chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse events reported. Patient arrived with sister to pharmacy on 10-23-21 to received second dose of covid vaccine. Had received a Moderna dose on 4-30-21 in a different state with no other doses given. Both patient and sister were very adamant about patient receiving second dose because she absolutely needed it to get into treatment on 10-26-21. We only carried Pfizer and we educated them that they should receive a Moderna dose. The were very persistent about receiving a Pfizer vaccine. Medical facility was closed so we could not call them for further information to set up an appointment for a Moderna dose since we did not carry it and did not know of anyone else in the area who carried it. Pharmacist was extremely overworked and overwhelmed with few education materials released on 10-21-21 regarding mixing and matching of doses. Being in a sensitive time situation and knowing that vaccines could be matched, pharmacist eventually gave Pfizer vaccine as second dose so patient could be admitted into treatment. After work on 10-23-21, pharmacist reviewed CDC guidelines and made the final determination that mixing was only for booster doses, not for the second dose. Pharmacist further reviewed resources provided by work on the morning of 10-24-21 and contacted district pharmacy supervisor. Pharmacist left a voice message for patient on 10-26-21 after visiting with supervisor to follow-up on patient, review current CDC guidelines and protocol and to provide education on how to report adverse effects on VAERS. Patient never returned call and she's likely in treatment.
This spontaneous report as received from a other health professional (Licensed Practical Nurse) refers to a patient of unknown age. Current conditions and medical history was not reported. On 23-OCT-2014, the patient was vaccinated with M-M-R II injection, lot number- H018948, expiry date- 18-OCT-2014, 0.5 milliliter, subcutaneously. Concomitant medications were not reported. On 23-OCT-2014, patient was administered an expired dose of vaccinated with M-M-R II. No adverse events were reported. Product quality complaint was not reported. Additional information has been requested.
fever & sz 48-72 hrs p/vax, intubation, hospitalization; no permanent injury all tests including EEG-neg; prolonged hospitalization due to difficulty in extubating pt;
Information has been received from a physician concerning a 77 year old female no drug reactions, or allergies who on 15-JUN-2007 was vaccinated with 0.65 ml zoster vaccine live (Oka/Merck). Concomitant therapy included simvastatin, for an unspecified indication. On 24-AUG-2007 the patient developed an itchy rash on her abdomen, that became "stingy" and scabbed over. The patient recovered on approximately 04 SEP 2007, "one week to ten days after the onset". No medical attention was sought. There was no product quality complaint. Additional information has been requested.
Admitted with adult respiratory distress syndrome, septic shock, pneumonia, COPD . Family chose comfort care instead of aggressive treatments and patient died. Vapotherm, BiPap, intubated, pressors
vaso-vagal event consisting of pallor, clammy skin, dec HR, dec peripheral perfusion; rx supine position;
Pt received vaccine that was prepared with expired diluent.  No side effect reported for event.
Starting approx. 2 hours after vaccination, pt experienced nausea, vomiting, and sweating which has continued over the past 24 hours
Several months after receiving the vaccine, I suffered from a heart attack and was taken to the hospital via ambulance. They did further bloodwork test and determined I had type 2 diabetes. They transported to another hospital that specializes in cardiology where a stent was in placed in my heart on 10/03/2022. The bloodwork panel determined my A1C levels were at 10.5 (extremely high) and my insulin levels were in the high 300s. Since then, I have routine checkups with my cardiologist, and my diabetes is being regulated. My blood pressure is back in normal range as well my insulin and A1C levels from my past checkup last month.
