chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept for two days Straight), EATING DISORDER (not able to eat), ILLNESS (sick for five days), ASTHENIA (no energy) and ADVERSE REACTION (bad reaction "worse than covid") in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 pneumonia on 08-Jan-2021.Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and PROTRIPTYLINE HCL for an unknown indication. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced HYPERSOMNIA (Slept for two days Straight), ILLNESS (sick for five days), ASTHENIA (no energy), ADVERSE REACTION (bad reaction "worse than covid"), VACCINATION SITE PAIN (Arm pain) and VOMITING (vomiting ten times). On an unknown date, the patient experienced EATING DISORDER (not able to eat). At the time of the report, HYPERSOMNIA (Slept for two days Straight), EATING DISORDER (not able to eat), ILLNESS (sick for five days), ASTHENIA (no energy), ADVERSE REACTION (bad reaction "worse than covid"), VACCINATION SITE PAIN (Arm pain) and VOMITING (vomiting ten times) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-JUN-2021 contains concomitant medication details. On 22-Jun-2021: Follow up received on 22-JUN-2021 contains No New Information
Patients vaccinated using old vial from 03/10/21; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients vaccinated using old vial from 03/10/21) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients vaccinated using old vial from 03/10/21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients vaccinated using old vial from 03/10/21) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter No treatment information was provided   This case was linked to MOD-2021-208074, MOD-2021-258552, MOD-2021-258572, MOD-2021-258587, MOD-2021-258599, MOD-2021-258615, MOD-2021-258632, MOD-2021-258644, MOD-2021-258660, MOD-2021-258672, MOD-2021-258682, MOD-2021-258689, MOD-2021-258691, MOD-2021-258693, MOD-2021-258697, MOD-2021-258699, MOD-2021-258700, MOD-2021-258702, MOD-2021-258703, MOD-2021-207548 (Patient Link).
Resident developed a 100.2 F temperature and shortness of breath.  Fever noted at 7:45 pm, Oxygen level was not above 88%, On-call RN was notified at 7:45 pm. RN advised staff to recheck vitals at 9:30 pm and to continue to monitor resident. Family was notified at 7:45 pm also.  At 9:30 pm, check of vitals was done. Temperature was 102.5F, SpO2 was 93%, BP 107/63, pulse 102. At 9:50 pm, Family member requested that resident be sent to Emergency Room. EMS was notified, patient transported to Hospital ER.
This spontaneous report has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dose and route were not reported) for prophylaxis, which was reconstituted with sterile diluent (lot # and expiration date were unknown). The vaccine was exposed to temperature excursion between 32 degrees Fahrenheit to 35 degrees Fahrenheit and 32 degrees Fahrenheit to 35 degrees Fahrenheit for unknown duration. There was no previous temperature excursion and the data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA003262: US-009507513-1708USA012210: US-009507513-1708USA012212: US-009507513-1708USA012213: US-009507513-1708USA012214.
(R) deltoid 2 1/2 x 2 inches swelling, redness, itching. Ice pack apply. (R) arm 4 1/2 x 4 inches swelling, redness, itching. Ice pack applied.
This patient received Covid19 vaccine. This PT has a history of Autism and was getting anxious post vaccination.  PT's mother was accompanying him when he began feeling dizzy, sweaty, hard of hearing and tightness in his Left arm where the vaccination was administered. PT was immediately evaluated by EMS and Fire Rescue on scene. PTs condition began to improve. PT declined transport.
developed some large marble size lymph node in the  left shoulder 1 is moving  and 2 are stationary.; swelling in the left shoulder; This is a spontaneous report from a contactable male consumer (Father). A 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date, UPC, NDC number: Unknown), dose 1 via an unspecified route of administration, administered in left arm on 07Apr2021 at 04:45 PM (age at vaccination was 18 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 13Apr2021, developed some large marble size lymph node in the left shoulder 1 was moving and 2 are stationary. The reporter wanted to know should his son take the second dose. Reporter stated, "He has a large round piece and it was moving. I can't tell you that if it is a lymph node or not, online it appeared to be a lymph node but I don't know for sure. He has three of them that developed on shoulder, three swollen balls, one ball moves, he can move that around an inch in either direction and the other two seems to be relatively stable and in one spot and are not very movable." The report was non-serious. No investigation assessment reported. Reporter stated, no, test he has not had any test. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever; This is a spontaneous report from a non-contactable consumer. A 29-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date (at the age of 29-years-old) and the patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient did receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date, the patient experienced fever. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment paracetamol (MANUFACTURER UNKNOWN). Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event fever was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This patient had multiple joint pain in Dec 00. Diagnosed with rheumatoid arthritis after the 4th Anthrax injection.
