chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 expired doses given to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 expired doses given to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 expired doses given to patients). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (5 expired doses given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date moved to refrigeration: 12Oct2021   Concomitant medication was not reported.  Treatment information was not reported.
This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (took the Moderna booster shot on 18Nov2021 got diarrhea ever since, from explosive to regular diarrhea) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Pfizer on 20-Jan-2021, Pfizer on 19-Feb-2021 and Flu shot (Patient got Flu shot two week prior). Past adverse reactions to the above products included No adverse event with Flu shot, Pfizer and Pfizer. Concurrent medical conditions included Hypertension. Concomitant products included FINASTERIDE for an unknown indication. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced DIARRHOEA (took the Moderna booster shot on 18Nov2021 got diarrhea ever since, from explosive to regular diarrhea). At the time of the report, DIARRHOEA (took the Moderna booster shot on 18Nov2021 got diarrhea ever since, from explosive to regular diarrhea) was resolving. The concomitant medications included Cholesterol medication and blood pressure medication. Patient was going to see doctor on the 28-Mar-2022. No treatment medications reported. Most recent FOLLOW-UP information incorporated above includes: On 28-Mar-2022: Follow up received contains No New Information.
Left knee stiffness, pain and swelling. The next day right knee stiffness pain and swelling which persisted for 2-3 days; left ankle stiffness and  pain, right and left wrist stiffness and pain which persisted for 4 days. 02/19/2015 right hand and fingers stiffness, pain and swelling still occurring.
Blisters starting at site of varicella and then continued to his legs and more generalized.
Vaccine was given on 12/23/20 on 01/07.21 went to get a routine physical and received an emergency call that my pallet blood count was around 10K instead of 150k.  Was instructed to go to the ER asap.  However didn't received the message until the next morning at 6:30am.  Was checked into the E.R. , given sterioids, pallets, hemogolibin.  Stayed overnight in the hospital was able to leaved the next day around 1pm with pallets at 47k.
experienced nausea; sore arm at the injection site; sore arm at the injection site; at night felt really tired; This is a spontaneous report from a non-contactable consumer (patient himself). A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 15Feb2021 (at the age of 55-year-old) at single dose for COVID-19 immunisation. The patient received the first dose of BNT162b2 on 26Jan2021 at the age of 55-year-old without any side effect. Concomitant medications were not reported. On 15feb2021 after second dose of vaccine the patient experienced sore arm at the injection site and at night felt really tired. On the morning of 16Feb2021 he experienced nausea lasting for a day. On 17Feb2021 the patient felt fine and the events resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
24 hours after vaccine injection I experienced swelling, heat, tenderness and nodules to my chin and cheeks where I had dermal filler injections  in March 2020. This did not resolve with Benadryl 50mg. On 1/10/21 I was given a Rx for prednisone and the tenderness and swelling resolved with 40 mg of Prednisone.
PATIENT HAD PREVIOUSLY RECEIVED 1 DOSE OF PNEUMOVAX 23 ON 11/10/2018 AND RECEIVED AN ANOTHER ONE ON 9/14/2021. PATIENT STATED HE HAD A REACTION BUT COULD NOT REMEMBER SINCE IT WAS LONG AGO.
Moderna COVID-19 Vaccine - High fever (102-103 degrees) for 24 hours, with mild fever for an additional 24 hours.  Headache and pain at injection site
High fever of 102 degrees F. Red bumps on cheeks and limbs two days after.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/12/21 2nd dose02/02/21 Diagnosed covid positive:08/29/21 Symptom onset:08/26/21 Exposure: Symptoms:cough, fatigue, muscle aches,loss of smell/taste,sore throat,runny nose.
Aaron did not experience any adverse events - he was watched for 30 minutes post administration. This report is just for documentation of patient receiving Janssen over pfizer at the clinic. Mom requested patient receive one shot of the J and J like dad, and intern administered J and J thinking the 12 years and older eligibility pertained to both vaccines.
1. Uncomfortable with my tongue 2. Irritation on the tip of my tongue became darker color and skin got hurt 3. Skin irritation 4. Less concentration 5. Nervous, angry.