DIZZY; CRYSTALS IN THE EAR CREATING IMBALANCE PROBLEMS; NUMB HEAD; RHINORRHEA; NASAL DISCHARGE; INJECTION SITE PAIN; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 31 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and alcohol use, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced dizzy. On APR-2021, the subject experienced crystals in the ear creating imbalance problems. On APR-2021, the subject experienced numb head. On APR-2021, the subject experienced rhinorrhea. On APR-2021, the subject experienced nasal discharge. On APR-2021, the subject experienced injection site pain. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nausea. Laboratory data included: Blood test (NR: not provided) came out to be clear., and COVID-19 (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, and fever, had not recovered from nausea, dizzy, crystals in the ear creating imbalance problems, and rhinorrhea, and the outcome of numb head and nasal discharge was not reported. This report was non-serious.
flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event; flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event; Initial information was received from on 17-Jan-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 6 years old female patient to whom influenza quadrivalent recombinant vaccine [Flublok] inadvertently ordered, staff administered to six patients, should have been influenza trival A-B subvirion no preservative vaccine [Fluzone] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.   On 04-Jan-2023, the patient received 0.5 ml dose of suspect influenza quadrivalent recombinant vaccine (lot UJ93AA; strength, formulation, frequency, expiry date: unknown) via intramuscular route in unknown administration site for prophylactic vaccination.  On 04-JAN-2023 the flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency: on same day).  It is unknown if there were lab data/results available  Action taken : not applicable.  Outcome : Unknown.   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 guidelines. 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.
The site of inoculation looks perfect for a  smallpox vaccine take. However, red, raised micro-pustules appeared 14-16 days post inoculation. Allegra 180mg will be given q Benadryl if Allegra doesn't
Information has been received from a medical assistant referring to a 6 month old male patient. No relevant medical history or concurrent conditions were reported. On 29-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322.  Additional information has been requested.
Energy level at zero. No treatment given.  It took two-three months to return to what felt like normal.
Generalized aching/body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized aching/body aches) and CHILLS (Chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    The patient's past medical history included COVID-19 in 2020, Foggy feeling in head (COVID brain fog) in 2020, Coughing blood in 2020 and COVID-19 pneumonia in 2020. Concurrent medical conditions included Hidradenitis suppurativa.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free pen. On an unknown date, the patient experienced PAIN (Generalized aching/body aches) and CHILLS (Chills). At the time of the report, PAIN (Generalized aching/body aches) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623988 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Non Significant follow-up(NNI)
On same day of vaccination of 2nd dose, patient developed tongue swelling and neck; joint aches
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Headache, Kidney absent, Hypertension, High cholesterol and Diabetes. Concomitant products included PANTOPRAZOLE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: Negative and (Negative) current covid test.         Relevant concomitant product usage were not reported by the reporter. No treatment details were added.    Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-June-2021, contains no significant information.
Approx 12hrs long-warm, dry, erythematous on rt side of face, trunk, leg, arm- to but not crossing midline inc sleepiness next day; Resolved w/o fever;
pt had her second dose of covid vacine. as she was sitting down to be observed, she had an epileptic seizure. pt was laid down and monitored until paramedics arrived
I am Triage RN and work with 4 LVNs in our clinic. On 6/9/14 one of our patients received the yellow fever vaccine, but the wrong diluent was used for the vaccine. Rather than using NaCl, the LVN used sterile water. Each yellow fever vaccine vial should correspond with a bottle of diluent. They each come in packages of 5. Theoretically, when we have to open a new package of vaccines, we should have to open a package of diluents as they correspond 1:1. Upon review, it was noted that in addition to this incident there were 2 extra vials of diluent in our med room. It is unclear why-whether two other patients received the vaccine with the incorrect diluent, or two vaccines were misplaced, etc., and there was no way to find out. We have tried to track this, look back at patient records, etc., to no avail. For the patient that we are sure did receive the vaccine with the incorrect diluent this writer called both the CDC as well as the manufacturer to determine whether there could be any adverse reactions and to ensure that the vaccine would still be effective. Ultimately the Manufacturer stated there has been no studies or data on this, but that they believe that the vaccine would still be immunogenic as the diluent that was used was without preservatives. We attempted to check the titers for this pt to ensure the vaccine was effective, but despite our efforts we were unable to accomplish this prior to his trip.