It was reported by Mother that child had low grade fever and was vomiting the evening  that the vaccine was administered.
no adverse events have been reported by the patient; a dose of PROQUAD was accidently administered to a 17 year old male on 9/20/22 instead of MMR-II; PROQUAD was accidently administered to a 17 year old male; This spontaneous report was received from a Nurse Manager and referred to a 17-year-old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 20-SEP-2022, the patient was accidently administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 ml, quantity: 1, lot #W007744, expiration date: 04-SEP-2023, administered subcutaneously (SQ) for prophylaxis (strength was not provided) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (wrong product administered and product administered to patient of inappropriate age). No adverse event had been reported by the patient.
I haven't taken my 2nd dose yet because google and some websites and the facility where I got; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Mar-2021 and was forwarded to Moderna on 23-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I haven't taken my 2nd dose yet because google and some websites and the facility where I got) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I haven't taken my 2nd dose yet because google and some websites and the facility where I got). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I haven't taken my 2nd dose yet because google and some websites and the facility where I got) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
Hallucinations; Delirium; Psychotic episodes; My sister received the moderns vaccine as the second dose. First was Pfizer; Paranoia; Confusion; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations), DELIRIUM (Delirium) and PSYCHOTIC DISORDER (Psychotic episodes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (First dose).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant), DELIRIUM (Delirium) (seriousness criterion medically significant), PSYCHOTIC DISORDER (Psychotic episodes) (seriousness criterion medically significant), INTERCHANGE OF VACCINE PRODUCTS (My sister received the moderns vaccine as the second dose. First was Pfizer), PARANOIA (Paranoia) and CONFUSIONAL STATE (Confusion). At the time of the report, HALLUCINATION (Hallucinations), DELIRIUM (Delirium), PSYCHOTIC DISORDER (Psychotic episodes), INTERCHANGE OF VACCINE PRODUCTS (My sister received the moderns vaccine as the second dose. First was Pfizer), PARANOIA (Paranoia) and CONFUSIONAL STATE (Confusion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products used were not provided by the reporter.  No treatment information was provided.  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.
Information has been received from a study conducted concerning a patient (age and gender not reported) who was vaccinated with a dose of MMR II (date, dose, route and lot #'s not reported). Concomitant suspect vaccine therapy included a dose of VARIVAX (date, dose, route and lot #'s not reported). It was reported that the patient died within 30 days of receiving the vaccines (date and cause of death not reported). This is one of several reports from the same source. No further information is available.
This spontaneous report was received from a pharmacist via a company representative refers to a patient of unknon age and gender. The patient's pertinent medical history, drug allergies/reactions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX (lot # L036823, expiry date 24-DEC-2016). The vaccine was exposed to a temperature of 34 Fahrenheit for 5 hours. No adverse event was reported. No product quality complaint was involved. Additional information has been requested.
12 days following vaccination pt developed fevers, chills, sweats, fatigue, decreased appetite, & 2 similar pox lesions on the (R) cheek,  appear to be the same age as the primary vaccination lesion.
Left arm at site was red, irritated & sore, patient called pharmacy - told  to take TYLENOL & watch it, redness resolved.
pt recv vax 25APR97 & the reporting MD said pt had exp mild systemic rxn to vax consisting of h/a & abd pain;also pt had devel red spots on legs;
On 2/17/04 at 3pm child c/o teary R eye and R side nostril hurting. At 7:45pm  mother noticed R side of face and neck swollen. At 9:30pm child was very hot to the touch. MOTRIN 400 mg (4 teaspoons) given. At 4:20 am on 2/18/10 temperature taken orally - 104 degrees. MOTRIN 400 mg  (4 teaspoons) given.  During the day the child was still swollen and was tired, temperature not taken
Subsequent to receiving vax, the pt developed flu-like symptoms. No further information was available at the date of this report. Manufacturer's Comment: The reporter indicated that 39 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Fever of 102, swelling, redness, weakness of the arm, and lumps in the arm pit (swollen lymph nodes?).  Patient went to the ER and received a steroid shot and were given prescriptions for keflex and prednisone.