Chief Complaint  pt arrives to triage with HA, fever, cough, off balance states +covid on Monday.  Patient is a 63 y/o female who presented with complaints of cough, fever, headache, and dizziness for the past week. Patient symptoms started on 12/26, she was diagnosed with COVID19 on 12/27. Patient reports persistent symptoms of dizziness, cough, and fevers 101.7 at home. She has had associated nausea and vomiting. She received 2 doses of the Pfizer vaccine in April, no booster. Due to persistent symptoms with no improvement she presented to the emergency department. Upon arrival patient was noted to be hypoxic with pulse ox in the 90s on room air. Routine lab work with Na 133, CO2 21, glucose 135. ABG pH 7.45, oCO2 35, pO251, HCO3 24.4 on room air. Patient has been placed on 2L O2 via NC. Hospitalist service asked to admit.  Currently on COVID Stepdown unit (01/05/2021).   Progress note of 01/05/2022:  Subjective  Feeling somewhat better, cough still bothersome. On 5L, unable to turn down to 4 without dropping. Energy level improving.    Review of Systems  Constitutional:  Negative.   Respiratory:  Shortness of breath, Cough.   Cardiovascular:  Negative.   Gastrointestinal:  Negative.   Genitourinary:  Negative.   Musculoskeletal:  Negative.   Integumentary:  Negative.   Neurologic:  Negative.   ROS reviewed as documented in chart   Objective  VS/Measurements   Vital Signs( 01/03/22 11:55:56 to current )  VITAL SIGN LAST CHARTED MINIMUM MAXIMUM  Blood Pressure 149/69   (01/04 11:11) 104/50   (01/04 05:00) 149/69   (01/04 11:11)  Heart Rate 46   (01/04 11:40) 46   (01/04 11:40) 74   (01/03 15:15)  Respirations 18   (01/04 11:40) 11   (01/04 08:00) 25   (01/03 17:16)  Temperature 97.4   (01/04 08:15) 96.8   (01/04 05:00) 98.7   (01/03 17:16)  SpO2 90   (01/04 11:40) 88   (01/04 00:00) 96   (01/04 10:00)  Oxygen Flow Rate 5   (01/04 11:40) 4   (01/04 11:30) 6   (01/04 09:00)  Weight 94.1   (01/04 11:29) 94.1   (01/04 11:29) 94.1   (01/04 11:29)
MD reported pregnant 14yo adm MR had emergency C-sect duet to fetal distress & inc BP; Full term infant delivered weighing 8lbs, 14oz suffered from various congenital anomalies WAES91041891;
Started heavy arm where site injected, ribs felt like caved in and then severe multiple joint pain arms, legs, back, neck. Pain was shooting from back to neck from back to legs. Nausea and vomiting, 101 fever, headache, chills.
Chills, body aches, headache, extreme fatigue. Also very sore at site of injection. All side effects are still on-going as of this report time.
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium
The evening after receiving shots, developed local redness and swelling at injection sites. Mild fever (100.2), seen at ER for shaking/trembling (not seizure)
Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date).   On 20th April 2019, the patient received the 2nd dose of Shingrix. On 21st April 2019, 1 days after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: There were no events discussed with dose number 1 of Shingrix. The patient experienced a sore arm beginning about a day after Shingrix vaccination. The patient continued to experience arm soreness. The reporter did not consent to follow up.
Injection site itching, redness approximately 10cm  diameter, slight induration that started 7 days after receiving injection.
Patient has had no adverse side effect but was given an expired dose of the 5-11yo COVID vaccine for their second dose.
A few days post vaccine #1 I noticed small rash on lower extremities, which progressed to hives all over body.  Saw dermatologist and started taking Allegra 4x/day.  Symptoms seemed to subside.  Received vaccine #2 on Jan 30th, and hives increased severely.  Went to ER on Jan 9th with swollen lips and eyes, and hives over entire body.  Received IV Solumedrol, IV Benadryl.  Followed up with Allergist who said I was having a reaction to the vaccine.   Am currently taking Doxepin 3 tabs/ nightly, Zyrtec 2x/day and Singulair.   I am on week # 12 with hives with no relief.
Mild Fever <100  12 hours strong Headache 72 hours Body Aches 24 hours
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patient post temperature excursion; Moderna COVID-19 vaccine administered to patient post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion).    This case contains information for the 91st of 104 patients described by the reporter.  Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26-May-2022 to 30-Sep-2022 and lot AR5186C was affected between 08-Sep-2022 to 27-Sep-2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to Department of Public Health, VAERS, Immunization Registry and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
Pt recvd vax 13JUL92 & on the same day few mins later devel flushing, lightheadedness, muscle weakenss, h/a, malaise, nausea & diarrhea;
Had flu shot on 10/8/2013. Began having low BP. Extreme dizziness/vertigo overnight and for 1-3 hours after awakening.
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reported limited information No concomitant and treatment medications were provided   Reporter did not allow further contact
The day I had the  shot at pharmacy I was getting the 1st of 2 shots for shingles (Shingrix version).  I recently changed GYNs and she wanted me to get all sorts of shots so they're up to date.  That day I only  had the 1st shingles shot but recently before that I had various other shots including: flu, 2nd pneumonia shot, tetanus shot, B12 shots,.  The only reactions I got from any of those was pain in the arm like someone punched me.  However, the reaction I got after the shingles (shringrix) shot was much worse and something I've not had before.  I had a painful arm, I had a rash/bruise-like marks on my arm (bluish red patches), extreme dizziness so couldn't stand up or even lie down comfortably and also had a low grade fever of about 100.2 or so as well as nausea.  I reported it to pharmacy and will now also report it to my primary care physician and also notified the surgeon's office who will be performing my 2nd upcoming surgery, as they need me to have a complete physical prior to the surgery, as well as various pre op radiology tests so needed them to be aware.  I was told by pharmacy to take Tylenol which I did and this helped to bring down the fever.  The next day (Monday) I had no fever but my arm rash marks were still there and I was still quite dizzy.  The dizziness slowly started going away as the day progressed.  I understand I will need to have the 2nd shingles (shingrix) shot in a few months and am concerned I will have the same reaction.
