the patient should have received one dose of Novartis H1N1 on one arm and another S-OIV FLUVIRIN on another arm but patient received second dose of Novartis H1N1 instead of FLUVIRIN. No adverse events were reported.
Infusion realred reaction; Hives; Lips were swelling; This is a spontaneous case initially received from a pharmacist on 24-Jan-2019, concerning a 22-year-old, adult female patient.  The patient had no pertinent medical history and no drug reactions or allergies. The patient had not received any concomitant medications.  On 07-Jan-2019, the patient was administered a high dose INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for an unknown indication. On the same day, the patient received a non-company suspect infusion Renflexis [infliximab abda, dose: 100 mg, route of administration, anatomical location, batch number and expiry date: not reported] for rheumatoid arthritis.  On the same day after vaccination, the patient experienced an infusion-related reaction which was described as hives and swollen lips 25 minutes inti infusion with Renflexis. It was reported that the infusion was stopped after an unknown amount of drug had been infused. The patient sought medical attention and was treated with unspecified medication. No lab tests or diagnosis were performed.  The outcome of the events was recovered on an unspecified date.  The reporter assessed the case as non-serious.; Reporter's Comments: A 22-year-old, female patient experienced an infusion-related reaction as hives and swollen lips, on the same day after administration with INN Flu Vaccine Seasonal and Renflexis infusion. The company assessed the causality of the event as related to the suspect vaccine due to plausible temporal relationship between event and suspect vaccine and the causal role of the suspect vaccine cannot be ruled out completely.
Got nauseous within minutes of vaccine. Waves of nausea over the next 6 hours.  Headache, lethargic, achy, slight fever, very sore arm and shoulder/neck.
Patient called pharmacy 9-1-14. States she was unable to lift arm for 2 days after receiving the vaccine. Had diarrhea and felt weak for two days.
Lips and area around lips went numb about a half hour after the 2nd vaccine was administered.  Numbness migrated to my left cheek a couple of hours later and was gone by about noon.  Elevated temperature around 5pm (99.8) the day of vaccination.  Started taking Tylenol.  Temperature the following day (100.9) and whole body skin sensitivity.  Slight temperature returned the next day (99.8), and no additional symptoms so far after a week.
sick; Initial information was received on 07-Feb-2021 regarding an unsolicited valid serious case received from Health Authorities via consumer or non healthcare professional [under reference number: US-SA-SAC20210210001019].  This case involves an adult patient who experienced sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, 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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome is unknown.  There will be no information on batch number for this case.; Sender's Comments: This case involves an adult patient who experienced sickness after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccines cannot be assessed.
BODY ACHES; FEVER; SEVERE HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, fever, and severe headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from body aches, fever, and severe headache. This report was non-serious.
Lymphadenopathy under left arm more 5 cm diameter; This is a spontaneous report from a contactable consumer. A 76-year-old male consumer (patient) reported for himself that he received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot  number unknown) via an unspecified route of administration in left arm on 26Feb2021 10:45 (at the age of 76-year-old) at single dose for COVID-19 immunisation. Relevant medical history was not reported. Concomitant medications were none. The patient was not administered with any other vaccine in four weeks. On 28Feb2021 the patient had lymphadenopathy under left arm more than 5cm diameter. The event was non-serious. Outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 14JUL97 & pt exp signs of involuntary muscle contraction 18-20 hr later (approx 3AM);adverse effect is still persisting w/no further info available;
Shots received at 9 AM. headache reported at 10 AM. Slept through lunch period (unusual behavior for this normal 9 year old male). Awoke from nap with SOB, which got progressively worse. ER visit 14:47 for severe SOB; condition improved with albuterol treatment. Febrile for 3 days; treated with Ibuprofen PRN every 4-6 hours. Peak temperature 102.5.
This spontaneous report as received from a other health professional via field employee refers to unknown number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date, unknown number of patients were vaccinated with PNEUMOVAX 23 vial (dose, route and frequency were not reported). Concomitant medications were not reported. On an unknown date, unknown number of patient have been revaccinated with PNEUMOVAX 23 and that an unknown number of patients have received more than 2 immunizations with PNEUMOVAX 23. No adverse effect reported. Product quality complaint was not reported. Additional information has been requested.