Swollen lymph nodes in right armpit, bruise in right arm which spread to right side of torso 12 hrs post vaccination. Vaccine was given in right arm. Symptoms improved 48 hrs after vaccination.
tachycardia; heartbeat was fast; This is a spontaneous report from a contactable consumer (patient). An 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection) via an unspecified route of administration on 03Mar2021 (Batch/Lot number: not reported) as first dose, single for COVID-19 immunization. Medical history included atrial fibrillation. The patient's concomitant medications were not reported. On 04Mar2021, the patient experienced an episode of tachycardia and heartbeat was fast. Patient wanted to know if this can be related to vaccine. She further asked that after the side effects she experienced, did she need to get the second dose. Laboratory tests on an unspecified date included heart rate: fast. The clinical outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
- Run down, malaise times 2 days starting a few hours after immunization -  - Resolving about 48 hours after.  - arm site still tender, low mobility & hard to raise arm completely -  - no redness at site of injection or fever noted
My period was longer and heavier than it usually is, now it?s just brown blood coming out consistently but not as heavy as before
Patient experienced pain during vaccine. Extremely sore arm over weekend following vaccine. Patient came in to see medical clinic on 11/11/2020 still experiencing arm pain.
This non valid spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown ages and gender. The patients' medical history, concomitant therapies and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (dose, route, anatomical place of vaccination and concentration were not provided) with lot # N022977 with expiration date of 23-AUG-2019, N023958 with expiration date of 01-SEP-2019 and N024567 with expiration date of 07-SEP-2019, for prophylaxis. Other suspect therapies included M-M-R II (dose, route, anatomical place of vaccination and concentration were not provided), with lot # N010496 with expiration date of 31-MAR-2019 and N013295 with expiration date of 28-APR-2019 which were diluted with sterile diluent. No adverse event was reported. Temperature/Time frame: -9 C to 8 C (-7.6F) for 190 Minutes. Previous temperature excursion: Yes. -14 C to-10 C (-10F) for 3 Hours. Was call because of a data logger: Yes.
This spontaneous report as received from a registered nurse refers to a 26 years old patient. On 02-MAY-2013 the patient was vaccinated with an expired first dose of M-M-R II (lot number 670080/0402AA, expiry date 16-MAR-2013). No adverse symptoms reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Findings: Rash present. Rash is urticarial.     Comments: P Findings: Rash present. Rash is urticarial.  Initially had nausea, fatigue, chills the day after the vaccine.
Approx 4 days post second COVID-19 vaccination dose patient with increase headaches and excessive fatigue.  Pt was seen twice at treatment facility and determined on second visit concern for myocarditis was warranted. Currently member is being evaluated for diagnosis.
Extreme fatigue, nausea, dizzy, swollen glands, hoarse voice, chills, 10cm diameter redness and swelling around the injection site. Also, warm to the touch.
Received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose of a vial after 12 hours of initial puncture) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose of a vial after 12 hours of initial puncture). On 18-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter. Vial was  punctured on 1 Jun 2021.   This case was linked to MOD-2021-418964 (Patient Link).
Fever and chills. Fever as high as 103.6 but constant since PM on 15 OCT to 18 Oct (and maybe longer - currently running 102 fever).
2/16/2021 He was transferred to the Regional Hospital of due to low pressure (systole), received CPR in the ambulance on the way to the hospital. He died on 2/19/2021 due to various complications, including pneumonia.
A non-serious spontaneous report of administration of expired product was received from a health professional concerning a 13-year-old male, subsequent to receiving FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 02-Jan-2011. The patient received the expired FLUMIST on 13-Jan-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 23-Mar-2011: Reporter confirmed that there was no late occurrence of adverse events.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Additional Details: Patient received the injection. After a couple of minutes, patients breathing became rapid.  I tried to calm her down.  A couple of minutes the patient said her throat was closing.  She made some gasping sounds. I gave her an injection of epinephrine 0.3mg. i called 911.  EMS took her to unspecified hospital after treating her.
couldn't lift my arms because they hurt; couldn't lift my arms because they hurt; Initial information received on 07-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who couldn't lift my arms because they hurt, while receiving vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for COVID-19 immunisation.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient couldn't lift my arms because they hurt (injection site pain) (unknown latency) following the administration of INFLUENZA VACCINE. On an unknown date the patient couldn't lift my arms because they hurt (musculoskeletal disorder) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for the events
Patient complained of a headache and a scratchy throat 15 minutes after receiving the vaccine.  Patient was administered Benadryl, IM, 50mg and discharged per pedis from clinic.  Vital signs were within normal limits, including oxygen saturation of 98% on room air during the scratchy throat and on dismissal.
Patient presented to emergency department on 8/14/2021 with chest pain and diffuse back pain. He was found to be COVID-19 positive and admitted for further management. He was treated with dexamethasone, remdesivir and supplemental oxygen. Patient was discharged on 8/30/2021 with home oxygen.