I was slurring speech and unbalanced. The diagnosis was a TIA(ministroke).
Patient reported at about 25 minutes after 1st dose of pfizer covid vaccine  she began to feel facial itching and flushing, similar to what she felt with previous anaphylaxis due to allergy immunotherapy. She was brought to the medical tent and given 50mg benadryl po and observed x 1 hour. No progression of symtpoms, vitals stable. No angioedema, throat or tongue swelling, difficulty breathing or speaking, sob, or wheezing. Symptoms had completely resolved prior to discharge. She was driven home by her husband.
turned red & was very uncomfortable duration of 1 hr; pt had this immed rxn p/2nd dose but mom reveals this @ the time of 3rd dose so 3rd dose not given;
Low-grade fever (no more than 100.5, ear)  beginning approximately 24 hours after shot and lasted through evening.  Self-resolving by morning of second full day (Friday).
Mild itching began at the injection site on approximately 1/1/21 and the itching has become more intense.  Redness and slight swelling at the injection site began on 1/5/2021.  Swelling is definite raised area similar to a hive and is just under 2 inches in diameter.  All symptoms are contained at the injection site and have not required any treatment thus far.
Patient had a little bit of swelling and redness on Tuesday in the left leg, the leg was better Wednesday am, but daycare called Wednesday afternoon to report his wrist were swollen.  When patient was picked up from daycare was noted what appeared to be hives/white welts on his cheeks and left thigh.  States that left leg was really swollen and red, hot and really rashy in appearance.  Welts on hands later appeared.  Patient remained his normal self and never acted like anything was wrong.  Patient was laughing, running, doing normal things.  Patient went to ER was diagnosed with allergic reaction to vaccine.  Benadryl was given and he is much improved.  Swelling much improved.  Left leg still appears reddened. 03/03/2006 Patient no longer has redness in his leg and no more hives, but left thigh remains a little raised.
Six patients received dose of Moderna vaccine beyond 30-day use by date; Six patients received dose of Moderna vaccine beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Six patients received dose of Moderna vaccine beyond 30-day use by date) and PRODUCT STORAGE ERROR (Six patients received dose of Moderna vaccine beyond 30-day use by date) in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 003J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Six patients received dose of Moderna vaccine beyond 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Six patients received dose of Moderna vaccine beyond 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Six patients received dose of Moderna vaccine beyond 30-day use by date) and PRODUCT STORAGE ERROR (Six patients received dose of Moderna vaccine beyond 30-day use by date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications was reported.  It was reported that vial was brought to clinic and placed in refrigerator on January 05 2022.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow up received contains no new information.
This spontaneous report has been received from a pharmacist concerning a patient of unknown gender and age. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with a dose of improperly stored ZOSTAVAX vial (strength, unit and route unspecified, lot # L032403 and Exp date 26-NOV-2016). No adverse effects were reported. Additional information has been requested.
COVID INFECTION 1 YEAR AFTER VACCINE SERIES COMPLETED    HIGH FLOW NC OXYGEN WITH 100%
On 10/16 the patient's mother reported the patient had a facial rash. The patient was treated with Benadryl. The rash was spreading and the patient had a sore throat and stuffy nose on 10/17. The patient was seen at the ER and treated with antibiotics and diagnosed with a throat infection. The patient's mother called on 10/19 and advised the took the patient to the Dr a couple of times and he thinks the patient may have a reaction to the vaccine. The patient was treated with steroids.
58 years old and received the Fluzone High Dose, no AE; 59 years old and received the Fluzone High Dose, no AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 59 years old female patient who received 0.5 ml dose INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number:UJ274AA and expiry date:26-May-2020) via unknown route in the right deltoid on 28-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to overdose and inappropriate age at vaccine administration.  It was reported that there were no side effects observed.  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.
01/18/2022 I thought I had a chest and head cold and when I went to my PCP for antibiotics he tested me for Covid and flu at the same time my Covid test came back positive. I was really tired and it took forever to build my energy back up. I had a hard time getting rid of phlegm in throat which was clear and had no color and my Doctor said that was a good thing. Symptoms lasted for 3 1/2 weeks.
Patient started to faint, I had him lay on the floor with his feet up which prevented him from fainting completely. He stated he started to feel sweaty, dizzy, and his vision started to turn white. He sat back up about 1 PM but then almost fainted again so put his feet up again.  After about 20 min he said he felt fine and left. We advised him to get a ride vs. driving. Patient has a fear of needles and thinks the reaction was because of that.