Extreme tiredness; chills; fever; muscle aches; runny nose; sore throat; nausea; pale skin; malaise; night sweats; This is a spontaneous report from a contactable 37-year-old Other HCP reported for herself. A 37 Years old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 on Arm left at single dose (lot: EL0140) for covid-19 immunisation. Medical history included PTSD, and anxiety. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included lamotrigine (LAMICTAL), clonazepam (KLONOPIN) and Zinc. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Jan2021 11:45 AM arm left at single dose (lot: EJ1685) for covid-19 immunisation. Covid test date (nasal swab Rapid) on 03Jan2021: positive. The patient experienced Extreme tiredness, chills, fever, muscle aches, runny nose, sore throat, nausea, pale skin, malaise, night sweats all on 24Jan2021 12:00 AM which were non serious. No treatments were received. Outcome of the events was recovering.
This spontaneous report was received from an approximately 62 years old female patient regarding herself. The patient's current conditions included breast cancer, AZO-STANDARD allergy, azithromycin allergy and SILVADENE allergy. On an unknown date in approximately October 2007 about 5 years ago, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # and route not reported) and with a dose of Influenza Virus Vaccine (manufacturer unknown) (lot # and route not reported) and her arm was sore for a couple of days. No concomitant medications were reported. No treatment was given. No laboratory diagnostics studies were performed. The patient had not sought medical attention. On an unknown date, the patient recovered from the event. The relatedness for event was unknown for PNEUMOVAX23 and Influenza Virus Vaccine (manufacturer unknown). Additional information is not expected.
Received shot for shingles, 9/14/07 flu like symptoms. Headache. Arm where shot was given was so sore had to lift it with other hand.  Still lots of pain in the arm had shot in.   Flu lasted 7 or 8 days.
Dizziness. Initial BP 74/52 (pulse 75). Water and granola bar given. F/u BP 107/79 (pulse 75).
Patient potentially received higher than the recommended 0.3ml dose of the Pfizer vaccine. As of Sunday 4/4, patient reports arm soreness at the injection site.
I was getting ready for work Tuesday morning and noticed my whole right side of face was paralyzed and drooped. I went into work and staff of the laboratory told me to go the clinic. The clinic then told me to go directly to ER. I had limited motor skills in right hand and numbness to tingling. The ER did an acute stroke assessment. I had MRI, CT scan and lab work. Everything came back fine but ER doctor diagnosed me with Balls Palsy and gave me a 7 day treatment of Prednisone. I had a follow up 3 days later with primary care provider. We scheduled additional MRI's and I was referred to Neurologist. The Neurologist did not rule out the vaccination. He said my cranial nerve 7 was effected and the drooping on right side of face but also carpal tunnel. He examined everything on June 27th and assessed my MRI's as well.
injection site reactions are worse with this vaccine /injection site reactions are worse with this vaccine than with other flu vaccines; This case was reported by a other health professional via sales rep and described the occurrence of injection site reaction in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The age at vaccination was not applicable for this report.. The reporter indicated the injection site reactions with the flu vaccines. The reporter was unable to obtain additional details. The reporter would not provide her any additional information. The reporter consented to follow up. This case had been linked to the case US2020019065, reported by same reporter.
Patient reports "numbness and tingling " in arm distal to the vaccination with normal neuro and Musculoskeletal exam. this began the moring after vaccination.  Also reporting headache, light sensitivity, (though unsure if related to ear infection or vaccination
COVID 19 Treatment; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2022 at 11:00 as dose 4 (booster), single (Lot number: FM7533) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Iodine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 04Sep2022, outcome "not recovered", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Sep2022) Negative, notes: 3 days after completing series of paxlovid; (04Sep2022) positive, notes: On 5th day after completing paxlovid I started to feel ill again and tested covid positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence with paxlovid from 26Aug2022 to 31Aug2022.  Clinical course: The patient received other medication in 2weeks. Patient Took paxlovid 5 days. Tested negative 3 days after completing series of paxlovid. On 5th day after completing paxlovid I started to feel ill again and tested covid positive again.