None- vaccine given 6 days post expiry; Dose 1 was Pfizer; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was Pfizer) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (dose 1 (lot number :EL0142)) on 11-Jan-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was Pfizer). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was Pfizer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.
Bladder inflammation; Throat swelling; severe drowsiness; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 35-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration was not reported), second dose via an unspecified route of administration, administered in arm right on 18Apr2021 10:00 (at the age of 35-year-old) as dose 2, single for COVID-19 immunization. Patient medical history included hidradenitis, migraine from an unknown date and unknown if ongoing followed by Keflex drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient did not have any history of UTIs. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration was not reported), first dose via an unspecified route of administration, administered in arm right on 28Mar2021 9:45 single for COVID-19 immunization. On 19Apr2021 03:00 the patient experienced bladder inflammation, severe burning pain when urinating, frequent urination, lower abdominal pain, throat swelling, severe drowsiness. Adverse events resulted in Emergency room and department or urgent care. Patient received treatment for events included Bactrim. The outcome of the events was resolving.   Information on the lot/batch number has been requested.
several years ago I lost my sense of smell. 6 days after receiving my first dose of covid 19 vaccine I noticed my sense of smell returned; This is a spontaneous report from a contactable consumer (patient). A 78-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. Medical history included lost of sense of smell several years ago. The patient's concomitant medications were not reported. The patient reported that several years ago, he/she lost his/her sense of smell. Six days after receiving the first dose of Covid 19 vaccine patient noticed that his/her sense of smell returned. Patient was thrilled. He/she was a healthy 78-year-old and wants to know if this a side effect of the vaccine or a coincidence. Outcome of the event was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained. No further information is expected.
Initial report received from a healthcare professional on 03 January 2013. A female patient, whose demographic details, medical history and concomitant medications were not reported, had received a dose of Tdap vaccine manufacturer unknown (lot number, site and route of administration, dosage and number in series were not reported) on an unspecified date. It was reported that, the patient had a reaction after vaccine administration. Laboratory date and corrective treatment were not reported. The patient's outcome was not reported. Documents held by sender: None.
Saturday night - extreme chills, which cycled with extreme feelings of overheatedness; extreme muscle weakness throughout whole body, could not move in bed; extreme thirst, dry mouth; nausea, no vomitting; exhaustion; diarrhea; sore injection site, tender area; sweats; could not sleep, could not get comfortable but did not have strength to change position Sunday morning and current - extreme thirst; exhaustion; diarrhea; waves of nausea on Sunday and Monday morning;  headache which is reduced with medication, but not completely gone; sunlight/lights are painful to eyes Medication: since Monday afternoon, 400mg ibProfin alternating with daytime cold relief (650mg acetaminophen) every 3 hours (so 400 mg ibprofin and 650mg acetaminophen total every 6 hours, taken at 3 hour increments)
Right deltoid is red, swollen, warm to touch, and painful. Denies respiratory symptoms. Patient instructed to monitor site, ice, follow up as needed.
Narrative: 57-year-old female with history of chronic asthma, hypertension, type 2 diabetes (A1C 6.0 in 7/2021), hyperlipidemia, schizoaffective/bipolar disorder, chronic tobacco use disorder who presented to the ED with worsening shortness of breath, cough, chest pain. Patient reports having the symptoms starting 7/12/2021 accompanied by myalgias, presented to the facility on 7/14/2021 when she tested positive for COVID-19. Reports worsening dyspnea, cough, chest pain today. Reports loss of taste, poor appetite over the past week along with wheezing, intermittent fevers and chills. Denies other symptoms such as palpitations, abd. pain, n/v at this time. On current presentation, patient febrile to 102.6, blood pressures 90s to 100s/50s, pulse 50s to 60s, 86% on room air, 94 to 95% on 4 L. ADMITTED TO MICU. INTUBATED 7/22 TO 7/26. RECOVERED AND WAS DISCHARGED TO HOME 7/29/21