Information has been received from a registered nurse concerning a currently 32 year old female patient. On 16-AUG-2000 the patient was vaccinated with a dose of MMR II (lot#, expiration date, dose and route not reported). The nurse stated the patient "showed delinquent for measles and mumps components but had been reviewed for rubella at an unspecified time in the past. Also there was no varicella in her (patient's) records." On an unknown date, the patient experienced migraines and she took TOPOMAX for treating it and she was also allergic to "other migraine medication" (names unspecified). The outcome of the events was unknown. On 06-MAY-2015, the patient was vaccinated with a dose of (Oka-Merck) PROQUAD, 0.5 ml, subcutaneously (capture into MARRS# 1505USA004606). Additional information has been requested.
Excessive swelling in armpit that extended to shoulder blade. Swelling lasted a few days (5-6), pain at injection site.  Extreme/abnormal fatigue, unusually extreme feeling of malaise, intermittent dizziness affecting normal activity,  Also, higher level of pain in lower back, nerve pain in legs and  feet still ongoing and requiring use of OTC (Tylenol), however the pain is still present, sometimes constant and sometimes intermittent.  Patient feels the vaccine caused increased pain sensations in back, legs and feet.
After my vaccine around approximately 17:45 in the afternoon of July 20, I went home to eat dinner with my family and get ready for bed. I went to bed around 22:00 and woke up around 02:00 the following morning not feeling right. I got up and went to the bathroom and the next thing I knew I was vomiting and had laid on the floor and could not get up. My mom came down to my bathroom and tried to get me up and I could not hear her fully it sounded as if I was listening to her talk underwater. My clothes and hair were soaked because my whole body was sweating so bad. My body felt like it was burning . I could not feel my legs and my arms and hands were numb/tingling. I felt like I was going to lose consciousness and so she tried to sit me up and put cold rags on me to help me cool off. I felt as if I had no control of my body. It lasted for about 15 minutes and then I had the shakes and was freezing cold. I was able to get back into my bed but  was so uncomfortable I could not sleep. Around 07:00 I had another similar episode but it did not last as long. After that I got back in my bed and was able to sleep for a little bit and for the next 18 hours I just felt very weak and sick to my stomach.
mom reports pt had been ill w/ear infect for the past wk;mom observed pt have a sz, t103 given APAP & took to pvt MD 28JUN96;
Patient waited the recommended 15 minutes seated in a chair.  At the 15 minute mark, patient stood up, walked roughly 20 feet from chair, spouse noticed that he was dizzy and patient fainted.  Patient quickly regained consciousness and moved to a nearby chair prior to a staff member reaching the patient.
*15 mins. after receiving the shot - short spell of dizziness and a small headache. Lasted approximately 15 minutes. *Within 30 mins. after receiving shot - cold chills/burning up. Lasted off and on throughout the night. Used Tylenol to help. Never registered a fever though.  *Within 30 mins. after receiving the shot - soreness in arm of shot from elbow to shoulder. Lasted 2 days. By end of 2nd day only a space of 3 inches tall on arm  located around the shot area was sore. *The morning after the shot - diarrhea. Lasted almost 2 days. Anything eaten went straight through. Still loose, but pasty now on day 3 morning. *Right after shot through day 2 - arms felt heavy and weak. *Day 2 and 3 - itching. Started light and only on arm of shot. Then by middle of morning on day 2, whole body itched and stayed that way through day 3. Only occasional itching on day 4. *Day 2 and 3 - Cheeks down to chin would break out in red blotches then fade away. It would resurface again every so often. By day 4 only cheeks would get lightly rosy. *Day 3 and 4 - Nauseous. Forced self to eat, but stomach was very uneasy and felt pressure (like you would throw up ) under chin. *Day 4 - Woke up extremely fatigued and weak. Lessened as day progressed, but still a feeling of tiredness and weakness.